(119 days)
Not Found
No
The summary describes a physical dental device for bruxism and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is intended to reduce damage to the teeth and prevent noise associated with bruxing or grinding, which are therapeutic claims.
No
The device is intended to protect against bruxism and teeth grinding, and to prevent associated noise and damage to teeth. It does not diagnose any condition.
No
The device description clearly states it is a physical nightguard comprised of bite pads and a retaining strap, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism and nighttime teeth grinding, and to reduce damage and noise associated with these conditions. This is a physical intervention within the mouth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical nightguard worn in the mouth.
- Lack of Diagnostic Function: There is no mention of the device analyzing any biological sample (blood, urine, saliva, etc.) or providing any diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rest Assured Ready to Wear Nite 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.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
The Rest Assured Ready to Wear Nite Protector is a posterior-occlusive nightguard, comprised of two molar bite pads connected by a buccal retaining strap. The device is fit to the user's mouth by adjusting the bite plates along the retaining strap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular or maxillary teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
Lastly, a 20 subject user study was conducted to verify that the limited labeling changes for device use were effective and well understood by the 20 subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk analysis for the subject device was performed per ISO 14971 and ISO 7405 was adhered to in the evaluation of biocompatibility of device materials.
In addition, the company performed wear testing on the subject device to evaluate the wear resistance (i.e., Alabama-type wear testing) of the device in comparison to various over-the-counter FDA-cleared predicate night guards. The wear resistance of the evaluated night guard material was comparable to the tested predicate devices with no abnormal evaluations.
Next, a third party testing laboratory tested the device to establish that the subject device was comparable to an identified predicate device with similar design. The third party laboratory verified that the subject device is comparable to the predicate device and can be used on the mandibular or maxillary teeth with the adjustable bite plates similar to the predicate device design.
Lastly, a 20 subject user study was conducted to verify that the limited labeling changes for device use were effective and well understood by the 20 subjects. Greater than 80% of the tested subjects agreed that the adjustable bite pads were acceptable and 95% of the subjects approved of the overall fitting process and fit their device correctly.
In sum, the above summarized bench testing and user study results confirm that the Rest Assured Ready to Wear is substantially equivalent to the claimed predicate devices in intended use, device design, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Greater than 80% of the tested subjects agreed that the adjustable bite pads were acceptable and 95% of the subjects approved of the overall fitting process and fit their device correctly.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
N/A
0
K//2879
JAN 2 7 2012
510(k) SUMMARY
Ranir, LLC's Rest Assured Ready to Wear Nite Protector
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jeff Fisher Vice President, Technology and Product Development, Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512
(616) 698-8880, ext. 1215 Phone: Facsimile: (616) 656-7650
Date Prepared: January 9, 2012
Name of Device and Name/Address of Sponsor
Rest Assured Ready to Wear Nite Protector
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512
Common or Usual Name
Nightguard
Classification Name
Mouthguard, Over-the-Counter
Classification Product Code
OBR
Predicate Devices
Ranir, LLC's Rest Assured Generation II Dental Protector (K091792) Ranir, LLC's Grind No More Version 2 (K091175) Splintek - Power Products Inc.'s SleepRight No Boil Dental Guard (K071404)
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Purpose of the Special 510(k) notice
The Rest Assured Ready to Wear Nite Protector is a modification to Ranir's Rest Assured Night Generation II Dental Protector (K091792).
Notably, the Rest Assured Ready to Wear is the same device as the Rest Assured II. with five minor differences: (1) the Rest Assured Ready to Wear is a posterior, occlusive mouthguard, whereas the Rest Assured II is a fully occlusive mouthguard; (2) the Rest Assured Ready to Wear is to be worn on either the mandibular or maxillary teeth, while the Rest Assured II is for maxillary teeth only: (3) while the Rest Assured II is fitted using the "boil and bite" technique, the Rest Assured Ready to Wear is fitted via adjustable bite plates without boiling; (4) the Rest Assured Ready to Wear is made of ELVALOY, ELVAX, and polypropylene, while the Rest Assured II is made from ELVAX and Dynaflex; and (5) labeling modifications to provide appropriate user fitting instructions.
Intended Use
The Rest Assured Ready to Wear Nite 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.
Technological Characteristics
The Rest Assured Ready to Wear Nite Protector is a posterior-occlusive nightguard, comprised of two molar bite pads connected by a buccal retaining strap. The device is fit to the user's mouth by adjusting the bite plates along the retaining strap.
Substantial Equivalence
The company's Rest Assured Ready to Wear has the same intended use and indications for use as the previously cleared predicate devices, the Rest Assured II, the Grind No More 2, and the SleepRight. In addition, the Rest Assured Ready to Wear has similar technological characteristics and principles of operation to the Rest Assured II, the Grind No More 2, and the SleepRight. Although there are minor differences between the Rest Assured Ready to Wear and the Rest Assured II, namely in the use of the device on the posterior portion of the mandible only, the change in the design and function of the adjustable bite plates, the change in materials, and the limited labeling changes, these minor differences do not raise new questions of safety or efficacy. The posterior-only occlusial design and use of the device on mandibular teeth are common to other cleared mouthguards, such as the previously cleared SleepRight and Grind No More 2 devices. The adjustable nature of the device is also supported by the SleepRight predicate. Although the materials used in the device have changed, each of the materials comprising the Rest Assured Ready to Wear are common to other cleared medical devices, including the named predicates. Finally, the limited labeling changes only provide appropriate instructions on how to fit the device properly and do not affect device safety or
2
effectiveness. Thus. the Rest Assured Ready to Wear is substantially equivalent to the claimed predicate devices.
Performance Testing
A risk analysis for the subject device was performed per ISO 14971 and ISO 7405 was adhered to in the evaluation of biocompatibility of device materials.
In addition, the company performed wear testing on the subject device to evaluate the wear resistance (i.e., Alabama-tvpe wear testing) of the device in comparison to various over-the-counter FDA-cleared predicate night guards. The wear resistance of the evaluated night guard material was comparable to the tested predicate devices with no abnormal evaluations.
Next, a third party testing laboratory tested the device to establish that the subject device was comparable to an identified predicate device with similar design. The third party laboratory verified that the subject device is comparable to the predicate device and can be used on the mandibular or maxillary teeth with the adjustable bite plates similar to the predicate device design.
Lastly, a 20 subject user study was conducted to verify that the limited labeling changes for device use were effective and well understood by the 20 subjects. Greater than 80% of the tested subjects agreed that the adjustable bite pads were acceptable and 95% of the subjects approved of the overall fitting process and fit their device correctly.
In sum, the above summarized bench testing and user study results confirm that the Rest Assured Ready to Wear is substantially equivalent to the claimed predicate devices in intended use, device design, safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the top and then separate into two distinct shapes at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Ranir. LLC . C/O Mr. Gerard J. Prud'homme Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K112879
Trade/Device Name: Rest Assured Ready to Wear Nite Protector Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: December 28, 2011 Received: December 28, 2011
Dear Mr. Prud'homme:
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.
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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 Compilance + files; 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 1 ou nike 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh foc
Anthony D. Watson, B.S., M.S., M.B.A. 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): 112879
Device Name: Rest Assured Ready to Wear Nite Protector
Indications for Use:
The Rest Assured Ready to Wear Nite Protector is indicated for use for protection against
bruxism or nighttime teeth grinding. The device is intended to successor in broads of tesared rically to weat Nite Protector is indicated for use for protection against
bruxism or nighttime teeth grinding. The device is intended to reduce damage 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) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112879