(183 days)
Not Found
No
The description details signal processing of EMG data to detect events and trigger stimulation, but does not mention AI or ML techniques for this processing or any other function.
Yes
The device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing temporalis muscle EMG activity and delivering electrical stimulation to relax the muscle and inhibit bruxing events, which are therapeutic effects.
Yes
The device is indicated to "aid in the evaluation and management of nocturnal bruxism" and records EMG activity to "detect a particular activity (tooth grinding/clenching)." It also stores EMG events which "can be transferred to a healthcare professional's PC for assessment of the user's bruxism." This indicates a diagnostic function for evaluation and assessment.
No
The device description explicitly states it consists of a stimulator, a docking station, and a tri-polar electrode, which are hardware components.
Based on the provided information, the GRINDCARE device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- GRINDCARE's Function: The GRINDCARE device works on the body (in vivo). It measures electrical activity of a muscle (EMG) and delivers electrical stimulation directly to the muscle. It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the evaluation and management of nocturnal bruxism by reducing muscle activity, not by analyzing bodily fluids or tissues.
Therefore, the GRINDCARE device falls under the category of a medical device that interacts directly with the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Product codes (comma separated list FDA assigned to the subject device)
NUW, KZM, HCC
Device Description
GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode.
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 stimulator. 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. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event. The EMG events are logged and stored on the device. 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 (for assessment of data)
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.
Clinical data are provided to demonstrate safety and effectiveness, and therefore, substantial equivalence of the GRINDCARE device for the proposed 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
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
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510(k) Summary 5.0
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the GRINDCARE device is provided below.
| Device Common Name: | Biofeedback device | MAR - 3 2010 |
|---|---|---|
| Device Proprietary Name: | GRINDCARE | |
| 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 | ||
| Classification | ||
| Regulation: | 21 CFR 890.1375 Diagnostic Electromyograph, Class II | |
| • 21 CFR 882.5050 Biofeedback device, Class II | ||
| 21 CFR 890.5850 Powered Muscle Stimulator, Class II | ||
| Panel: | Dental | |
| Neurology | ||
| Physical Medicine | ||
| Product Code: | NUW: Stimulator, Muscle, Powered, Dental | |
| KZM: Device, Muscle Monitoring, Dental | ||
| • HCC: Device, Biofeedback |
Indication for Use:
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Device Description:
GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode.
...
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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 stimulator. 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. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event. The EMG events are logged and stored on the device. 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.
Device performance will also be in conformance to the following standards prior to marketing:
- 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 60601-2-10: Medical Electrical Equipment Part 2: Particular Requirements for . the Safety of Nerve and Muscle Stimulators
- 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 device meets requirements of FCC CFR 47 Part 15, Subpart C. Clinical data are provided to demonstrate safety and effectiveness, and therefore, substantial equivalence of the GRINDCARE device for the proposed indication for use.
Substantial Equivalence:
The GRINDCARE device is a biofeedback device that is intended to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep. It uses EMG to sense contraction of the temporalis
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Image /page/2/Picture/1 description: The image shows a handwritten number, K092675. The number is written in black ink on a white background. The number is underlined with a black line. The handwriting is cursive and slightly slanted.
muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event.
GRINDCARE is substantially equivalent to the following predicate devices:
- SLP, Inc Bitestrip (K030869) .
- Myotronics Noromed Model J-5 Myomonitor (K031998) ●
- Cole and Associates Mentamove (K040849) .
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 graphic of three wavy lines, resembling a flag or banner, positioned to the right of the text.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medotech A/S C/O Ms. Calley Herzog Consultant Biologics Consulting Group, Incorporated 13417 Quivas Street Westminster, Colorado 80234
MAR - 3 2010
Re: K092675
Trade/Device Name: Grindcare Regulation Number: 21CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: II Product Code: HCC Dated: February 24, 2010 Received: February 26, 2010
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Director
Division of Ana
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Eyaluation Center for Devices and
Radiological Health
Enclosure
5
4.0 Indications for Use Statement
510(k) Number (if known):
Device Name: GRINDCARE
Indications For Use:
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Prescription Use × (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)
Suven Ray
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K092675
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