(234 days)
No
The summary describes a physical, customized dental splint and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to alleviate jaw and muscle pain related to bruxism, which is a therapeutic effect.
No
The device is intended for protection of teeth and restorations from the forces of bruxism and acts as a protective barrier; it does not measure, analyze, or provide information for diagnosis.
No
The device description explicitly states it is a "removable intraoral device" consisting of "patient-specific splints," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "protection of teeth and restorations from the forces of bruxism." This describes a physical intervention to protect structures within the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a "removable intraoral device" that acts as a "protective barrier for teeth and restorations." This is a physical device used directly on the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Narval Brux is a medical device, specifically a dental device, used for a therapeutic and protective purpose.
N/A
Intended Use / Indications for Use
The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
Product codes
MQC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and restorations (intraoral)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in silhouette.
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 For
Use Statement | The Narval Brux is
intended for protection of
teeth and restorations from
the forces of bruxism. | The SomnoBrux Splints are
used for the protection of
teeth and restorations from
the 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.