(21 days)
The Rest Assured Generation II Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
The Rest Assured II is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method.
This 510(k) summary (K091792) for Ranir, LLC's Rest Assured Generation II Dental Protector does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets them. This document is a Summary of Substantial Equivalence, which focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices. It does not typically include a de novo clinical study with detailed acceptance criteria and performance metrics in the way you've outlined for diagnostic AI products.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document is a 510(k) summary, not a clinical trial report. It asserts substantial equivalence based on similar intended use and technological characteristics to predicate devices. It does not provide specific performance metrics in the way a diagnostic device would (e.g., sensitivity, specificity, accuracy).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No test set or study data is presented in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. No ground truth establishment or expert review is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No adjudication method is mentioned as no test set is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be extracted. An MRMC study is not mentioned. This device is a physical dental protector, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. No ground truth is described.
8. The sample size for the training set
- Cannot be extracted. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Cannot be extracted. No training set or ground truth establishment relevant to an algorithm is mentioned.
Summary regarding acceptance criteria and study for K091792:
The provided document (K091792) is a 510(k) summary for a physical medical device (dental protector), not an AI-based diagnostic tool. The submission strategy relies on substantial equivalence to predicate devices. This means that the device's safety and effectiveness are established by demonstrating that it has the same intended use, similar technological characteristics, and principles of operation as legally marketed devices, and that any minor differences do not raise new questions of safety or effectiveness.
Therefore, the submission does not contain a study with detailed performance metrics, test sets, or ground truth establishment as would be expected for a diagnostic or AI-driven medical device. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the predicate devices (Ranir, LLC's Rest Assured Night Protector (K063229) and Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220)), which the FDA confirmed the device met.
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510(k) SUMMARY
Ranir, LLC's Rest Assured Generation II Dental Protector
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan Regulatory Counsel to Ranir, LLC Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004
(202) 637-5794 Phone: Facsimile: (202) 637-5910
Date Prepared: June 16, 2009
Name of Device and Name/Address of Sponsor
Rest Assured Generation II Dental Protector
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 Phone: (616) 698-8880 Facsimile: (616) 656-7650
Common or Usual Name
Nightguard
Classification Name
Mouthguard, Over-the-Counter
Classification Product Code
OBR
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Predicate Devices
Ranir, LLC's Rest Assured Night Protector (K063229) Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220)
Purpose of the Special 510(k) notice.
The Rest Assured Generation II is a modification to Ranir's Rest Assured Night Protector (K063229).
Intended Use
The Rest Assured II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Technological Characteristics
The Rest Assured II is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. Similarly, the predicate devices are fully occlusive nightguards fitted by the "boil and bite method"; therefore, the Rest Assured II is technologically similar to the predicate devices.
Substantial Equivalence
The Rest Assured II is as safe and effective as the predicate devices. The Rest Assured II has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Rest Assured II and the predicate devices raise no new questions of safety or effectiveness. Thus, the Rest Assured II is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2009
Ranir, LLC C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004
Re: K091792
Trade/Device Name: Rest Assured Generation II Dental Protector Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 16, 2009 Received: June 17, 2009
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kahan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Purres
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Rest Assured Generation II Dental Protector
Indications for Use:
The Rest Assured Generation II Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Prescription Use (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rha Muly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091792
N/A