SNORENTI by JAMES P BOYD | FDA 510(k) Summary

Quiet Night This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
Quiet Night MA This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. This appliance is intended for use when the Quiet Night is ineffective.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device "Quiet Night Sleep Appliance" and "Quiet Night MA Sleep Appliance" has been found substantially equivalent to legally marketed predicate devices.

The letter mentions:

Trade/Device Name: Quiet Night Sleep Appliance, Quiet Night MA Sleep Appliance
Regulation Number: 872.5570
Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea
Regulatory Class: IIProductName: LQZ
Indications For Use:
- Quiet Night: Treatment of mild to moderate obstructive sleep apnea.
- Quiet Night MA: Treatment of mild to moderate obstructive sleep apnea, intended for use when the Quiet Night is ineffective.

However, the document does not include:

A table of acceptance criteria and reported device performance.
Sample size or data provenance for any test set.
Number or qualifications of experts for ground truth establishment.
Adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size.
If a standalone performance study was done.
The type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

This kind of detailed performance data is typically found in the 510(k) submission itself, which is not fully included in this document. The provided text is the FDA's decision letter, not the full submission or a detailed study report.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a bird in flight or a stylized human figure.

FEB 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. James P. Boyd 710 Midofi Court Solana Beach, California 92075

Re: K032410

KU32410
Trade/Device Name: Quict Night Sleep Appliance, Quiet Night MA Sleep Appliance Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LQZ Dated: November 30, 2004 Received: November 30, 2004

Dear Dr. Boyd:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to devroes that hat tie Act (Act) that do not require approval of a premarket the rederal P ood, Drug, and Commons, therefore, market the device, subject to the general approval appliederon (1777).
Controls provisions of the Act. The general controls provisions of the Act include controls providents of the stration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (See as a vijional controls. Existing major regulations affecting (FMA), it may be subject to have adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements concerning your device in the Federal Register

{1}------------------------------------------------

Page 2 - Dr. Boyd

Please be advised that FDA's issuance of a substantial equivalence determination does not
es and Please be advised that FDA s Issualice of a successarias with other requirements
mean that FDA has made a determination that your devices with other requires mean that FDA has made a decemmanon half your and your and limited to: registration of the Act or any rederal statues and reguirements, including, but not limited to: registration
You must comply with all the Act 's requirements, including ad momufecturing You must comply with an the Act s requirements intelling manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820); and i and listing (21 CFR Part 807), laocling (21 CFR Part 800), go
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin malicating your device of your device to a premarket notification. The PDA iniding of substantial of as a many of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), a If you desire specific advice for your device of (240) 276-0115. Also, please note the regulation please contact the Office or Comphanes are (21CFR Part 807.97). You entitled, "Misoranding by reference to premation on your responsibilities under the Act from the may obtain offer general information on Journational and Consumer Assistance at its toll-free Division of Simala of Simal (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susem Rios'

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K032410

Indications for Use

510(k) Number (if known): K032410

I. Quiet Night Device Name: 2. Quiet Night MA

Indications For Use:

1. Quiet Night This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
1. Quiet Night MA This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. This appliance is intended for use when the Quiet Night is ineffective.

Suan Pan

vision Sign-Off) ision of Anesthssiology, General Hospital, ്കാരം

Number: 1635710

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Regulation Number and Section

§ 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.”