(90 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also missing, which would be a key place to find such information.
Yes
The device is intended for the "treatment" of snoring, which indicates a therapeutic purpose.
No
Explanation: The device is described as a "treatment for snoring," indicating a therapeutic purpose rather than a diagnostic one.
No
The provided text only describes the intended use of a device called "Adjustable TheraSnore" for treating snoring. It does not contain any information about the device's description, components, or how it achieves its intended use. Without a device description, it's impossible to determine if it's software-only or includes hardware.
Based on the provided information, the Adjustable TheraSnore is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a treatment for snoring." This describes a therapeutic device used to address a physical condition within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Measuring biomarkers or other biological indicators
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Adjustable TheraSnore, as described, is a physical device used to treat a symptom (snoring), not to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The Adjustable TheraSnore is a treatment for snoring
Product codes
LRK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows the date November 12, 1997. The month is abbreviated to NOV. The numbers are in a simple, sans-serif font. The image is a close-up of the date.
Distar Incorporated ·C/O Mr. Stephen A. Brown Attorney At Law 214 West Cork Street 22601-4136 Winchester, Virqinia
K973038 Re : Adjustable Therasnore Trade Name: Requlatory Class: Unclassified Product Code: LRK Dated: August 13, 1997 Received: August 14, 1997
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. ·
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Page 2 - Mr. Brown
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia wequivalence of your device to a legally rinding of babbandaries, cresults in a classification for your marketed predicate actres your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 331 1032. Thursdayice, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Time thy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known) | K973038 |
|---|---|
| Device Name | Adjustable TheraSnore |
| Indications For Use: | The Adjustable TheraSnore is a treatment for snoring |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Consurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
| | | |
Susan Punn
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K973038
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