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 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.

AI/ML Overview

Below is the information regarding the acceptance criteria and the study proving the device meets those criteria, extracted from the provided text.

A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for each physiological measurement (e.g., heart rate accuracy within X BPM). Instead, it states that the "Performance Characteristics" of the proposed device are "Identical" to the predicate device (K183078) for all listed physiological data types and other features. The "Performance Characteristic" table (Table 4) lists the capabilities and ranges for each measured parameter. Therefore, the "acceptance criteria" are implied to be the same as the established performance of the predicate device.

Performance Characteristic	Predicate (K183078) Performance (Implied Acceptance Criteria)	Proposed Device Performance (Reported)
Wireless Transmission	Bluetooth Low Energy (BT4.1) technology	Identical
Data encryption	Advanced Encryption Standard-CCM mode	Identical
Radio Frequency	2.4GHz ISM band, FCC Part 15 Complied	Identical
ECG Dynamic Range	Range: -10mV to +10mV	Identical
Heart Rate (stationary & ambulatory)	Range: 30 - 200 BPM	Identical
Respiratory Rate	Range: 10-30 breaths per minute	Identical
Skin Temperature	Range: 15°C - 50 °C (61°F - 113°F)	Identical
Ambient Temperature	Range: 15°C - 50 °C (61°F - 113°F)	Identical
Body Temperature	Range: 32°C - 42°C	Identical
Fall Detection	Range: Fall or No Fall	Identical
Step Count	Range: 0 - 65535 steps	Identical
Posture Detection	Postures detected include lying down, upright, walking, running and leaning.	Identical
R-R Interval	Measurement of the interval from the R wave peak of one QRS complex to the next R-wave peak on the electrocardiogram, enhanced QRS performance during motion.	Identical
Heart Rate Variability	Quantifies the variation in the beat-to-beat interval time series obtained from the ECG waveform. Detects each QRS peak with high temporal accuracy. Measurement of the R wave to R wave (RR) interval allows short and long-term variability analysis to determine analytics such as mean, median, standard deviation, frequency content, etc.	Identical
Low Power Mode	When patch is off the body, processor goes into a low power mode, resulting in reduced current draw.	Identical

New Feature/Modification	Predicate (K183078) Performance	Proposed Device Performance
Duration of Use	5 days (120 hours)	7 days (168 hours)

Sample size used for the test set and the data provenance
- The document states that substantial equivalence is based upon "benchtop performance testing" and lists several tests: "Wear Duration Testing", "Battery operating life testing", and "EOL Detection after 168 hours".
- The sample size for these tests is not specified in the provided text.
- The data provenance is not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the provided documentation describes benchtop performance testing, not a study involving human interpretation or ground truth established by experts for a test set.
Adjudication method for the test set
- This information is not applicable as the provided documentation describes benchtop performance testing, not a study requiring adjudication of expert interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- An MRMC comparative effectiveness study was not done. The study described is a benchtop performance validation for an extended wear duration, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document refers to "benchtop performance testing" which is essentially a standalone evaluation of the device's technical specifications and extended wear duration. It is not an "algorithm only" performance study in the context of AI, but rather a direct measurement of the device's physical and functional performance (e.g., battery life, EOL detection).
The type of ground truth used
- For the benchtop tests (Wear Duration, Battery operating life, EOL Detection), the ground truth would be objective pre-defined technical specifications and direct measurements (e.g., a timer measuring 168 hours, battery voltage measurements, sensor output at end-of-life).
The sample size for the training set
- This information is not applicable. The device (VitalPatch Biosensor) measures physiological parameters through sensors and firmware. It's not an AI/ML device that requires a training set in the typical sense for classification or prediction from complex data (like images). The firmware updates are minor changes to support extended duration and bug fixes.
How the ground truth for the training set was established
- This information is not applicable for the reasons stated above. The device is not based on machine learning from a training set with established ground truth.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +1.408.963.4600 Fax: +1.408.963.2828

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

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.

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 monitoringsystem intended for use by healthcare professionals forcontinuous collection of physiological data in home andhealthcare settings. This can include heart rate,electrocardiography (ECG), heart rate variability, R-Rinterval, respiratory rate, body temperature, skintemperature, activity (including step count), and posture(body position relative to gravity including fall). Data aretransmitted wirelessly from the VitalConnect Sensor forstorage and analysis. The VitalConnect Platform caninclude the ability to notify healthcare professionals whenphysiological data fall outside selected parameters.The device is intended for use on general care patients whoare 18 years of age or older as a general patient monitor, toprovide physiological information. The data from theVitalConnect Platform are intended for use by healthcareprofessionals as an aid to diagnosis and treatment. Thedevice is not intended for use on critical care patients.	The VitalConnect Platform is a wireless remote monitoringsystem intended for use by healthcare professionals forcontinuous collection of physiological data in home andhealthcare settings. This can include heart rate,electrocardiography (ECG), heart rate variability, R-Rinterval, respiratory rate, body temperature, skintemperature, activity (including step count), and posture(body position relative to gravity including fall). Data aretransmitted wirelessly from the VitalConnect Sensor forstorage and analysis. The VitalConnect Platform caninclude the ability to notify healthcare professionals whenphysiological data fall outside selected parameters.The device is intended for use on general care patients whoare 18 years of age or older as a general patient monitor, toprovide physiological information. The data from theVitalConnect Platform are intended for use by healthcareprofessionals as an aid to diagnosis and treatment. Thedevice is not intended for use on critical care patients.

Predicate (K183078)

Subject Device

The VitalConnect Platform is a wireless remote monitoringsystem intended for use by healthcare professionals forcontinuous collection of physiological data in home andhealthcare settings. This can include heart rate,electrocardiography (ECG), heart rate variability, R-Rinterval, respiratory rate, body temperature, skintemperature, activity (including step count), and posture(body position relative to gravity including fall). Data aretransmitted wirelessly from the VitalConnect Sensor forstorage and analysis. The VitalConnect Platform caninclude the ability to notify healthcare professionals whenphysiological data fall outside selected parameters.The device is intended for use on general care patients whoare 18 years of age or older as a general patient monitor, toprovide physiological information. The data from theVitalConnect Platform are intended for use by healthcareprofessionals as an aid to diagnosis and treatment. Thedevice 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-leadbipolar ECG at a sampling rate of 125Hz	Identical
Skin Thermistor	Mounted on the patch. Designed tomonitor skin temperatures when thepatch is attached to the skin.	Identical
Ambient Thermistor	Designed to monitor ambienttemperature to more accurately calculatebody temperature using the skintemperature input.	Identical
Flexible Assembly	Provides a connection between the ECGelectrodes, thermistors and patchelectronics. The flexible circuit is sealedwithin the patch.	Identical
Firmware	Version 3.1.0.1 to support functionslisted in Table 4 for Predicate(K183078)	Version 3.2.1.0 of firmware fixes a bugand allows configuration for 120-hourpatch life timer or 168-hour patch-lifetimer.

Table 4 – Device Performance Characteristics Comparison

PerformanceCharacteristic	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 bandFCC Part 15 Complied	Identical
ECG Dynamic Range	The Sensor electrodes make contact withthe skin to measure the differential voltagegenerated from the heart. The resultinganalog ECG waveform is digitized so thatthe data can be streamed to a display orrecording device.Range: -10mV to +10mV	Identical
Heart Rate (stationaryand ambulatory)	Heart rate is measured and calculated inBeats Per Minute (BPM) both for stationaryand ambulatory use.Range: 30 - 200 BPM	Identical
Respiratory Rate	From a combination of ECG and tri-axialaccelerometer sensor signals, the VitalConnect Sensor can accurately measure therespiratory rate of the person, irrespective ofwhether the person is stationary orambulatory.Range: 10-30 breaths per minute	Identical
Skin Temperature	Using a thermistor sensor on the Patch,which is in close proximity to the skin, theVital Connect Sensor accurately measuresthe temperature of the skin, reporting thetemperature in degrees Centigrade. Aknown quantity of current generated by thesensor is converted to a voltage that isaccurately matched to skin temperature.Range: 15°C - 50 °C (61°F - 113°F)	Identical
Ambient Temperature	Using an additional thermistor sensor on thePatch, which is away from the skin, theVitalConnect Biosensor accuratelymeasures patch ambient temperature,reporting the temperature in degreesCentigrade. A known quantity of currentgenerated by the sensor is converted to avoltage that is accurately matched to theambient temperature.Range: 15°C - 50 °C (61°F - 113°F)	Identical
Body Temperature	A calculated value as a function of the skinand ambient temperatures.Range: 32°C - 42°C	Identical
Fall Detection	Using a tri-axial accelerometer and digitalsignal processing techniques, the VitalConnect Sensor detects falls whileminimizing false notifications.Range: Fall or No Fall	Identical
Step Count	The Vital Connect Sensor also uses the tri-axial accelerometer to compute step count.As the person walks, the Vital ConnectSensor is capable of distinguishing stepsfrom other movements. The detected stepsare accumulated to provide an accurate stepcount.Range: 0 - 65535 steps	Identical
Posture Detection	Using the built-in tri-axial accelerometer,the Vital Connect Sensor can determine theposture of the person and provide wirelessreal-time updates to a central server.Postures detected include lying down,upright, walking, running and leaning.	Identical
R-R Interval	The R-R interval is the measurement of theinterval from the R wave peak of one QRScomplex to the next R-wave peak on theelectrocardiogram. The device has enhancedQRS performance during motion.	Identical
Heart Rate Variability	HRV quantifies the variation in the beat-to-beat interval time series obtained from theECG waveform. Using advanced signalprocessing algorithms, the Sensor detectseach QRS peak with high temporalaccuracy. Measurement of the R wave to Rwave (RR) interval allows short and long-term variability analysis to determineanalytics such as mean, median, standarddeviation, frequency content, etc.	Identical
Low Power Mode	When patch is off the body, to conservebattery power, the processor goes into a lowpower mode, resulting in reduced currentdraw	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.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).