The Rest Assured® Extra Comfort Nite Protector is indicated for use for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Description

The Rest Assured Extra Comfort Nite Protector is indicated 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 teeth grinding.
The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Ranir, LLC's Rest Assured® Extra Comfort Nite Protector based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance
Biocompatibility	ISO 14971:2007 (Risk Management)	Complies
	ISO 7405:2008 (Biocompatibility)	Complies, deemed appropriate for intended use and duration of exposure. No safety risk from leachables/extractables.
	ISO 10993-1:2009 (Evaluation & Testing)	Complies
	ISO 10993-3:2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity)	Complies
	ISO 10993-5:2009 (In vitro Cytotoxicity)	Complies
	ISO 10993-10:2010 (Irritation & Skin Sensitization)	Complies
	ISO 10993-11:2010 (Systemic Toxicity)	Complies
	ISO 10993-17:2002 (Leachable Limits)	Complies
	Cytotoxicity	Passed
	Oral Mucosal Irritation	Passed
	Acute Systemic Toxicity	Passed
	Sensitization	Passed
	Material Mediated Pyrogenicity	Passed
	Leachables/Extractables Characterization	Passed
	Genotoxicity	Passed
Physical Characteristics	Comparison to predicate device ("Doctor's Advance Comfort Night Guard")	Found to be comparable
	Workmanship	Found to be comparable
Performance	Comparison to predicate device	Found to be comparable
	Simulated Wear Testing	Confirmed modifications do not impact structural integrity.
	Boil and Bite Testing	Confirmed modifications do not impact structural integrity.
Hazards	Comparison to predicate device	Found to be comparable

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for the various tests (e.g., number of devices tested for biocompatibility, simulated wear, or boil and bite testing).

Regarding data provenance, the testing was conducted by:

North American Science Associates, Inc. ("NAMSA") for comprehensive biocompatibility testing.
A "third party testing" firm for evaluation of physical characteristics, workmanship, performance, and hazards against a predicate device.

The country of origin for the data is not specified beyond "North American Science Associates, Inc." or "third party testing," though the submitter (Ranir, LLC) is based in the U.S. and the submission is to the FDA. The studies appear to be prospective as they were conducted specifically for this device modification and submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a physical dental protector, and the performance testing focuses on material properties, physical characteristics, and simulated use rather than diagnostic accuracy or human interpretation. Therefore, there's no "ground truth" derived from experts in the same way there would be for an AI-powered diagnostic device analyzing medical images. The "ground truth" here is established by the results of standardized tests and evaluations against predicate devices.

4. Adjudication Method for the Test Set

This is not applicable. As explained above, the tests are objective measurements and comparisons, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Rest Assured® Extra Comfort Nite Protector is a physical dental device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm-only performance study was not conducted. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing in this submission is established through:

Compliance with recognized consensus standards (ISO standards) for biocompatibility and risk management.
Objective laboratory testing results for cytotoxicity, irritation, toxicity, sensitization, pyrogenicity, and leachables/extractables.
Direct comparison to a legally marketed predicate device ("Doctor's Advance Comfort Night Guard") for physical characteristics, workmanship, performance, and hazards.
Simulated wear and boil-and-bite testing to confirm structural integrity after modifications.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device submission, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set.

Summary

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K 133423 DEC 20 2013

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4701 East Paris Avenue SE
Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820

Attachment 8

510(k) Summary

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DEC 2 0 2013

4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820

510(k) SUMMARY Ranir, LLC's Rest Assured Extra Comfort Nite Protector Dental Protector

Submitter's Name:	Ranir, LLC
Address:	4701 East Paris Avenue SEGrand Rapids, MI 49512
Telephone Number:	Phone: (616) 698-8880 ext. 1278Facsimile: (616) 222-0710
Contact Person:	Paula Bojsen, Global Regulatory Compliance Manager
Date Prepared:	October 30, 2013

2. Device Name:

Proprietary or Trade Name:	Rest Assured® Extra Comfort Nite Protector (ModelBRX-220013)[Private Labeler Name] Extra Comfort Nite (or"Night") Protector[Private Labeler Name] Nite (or “Night”) Protector[Private Labeler Name] Dental Protector



Common or Usual Name:	Dental protectorNightguard
Classification Name:	Mouthguard, Over-the-Counter
Product Code:	OBR

3. Predicate Devices:

Ranir, LLC's Rest Assured® Ready to Wear Nite Protector	(K112879)
Ranir, LLC's Rest Assured® Generation II Dental Protector	(K091792)
Prestige Brand's The Doctor's Advanced Comfort Night Guard	(K073220)

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Image /page/2/Picture/0 description: The image shows the word "Ranir." to the right of a plus sign. The plus sign is bolded and black. The word "Ranir." is also bolded and black.

4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820

4. Device Description

5. Purpose of the Special 510(k) notice.

The Rest Assured® Extra Comfort Nite Protector is a modification to Ranir's Rest Assured® Generation II Night Protector (K091792).

6. Intended Use:

7. Technological Characteristics:

The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method. Similarly, the predicate devices are occlusive nightguards fitted by the "boil and bite" method"; therefore, the Rest Assured® Extra Comfort Nite Guard is technologically similar to the predicate devices.

8. Performance Testing:

The Rest Assured® Extra Comfort Nite Guard complies with the following recognized consensus standards:

. lSO 14971:2007, Medical devices - Application of risk management to medical devices
ISO 7405:2008, Dentistry Evaluation of biocompatibility of medical devices . used in dentistry
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
. ISO 10993-3:2003, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for . in vitro cytotoxicity
. ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ISO 10993-11:2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
. ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

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Image /page/3/Picture/0 description: The image shows the word "Ranir" with a plus sign to the left of the word and a period to the right of the word. The word is written in a sans-serif font. The plus sign is made up of four lines that intersect in the middle. The period is small and round.

4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820

Ranir contracted with the North American Science Associates, Inc. ("NAMSA") to conduct comprehensive biocompatibility testing on the finished Rest Assured® Extra Comfort product, and NAMSA concluded that the combination of Elvax® and Elvaloy® used in the final Rest Assured® device demonstrated appropriate biocompatibility for its intended use and duration of exposure. This testing is similar and produced similar results as compared to the Gen II predicate device.

Comprehensive biocompatibility testing conducted by NAMSA was for cytotoxicity, oral mucosal irritation, acute systemic toxicity, sensitization, material mediated pyrogenicity, leachables / extractables characterization, systemic toxicity, and genotoxicity. It was found that the material combination is biocompatible for the intended use and anticipated duration of use, and there are no leachables / extractables that pose a safety risk.

The Rest Assured® Extra Comfort Nite Guard was compared to the Doctor's Advance Comfort Night Guard and evaluated for physical characteristics. workmanship, performance, and hazards by third party testing. Ranir's Rest Assured® Extra Comfort Nite Guard was found to be comparable to this predicate device.

Simulated wear testing, and boil and bite testing, was also conducted on the Rest Assured® Extra Comfort Nite Guard. These tests confirm that the modifications with respect to the predicate Gen II device do not impact structural integrity.

All verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

9. Substantial Equivalence

The Rest Assured® Extra Comfort Nite Guard possesses the same indications for use, technological characteristics, and principles of operation as the predicate devices (the currently marketed Ranir, LLC's Rest Assured® Generation II Dental Protector (091792), Rest Assured® Ready to Wear Nite Protector (K112879), and The Doctor's Advanced Comfort Fit Nightguard (K073220). The minor technological differences between the Rest Assured® Extra Comfort Nite Protector and the predicate devices raise no new questions of safety or effectiveness. Thus, the Rest Assured® Extra Comfort Nite Protector is substantially equivalent. All materials used are in the predicate devices, in different mixtures/combinations.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2013

Ranir, LLC Ms. Paula Bojsen Global Regulatory Compliance Manager 4701 East Paris Avenue SE Grand Rapids, MI 49512

Re: K133423

Trade/Device Name: Rest Assured® Extra Comfort Nite Protector (Model BRX-220013) Regulation Number: Unclassified Regulation Name: Mouthguard Over-The-Counter Regulatory Class: Unclassified Product Code: OBR Dated: September 17, 2013 Received: September 20, 2013

Dear Ms. Bojsen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Ms. Bojsen

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Rest Assured® Extra Comfort Nite Protector

Indications for Use (Describe)

The Rest Assured® Extra Comfort Nie 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 teeth grinding.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SE SERVICE OF COLLECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR BOOM OF

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Mary S. Runner -S 2013.12.18 08:37:11 -05'00'

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

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Regulation Number and Section

N/A