Transcript Document 7176322

Snoring and Obstructive Sleep
Apnea (OSA) Devices
Dental Devices Branch
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
October 6, 2004
Kevin Mulry, D.D.S., M.P.H.
Scope of Dental Devices for Panel
Discussion
Includes:
• Intraoral devices
– fitted over teeth
– removable
Does not include:
• Implantable devices
• Surgical devices
• CPAP
• Diagnostic Devices
Regulatory History
• Panel Meeting in 1997 for classification
– Panel recommendation - Class II Special Control
• Sponsors need to submit a 510(k) (premarket
notification)
• Published a Class II Special Controls Guidance
Document
• NSE decision for OTC device
• Some sponsors have requested that these devices be
made available OTC. That is the reason we are asking
for your input today as to what data sponsors should
submit to provide reasonable assurance of safety and
effectiveness for OTC use.
Regulation
• 21CFR 872.5570 Intraoral devices for
snoring and intraoral devices for snoring
and obstructive sleep apnea are devices
that are worn during sleep to reduce the
incidence of snoring and to treat
obstructive sleep apnea. The devices are
designed to increase the patency of the
airway and to decrease air turbulence and
airway obstruction.
Class II Special Controls Guidance
Document
• Data needed in a 510(k) submission
• Risks to health and recommended
mitigation measures
• Biocompatibility testing
• Clinical testing
• Labeling
Types of Dental Device Designs
To date FDA has cleared the following types
of devices under this regulation:
• Tongue retaining devices
• Mandibular repositioning devices
• Palatal lifting devices
Cleared Indications
• Treating snoring
• Treating snoring and/or mild to moderate
OSA
• Prescription use only
• Tongue Retaining
Device
• Mandibular Repositioning
Device
Boil and Bite Mandibular
Repositioning
Palatal Lifting
Device
Trends in Device Design
• Mainly mandibular repositioning devices
• Early designs:
– Custom impressions
– Orthodontic hardware
– Self-adjusting advancement mechanisms
• New Designs:
– Boil and Bite devices
• Thermoplastic materials
• Pre-set advancements
Individual Impression
Boil and Bite
Labeling Recommendations
Contraindications
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Central sleep apnea
Severe respiratory disorders
Loose teeth or advanced periodontal disease
Under 18 years of age
Edentulous
Warnings
Use of device may cause:
• Tooth movement or changes in dental occlusion
• Gingival or dental soreness
• Pain or soreness of the TMJ
• Obstruction of oral breathing
• Excessive salivation
Clinical Testing for Snoring and/or
OSA Submission Clearance
• Snoring – performance measurements
that include rate of reduction of snoring
based on clinical observation
• OSA – clinical data, that includes baseline
and post-insertion polysomnograms
measuring the apneic events, the apneahypopnea index, oxygen saturation, etc.,
are provided for a new design, new
technology or new indication for use.
Differences from ENT Devices
• All dental devices for snoring and/or OSA are
intraoral
• All dental devices are prescription devices, i.e.,
no intraoral dental devices for the treatment of
snoring and/or OSA have been cleared as OTC
devices
• Due to similarities in design, intraoral devices for
both snoring and OSA pose similar risks based
on correct selection and fitting of the appliance
rather than whether the treatment is for snoring
or OSA
Why cleared as prescription only
devices?
• Intraoral devices present different risks than the
ENT devices.
– Varied in design and application
– Correct selection and fitting is important in preventing
injury
• Clinical care by a Dentist is critical in the
diagnosis of:
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Periodontal disease
Decayed, missing, and filled teeth
Protrusive range
TMJ status
Parafunctions – clenching and grinding
OTC Protocols Submitted
The Dental Devices Branch has received clinical protocols from
sponsors to support OTC use for the treatment of snoring and
anticipate receiving protocols for OSA.
Issues that have been addressed in the protocols include:
• the intervention of a dentist or other competent intermediary to
assess the general health status, oral health status and/or the
appropriateness of the individual device prior to the patient
receiving the device
• Lay person self-assessment of snoring versus OSA
• Directions for use for self-fitting the oral appliance and
self-assessment of the fit
Considerations for OTC Use
OTC devices require adequate directions for use
for the lay person. In discussing data for OTC
use you may wish to consider the following:
• Can the lay person accurately self-diagnose
their medical condition?
• Can the lay person accurately self-diagnose
their oral health status?
• Can the lay person chose the correct oral
appliance and fit it accurately such that the
device is safe and effective and does not cause
adverse events?