(234 days)
The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
The Narval Brux is a removable intraoral device used for protecting teeth and restorations aqainst the forces of bruxism. It consists of patient-specific splints that fit separately over the upper or lower teeth. The design of the splints is dependent on the patient needs.
The device functions as a protective barrier for teeth and restorations by creating physical separation between posterior occlusal surfaces and/or anterior incisal edges which will prevent tooth damage caused by grinding, bruxing and may help alleviate jaw and muscle pain.
The device is customized for each patient based on the clinician prescription.
The provided document is a 510(k) summary for the Narval Brux device, which is a mouthguard intended for the protection of teeth and restorations from bruxism.
The document does not describe a clinical study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/ML device would. Instead, this 510(k) submission establishes substantial equivalence to a predicate device (SomnoBrux Splint(s), K102909) through non-clinical testing.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from this document.
Here's an attempt to answer the questions based on the provided information, noting where information is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
For the Narval Brux, the acceptance criteria are not presented as quantitative performance metrics (e.g., sensitivity, specificity) but rather as successful completion of non-clinical tests ensuring comparable safety and efficacy to a predicate device.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass biocompatibility tests per ISO 10993 (cytotoxicity, sensitization). | Non-clinical data submitted included biocompatibility (cytotoxicity, sensitization per ISO 10993) and demonstrated substantial equivalence. |
| Software Validation | Software functions as intended and is safe. | Non-clinical data submitted included software validation and demonstrated substantial equivalence. |
| Cleaning Validation | Device can be effectively cleaned for reusable use. | Non-clinical data submitted included cleaning validation and demonstrated substantial equivalence. |
| Performance Testing | Withstand static compression forces representative of bruxism without failure to protect teeth. | Non-clinical data submitted included performance testing (static compression) and demonstrated substantial equivalence. |
| Substantial Equivalence | Demonstrate that the device does not raise new issues of safety or efficacy compared to the predicate device, based on similar Indications for Use, technological characteristics, and performance characteristics. | Based on the testing performed (biocompatibility, software validation, cleaning validation, and performance testing), it was concluded that the subject device does not raise new issues of safety or efficacy. The Narval Brux was assessed to be substantially equivalent to the predicate device (K102909). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable in the context of this 510(k) submission, as no human clinical test set (like an AI/ML model's test set) was used. The submission focuses on non-clinical engineering and material tests.
- Data Provenance: Not specified for the non-clinical tests. Non-clinical data typically refers to laboratory or bench testing.
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. Ground truth, in the AI/ML context, is not relevant for this type of non-clinical device submission. The "ground truth" here would be the validated performance of the materials and design against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set requiring expert 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 done. This type of study is relevant for AI/ML diagnostic or assistive technologies, not for a physical medical device like a mouthguard, especially when establishing substantial equivalence via non-clinical data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" or basis for evaluation in this submission stems from established engineering standards, material safety standards (ISO 10993 for biocompatibility), and performance test methodologies (static compression) for mouthguards. The substantial equivalence argument relies on the new device performing equivalently to the predicate device in these non-clinical aspects.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set mentioned in this document.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML training set described.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 13,2015
ResMed Corp. Larissa D'Andrea Director, Government and Regulatory Affairs 9001 Spectrum Center Blvd. San Diego, CA 92123
Re: K143623
Trade/Device Name: Narval Brux Regulation Number: None Regulation Name: Mouthguard Regulatory Class: Unclassified Product Code: MQC Dated: July 16, 2015 Received: July 17, 2015
Dear Ms. D'Andrea:
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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Page 2 - Ms. D'Andrea
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 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/ResourcesforYou/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.
Susan Runyon DDS, MA
Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known):
Device Name:
Narval Brux
Indications for Use:
The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
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510(k) SUMMARY
Date Prepared 13 July 2015
- Submitter Ms. Larissa D'Andrea Regulatory Affairs Manager
- Official Contact Ms. Larissa D'Andrea Requlatory Affairs Manager 9001 Spectrum Center Blvd San Diego CA 92123 USA Tel: (858) 836-6837
Device Trade Name Narval Brux
- Device Common Name Mouthguard Classification Unclassified Product Code MQC
- Predicate Devices SomnoMed Inc., SomnoBrux® Splint(s), K102909
- Description The Narval Brux is a removable intraoral device used for protecting teeth and restorations aqainst the forces of bruxism. It consists of patient-specific splints that fit separately over the upper or lower teeth. The design of the splints is dependent on the patient needs.
The device functions as a protective barrier for teeth and restorations by creating physical separation between posterior occlusal surfaces and/or anterior incisal edges which will prevent tooth damage caused by grinding, bruxing and may help alleviate jaw and muscle pain.
The device is customized for each patient based on the clinician prescription.
- Intended Use The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
Technological
- Characteristics Based on the comparative analysis of technological characteristics. Narval Brux and SomnoBrux are substantially equivalent. Both are patient-specific devices which cover posterior occlusal surfaces and/or anterior incisal edges and act as protective barriers for teeth and restorations from the effects of bruxism. Any minor design and material differences do not affect safety and performance.
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| New Device: | Predicate Device:SomnoBrux Splint(s)(K102909)SomnoMed Inc. | |
|---|---|---|
| Indication ForUse Statement | The Narval Brux isintended for protection ofteeth and restorations fromthe forces of bruxism. | The SomnoBrux Splints areused for the protection ofteeth and restorations fromthe forces of Bruxism. |
| Materials | Nylon | Acrylic |
| Prescription /Over the Counter | Prescription | Prescription |
| Single Use /Reusable | Reusable | Reusable |
| Fixed /Removable | Removable | Removable |
| Sterile / Non-Sterile | Non-sterile | Non-sterile |
Summary of Non-Clinical and Clinical Testing
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility (cytotoxicity, sensitization per ISO 10993), software validation, cleaning validation, and performance testing (static compression). The non-clinical data included in this submission demonstrate substantial equivalence to the predicate device K102909.
Clinical data were not submitted in this premarket notification.
Substantial Equivalence Conclusion
Based on the testing performed, including biocompatibility, software validation, cleaning validation, and performance testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Narval Brux are assessed to be substantially equivalent to the predicate device.
N/A