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.

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:

removal of the pacemaker contraindication from the VitalPatch instructions for use,
heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate are not intended for patients with pacemakers.
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 store heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate.

AI/ML Overview

The document provided describes a 510(k) premarket notification for the VitalConnect Biosensor, specifically addressing modifications to allow its use with patients who have pacemakers. The primary study presented focuses on ensuring that the device's functionality does not interfere with pacemakers and that certain physiological measurements are appropriately suppressed when a pacemaker is detected.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't present a single, concise table of acceptance criteria and reported device performance in the format requested. Instead, it discusses performance characteristics and verification activities related to specific aspects of the device, particularly regarding its functionality with pacemakers.

Based on the "Performance Data" section, two key areas with implied acceptance criteria and reported performance are:

Table 1: Implied Acceptance Criteria and Reported Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
EMI Interference on Pacemaker	EMI interference on the pacemaker by the VitalPatch Biosensor is within allowable limits for pacemakers complying with ISO 14117:2012 and ANSI/AAMI PC69:2000.	"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 ANSI/AAMI PC69:2000." (No detailed results or specific limit values provided in this summary.)
Pacemaker Status Check & Functionality	If a pacemaker is indicated as present, the device will not transmit or store heart rate, ECG, heart rate variability, R-R interval, and respiratory rate. When a pacemaker is indicated as absent, these functions are correctly displayed/transmitted/stored.	"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." (No specific metrics like accuracy or reliability percentages are provided in this summary, only a statement of positive performance.)
Heart Rate Performance (non-pacemaker)	Satisfies clinical acceptance criteria in non-pacemaker subjects after bug fixes.	"Testing shows the Heart Rate after modifications satisfies the clinical acceptance criteria in non-pacemaker subjects." (No specific clinical acceptance criteria are detailed in this summary.)
Battery Current Draw (Predicate vs. Subject)	Subject device draws the same amount of current as the predicate device under the same operating scenario.	"When tested under the same operating scenario, the predicate and subject device draw same amount of current. Hence, the battery current consumption between the predicate and subject device is substantially equivalent."

Study Information:

The document describes several verification and validation activities rather than a single, comprehensive "study" with a traditional design for evaluating a diagnostic algorithm.

1. Sample size used for the test set and the data provenance:

EMI Interference Testing: Not specified.
Pacemaker Status Check Test: Not specified.
Heart Rate Performance (non-pacemaker subjects): Not specified.
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." The number of subjects is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The mention of "non-pacemaker human subjects" for clinical studies implies prospective data collection, but details are lacking.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The described tests are primarily performance evaluations of device functionality and safety, not diagnostic accuracy requiring expert ground truth for interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations for a test set.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The document focuses on device performance and safety, particularly concerning pacemaker compatibility, not on human reader performance with or without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the tests described are primarily standalone performance evaluations of the device's firmware and hardware functionalities, independent of human interpretation or assistance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

EMI Interference: Ground truth would be established by regulatory standards (ISO 14117:2012 and ANSI/AAMI PC69:2000) and possibly measurements from calibrated equipment.
Pacemaker Status Check Test: Ground truth for pacemaker presence would be the actual state of the patient (e.g., presence of a pacemaker) and the expected device response (suppression of certain measurements).
Heart Rate Performance (non-pacemaker subjects): For heart rate and respiratory rate, ground truth would likely come from a reference standard device or method, although not explicitly stated.
Battery Current Draw: Ground truth is measured current consumption.

7. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense for learning patterns from data to make predictions or classifications. The "firmware" being modified refers to programmed logic, not a learned model.

8. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned for an AI/ML algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K192757

Device Name VitalConnect Biosensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ 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) 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

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.
1. 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

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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.

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Table 1 C e T. ાર .. f TT

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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-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 3.2.1.0 of firmware fixes a bugand allows configuration for 120-hourpatch life timer or 168-hour patch-lifetimer.	The firmware in subject device fixesbugs, is modified to attenuate distortionsdue to pacemaker artifacts. If pacemakeris indicated as present, the device will nottransmit or store heart rate,electrocardiography (ECG), heart ratevariability, R-R interval, and respiratoryrate.

Table 4 – Device Performance Characteristics Comparison

PerformanceCharacteristic	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 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 when pacemaker is indicatedas absent; ECG is not available forpatients with pacemakers
Heart Rate (stationaryand ambulatory)	Heart rate is measured and calculated inBeats Per Minute (BPM) both for stationaryand ambulatory use.Range: 30 - 200 BPM	Identical when pacemaker is indicatedas absent; Heart rate is not available forpatients with pacemakers
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 when pacemaker is indicatedas absent; Respiratory rate is notavailable for patients with pacemakers
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 when pacemaker is indicatedas absent; R-R interval is not availablefor patients with pacemakers
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 when pacemaker is indicatedas absent; HRV is not available forpatients with pacemakers
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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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.

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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.

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).