(283 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use describes a physical device for dental protection and TMD relief.
Yes.
The intended use includes the temporary relief and treatment of medical conditions (Temporal Mandibular Disorder and bruxism) and associated symptoms (headaches and pains).
No
The intended use focuses on protection, temporary relief, and treatment of bruxism and TMD symptoms, not on diagnosing a condition.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (protection of teeth, relief of TMD and bruxism) are related to the physical treatment and management of conditions within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: While the description is "Not Found," the intended use strongly suggests a physical device like a mouthguard or splint, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The absence of information about image processing, AI/ML, input imaging modality, anatomical site, patient age range, user/care setting, training/test sets, performance studies, key metrics, and predicate/reference devices further supports that this is not an IVD. These are common elements found in submissions for diagnostic devices, especially those involving software or imaging.
In summary, the intended use clearly places this device in the category of a therapeutic or protective device, not a diagnostic one.
N/A
Intended Use / Indications for Use
- Protection of teeth and restorations from injury due to bruxism.
- Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Product codes
MOC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads in profile, representing health, humans, and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2015
SICAT GmbH & Co. KG Dr. Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, 53177 DE GERMANY
Re: K143655 Trade/Device Name: SICAT OPTIMOTION Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: August 15, 2015 Received: August 24, 2015
Dear Dr. Breuer:
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.
1
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 devicerelated 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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
for 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
2
Indications for Use
K143655 510(k) Number (if known):
Device Name:
SICAT OPTIMOTION_
Indications for Use:
-
Protection of teeth and restorations from injury due to bruxism.
-
Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension.
-
Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)________________________________________________________________________________________________________________________________________________________________________