(45 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices.
No
The only information provided is "Snorefree" under device description, which is insufficient to determine if the device is therapeutic.
No
The provided information for the device "Snorefree" does not include any details under "Intended Use / Indications for Use", "Device Description", "Summary of Performance Studies", "Key Metrics", or any other section that would suggest it is used for diagnosis. The name "Snorefree" implies it's a treatment or a device to prevent snoring, not diagnose a condition.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device's nature and function. Without details on the intended use, device description beyond the name, and any mention of hardware or software components, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is highly unlikely that "Snorefree" is an IVD (In Vitro Diagnostic) device.
Here's why:
- Lack of Key IVD Indicators: The provided text contains none of the typical information associated with IVD devices. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to diagnose diseases or conditions. The description "Snorefree" and the absence of any mention of samples, analysis, or diagnostic purposes strongly suggest it's not an IVD.
- Missing Information: The lack of information on intended use, device description beyond the name, and performance studies further supports the conclusion that this is not a regulatory submission or description of an IVD.
Conclusion:
Based solely on the provided text, "Snorefree" does not appear to be an In Vitro Diagnostic device. It is more likely a product related to snoring, potentially a device worn or used externally.
N/A
Intended Use / Indications for Use
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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
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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
Image /page/0/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. To the right of the text is a symbol consisting of three parallel lines that curve slightly upwards. Below the lines is a crescent shape.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN - 4 1996
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scott E. Feldman, D.D.S. Scott Feldman D.D.S. & Norman Shapiro D.D.S. 6319 Desota Avenue, Suite 401 Woodland Hills, California 91367
Re: K925336 Snorefree Trade Name: Regulatory Class: Unclassified Product Code: LRK November 2, 1995 Dated: November 20, 1995 Received:
Dear Dr. Feldman:
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 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 against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 320) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. 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 - Dr. Feldman
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HF2-300) at (301) 594-4639. Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
B. C. Whitmarsh'
Timothy /A. Ulatowski Acting Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health