(574 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology commonly associated with AI/ML in medical devices. The description is limited to the intended use of an appliance for sleep apnea.
Yes
The device is indicated for the "treatment of mild to moderate obstructive sleep apnea," which is a therapeutic purpose.
No
The device is indicated for the treatment of mild to moderate obstructive sleep apnea, not for diagnosis.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate obstructive sleep apnea." This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description, Image Processing, AI/ML, Input Imaging Modality, Anatomical Site, Patient Age Range, Training/Test Set Descriptions, Performance Studies, Key Metrics: None of these sections mention anything related to analyzing biological samples (like blood, urine, tissue) or performing diagnostic tests.
- Intended User / Care Setting: "Prescription Use" is common for therapeutic devices.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is clearly intended for use in vivo (within the body) as a treatment appliance.
N/A
Intended Use / Indications for Use
- 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.
Product codes
LQZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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
Indications for Use
510(k) Number (if known): K032410
I. Quiet Night Device Name: 2. Quiet Night MA
Indications For Use:
-
- 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.
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)