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K Number
K955336
Device Name
SNOREFREE
Manufacturer
SCOTT FELDMAN DDS & NORMAN SHAPIRO DDS
Date Cleared
1996-01-04

(45 days)

Product Code
LRK
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Snorefree

AI/ML Overview

This document is a letter from the FDA to Dr. Scott E. Feldman regarding the 510(k) premarket notification for a device named "Snorefree." The letter states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore, it can be marketed subject to general controls provisions of the Act.

The document does not contain information about:

  1. Acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or details about the test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi reader multi case (MRMC) comparative effectiveness study.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This letter is a regulatory approval document based on substantial equivalence, not a study report detailing performance metrics and validation methods. Therefore, I cannot extract the requested information from 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.”