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K Number
K021569
Device Name
RESTFUL NIGHTS, IST-APPLIANCE
Manufacturer
OTTAWA DENTAL LABORATORY
Date Cleared
2004-03-15

(671 days)

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

The 1ST™ - Appliance Intraoral Snoring-Therapy Appliance is designed for the treatment of snoring and mild obstructive sleep apnea.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed study information, acceptance criteria, and performance metrics required to answer your request. The document is an FDA 510(k) clearance letter for a device named "Restful Nights 186 - Appliance" (also referred to as "1ST™ - Appliance Intraoral Snoring-Therapy Appliance").

This letter primarily states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It lists:

  • Trade/Device Name: Restful Nights 186 - Appliance
  • Regulation Number: 21 CFR 872.5570
  • Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea
  • Regulatory Class: II
  • Product Code: LRK
  • Indications for Use: The 1ST™ - Appliance Intraoral Snoring-Therapy Appliance is designed for the treatment of snoring and mild obstructive sleep apnea.

However, the document does NOT provide:

  1. A table of acceptance criteria or reported device performance.
  2. Details about any specific study (sample sizes, data provenance, experts, adjudication methods).
  3. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
  4. The type of ground truth used.
  5. Training set details.

The FDA 510(k) clearance process focuses on substantial equivalence to existing devices, and the detailed efficacy and performance study data, if submitted, is typically not included in the public clearance letter itself.

§ 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.”