Snoring and Obstructive Sleep Apnea Snoring and Obstructive Sleep Apnea (OSA) Devices for Over-the-counter (OSA) Devices for Over-the-counter

(OTC) Use(OTC) Use

Ear, Nose, and Throat Devices BranchEar, Nose, and Throat Devices Branch October 6, 2004

Snoring / OSA DevicesSnoring / OSA Devices

Ear, Nose, Throat Devices BranchEar, Nose, Throat Devices Branch

• Nasal DilatorsNasal Dilators•Cervical PillowsCervical Pillows

• Mandibular Support DevicesMandibular Support Devices

Anesthesiology and Anesthesiology and Respiratory Devices BranchRespiratory Devices Branch

•CPAPCPAP

General Surgery Devices BranchGeneral Surgery Devices Branch

•LasersLasers•RFRF

Dental Devices BranchDental Devices Branch

•Oral AppliancesOral Appliances•Jaw Positioning DevicesJaw Positioning Devices

Nasal DilatorNasal Dilator21CFR 874.390021CFR 874.3900

• A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow.

• Class I: ENT Devices Panel Meeting, Oct. 1990

• Cleared for OTC indications

Nasal Dilator (cont’d)Nasal Dilator (cont’d)

Breathe With Breathe With EezEezTMTM

InternalInternal

NozoventNozovent®®

ExternalExternalBreathe EZBreathe EZTMTM

Breathe Right Nasal Breathe Right Nasal Strip®Strip®

Nasal Dilators: OTC Snoring Nasal Dilators: OTC Snoring IndicationIndication

• K904290 Nozovent® (WPM Int’l)– Clinical data provided to support

snoring•Petruson B. Arch Otolaryngol Head Neck

Surg 1990;116:462-4.•Petruson B. Rhinology 1988;26:289-92.

– Cleared 8/20/91 for snoring OTC

FDA Policy: Nasal Dilators for FDA Policy: Nasal Dilators for Snoring OTCSnoring OTC

• Assuming same indications for use/ technological characteristics no clinical data required

• Following FDAMAClass I (exempt) status effective 4/7/99

• New technological characteristics/new intended use would still require 510(k) and clinical data

• No OSA indications for use cleared to date

FDA Policy: Nasal Dilators for FDA Policy: Nasal Dilators for Snoring OTCSnoring OTC

• Labeling Precautions/Warnings– Seek medical attention for abnormal

breathing patterns during sleep, daytime sleepiness, difficulty breathing, etc.

– Cease use if skin/mucosal irritation– Do not exceed recommended duration

of use– Not for use under 5 yr

Nasal Dilators Cleared for Nasal Dilators Cleared for Snoring OTCSnoring OTC

510(k)510(k) DeviceDevice CompanyCompany ClearanceClearanceK904290 Nozovent® WPM

International8/20/91

K953772 Breathe Right®

Nasal StripCNS, Inc. 10/20/95

K955233 Easy BreathingTM Corbet Lair, Inc. 12/21/95

K962400 AIR·MAX™ American White Cross

9/9/96

K962698 ClearPassageTM

PowerStripTM

Acutek 9/9/96

K874089 Breathe With EezTM

Breathe With Eez, Inc.

5/7/98*(add to file)

K982929 MaxAir™ HNL Technologies 9/9/98

Cervical PillowsCervical Pillows

Cervical PillowsCervical Pillows

• No classification regulation for cervical pillows for snoring/OSA indications

• Fall within definition of medical device per §201(h) of FD&C Act

FDA Policy: “Snoring” FDA Policy: “Snoring” PillowsPillows

• Regulatory enforcement discretion applied for snoring indication only– No 510(k) Premarket Notification

required– No enforcement of 21 CFR 807

(Registration and Listing Requirements)

– Still subject to adulteration and misbranding provisions of FD&C Act

– Policy subject to change

FDA Policy: “Snoring” Pillows FDA Policy: “Snoring” Pillows (cont’d)(cont’d)

• Labeling Conditions– No other medical claims (e.g., OSA)– Warnings: “The user of this pillow should consult with their

physician for evaluation of obstructive sleep apnea or other respiratory disorders if your snoring is accompanied by any of the following symptoms:• Frequent excessive daytime sleepiness• Periods of not breathing, as observed by bed partners• Awakening short of breath, choking or gagging

– Contraindications:• A history of heart disease• Being substantially overweight

“Note: Not for use by infants or children Do not use if pain or discomfort results”

Cervical Pillows for OSA Cervical Pillows for OSA IndicationIndication

• K990871 PillowPositive II Cervical Pillow (Life Sleep Systems, Inc.)

– Prior marketing for snoring indication (PillowPositive Cervical Pillow)

– Submitted clinical data supporting mild OSA indication:•Kushida CA et al., Sleep Res Online. 1999;2:7-

10.•Kushida CA et al., Sleep Breath. 2001;5:71-8.

K990871PillowPositive II™ K990871PillowPositive II™ (cont’d)(cont’d)

• Cleared 6/10/99 for snoring and mild OSA

• Prescription use only• Warnings/Contraindications

Cervical Pillows for Cervical Pillows for Mild Mild OSA OSA OTCOTC

• K023010 Popitz Pillow (Aeolus Int’l Corp.)– “sniff” position– Snoring/mild OSA OTC indication cleared

10/01/02• Clinical data supporting effectiveness in mild

OSA• Primary snoring vs. mild OSA• Long history of safe use for snoring pillows OTC• Adequate directions for use

• K040161 Sona Pillow (Sleep Devices, Inc.)– Cleared 4/30/04 for snoring/mild OSA OTC

Mandibular Support DevicesMandibular Support Devices

• Support mandible in the closed position– Similar to

CPAP accessory chinstraps

Mandibular Support Devices Mandibular Support Devices (cont’d)(cont’d)

• No classification regulation• No 510(k)s to date• Clinical studies

– Meurice et al. Am J Respir Crit Care Med 1996;153:255-9

– Hollowell et al. J Appl Physiol 1991;71:2267-73

Adverse Event ReportsAdverse Event Reports(MAUDE Database)(MAUDE Database)

• Nasal Dilator– 2 reports of skin irritation– 1 report eye irritation– 1 internal nasal dilator displaced into

posterior nasal cavity• Cervical Pillows

– No adverse events to date• Mandibular Support Device

– One transient case of airway obstruction with an illegally marketed device