VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 6, 2020 VitalConnect, Inc. Cynthia Merrell Vice-President, QA & RA 224 Airport Parkway. Suite 300 San Jose, California 95110 Re: K192757 Trade/Device Name: VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor - bag of 20, VitalPatch 7D Biosensor - bag of 20 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: September 30, 2019 Received: September 30, 2019 Dear Cynthia Merrell: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192757 Device Name VitalConnect Biosensor #### Indications for Use (Describe) The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. VitalPatch device can be used on patients with pacemakers that comply with ISO 14117:2012 and ANSVAAMI PC69:2000 without deviations. Heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are not intended for patients with pacemakers. The device is not intended for use on critical care patients. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="text-decoration: overline;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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 This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR §807.92: #### 1. SUBMITTER VitalConnect, Inc. Address 224 Airport Parkway, Suite 300 San Jose, CA, 95110, USA Tel: +1.408.963.4600 Fax: +1.408.963.2828 Contact Person: Cynthia Merrell, VP QA&RA Date Prepared: Feb 05, 2020 | II. DEVICE | | |------------------------------|-----------------------------------| | Name of Device: | VitalPatch | | Classification Name: | Cardiovascular Monitoring Devices | | Regulation: | 21 CFR §870.2910, 21 CFR 870.1025 | | Regulatory Class: | Class II | | Product Classification Code: | DRG, DSI, MHX | PREDICATE DEVICE == Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): Vital Connect, Inc. VitalPatch® Biosensor K190916 No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION VitalPatch is a wearable biosensor designed to measure a patient's vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). VitalPatch was most recently cleared in K190916. There are three device modifications included in this 510(k) pre-submission: - 1. removal of the pacemaker contraindication from the VitalPatch instructions for use, - heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate 2. are not intended for patients with pacemakers. - 3. the patch setup procedure interface was modified to select whether the patient has a pacemaker; the response inhibits as appropriate the functions not intended for patients with pacemaker. If pacemaker is indicated as present, the device will not transmit or {4}------------------------------------------------ store heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate. #### V. INDICATIONS FOR USE The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. VitalPatch device can be used on patients with pacemakers that comply with ISO 14117:2012 and ANSI/AAMI PC69:2000 without deviations. Heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are not intended for patients with pacemakers. The device is not intended for use on critical care patients. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE The intended use and technological features of the proposed Vital Connect Platform do not substantially differ from the legally marketed predicate device. The Vital Connect Platform and the predicate device have substantially equivalent intended uses and methods of operation. {5}------------------------------------------------ #### Table 1 C e T. ાર .. f TT {6}------------------------------------------------ | Dimension | Predicate (K190916) | Subject Device | |-----------|---------------------|----------------| | Length | 120 mm | 120 mm | | Width | 40.6 mm | 40.6 mm | | Height | 9.4 mm | 9.4 mm | #### Table 2 Size Comparison of the adhesive patch # Table 3 Component Comparison of the Predicate and Subject Devices | Component | Predicate (K190916) | Proposed Device | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ECG electrodes | Allow the recording of a single-lead<br>bipolar ECG at a sampling rate of 125<br>Hz | Identical | | Skin Thermistor | Mounted on the patch. Designed to<br>monitor skin temperatures when the<br>patch is attached to the skin. | Identical | | Ambient Thermistor | Designed to monitor ambient<br>temperature to more accurately calculate<br>body temperature using the skin<br>temperature input. | Identical | | Flexible Assembly | Provides a connection between the ECG<br>electrodes, thermistors and patch<br>electronics. The flexible circuit is sealed<br>within the patch. | Identical | | Firmware | Version 3.2.1.0 of firmware fixes a bug<br>and allows configuration for 120-hour<br>patch life timer or 168-hour patch-life<br>timer. | The firmware in subject device fixes<br>bugs, is modified to attenuate distortions<br>due to pacemaker artifacts. If pacemaker<br>is indicated as present, the device will not<br>transmit or store heart rate,<br>electrocardiography (ECG), heart rate<br>variability, R-R interval, and respiratory<br>rate. | ### Table 4 – Device Performance Characteristics Comparison | Performance<br>Characteristic | Predicate (K190916) | Proposed Device | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Wireless Transmission | Bluetooth Low Energy (BT4.1) technology | Identical | | Data encryption | Advanced Encryption Standard-CCM mode | Identical | | Radio Frequency | 2.4GHz ISM band<br>FCC Part 15 Complied | Identical | | | | | | ECG Dynamic Range | The Sensor electrodes make contact with<br>the skin to measure the differential voltage<br>generated from the heart. The resulting<br>analog ECG waveform is digitized so that<br>the data can be streamed to a display or<br>recording device.<br>Range: -10mV to +10mV | Identical when pacemaker is indicated<br>as absent; ECG is not available for<br>patients with pacemakers | | Heart Rate (stationary<br>and ambulatory) | Heart rate is measured and calculated in<br>Beats Per Minute (BPM) both for stationary<br>and ambulatory use.<br>Range: 30 - 200 BPM | Identical when pacemaker is indicated<br>as absent; Heart rate is not available for<br>patients with pacemakers | | Respiratory Rate | From a combination of ECG and tri-axial<br>accelerometer sensor signals, the Vital<br>Connect Sensor can accurately measure the<br>respiratory rate of the person, irrespective of<br>whether the person is stationary or<br>ambulatory.<br>Range: 10-30 breaths per minute | Identical when pacemaker is indicated<br>as absent; Respiratory rate is not<br>available for patients with pacemakers | | Skin Temperature | Using a thermistor sensor on the Patch,<br>which is in close proximity to the skin, the<br>Vital Connect Sensor accurately measures<br>the temperature of the skin, reporting the<br>temperature in degrees Centigrade. A<br>known quantity of current generated by the<br>sensor is converted to a voltage that is<br>accurately matched to skin temperature.<br>Range: 15°C - 50 °C (61°F - 113°F) | Identical | | Ambient Temperature | Using an additional thermistor sensor on the<br>Patch, which is away from the skin, the<br>VitalConnect Biosensor accurately<br>measures patch ambient temperature,<br>reporting the temperature in degrees<br>Centigrade. A known quantity of current<br>generated by the sensor is converted to a<br>voltage that is accurately matched to the<br>ambient temperature.<br>Range: 15°C - 50 °C (61°F - 113°F) | Identical | | Body Temperature | A calculated value as a function of the skin<br>and ambient temperatures.<br>Range: 32°C - 42°C | Identical | | Fall Detection | Using a tri-axial accelerometer and digital<br>signal processing techniques, the Vital<br>Connect Sensor detects falls while<br>minimizing false notifications.<br>Range: Fall or No Fall | Identical | | Step Count | The Vital Connect Sensor also uses the tri-<br>axial accelerometer to compute step count.<br>As the person walks, the Vital Connect<br>Sensor is capable of distinguishing steps<br>from other movements. The detected steps<br>are accumulated to provide an accurate step<br>count.<br>Range: 0 - 65535 steps | Identical | | Posture Detection | Using the built-in tri-axial accelerometer,<br>the Vital Connect Sensor can determine the<br>posture of the person and provide wireless<br>real-time updates to a central server.<br>Postures detected include lying down,<br>upright, walking, running and leaning. | Identical | | R-R Interval | The R-R interval is the measurement of the<br>interval from the R wave peak of one QRS<br>complex to the next R-wave peak on the<br>electrocardiogram. The device has enhanced<br>QRS performance during motion. | Identical when pacemaker is indicated<br>as absent; R-R interval is not available<br>for patients with pacemakers | | Heart Rate Variability | HRV quantifies the variation in the beat-to-<br>beat interval time series obtained from the<br>ECG waveform. Using advanced signal<br>processing algorithms, the Sensor detects<br>each QRS peak with high temporal<br>accuracy. Measurement of the R wave to R<br>wave (RR) interval allows short and long-<br>term variability analysis to determine<br>analytics such as mean, median, standard<br>deviation, frequency content, etc. | Identical when pacemaker is indicated<br>as absent; HRV is not available for<br>patients with pacemakers | | Low Power Mode | When patch is off the body, to conserve<br>battery power, the processor goes into a low<br>power mode, resulting in reduced current<br>draw. | Identical | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Pacemaker spikes | EMI interference on the pacemaker was not tested due to pacemaker contraindication. VitalPatch device does not detect or display pacemaker spikes. Effect of pacemaker spikes on ECG signal was not tested due to pacemaker contraindication. Effect of pacemaker spikes on heart rate was not tested due to pacemaker contraindication. Effect of pacemaker spikes on respiratory rate was not tested due to pacemaker contraindication. | Testing is performed to show that EMI interference on the pacemaker by the VitalPatch Biosensor is within allowable limits for pacemakers that comply with ISO 14117:2012 and ANSI/AAMI PC69:2000 VitalPatch device does not detect or display pacemaker spikes. Display of ECG signal is not available for patients with pacemakers. Heart Rate values (including heart rate variability and R-R interval) is not available for patients with pacemakers. Respiratory Rate is not available for patients with pacemakers. | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### PERFORMANCE DATA VII. Verification and validation activities established the safety and performance characteristics of the proposed device with respect to the predicate. The following performance data have been provided in support of the substantial equivalence determination: # Sterilization & Shelf-life Testing The Vital Connect Platform is provided non-sterile, and therefore sterilization data is not provided. Accelerated aging data was provided to support a shelf-life of 9 months as previously cleared. # Biocompatibility Testing Biocompatibility testing, previously conducted, included in-vitro cytotoxicity, irritation and sensitization, according to the recommendations of ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing. # Electrical safety and electromagnetic compatibility (EMC) Testing was performed to show that EMI interference on the pacemaker by the VitalPatch Biosensor is within allowable limits for pacemakers that comply with ISO 14117:2012 and ANSVAAMI PC69:2000. # Software Verification and Validation Testing Software verification and validation testing was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider. {10}------------------------------------------------ # Benchtop & Simulated Use Testing The following testing was performed to assess the performance of the subject device in the presence of pacemaker: - . Performance testing of heart rate in non-pacemaker subjects after bug fixes. - Summary: Testing shows the Heart Rate after modifications satisfies the clinical o acceptance criteria in non-pacemaker subjects. - Pacemaker Status Check Test - O Summary: Testing shows that if pacemaker is indicated as present, the device will not transmit or store heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate. Moreover, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are correctly displayed/transmitted/stored when pacemaker is indicated as absent. - Battery current draw testing of subject device - Summary: When tested under the same operating scenario, the predicate and subject o device draw same amount of current. Hence, the battery current consumption between the predicate and subject device is substantially equivalent. ### Animal Study Animal performance testing was not required for this device. # Clinical Studies Clinical testing was performed in non-pacemaker human subjects to demonstrate substantial equivalence in heart rate and respiratory rate of the subject device. #### VIII. CONCLUSIONS The subject device is substantially equivalent in design and intended use to the predicate device. Any differences between the subject device and the predicate device have no significant influence on performance testing. Therefore, the subject device raises no new issues of safety or effectiveness from the predicate device.