TEETHAN 2.0

K161716 · Bts S.P.A. · KZM · Dec 21, 2016 · Physical Medicine

Device Facts

• Record ID: K161716
• Device Name: TEETHAN 2.0
• Applicant: Bts S.P.A.
• Product Code: KZM · Physical Medicine
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system. To measure relative (intra-patient) levels of activity of 2 muscles during a functional act.

Device Story

TEETHAN 2.0 is a diagnostic electromyograph system. It records electrical activity from two muscles of the stomatognathic system (specifically temporalis or masseter) using surface electrodes. The device processes these signals to provide clinicians with relative (intra-patient) levels of muscle activity during functional tasks. Used in clinical settings by healthcare professionals to aid in diagnosis and evaluate treatment efficacy. The output provides quantitative data on muscle function, assisting clinicians in assessing stomatognathic system performance and monitoring changes over time.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use consistent with predicate devices.

Technological Characteristics

Diagnostic electromyograph (Class II, Product Code KZM). System records electrical activity of two muscles (temporalis or masseter) via surface electrodes. Operates as a diagnostic tool for the stomatognathic system. Connectivity and software details not specified in provided documentation.

Indications for Use

Indicated for patients requiring clinical monitoring of stomatognathic system muscles (temporalis or masseter) to aid in diagnosis and treatment evaluation by recording electrical activity and measuring relative intra-patient muscle activity levels during functional acts.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Submission Summary (Full Text)

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

December 21, 2016

BTS S.p.A. c/o Julie Sherman Pr Medical Research Manager NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis, Minnesota 55422

Re: K161716

Trade/Device Name: TEETHAN 2.0 Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: KZM Dated: November 29, 2016 Received: December 1, 2016

Dear Julie Sherman:

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.

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161716

Device Name TEETHAN 2.0

#### Indications for Use (Describe)

- · To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
· To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system

· To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

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| | Type of Use (Select one or both, as applicable) |

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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