GRINDCARE MEASURE

K113677 · Medotech A/S · KZM · Apr 5, 2012 · Physical Medicine

Device Facts

• Record ID: K113677
• Device Name: GRINDCARE MEASURE
• Applicant: Medotech A/S
• Product Code: KZM · Physical Medicine
• Decision Date: Apr 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

Device Story

Portable electromyographic (EMG) monitoring device; records temporalis muscle activity during sleep. Input: EMG signals via tri-polar electrode/double-adhesive patch on forehead. Processing: Recorder logs/processes EMG signals to detect tooth grinding/clenching events. Output: Stored EMG data transferred to healthcare professional's PC for assessment. Usage: Home setting; patient-applied. Clinical impact: Aids clinicians in evaluating bruxism; facilitates diagnosis/management decisions.

Clinical Evidence

Bench testing only. Device shown to meet design specifications and relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40).

Technological Characteristics

Portable EMG monitor; tri-polar electrode with conductive gelpads; lithium-ion rechargeable battery; docking station; wireless data transfer to PC; microprocessor-controlled; software-based signal processing.

Indications for Use

Indicated for patients requiring evaluation of nocturnal bruxism via measurement of temporalis muscle EMG activity during sleep.

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.

Predicate Devices

• GRINDCARE (K092675)
• SLP, Inc Bitestrip (K030869)

Submission Summary (Full Text)

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## APR - 5 2012

## 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the GRINDCARE MEASURE device is provided below.

| Device Common Name: | Dental Muscle Monitoring Device |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | GRINDCARE MEASURE |
| Submitter: | Medotech A/S<br>Marielundvej 43A-DK-2730 Herlev<br>Phone: [phone] |
| Contact: | Calley Herzog, Consultant<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | March 1, 2012 |
| Classification<br>Regulation: | 21 CFR 890.1375 Diagnostic electromyography, Class II |
| Panel: | Dental |
| Product Code: | KZM: Dental Muscle Monitoring Device |
| Predicate Devices: | GRINDCARE - K092675<br>SLP, Inc Bitestrip - K030869 |

#### Indication for Use:

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

#### Device Description:

GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and

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connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

#### Performance Data:

Device testing was performed and the device was shown to meet its design specifications.

As stated in the previous 510(k) (K092675) device performance has been tested and meets the following standards which also apply to the GRINDCARE MEASURE:

- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety .
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-40: Medical Electrical Equipment Part 2-40: Particular Requirements for . the Safety of Electromyographs and Evoked Response Equipment

RF function of the GRINDCARE MEASURE meets requirements of FCC CFR 47 Part 15, Subpart C.

## Conclusions drawn from testing:

The performance testing demonstrates that GRINDCARE MEASURE is safe and has acceptable performance for the proposed intended use and indication for use.

## Substantial Equivalence:

The GRINDCARE MEASURE device is intended to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep. It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events.

GRINDCARE MEASURE is substantially equivalent to the following predicate devices:

- . GRINDCARE (K092675)
- SLP. Inc Bitestrip (K030869) .

| 510(k) Number | TBD | K092675 | K030869 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medotech | Medotech | SLP Inc |
| Device Name | GRINDCARE<br>MEASURE | GRINDCARE | BiteStrip |
| 510(k) Number | TBD | K092675 | K030869 |
| Manufacturer | Medotech | Medotech | SLP Inc |
| Device Name | GRINDCARE<br>MEASURE | GRINDCARE | BiteStrip |
| Regulation | 890.1375 | 890.1375, 882.5050 | 890.1375 |
| Product Code | KZM | KZM, HCC | KZM (muscle monitoring<br>device, dental) |
| Indication for Use | The GRINDCARE<br>MEASURE device is<br>indicated to aid in the<br>evaluation of<br>nocturnal bruxism by<br>measuring the<br>temporalis muscle<br>EMG activity during<br>sleep. | The Grindcare device<br>is indicated to aid in<br>the evaluation and<br>management of<br>nocturnal bruxism by<br>reducing the<br>temporalis muscle<br>EMG activity during<br>sleep. | The BiteStrip is generally<br>indicated for use by<br>orofacial pain<br>professionals or dentists to<br>aid in the evaluation and<br>management of nocturnal<br>masticatory muscles<br>activity disorders, which<br>may be related to the<br>patient's bruxism,<br>temporomandibular<br>disorder (TMD) or other<br>oral function disorders<br>during sleep. |
| BASIC UNIT<br>CHARACTERISTICS | | | |
| Power Source | Lithium-ion<br>rechargeable battery | Lithium-ion<br>rechargeable battery | Lithium battery |
| Number of Output<br>Channels | N/A | 1 | N/A |
| Software<br>Firmware/<br>Micro-processor<br>Control | Yes | Yes | Yes |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

APR - 5 2012

Medotech A/S · C/O Ms. Calley Herzog Consultant Biologics Consulting Group, Incorporated 13417 Ouivas Street Westminster, Colorado 80234

Re: K113677

Trade/Device Name: GRINDCARE MEASURE Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: II Product Code: KZM Dated: March 7, 2012 Received: March 8, 2012

Dear Ms. Herzog:

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. Herzog

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological.Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, . Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Medotech A/S

GRINDCARE MEASURE

113677

# 18

#### Indications for Use Statement 4.0

510(k) Number (if known):

Device Name: GRINDCARE MEASURE

Indications For Use:

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Ross

Jivision Sign-Off) : vivision of Anesthesiology, General Hospital "Ifection Control, Dental Devices

: 10(k) Number: K113677

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