GRIND NO MORE GENERATION II

• K Number: K094020
• Device Name: GRIND NO MORE GENERATION II
• Manufacturer: RANIR LLC
• Date Cleared: 2010-01-25 ( 27 days)
• Product Code: OBR
• Regulation Number: N/A
• Type: Special
• Panel: Dental
• Reference & Predicate Devices: K091175 , K063229
• Predicate For: N/A

Intended Use

The Grind No More Generation 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.

Device Description

Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate.

AI/ML Overview

This document describes a Special 510(k) notice for "Grind No More Generation II," a mouthguard designed to protect against bruxism. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing detailed acceptance criteria through performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found or required for a Special 510(k) submission for a device like a mouthguard, which primarily relies on technological similarity and established safety/effectiveness of predicate devices.

Here's a breakdown of why specific information is missing and what can be inferred from the provided text:

Missing Information and Reasons:

• 1. A table of acceptance criteria and the reported device performance: Not provided. For a Special 510(k) based on substantial equivalence, specific performance acceptance criteria and new performance data (beyond demonstrating technological similarity) are generally not required if the changes are minor and do not raise new questions of safety or effectiveness. The device's performance is assumed to be similar to its predicate devices.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No new performance study (test set) was conducted to support this Special 510(k). The submission relies on the established safety and effectiveness of the predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth assessment by experts for a test set is typically for performance validation studies, which were not performed in this case.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is a medical device (mouthguard), not an AI-powered diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance studies were not conducted for this device's submission. The "ground truth" for showing substantial equivalence relies on the regulatory approval and safety/effectiveness history of the predicate devices.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information Available from the Document:

While the requested specifics are not present, we can understand the basis of the submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):

• Acceptance Criteria for Special 510(k): The primary acceptance criterion for a Special 510(k) in this context is demonstrating that the modified device (Grind No More Generation II) is substantially equivalent to its predicate devices (Grind No More 2 and Rest Assured Nite Protector).
• Demonstration of Substantial Equivalence: This is achieved by showing that the new device has:
  • The same intended uses (protection against bruxism/nighttime teeth grinding, reducing damage to teeth, preventing noise).
  • Similar indications.
  • Similar technological characteristics and principles of operation.
  • Minor technological differences that raise no new questions of safety or effectiveness.

Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the comparison to predicate devices and the argument for substantial equivalence, as presented in the Special 510(k) notice.

• Device Performance (as reported):
  • "Grind No More Generation II is as safe and effective as the predicate devices."
  • It "has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices."
  • The "minor technological differences... raise no new questions of safety or effectiveness."

Predicate Devices:

• Ranir, LLC's Grind No More 2 (K091175)
• Ranir, LLC's Rest Assured Nite Protector (K063229)

Technological Characteristics of the Grind No More Generation II:

• Anterior and posterior occlusive mouthguard.
• Consists of two molar bite plates and an anterior bite plate connected by a buccal retention band.
• Molar bite plates are grooved with vertical positioners for enhanced retention (similar to Grind No More 2).
• Addition of an anterior bite plate (the primary modification from Grind No More 2, but technologically similar to the predicate Rest Assured).

In summary, for this specific Special 510(k) submission, the "acceptance criteria" and "study" are less about novel performance data and more about demonstrating that the minor modifications to an already approved device do not alter its fundamental safety and effectiveness compared to its predicates.

Summary

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K09 4020

510(k) SUMMARY

Ranir, LLC's Grind No More Generation II

JAN 2 5 2010

: |

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

Phone:	[phone]
Facsimile:	[phone]

Date Prepared: December 10, 2009

Name of Device and Name/Address of Sponsor

Grind No More Generation II

Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512

[phone] Phone: Facsimile: [phone]

Common or Usual Name

Mouthguard

Classification Name

Mouthguard, Over-the-Counter

Classification Product Code

OBR

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Predicate Devices

Ranir, LLC's Grind No More 2 (K091175) Ranir, LLC's Rest Assured Nite Protector (K063229)

Purpose of the Special 510(k) notice.

The Grind No More Generation II is a modification to Ranir's Grind No More 2 (K091175).

Intended Use

Grind No More Generation 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

Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate. However, there are multiple FDA cleared mouthguards that incorporate both anterior and posterior occlusion, such as the predicate Rest Assured. Therefore, the Grind No More Generation II is technologically similar to the predicate devices.

Substantial Equivalence

Grind No More Generation II is as safe and effective as the predicate devices. Grind No More Generation II has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More Generation II and the predicate devices raise no new questions of safety or effectiveness. Thus, the Grind No More Generation II is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.

Public Health Service

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

JAN 9 5 2010

Ranir LLC C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan and Hartson LLP 555 Thirteenth Street, N.W. Washington, District of Columbia 20004

Re: K094020

Trade/Device Name: Grind No More Generation II Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: OBR Dated: December 29, 2009 Received: December 29, 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for

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):

Device Name: Grind No More Generation II

Indications for Use:

The Grind No More Generation 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.

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)

RSBetz DDS for Dr. K.P. Mulay

(Division Sign-Off) ( (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

N/A