Transcript Document 7273322

Snoring and Obstructive Sleep Apnea (OSA)
Devices for Over-the-counter (OTC) Use
Ear, Nose, and Throat Devices Branch
October 6, 2004
Snoring / OSA Devices
Dental Devices Branch
•Oral Appliances
•Jaw Positioning Devices
Anesthesiology and
Respiratory Devices Branch
•CPAP
Ear, Nose, Throat Devices Branch
• Nasal Dilators
•Cervical Pillows
• Mandibular Support Devices
General Surgery Devices Branch
•Lasers
•RF
Nasal Dilator
21CFR 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)
External
Internal
Breathe With EezTM
Breathe Right Nasal Strip®
Nozovent®
Breathe EZTM
Nasal Dilators: OTC Snoring Indication
• 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 Snoring OTC
• Assuming same indications for use/
technological characteristics no clinical
data required
• Following FDAMAClass 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 Snoring 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 Snoring OTC
510(k)
Device
Company
Clearance
K904290
Nozovent®
WPM International
8/20/91
K953772
Breathe Right® Nasal
Strip
CNS, 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 Pillows
Cervical 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” Pillows
• 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 (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 Indication
• 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™ (cont’d)
• Cleared 6/10/99 for snoring and mild OSA
• Prescription use only
• Warnings/Contraindications
Cervical Pillows for Mild OSA OTC
• 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 Devices
• Support mandible
in the closed
position
– Similar to CPAP
accessory
chinstraps
Mandibular Support Devices (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 Reports
(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