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					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
                             Ear, Nose, Throat Devices Branch
    •Oral Appliances
 •Jaw Positioning Devices           • Nasal Dilators
                                   •Cervical Pillows
                              • Mandibular Support Devices




   Anesthesiology and
Respiratory Devices Branch
                             General Surgery Devices Branch
         •CPAP
                                        •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 EZTM
Breathe Right Nasal Strip®




                                         Nozovent®
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   CNS, Inc.           10/20/95
          Strip
K955233   Easy BreathingTM       Corbet Lair, Inc.   12/21/95

K962400   AIR·MAX™               American White      9/9/96
                                 Cross
K962698   ClearPassageTM         Acutek              9/9/96
          PowerStripTM
K874089   Breathe With EezTM     Breathe With Eez,   5/7/98*
                                 Inc.                (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

				
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