(322 days)
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding.
NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
The provided text describes a 510(k) submission for a non-diagnostic medical device (a mouth guard), not an AI/ML-enabled diagnostic device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are relevant to AI/ML device performance evaluation, are largely not present in this document.
However, I will extract the information that is present concerning the device's "performance" in the context of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (NightGuard mouth guard), the "acceptance criteria" and "performance" are framed around substantial equivalence to predicate devices, rather than quantitative performance metrics like sensitivity or specificity. The primary "performance" characteristic is its ability to serve the intended use.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (NightGuard) |
|---|---|
| Indications for Use: Protection against bruxism and nighttime teeth grinding; reduce damage to teeth; prevent noise associated with bruxing and grinding. | Same as predicate devices (Doctor's Nightguard, Ez Splint PM, Dr Hays Bite Guard) |
| Design: Adjustable Pre-formed oral device | Same as predicate devices |
| Materials: Thermoplastic Resin | Thermoplastic Resin (Same as predicate Doctor's Night Guard) |
| Method of Manufacture: Injection Molded | Same as predicate devices (Ez Splint PM, Dr. Hays Bite Guard are also molded, though Dr. Hays is dental laboratory molded) |
| Prescription Device: No | No (Same as predicate Doctor's Night Guard) |
| Reusable: Yes, single patient | Yes, single patient (Same as predicate devices) |
| Method of Disinfection: Warm water, soap and air dry | Same as predicate devices |
Study That Proves the Device Meets the Acceptance Criteria:
Based on the provided document, no specific study was performed to "prove" the device meets acceptance criteria in the context of performance metrics. For this 510(k) submission, the "proof" is established through a comparison to legally marketed predicate devices to demonstrate substantial equivalence.
Here's why and what was reported:
- Non-Clinical Tests Performed: "No non-clinical tests were preformed for the determination of substantial equivalence."
- Clinical Tests Performed: "No clinical tests were preformed for the determination of substantial equivalence."
- Conclusions Drawn From Non-Clinical and Clinical Tests: "No conclusions were drawn from Non-clinical and Clinical Test."
- Overall Conclusion: "NightGuard is as safe, as effective, and performs as well as or better than the predicated device." This conclusion is drawn purely from the narrative and tabular comparison of features with the predicate devices, not from direct testing of the NightGuard itself.
Given that this is a 510(k) for a non-diagnostic, non-AI device, the subsequent questions are not applicable. I will explicitly state why for each:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or data was used as no clinical or non-clinical studies were performed for this 510(k). The determination was based on comparison to predicate devices.
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)
- Not applicable. No test set was used, and therefore no ground truth was established by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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 device is not an AI/ML diagnostic. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no performance studies were conducted. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device and does not have a training set.
{0}------------------------------------------------
510(k) Summary
[As Required by 21 CFR 807.92(c)]
MAR i 2 2007
1. Owner Information: [807.92(a)(1)]
Alpine Oral Care, LLC Owner's Name: . 4003 Leeland Ave Owner's Address: Houston, TX 77003 Telephone: (713) 223-8899 Fax: (713) 223-0982
Contact Person: Cathy Teng
Date Prepared: 02/15/07
2. Device Name: [807.92(a)(2)]
Trade Name: NightGuard
Common Name: mouth guard
Mouth guards have yet to be classified.* Classification:
*Predicate products are classified under the following: Mouth guard Device: Product Code: MQC Review Panel: Dental
3. Predicate Devices: [807.92(a)(3)]
| Device | Applicant | 510(k) | Decision Date |
|---|---|---|---|
| Doctor's Nightguard | Dental Concepts, LLC | K053580 | 03/03/06 |
| Ez Splint & Ez Splin | Power Products, Inc. | K022809 | 10/17/2003 |
| Dr. Hays Bite Guard | Inventive Resources, Inc. | K014079 | 02/22/2002 |
4. Device Description: [807.92(a)(4)]
{1}------------------------------------------------
NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
5. Intended Use: [807.92(a)(5)]
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding
6. Comparison to Predicate Device: [807.92(a)(6)]
Narrative Comparison:
The Night Guard is composed of a soft thermoplastic resin. When the product is heated and cooled briefly the material can be molded to fit the upper teeth. The predicate devices, are the same or substantial equivalent in terms of design, material, chemical composition as outlined in the follow table.
| Feature | NightGuard | Doctor'sNight Guard | Ez Splint PM | Dr HaysBite Guard |
|---|---|---|---|---|
| Indicationsfor Use | The Night Guardis intended forprotection againstbruxism andnighttime teethgrinding. It isintended to reducedamage to teeth andto prevent the noiseassociated withbruxing and grinding | Same | Same | Same |
| Design | Adjustable Pre-formed oral device | Same | Same | Same |
| Materials | Thermoplastic Resin | ThermoplasticResin | Elvax strap,polypropelene andkraton bite pads | Lexan&Evax |
| Method ofManufacture | Injection Molded | Same | Same | DentalLaboratory |
Table: 3-1
{2}------------------------------------------------
| molded | ||||
|---|---|---|---|---|
| PrescriptionDevice | No | Same | Yes | Yes |
| Reusable | Yes, single patient | Same | Same | Same |
| Method ofDisinfection | Warm water, soapand air dry | Same | Same | Same |
7. Non-Clinical Tests Performed [807.92(b)(1)]
No non-clinical tests were preformed for the determination of substantial equivalence.
8. Clinical Tests Preformed [807.92(b)(2)]
No clinical tests were preformed for the determination of substantial equivalence.
9. Conclusions Drawn From Non-Clinical and Clinical Tests [807.92(b)(3)]
No conclusions were drawn from Non-clinical and Clinical Test.
10. Conclusion
NightGuard is as safe, as effective, and performs as well as or better than the predicated device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cathy Teng Manager Alpine Oral Care, LLC 4003 Leeland Avenue Houston, Texas 77003
MAR 1 2 2007
Re: K061122
Trade/Device Name; Night Guard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: February 23, 2007 Received: February 28, 2007
Dear Ms. Teng:
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 such 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.
{4}------------------------------------------------
Page 2 -Ms. Teng
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
1122
1
Indications for Use
510(k) Number : K061122
Device Name: Night Guard
Indications for Use:
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the negations would with bruxing and grinding.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use xx AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Suser Riomer
N/A