0u 0dun -re responsible third party official regulatory ... · or use with acuson s1000, s2000 and...

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service__________________________________________________________________________________________________________________________

Food and Drug Administration10903 New Hampshire AvenueDocument Control Center – WO66-G609Silver Spring, MD 20993-0002

Siemens Medical Solutions USA, Inc.

Responsible Third Party OfficialRegulatory Technology Services, LLC1394 25th Street, NWBUFFALO MN 55313

Re: K163635Trade/Device Name: ACUSON S1000, S2000, S3000™ Diagnostic Ultrasound SystemsRegulation Number: 21 CFR 892.1550Regulation Name: Ultrasonic pulsed doppler imaging systemRegulatory Class: IIProduct Code: IYN, IYO, ITX, OBJDated: December 21, 2016Received: December 22, 2016

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

January 12, 2017

— Mr. Mark Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs, Ph.D.DirectorDivision of Radiological HealthOffice of In Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

For

of 27

Diagnostic U

ltrasound Indications for Use Form

510 (k) Num

ber (if known):____________________

Device N

ame:

ACU

SON

S1000, S2000and

S3000 Ultrasound System

sIntended U

se:U

ltrasound imaging or fluid flow

analysis of the human body as follow

s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Ima ging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC

IntraoperativeP

P P

PP

PB

MD

C

Note 2

IntraoperativeN

eurologicalP

ediatricP

P P

PP

PB

MD

CSm

all Organ

P P

PP

PP

BM

DC

N

ote 1N

eonatal Cephalic

P P

PP

PP

BM

DC

Adult Cephalic

P P

PP

PP

BM

DC

Cardiac

P P

PP

PP

BM

DC

Trans-esophagealP

P P

PP

PB

MD

CTransrectal

P P

PP

PB

MD

CTransvaginal

P P

PP

PB

MD

CTransurethralIntravascularP

eripheral vesselP

P P

PP

PB

MD

CLaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

PB

MD

C

Musculo-skeletal

SuperficialP

P P

PP

PB

MD

C

Other (specify)

Neonatal C

ardiacP

P P

PP

PB

MD

C

N = new

indication; P = previously cleared by FD

A K

162243

Additional Com

ments:

Note 1 For exam

ple: breast, testes, thyroid, penis, prostate, etc.N

ote 2 For example: vascular, abdom

inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

______________________________________________________________C

oncurrence of Center for D

evices and Radiological H

ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

12L4 Transducer for use with AC

USO

N S1000, S2000 and


sIntended U

se:U


analysis of the human

body asfollow

s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetalAbdom

inalIntraoperativeIntraoperativeN

eurologicalP

ediatricP

P P

PP

BM

DC

Small O

rganP

PP

PB

MD

C

Note 1

Neonatal C

ephalicAdult C

ephalicC

ardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularP

eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

BM

DC

Musculo-skeletal

SuperficialO

ther (specify)N

= new indication; P = previously cleared by FD

A K162243

Additional Com

ments:

Note 1 For exam

ple: breast, testes, thyroid, penis, prostate, etc.N

ote 2 For example: vascular, abdom

inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

______________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):_________________________

Device N

ame:

CW

2 Probeforuse

with

ACU

SON

S1000, S2000and

S3000U

ltrasound Systems

Intended Use:

Ultrasound im

aging or fluid flow analysis of the hum

an body as follows:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

PAbdom

inalP

IntraoperativeP

Note 2

IntraoperativeN

eurologicalP

ediatricP

Small O

rganP

Note 1

Neonatal C

ephalicP

Adult Cephalic

PC

ardiacP

Trans-esophagealTransrectalTransvaginalTransurethralIntravascularP

eripheral vesselP

LaparoscopicM

usculo-skeletalC

onventionalP

Musculo-skeletal

SuperficialP

Other (specify)

N = new


A K

162243

Additional Com

ments:

Note 1

For example: breast, testes, thyroid, penis, prostate, etc.

Note 2

For example: vascular, abdom

inal

(PLEASE D

O N

OT W

RITE BE

LOW

THIS LIN

E-CO

NTIN

UE O

N AN

OTH

ER PA

GE IF N

EEDED

)________________________________________________________________________

Concurrence of C

enter for Devices and R

adiological Health (C

DR

H)

of 27

Diagnostic U


510 (k) Num

ber (if known):

_________________________D

evice Nam

e:C

W5 Probe

forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U


analysis of the human body as

follows:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Ima ging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

PAbdom

inalP

IntraoperativeP

Note 2

IntraoperativeN

eurologicalP

Pediatric

PSm

all Organ

PN

ote 1N

eonatal Cephalic

PAdult C

ephalicP

Cardiac

PTrans-esophagealTransrectalTransvaginalTransurethralIntravascularP

eripheral vesselP

LaparoscopicM

usculo-skeletalC

onventionalP

Musculo-skeletal

SuperficialP

Other (specify)

N = new


A K

162243

Additional Com

ments:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPA

RATE P

AGE IF N

EEDED

)________________________________________________________________________

Concurrence of C

enter for Devices and R

adiological Health (C

DR

H)

of 27

Diagnostic U


510 (k) Num

ber (ifknow

n):______________________

Device N

ame:

EC9-4

Transducerforusew

ithA

CU

SO

N S1000, S2000

andS3000 U

ltrasoundS

ystems

Intended Use:

Ultrasound im


an body as follows:

Mode of O

peration

Clinical A

pplicationA

B

M

PW

D

CW

DC

olorD

opplerA

mplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PBM

DC

Abdom

inalP

P P

PP

BMD

CIntraoperativeIntraoperativeN

eurologicalP

ediatricS

mall O

rganP

P P

PP

BMD

C

Note 1

Neonatal C

ephalicP

P P

PP

BMD

CA

dult Cephalic

Cardiac

Trans-esophagealTransrectal

P P

PP

PBM

DC

TransvaginalP

P P

PP

BMD


eripheral vesselLaparoscopicM

usculo-skeletalC

onventionalM

usculo-skeletalS

uperficialO

ther (specify)N

= new indication; P

= previously cleared by FDA

K162243

Additional Com

ments:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

______________________D

evice Nam

e:M

C9-4 Transducer foruse

with

ACU

SON

S1000, S2000and

S3000U

ltrasound Systems

Intended Use:

Ultrasound im

agingor fluid flow


s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom

inalP

P P

PP

BM

DC

IntraoperativeIntraoperativeN

eurologicalP

ediatricSm

all Organ

P P

PP

PB

MD

C

Note 1

Neonatal C

ephalicP

P P

PP

BM

DC

Adult Cephalic

Cardiac

Trans-esophagealTransrectal

P P

PP

PB

MD

CTransvaginal

P P

PP

PB

MD



usculo-skeletalC

onventionalM

usculo-skeletalSuperficialO

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (ifknown):____________________

Device N

ame:

9L4 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom


eurologicalP

ediatricP

P P

PP

BM

DC

Small O

rganP

P P

PP

BM

DC

N

ote 1N

eonatal Cephalic

P P

PP

PB

MD

CAdult C

ephalicP

P P

PP

Cardiac

P P

PP

PB

MD

CTrans-esophagealTransrectalTransvaginalTransurethralIntravascularP

eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

BM

DC

Musculo-skeletal

SuperficialP

P P

PP

BM

DC

Other (specify)

N = new


A K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

14L5 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetalAbdom


eurologicalP

ediatricSm

all Organ

P P

PP

PB

MD

C

Note 1

Neonatal C

ephalicAdult C

ephalicC


eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

BM

DC

Musculo-skeletal

SuperficialO

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

4P1 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U

ltrasound imaging orfluid flow


s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC


eurologicalP

ediatricSm

all Organ

Neonatal C

ephalicAdult C

ephalicP

P P

PP

PB

MD

CC

ardiacP

P P

PP

PB

MD



usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth(CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

6C2

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom

inalP

P P

PP

BM

DC


eurologicalP

ediatricP

P P

PP

BM

DC

Small O

rganN

eonatal Cephalic

Adult Cephalic

Cardiac


eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243A

dditional Com

ments:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

4C1 Transducer foruse

with

ACU

SON

S1000, S2000and

S3000U

ltrasound Systems

Intended Use:

Ultrasound im


an body as follows:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC


eurologicalP

ediatricSm

all Organ

P P

PP

PP

BM

DC

N

ote 2N

eonatal Cephalic

Adult Cephalic

Cardiac

P P

PP

PP

BM

DC


eripheral vesselP

P P

PP

PB

MD

CLaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

) (Signature)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

6C1

HD

Transducer forusew

ithAC

USO

N S2000

andS3000 U

ltrasoundSystem

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC


eurologicalP

ediatricSm

all Organ

P P

PP

PP

BM

DC

N

ote 2N

eonatal Cephalic

Adult Cephalic

Cardiac

P P

PP

PP

BM

DC


eripheral vesselP

P P

PP

PB

MD

CLaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

8C3

HD

Transducer forusew

ithAC

USO

N S2000

andS3000 U

ltrasoundSystem

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom

inalP

P P

PP

BM

DC


eurologicalP

ediatricP

P P

PP

BM

DC

Small O

rganP

P P

PP

BM

DC

N

ote 2N

eonatal Cephalic

Adult Cephalic

Cardiac


eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

4V1 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom

inalP

P P

PP

BM

DC


eurologicalP

ediatricSm

all Organ

Neonatal C

ephalicAdult C

ephalicC



usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

10V4 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC


eurologicalP

ediatricP

P P

PP

PB

MD

CSm

all Organ

Neonatal C

ephalicP

P P

PP

PB

MD

CAdult C

ephalicC

ardiacP

P P

PP

PB

MD


eripheral vesselP

P P

PP

PB

MD

CLaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):____________________

Device N

ame:

14L5 SP Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIndications For U

se:D

iagnosticim


an body as follows:

Clinical A

pplication

Mode of O

peration

AB

M

PW

D

CW

DC

olorD

opplerAm

plitudeD

oppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetalAbdom

inalIntraoperative

P P

PP

PB

MD

C

Note 2

IntraoperativeN

eurologicalP

ediatricSm

all Organ

P P

PP

PB

MD

C

Note 1

Neonatal C

ephalicAdult C

ephalicC

ardiacP

P P

PP

BM

DC

TransesophagealTransrectalTransvaginalTransurethralIntravascularP

eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

BM

DC

Musculo-skeletal

SuperficialO

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k)Num

ber (if known):____________________

Device N

ame:

7CF2

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000 U

ltrasoundSystem

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PW

D

CW

DC

olorD

opplerA

mplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PBM

DC

Abdom

inalP

P P

PP

BMD


eurologicalP

ediatricS

mall O

rganN

eonatal Cephalic

Adult C

ephalicC



usculo-skeletalC

onventionalM

usculo-skeletalS

uperficialO

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

_________________

Device N

ame:

7CF1

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PW

D

CW

DC

olorD

opplerA

mplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PBM

DC

Abdom

inalP

P P

PP

BMD


eurologicalP

ediatricS

mall O

rganN

eonatal Cephalic

Adult C

ephalicC



usculo-skeletalC

onventionalM

usculo-skeletalS

uperficialO

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

_____________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (ifknown):________________________

Device N

ame:

9EVF4 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PB

MD

CAbdom


eurologicalP

ediatricSm

all Organ

Neonatal C

ephalicP

P P

PP

BM

DC

Adult Cephalic

Cardiac

Trans-esophagealTransrectalTransvaginal

P P

PP

PB

MD



usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243A

dditional Com

ments:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

__________________D

evice Nam

e:V5M

sTransducer foruse

with

ACU

SON

S1000, S2000and

S3000U

ltrasound Systems

IntendedU

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetalAbdom


eurologicalP

ediatricSm

all Organ

Neonatal C

ephalicAdult C

ephalicC

ardiacTrans-esophageal

P P

PP

PP

BM

DC

TransrectalTransvaginalTransurethralIntravascularP


usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

____________________D

evice Nam

e:18L6

HD

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetalAbdom


eurologicalP

ediatricSm

all Organ

P P

PP

PB

MD

C

Note 1

Neonatal C

ephalicAdult C

ephalicC

ardiacP

P P

PP

BM

DC


eripheral vesselP

P P

PP

BM

DC

LaparoscopicM

usculo-skeletalC

onventionalP

P P

PP

BM

DC

Musculo-skeletal

SuperficialP

P P

PP

BM

DC

Other (specify)

N = new


A K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

_______________________D

evice Nam

e:8V3 Transducer foruse

with

ACU

SON

S1000, S2000and

S3000U

ltrasound Systems

Intended Use:

Ultrasound im


an body as follows:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal


eurologicalP

ediatricP

P P

PP

PB

MD

CSm

all Organ

Neonatal C

ephalicP

P P

PP

PB

MD

CAdult C

ephalicC

ardiacP

P P

PP

PB

MD



usculo-skeletalC

onventionalM


ther (specify)N

eonatal Cardiac

P P

PP

PP

BM

DC

N = new


A K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

________________________D

evice Nam

e:4V1c

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC

IntraoperativeP

P P

PP

PB

MD

C

Note 2

IntraoperativeN

eurologicalP

P P

PP

PB

MD

C

Pediatric

P P

PP

PP

BM

DC

Small O

rganN

eonatal Cephalic

Adult Cephalic

P P

PP

PP

BM

DC

Cardiac

P P

PP

PP

BM

DC


eripheral vesselP

P P

PP

PB

MD

CLaparoscopicM

usculo-skeletalC

onventionalM


ther (specify)N

eonatal Cardiac

P P

PP

PP

BM

DC

N = new


A K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

_______________________D

evice Nam

e:EV-8C

4 Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

peration

Clinical A

pplicationA

B

M

PWD

C

WD

Color

Doppler

Amplitude

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify)O

ther(S

pecify)

Ophthalm

icFetal

P P

PP

PP

BM

DC

Abdominal

P P

PP

PP

BM

DC

IntraoperativeP

ediatricSm

all Organ

Neonatal C

ephalicAdult C

ephalicC

ardiacTrans-esophagealTransrectalTransvaginal

P P

PP

PP

BM

DC

TransurethralIntravascularP


usculo-skeletalC

onventionalM


ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

Note 1


Note 2


inal

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

____________________D

evice Nam

e:V7M

Transducer forusew

ithAC

USO

N S1000, S2000

andS3000

Ultrasound System

sIntended U

se:U



s:

Mode of O

perationC

linical Application

AB

M

PW

D

CW

DC

olorD

opplerP

ower

(Am

plitude)D

oppler

Color

Velocity

Imaging

Com

bined(S

pecify) *H

armonic

Imaging

Other

(Specify)

Ophthalm

icFetalA

bdominal

PP

PP

PP

PP


eurologicalP

ediatricP

P P

PP

PP

PS

mall O

rganN

eonatal Cephalic

Adult C

ephalicC

ardiacP

P P

PP

PP

PTrans-esophageal

PP

PP

PP

PP

TransrectalTransvaginalTransurethralIntravascularP

eripheral VesselLaparoscopicM

usculo-skeletal(C

onventional)M

usculo-skeletal(Superficial)O

ther (specify)N

= new indication; P


K162243

Additional C

omm

ents:

*Com

binations include: B+M, B+PW

D, B+C

WD

, B+Color D

oppler, B+M+ C

olor Doppler, B+PW

D+C

olorD

oppler, B+CW

D+C

olor Doppler, B

+Power D

oppler, B+M

+Power D

oppler, B+PW

D+P

ower D

oppler,B+C

WD

+Pow

er Doppler, B

+Clarify VE

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (ifknow

n):__________________

Device N

ame:

AcuNav 8F U

ltrasound Catheter foruse

with

ACU

SON

S1000, S2000and


sIntended U

se:The AcuN

av� U

ltrasound Catheter is intended for intra-cardiac and

intraluminal visualization of cardiac and great vessel anatom

y and physiologyas w

ell as visualization of other devices in the heart of adult and pediatricpatients.

Mode of O

perationC

linical Application

A B

M

PWD

C

WD

Color

Doppler

Pow

er(Am

plitude)D

oppler

Color

Velocity

Imaging

Com

bined(S

pecify) *O

ther:H

armonic

Imaging

Ophthalm

icFetalAbdom

inalIntraoperative(V

ascular)Intraoperative(N

eurological)P

ediatric

PP

PP

PP

PSm

all Organ

Neonatal C

ephalicAdult C

ephalicC

ardiac

PP

PP

PP

PTrans-esophagealTransrectalTransvaginalTransurethralIntra-Lum

inal

PP

PP

PP

PP

eripheral Vessel

LaparoscopicM

usculo-skeletalC

onventionalM

usculo-skeletalSu perficialO

ther (Intra-Cardiac)

PP

PP

PP

PN

= new indication; P


K162243

Additional C

omm

ents:

*Com

binations include: B+M, B+PW

D, B+C

WD

, B+Color D

oppler, B+M+ C

olor Doppler, B+PW

D+C

olorD

oppler, B+CW

D+C

olor Doppler, B

+Power D

oppler,B

+M+Pow

er Doppler, B

+PWD

+Pow

er Doppler,

B+CW

D+Pow

er Doppler

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 27

Diagnostic U


510 (k) Num

ber (if known):

___________________D

evice Nam

e:AcuN

av 10F Ultrasound C

atheter forusew

ithAC

USO

N S1000, S2000

and S3000 Ultrasound System

sIntended U

se:The AcuN

av� U

ltrasound Catheter is intended for intra-cardiac and

intraluminal visualization of cardiac and great vessel anatom

y and physiologyas w

ell as visualization of other devices in the heart of adult and pediatricpatients.

Mode of O

perationC

linical Application

A B

M

PWD

C

WD

Color

Doppler

Pow

er(A

mplitude)

Doppler

Color

Velocity

Imaging

Com

bined(S

pecify) *O

ther:H

armonic

Imaging

Ophthalm

icFetalAbdom

inalIntraoperative(V

ascular)Intraoperative(N

eurological)P

ediatric

PP

PP

PP

PSm

all Organ

Neonatal C

ephalicAdult C

ephalicC

ardiac

PP

PP

PP

PTrans-esophagealTransrectalTransvaginalTransurethralIntra-Lum

inal

PP

PP

PP

PP

eripheral Vessel

LaparoscopicM

usculo-skeletalC

onventionalM

usculo-skeletalSu perficialO

ther (Intra-Cardiac)

PP

PP

PP

PN

= new indication; P


K162243

Additional C

omm

ents:

*Com

binations include: B+M

, B+PW

D, B

+CW

D, B+C

olor Doppler, B

+M+ C

olo Doppler, B

+PWD

+Color

Doppler, B+C

WD

+Color D

oppler, B+Pow

er Doppler, B

+M+Pow

er Doppler, B

+PWD

+Pow

er Doppler,

B+CW

D+Pow

er Doppler

(PLEASE DO

NO

T WR

ITE BELOW

THIS LIN

E-CO

NTIN

UE O

N A SEPAR

ATE PAG

E IF NEED

ED)

________________________________________________________________________C



ealth (CD

RH

)

of 40

510(k) SummaryJuly 23, 2016

1. Sponsor: Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043

Contact Person: Sulgue ChoiTelephone: (425) 281-9898

2. Device Name: Acuson S1000, S2000, S3000™ Diagnostic Ultrasound Systems

May also be marketed as:ACUSON Oxana 1 Ultrasound SystemACUSON Oxana 2 Ultrasound SystemACUSON Oxana 3 Ultrasound SystemACUSON Oxana 2 Ultrasound Automated Breast Volume Scanner

(ACUSON Oxana 2 ABVS)ACUSON Ultrasound Automated Breast Volume Scanner

(ACUSON ABVS)

Common Name: Diagnostic Ultrasound System

Classification:Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System FR # 892.1550Product Code 90-IYN

Ultrasonic Pulsed Echo Imaging System FR # 892.1560Product Code 90-IYO

Diagnostic Ultrasound Transducer FR # 892.1570Product Code 90-ITX

Diagnostic Ultrasound Catheter FR # 870.1200Product Code OBJ

Manufacturing Site:Siemens Medical Solutions USA, Inc.,2500 Millbrook Drive, Suite BMountain View, California 94043Buffalo Grove, IL 60089

3. Legally Marketed Predicate DevicesThe modified Acuson S1000, S2000, S3000 Ultrasound Systems are substantially equivalentto the company’s own systems:

Siemens Medical Solutions, Inc. S-Family Ultrasound SystemsUltrasound Division 510(k) Submission

Page 10 of 40

System 510(k)S1000 K162243S2000 K162243S3000 K162243

4. Device Description:The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasoundsystems with and on-screen display for thermal and mechanical indices related to potentialbio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasoundecho data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW)Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, orHarmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

5. Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal,Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of theovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic,Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal,intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional),musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provideinformation to the clinician that may be used adjunctively with other medical data obtained bya physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability tomeasure Intima Media Thickness and the option to reference normative tables that have beenvalidated and published in peer-reviewed studies. The information is intended to provide thephysician with an easily understood tool for communicating with patients regarding state oftheir cardiovascular system. This feature should be utilized according to the “ASE ConsensusStatement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and EvaluateCardiovascular Disease Risk: A Consensus Statement from the American Association ofEchocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society forVascular Imaging”.

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminalvisualization of cardiac and great vessel anatomy and physiology, as well as visualization ofother devices in the heart of adult and pediatric patients.

6. Summary of Technological Characteristics

The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as thecompany’s own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems(K162243) with regard to both intended use and technological characteristics. Both the subjectultrasound systems and the predicate ultrasound systems function in the same manner as alldiagnostic ultrasound systems and transducers.


Page 11 of 40

Feature / CharacteristicAcuson

S1000/S2000/S3000This Submission

AcusonS1000/S2000/S3000

K# 162243

Indications for Use:ƒ Fetal ∏ ∏ƒ Abdominal ∏ ∏

ƒ Intraoperative ∏ ∏ƒ Intraoperative neurological -- --ƒ Pediatric ∏ ∏ƒ Small Organ ∏ ∏ƒ Neonatal cephalic ∏ ∏

ƒ Adult Cephalic ∏ ∏ƒ Cardiac ∏ ∏

ƒ Trans-esophageal ∏ ∏ƒ Transrectal ∏ ∏ƒ Transvaginal ∏ ∏ƒ Peripheral vessel ∏ ∏ƒ Laparoscopic -- --ƒ Musculo-skeletal (conventional) ∏ ∏ƒ Musculo-skeletal (superficial) ∏ ∏Center Frequencies Supported:ƒ 2.0 MHz ∏ ∏ƒ 3.0 MHz ∏ ∏ƒ 3.2 MHz ∏ ∏ƒ 3.3 MHz ∏ ∏ƒ 4.2 MHz ∏ ∏ƒ 4.4 MHz ∏ ∏ƒ 4.8 MHz ∏ ∏ƒ 5.0 MHz ∏ ∏

ƒ 5.2 MHz ∏ ∏ƒ 6.0 MHz ∏ ∏

ƒ 6.5 MHz ∏ ∏ƒ 6.9 MHz ∏ ∏

ƒ 9.5 MHz ∏ ∏ƒ 10.0 MHz ∏ ∏Modes:ƒ B ∏ ∏ƒ Parallel processing in B mode ∏ ∏

ƒ M ∏ ∏ƒ PWD (Pulsed Wave Doppler) ∏ ∏ƒ CWD (Continuous Wave

Doppler)∏ ∏

ƒ D (Color Doppler) ∏ ∏

ƒ Amplitude Doppler ∏ ∏ƒ Combined (BMDC) ∏ ∏Features:Quad processing in color ∏ ∏

ƒ Native™ tissue harmonicimaging

∏ ∏


Page 12 of 40

Feature / CharacteristicAcuson

S1000/S2000/S3000This Submission

AcusonS1000/S2000/S3000

K# 162243

ƒ SieScape™ panoramicimaging

∏ ∏

ƒ Color SieScape™ panoramicimaging

∏ ∏

ƒ 3-Scape™ real-time 3Dimaging

∏ ∏

ƒ fourSight™ 4D transducertechnology

∏ ∏

ƒ TEQ™ ultrasound technology ∏ ∏

ƒ Cardiac Imaging physiological signal display

∏ ∏

ƒ syngo ® Auto OBmeasurements

∏ ∏

ƒ Advanced SieClear™ spatialcompounding

∏ ∏

ƒ STIC (Fetal Heart Imaging) ∏ ∏

ƒ Amnioscopic rendering ∏ ∏

ƒ Cadence contrast agentimaging

∏ ∏

ƒ Clarify™ vascularenhancement technology

∏ ∏

ƒ eSie™ Touch elasticity imaging ∏ ∏

ƒ syngo ® Auto Left heart ∏ ∏

ƒ syngo ® Velocity VectorImaging

∏ ∏

ƒ Semi Auto-segmentation (eSieCalc) ∏ ∏

ƒ Custom Tissue Imaging /Speed of Sound

∏ ∏

ƒ AHP ∏ ∏

ƒ eSie Fusion (S3000 only) ∏ ∏

ƒ VTI (S2000 & S3000 only) ∏ ∏Wireless ∏ ∏Monitor: 21” FPD ∏ ∏Output Display Standard (Track 3) ∏ ∏Patient Contact Materials Tested to ISO 10993-1 Tested to ISO 10993-1UL 60601-1 Certified ∏ ∏Indications for Use ∏ ∏


Page 13 of 40

7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfectioneffectiveness as well as thermal, electrical, electromagnetic and mechanical safety and hasbeen found to conform with applicable medical device safety standards. The system complieswith the following voluntary standards:

ƒ AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and MechanicalAcoustic Output Indices on Diagnostic Ultrasound Equipment

ƒ AIUM/NEMA UD-2, Acoustic Output Measurement Standard for DiagnosticUltrasound

ƒ IEC 62359, Test methods for the determination of thermal and mechanical indicesƒ Safety and EMC Requirements for Medical Equipment

o IEC 60601-1o IEC 60601-1-2o IEC 60601-2-18o IEC 60601-2-37

ƒ ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged. Testingwas performed to verify the software release.

8. A summary discussion of the clinical tests submitted, referenced, or relied on for adetermination of substantial equivalence.

Since the S1000, S2000, S3000 systems in this submission use the same technology andprinciples as existing devices, clinical studies were not required to support substantialequivalence.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDAguidelines. The design and development process of the manufacturer conforms with 21 CFR820 Quality System Regulation and ISO 13485:2003 quality system standards. The product isdesigned to conform to applicable medical device safety standards and compliance is verifiedthrough independent evaluation with ongoing factory surveillance. Therefore it is the opinion ofSiemens Medical that the S1000, S2000 and S3000 systems are substantially equivalent withrespect to safety and effectiveness to devices currently cleared for market.

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