GrindCare System

{0}------------------------------------------------ Image /page/0/Picture/1 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 design featuring three human profiles facing right, with flowing lines representing movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 1, 2017 Sunstar Suisse S.A. % Calley Herzog Senior Consultant Biologics Consulting Group 400 N. Washington St., Suite 100 Alexandria, Virginia 22314 Re: K163448 Trade/Device Name: GrindCare System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC, KZM, NUW Dated: August 3, 2017 Received: August 4, 2017 #### Dear Calley 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. 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 {1}------------------------------------------------ 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 (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 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, Andrew I. Steen -S for Lori A. Wiggins, MPT, CLT Acting 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 510(k) Number (if known) K163448 Device Name GrindCare System #### Indications for Use (Describe) The Grind Care System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the GrindCare System is provided below. | Device Common Name: | Biofeedback Device | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name: | GrindCare System | | Applicant: | Sunstar Suisse S.A.<br>Route de Pallatex 11, 1163 Etoy<br>Switzerland<br>+41-21-821-0500 | | Prepared by: | Calley Herzog<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>cherzog@biologicsconsulting.com<br>Phone: 720-883-3633<br>Fax: 703-548-7457 | | Date Prepared: | August 31, 2017 | | Classification Regulation: | 882.5050 - Biofeedback device, Class II | | Panel / Product Code: | Neurology / HCC | | Secondary Product Codes: | KZM - Diagnostic Electromyograph<br>NUW - Powered Muscle Stimulator, Dental | | Predicate Device: | GrindCare, K092675 | ### Indication for Use: The GrindCare System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep. # Device Description: The GrindCare System is a portable electromyographic (EMG), electrical stimulation, and biofeedback device. It consists of a Sensor that is adhered to the skin over the temporalis muscle by means of an adhesive, disposable, single-use GelPad. The System also includes a Docking Station, USB Cable, and Power Adaptor. The Sensor and Docking Station record and store EMG activity data, which is transferred from the Docking Station to the GrindCare Mobile App, which allows the user to review grinding and stimulation data and enter diary notes. The Sensor 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. Bruxism is the occurrence of {4}------------------------------------------------ (typically sleep) grinding and clenching of the jaw and is one of the most common sleep disorders. The components of the GrindCare System: - . Sensor: A self-contained and battery powered component, to be placed on the skin of the patient. It records EMG activity and reacts with electrical stimulation when muscle activity is detected. - Docking Station: A USB-powered device, where the Sensor is inserted when not in use for charging and to transfer data. Both charging and data transfer is performed wirelessly. - USB Cable: A USB cable with a micro-USB connector in one end and a standard USB connector at the other end used for power (no data transfer is possible). - Power Adapter - . GelPad: GrindCare is to be used with an adhesive, single-use GelPad. One pack of 28 GelPads is provided with the device and additional GelPads can be purchased separately. The GrindCare device is not intended to be used with any other gel pads. - GrindCare App: An iOS and Android mobile app that allows the user to review grinding and stimulation data and enter diary notes. ### Substantial Equivalence Discussion: The predicate device is a previous version of the GrindCare System and was cleared in K092675. The predicate device is based on the same principle of operation as the subject device, but uses a modified detection algorithm. The table below provides a comparison of the technological features of the subject device to the predicate device. | | Proposed Device | Predicate Device | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | TBD | K092675 | | Applicant | Sunstar | Medotech A/S | | Device Name | GrindCare System | GRINDCARE | | Classification Regulation | 882.5050 | 882.5050 | | Product Code<br>Subsequent Product<br>Codes | HCC: Biofeedback Device<br>NUW: Powered Muscle<br>Stimulator, Dental<br>KZM: Muscle Monitoring<br>Device, Dental | HCC: Biofeedback Device<br>NUW: Powered Muscle Stimulator,<br>Dental<br>KZM: Muscle Monitoring Device,<br>Dental | | Number of Output<br>Channels | 1 | 1 | | Number of Output Modes | 1 | 1 | | Waveform | Biphasic symmetrical | Biphasic symmetrical | | | Proposed Device | Predicate Device | | Shape | Rectangular | Rectangular | | Placement | On the skin at the temple, over<br>the Temporalis Anterior muscle. | On the skin at the temple, over the<br>Temporalis Anterior muscle. | | Regulated Current or<br>Regulated Voltage? | Regulated Current | Regulated Current | | Maximum Output<br>Voltage | 40 V | 40 V | | Maximum Output<br>Current | 7 mA | 7 mA | | Pulse Width | $500 \mu s$ | $500 \mu s$ | | Frequency | 230 pulses/sec | 230 pulses/sec | | Net Charge | 0 (charge balanced) | 0 (charge balanced) | | Maximum Phase Charge | $1.75\mu C$ | $1.75\mu C$ | | Maximum Current<br>Density | $35mA/cm^2$ | $35mA/cm^2$ | | Maximum Power Density | $0.022 W/cm^2$ | $0.022 W/cm^2$ | | Electrode | Conductive gel w/adhesive<br>galvanic tripolar electrode | Conductive gel w/adhesive galvanic<br>tripolar electrode | | Input Impedance | 4.4MOhms | 4.4MOhms | | Common Mode Rejection<br>Ratio | 90dB | 90dB | | Power Source / Charging | 70mAh LiPo<br>IEC 62133 compliant Lithium-<br>ion rechargeable battery in the<br>Sensor<br>Inductive (wireless) link for<br>charging the Sensor battery. | 340mAh LiPo<br>Lithium-ion rechargeable battery in<br>the Stimulator and GrindDock<br>Gold spring contacts for charging<br>the Stimulator when docked in the<br>GrindDock. | | Average Battery Charge<br>Time | 3.5 hours | 3.5 hours | | Communication | Infrared link for transferring data<br>from Sensor to Docking Station.<br>Bluetooth communication for<br>transferring data from Docking<br>Station to GrindCare App. | Zigbee type radio link for<br>communication between Stimulator<br>and GrindDock | | Data Storage | Sensor stores only a single<br>session of data. Docking Station<br>stores up to 5 years of data. | Stimulator stores up to 30 sessions<br>of data.<br>No data stored on the GrindDock | | | Proposed Device | Predicate Device | | PCB Size | 35x19mm | 45x30mm | | Microprocessor | Docking Station:<br>MSP430-F5333 processor<br>Sensor:<br>MSP430-F5338 processor | GrindDock:<br>MSP430-F2618 processor<br>Stimulator:<br>MSP430-F2618 processor | | Viewing the Data | Bluetooth type radio link for<br>communication between Docking<br>Station and GrindCare App on an<br>iOS or Android device. There is<br>no display on the device.<br>Mobile App is used to view the<br>data. | Data transferred by USB to a PC.<br>LCD display on the GrindDock. | | Grind Threshold | Automatically calculated<br>continuously based on<br>background noise. | Determined by user input before<br>each use. | {5}------------------------------------------------ {6}------------------------------------------------ ## Comparison of Indications: Predicate device indication statement (K092675): The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep. Subject device indication statement: The GrindCare System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep. As shown above, the indication statement of the subject device is equivalent to that of the predicate device. The term "nocturnal bruxism" has been replaced with "sleep bruxism", to reflect the generally accepted terminology used in the scientific community to describe the behavior, as this type of bruxism is linked to the awake/sleep state and not to the time of day/night. The change is a clarification of the indication statement and does not represent a change to the intended use. ### Discussion of Technological Differences: Power Source / Charging - In the predicate device both the GrindDock and the Stimulator were battery powered. In the subject device the Sensor battery is charged wirelessly. The lithium-ion battery complies with the FDA-recognized standard IEC 62133. Power to the Docking Station comes from a USB adapter or a USB port. Performance testing demonstrated the functionality of the wireless charging. Communication - The predicate device used a Zigbee type radio link for communication between Stimulator and GrindDock. The subject device uses an infrared link for transferring data from Sensor to Docking Station and Bluetooth communication for transferring data from the Docking Station to the GrindCare App. Performance testing demonstrated the functionality of {7}------------------------------------------------ communication between the Sensor and the Docking Station and between the Sensor and the GrindCare App. Data Storage - In the predicate device, the Stimulator stored up to 30 nights of data. In the subject device, the Sensor stores one night of data, but every time it is inserted into the Charger, the data is transferred. The Charger can store data from up to 5 years of typical use. Performance testing demonstrated the functionality of the data storage and transfer. PCB Size - All input and output circuitry relating to patient contact is unchanged and specifications are the same. Only the circuitry that generates the compliance voltage for the stimulation circuit has been redesigned, to reduce size and improve efficiency. Performance testing demonstrated the functionality of the PCB. Microprocessor - The microprocessor chosen for the subject device is similar to the processor in the predicate device. There are no differences that have any impact on functionality or performance requirements for the subject device compared to the predicate device. Performance testing demonstrated the functionality of the microprocessor. Viewing the Data - In the predicate device, the data was viewed on the GrindDock device, on the LCD display or was uploaded to a PC to be viewed in a dedicated program, the GrindCare Manager. In the subject device, the data is viewed on a portable device, based on either the Android operating system or the iOS operating system (iPhones, iPads). Performance testing demonstrated the functionality of the GrindCare App. Grind Threshold - Like the predicate device, the subject device detects grinds by comparing the amplitude of the signal generated by the user's muscle activity to a baseline, or background noise level. The subject device calculates the threshold differently than the predicate device. This difference in setting the threshold for a grinding event does not change the intended use of the device as a biofeedback system for reducing muscle activity during sleep. For both devices, a grind is defined as measured muscle activity that is quantifiably above background noise. Once a grind is detected, the subject device provides the identical stimulation signal as was provided by the predicate device. Performance testing demonstrated equivalent performance of the grind detection algorithm to the predicate device. Shelf Life - The 510(k) for the predicate device did not indicate a shelf life, the GelPads are now labeled with a shelf life of 24 months. Performance testing demonstrated that the device meets specifications after 24-months. | Type | Description of Testing or Standard Referenced | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Verification<br>Testing | Hardware, Algorithm and System Level Testing was completed to verify that the<br>device meets design and performance specifications and is equivalent to the<br>predicate device. | | Safety | IEC 60601-1: 2005 + CORR1:2006 + CORR.2:2007 + AM1:2012<br>Medical electrical equipment -- Part 1: General Requirements for basic safety and<br>essential performance | # Performance Data Provided to Establish Substantial Equivalence: {8}------------------------------------------------ | Type | Description of Testing or Standard Referenced | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | IEC 60601-2-40: 1998 Medical electrical equipment - Part 2-40: Particular<br>requirements for the safety of electromyographs and evoked response equipment | | | IEC 60601-1-6: 2010 (Third Edition) + A1:2013 Medical electrical equipment Part<br>1-6 General requirements for safety - Collateral Standard: Usability | | | IEC 60601-1-11: 2010 (First edition) Medical Electrical Equipment - Part 1-11:<br>General Requirements for Basic Safety and Essential Performance – Collateral<br>Standard: Requirements for Medical Electrical Equipment and Medical Electrical<br>System Used in Home Healthcare Environment | | EMC | IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general<br>requirements for basic safety and essential performance - collateral standard:<br>electromagnetic compatibility - requirements and tests. | | Battery<br>Certification | IEC 62133 Edition 2.0: 2012-12, secondary cells and batteries containing alkaline<br>or other non-acid electrolytes - safety requirements for portable sealed secondary<br>cells, and for batteries made from them, for use in portable applications | | Wireless<br>Coexistence | Testing to demonstrate wireless coexistence with other FR transmitters common in<br>the home environment. | | Biocompatibility<br>of Gelpad | ISO 10993-5:2009 biological evaluation of medical devices - part 5: tests for in<br>vitro cytotoxicity. | | | ISO 10993-10: 2010 biological evaluation of medical devices - part 10: tests for<br>irritation and skin sensitization | | Shelf Life | Shelf life testing was performed that demonstrates the device continues to meet<br>performance specifications for the 24-month shelf life of the gelpads. | | Usability<br>Testing | Subjects were observed while completing device and app critical tasks. Use error<br>information (including an evaluation of labeling comprehension) was analyzed.<br>The study demonstrated that users and prescribers were able to perform the tasks<br>associated with use of the GrindCare device with the GrindCare App. | | Clinical Data | The clinical study demonstrated that the modified detection algorithm decreased<br>the number of EMG events per hour by 32.45% over baseline. | | | Like the predicate device, the subject device demonstrated a statistically significant<br>reduction on the number of EMG events per hour on a representative patient<br>population. | # Substantial Equivalence: The predicate device is a previous version of the GrindCare System and was cleared in K092675. The subject device has the same intended use as the predicate device and delivers the identical stimulation signal. The technical differences between the subject device and the predicate device are supported by performance testing to demonstrate that the differences do no raise new questions of safety or effectiveness. Therefore, the subject device can be found substantially equivalent to the predicate device.