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K Number
K061228
Device Name
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
Manufacturer
BRYAN KEROPIAN DDS
Date Cleared
2006-05-26

(24 days)

Product Code
LQZ
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
K032410,K052862,K053065,K022891,K103808,K991948,K010876
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring.
  2. Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary and FDA decision letter for a medical device called the "Full Breath Sleep Appliance With Posterior Tongue Depressor."

Here's what the document does provide:

  • Device Name: Full Breath Sleep Appliance With Posterior Tongue Depressor (and other variations)
  • Applicant: Bryan Keropian DDS
  • Proposed Product Code: LQZ
  • Proposed Device Classification: Jaw Repositioning Device
  • Indications for Use:
    • Treatment of snoring
    • Treatment of mild to moderate obstructive sleep apnea
  • Substantial Equivalence (SE) Claim: The device claims substantial equivalence to several predicate devices for the treatment of mild and moderate OSA, snoring, and bruxism.

The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria. This is common for 510(k) submissions, where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot populate the requested table or provide information about a study proving acceptance criteria as that data is not present in the provided text.

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. 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. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”