(84 days)
Not Found
Not Found
No
The summary describes a physical, custom-fitted oral device for snoring reduction and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as reducing or alleviating snoring, which constitutes a therapeutic effect by treating a medical condition.
No
The device's intended use is to alleviate snoring by repositioning the tongue and jaw, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "single piece device which is form custom fitted to the users upper and lower teeth and inner lips," indicating it is a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring by physically repositioning the tongue and lower jaw. This is a mechanical action within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on laboratory tests.
Therefore, the Snore Peace® device, as described, falls under the category of a medical device used for a physical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for The Snore Peace® is for snore reduction/prevention.
To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.
Product codes
LRK
Device Description
The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue and lower jaw, upper and lower teeth and inner lips
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)
Snore-Ezzer by Snore-Ezzer, LLC, Snore Tec by Marketing Technologies, Inc, Therasnore by Dr. Thomas E. Meade
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Page 10 of 10
The Snore Peace® Premarket Notification 510(K) Summary
Submitter:
The Snore Peace® Group 24791 Via San Felipe Mission Viejo, California 92692 Contact Person: David V. Sheehan Phone: 949-380-8323 FAX: 949-454-0211
Date Summary was prepared: June 1, 1998
Device Name:
| Trademark: | The Snore Peace® |
|---|---|
| Common Name: | Anti-snoring device |
| Classification: | Unclassified |
| Product Code: | LRK |
Description:
The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.
Intended Use:
The intended use for The Snore Peace® is for snore reduction/prevention.
Substantial Equivalence:
The Snore Peace® is substantially equivalent to many legally marketed devices in The United States including Snore-Ezzer by Snore-Ezzer, LLC: Snore Tec by Marketing Technologies, Inc; and Therasnore by Dr. Thomas E. Meade.
Safety & Efficacy:
The Snore Peace® works in a similar manner to other comparative predicate devices and the intended use is the same. Any differences between our product and predicate devices are minor in nature and raise no new safety concerns. The effectiveness and suitability to the intended purpose of The Snore Peace® is assured via the widespread use and length of use of the many similar devices on the market. As such, the safe use of The Snore Peace® by many users, under the prescription and custom fitting of a physician is assured.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three human profiles incorporated into the design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Mr. DaviD V. Sheehan Managing Director The Snore Peace® Group 24791 Via San Felipe Mission Viejo, California 92692
Re : K981923 Trade Name: The Snore Peace® Requlatory Class: Unclassified Product Code: LRK Dated: June 1, 1998 Received: June 1, 1998
Dear Mr. Sheehan:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Mr. Sheehan
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
1000
- 1 270
The Snore Peace® Premarket Notification Statement for Indications of Use
The Snore Peace® Device Name:
Indication For Use: To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use_ or (Per 21 CFR 801.109) Argar Ange (Division Sign-Off) ( Division of Dental, Infection Control, and General of Dental, Intection of General Hospital Devices 510(k) Number