(113 days)
Not Found
No
The description mentions signal processing to detect activity but does not use terms like AI, ML, or related concepts, nor does it describe training or test sets typically associated with such technologies.
No.
The device is used for evaluation and measurement of nocturnal bruxism by measuring muscle activity, not for treatment.
Yes
The device is indicated to "aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep." This involves collecting data (EMG activity) and processing it to detect specific events (tooth grinding/clenching) for assessment by a healthcare professional, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it consists of a recorder, a tri-polar electrode, and a docking station, which are hardware components.
Based on the provided information, the GRINDCARE MEASURE device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes things like blood, urine, tissue, etc.
- The GRINDCARE MEASURE device measures physiological activity on the human body. It directly measures the electrical activity of the temporalis muscle using electrodes placed on the skin.
The device is a physiological monitoring device that measures a biological signal (EMG) from the body's surface to aid in the evaluation of a condition (nocturnal bruxism). This falls outside the definition of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KZM
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
temporalis muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
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. The performance testing demonstrates that GRINDCARE MEASURE is safe and has acceptable performance for the proposed intended use and indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
iof3
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 |
| Marielundvej 43A-DK-2730 Herlev | |
| Phone: +45 86 72 15 00 | |
| Contact: | Calley Herzog, Consultant |
| Biologics Consulting Group, Inc. | |
| Phone: 720-883-3633 | |
| Fax: 720-293-0014 | |
| Email: cherzog@bcg-usa.com | |
| Date Summary Prepared: | March 1, 2012 |
| Classification | |
| Regulation: | 21 CFR 890.1375 Diagnostic electromyography, Class II |
| Panel: | Dental |
| Product Code: | KZM: Dental Muscle Monitoring Device |
| Predicate Devices: | GRINDCARE - K092675 |
| 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
1
273
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:
| 510(k) Number | TBD | K092675 | K030869 |
|---|---|---|---|
| Manufacturer | Medotech | Medotech | SLP Inc |
| Device Name | GRINDCARE | ||
| MEASURE | GRINDCARE | BiteStrip | |
| 510(k) Number | TBD | K092675 | K030869 |
| Manufacturer | Medotech | Medotech | SLP Inc |
| Device Name | GRINDCARE | ||
| MEASURE | GRINDCARE | BiteStrip | |
| Regulation | 890.1375 | 890.1375, 882.5050 | 890.1375 |
| Product Code | KZM | KZM, HCC | KZM (muscle monitoring |
| device, dental) | |||
| 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. | The Grindcare device | ||
| is indicated to aid in | |||
| the evaluation and | |||
| management of | |||
| nocturnal bruxism by | |||
| reducing the | |||
| temporalis muscle | |||
| EMG activity during | |||
| sleep. | The BiteStrip is generally | ||
| indicated for use by | |||
| orofacial pain | |||
| professionals or dentists to | |||
| aid in the evaluation and | |||
| management of nocturnal | |||
| masticatory muscles | |||
| activity disorders, which | |||
| may be related to the | |||
| patient's bruxism, | |||
| temporomandibular | |||
| disorder (TMD) or other | |||
| oral function disorders | |||
| during sleep. | |||
| BASIC UNIT | |||
| CHARACTERISTICS | |||
| Power Source | Lithium-ion | ||
| rechargeable battery | Lithium-ion | ||
| rechargeable battery | Lithium battery | ||
| Number of Output | |||
| Channels | N/A | 1 | N/A |
| Software | |||
| Firmware/ | |||
| Micro-processor | |||
| Control | Yes | Yes | Yes |
2
.
.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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
Page 1 of _1