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

K190916 · Vitalconnect, Inc. · DRG · Jun 7, 2019 · Cardiovascular

Device Facts

• Record ID: K190916
• Device Name: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
• Applicant: Vitalconnect, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended 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. The device is not intended for use on critical care patients.

Device Story

Wearable biosensor (VitalPatch) collects physiological signals (ECG, skin/ambient temperature, tri-axial accelerometer data); transmits data wirelessly via Bluetooth Low Energy to central server for storage/analysis; used by healthcare professionals in home/clinical settings to monitor general care patients. Device processes inputs to calculate heart rate, respiratory rate, HRV, R-R interval, step count, and posture; detects falls; notifies clinicians of out-of-parameter data. Output aids diagnosis and treatment decisions. Modification extends wear duration from 5 to 7 days (168 hours).

Clinical Evidence

No clinical data. Substantial equivalence established via benchtop performance testing, including wear duration, battery life, and EOL detection testing for 168-hour operation. Biocompatibility, electrical safety (IEC 60601-1 series), and EMC (IEC 60601-1-2) testing previously conducted.

Technological Characteristics

Wearable patch with ECG electrodes, skin/ambient thermistors, and tri-axial accelerometer. Wireless connectivity via Bluetooth Low Energy (2.4GHz ISM band). Data encrypted via AES-CCM. Dimensions: 120 x 40.6 x 9.4 mm. Firmware v3.2.1.0. Complies with IEC 60601-1, 60601-1-11, 60601-2-25, 60601-2-47, and FCC Part 15.

Indications for Use

Indicated for general care patients 18 years or older for continuous collection of physiological data (ECG, heart rate, HRV, R-R interval, respiratory rate, body/skin temperature, activity, posture) in home and healthcare settings. Not for critical care patients.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• VitalPatch® VitalConnect Platform (K183078)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

K190196 % Cynthia Merrell Vice-President QA &RA VitalConnect Inc. Contact Address

Re: K190196

Trade/Device Name: VitalPatch® Biosensor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: June 7, 2019 Received: April 9, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Matthew Hillebrenner Deputy Director 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

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# Indications for Use

510(k) Number (if known) K190196

Device Name VitalPatch 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. The device is not intended for use on critical care patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

#### 1. SUBMITTER VitalConnect, Inc. Address 224 Airport Parkway, Suite 300 City, State, Zip USA San Jose, CA, 95110, USA Tel: [phone] Fax: [phone]

Contact Person: Cynthia Merrell, VP QA&RA Date Prepared: April 4, 2019

| II. DEVICE | |
|------------------------------|-------------------------------------|
| Name of Device: | VitalPatch Biosensor |
| Classification Name: | Cardiovascular Monitoring Devices 2 |
| Regulation: | CFR §870.2910, 21 CFR 870.1025 |
| Regulatory Class: | Class II |
| Product Classification Code: | DRG, DSI, MHX |

PREDICATE DEVICE |||.

| Predicate Manufacturer: | Vital Connect, Inc. |
|-------------------------|-----------------------------------|
| Predicate Trade Name: | VitalPatch® VitalConnect Platform |
| Predicate 510(k): | K183078 |

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, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). VitalPatch was most recently cleared in K183078.

The following modifications are proposed for the VitalPatch wearable biosensors:

- . Increasing the duration for use from 5 days (120 hours) to 7 days (168 hours). This includes a minor software change and minor changes to the IFU.
All other 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) cleared in K183078 remain the same.

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#### INDICATIONS FOR USE V.

VitalConnect, Inc.

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. 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.

| Predicate (K183078) | Subject Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The VitalConnect Platform is a wireless remote monitoring<br>system intended for use by healthcare professionals for<br>continuous collection of physiological data in home and<br>healthcare settings. This can include heart rate,<br>electrocardiography (ECG), heart rate variability, R-R<br>interval, respiratory rate, body temperature, skin<br>temperature, activity (including step count), and posture<br>(body position relative to gravity including fall). Data are<br>transmitted wirelessly from the VitalConnect Sensor for<br>storage and analysis. The VitalConnect Platform can<br>include the ability to notify healthcare professionals when<br>physiological data fall outside selected parameters.<br><br>The device is intended for use on general care patients who<br>are 18 years of age or older as a general patient monitor, to<br>provide physiological information. The data from the<br>VitalConnect Platform are intended for use by healthcare<br>professionals as an aid to diagnosis and treatment. The<br>device is not intended for use on critical care patients. | The VitalConnect Platform is a wireless remote monitoring<br>system intended for use by healthcare professionals for<br>continuous collection of physiological data in home and<br>healthcare settings. This can include heart rate,<br>electrocardiography (ECG), heart rate variability, R-R<br>interval, respiratory rate, body temperature, skin<br>temperature, activity (including step count), and posture<br>(body position relative to gravity including fall). Data are<br>transmitted wirelessly from the VitalConnect Sensor for<br>storage and analysis. The VitalConnect Platform can<br>include the ability to notify healthcare professionals when<br>physiological data fall outside selected parameters.<br><br>The device is intended for use on general care patients who<br>are 18 years of age or older as a general patient monitor, to<br>provide physiological information. The data from the<br>VitalConnect Platform are intended for use by healthcare<br>professionals as an aid to diagnosis and treatment. The<br>device is not intended for use on critical care patients. |

#### Table 1 Comparison of Indications for Use (the indications for use are identical)

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#### Table 2 Size Comparison of the adhesive patch

| Dimension | Predicate (K183078) | Subject Device |
|-----------|---------------------|----------------|
| Length | 115 mm | 120 mm |
| Width | 35.6 mm | 40.6 mm |
| Height | 7.5 mm | 9.4 mm |

#### Table 3 Component Comparison of the Predicate and Subject Devices

| Component | Predicate (K183078) | 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 3.1.0.1 to support functions<br>listed in Table 4 for Predicate<br>(K183078) | 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. |

#### Table 4 – Device Performance Characteristics Comparison

| Performance<br>Characteristic | Predicate (K183078) | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |

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### VII. PERFORMANCE DATA

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.

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## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the VitalPatch. The device complies with the IEC 60601-1, IEC 60601-1-11. IEC 60601-2-25, and the IEC 60601-2-47 standards for safety. The device also complies with the IEC 60601-1-2 standard for EMC, IEC/TS 62657-2 and FCC CRF47 Part 15 Subpart C standards for wireless communication.

## 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 determined as 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.

# Benchtop & Simulated Use Testing

The following testing was provided to demonstrate the safe and effective performance of the subject device for 168 hours:

- Wear Duration Testing .
- . Battery operating life testing
- . EOL Detection after 168 hours

# Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

# Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the VitalPatch. Instead, substantial equivalence is based upon benchtop performance testing.

### 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 safety or effectiveness as established through performance testing. The subject device raises no new issues of safety or effectiveness from the predicate device.