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 Biosensor 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 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 K163453.

The following modifications are proposed for the VitalPatch wearable biosensors:

. An ambient temperature sensor is added to the original VitalPatch, which was most recently cleared in K163453, to measure ambient temperature. The measured ambient temperature along with the measured skin temperature cleared in K163453 are used to calculate the body temperature.
. An updated IFU for VitalPatch has been created to reflect the temperature sensor changes.

All other 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) cleared in K163453 remain the same.

AI/ML Overview

The provided document is a 510(k) summary for the VitalConnect Platform and VitalPatch Biosensor. It details the device's characteristics, indications for use, and comparison to a predicate device (K163453). However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system as implied by some of the questions.

The document states that the new VitalPatch Biosensor adds an ambient temperature sensor to calculate body temperature. It focuses on demonstrating substantial equivalence to the previously cleared predicate device for general physiological monitoring (heart rate, ECG, respiratory rate, skin temperature, activity, posture, fall detection).

Here's an analysis based on the available information and a direct answer to your questions, noting what cannot be answered from the provided text:

Key Takeaway: This document describes a medical device clearance related to a hardware modification (adding an ambient temperature sensor) and a derived vital sign (body temperature). It explicitly states that clinical studies were not required for this clearance, and the substantial equivalence was based on benchtop performance testing. Therefore, many of the questions related to MRMC studies, expert consensus, and large test/training datasets for AI models are not applicable or answerable from this specific document.

1. A table of acceptance criteria and the reported device performance:

The document summarizes the performance characteristics of the proposed device by comparing them to the predicate device in Table 4. It treats "Identical" as meeting the acceptance criteria set by the predicate. For new features, it lists the range.

Performance Characteristic	Predicate (K163453) Acceptance Criteria / Performance	Proposed Device Performance / Acceptance Criteria
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	Differential voltage from heart, digitized	Identical
Heart Rate	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	N/A (Predicate did not measure this)	Range: 15°C - 50 °C (61°F - 113°F)
Body Temperature	N/A (Predicate did not calculate this)	Range: 32°C - 42°C (Calculated from skin & ambient)
Fall Detection	Range: Fall or No Fall	Identical
Step Count	Range: 0 - 65535 steps	Identical
Posture Detection	Lying down, upright, walking, running, leaning	Identical
R-R Interval	Measurement of R-R peak, enhanced QRS performance	Identical
Heart Rate Variability	Quantifies variation in beat-to-beat interval	Identical
Low Power Mode	Reduced current draw when off body	Identical

For "Body Temperature," the criteria are implied to be that the proposed device can derive this value within the specified range (32°C - 42°C). The document confirms that "Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers." This suggests the acceptance criterion for body temperature derivation would be accuracy against a gold standard (oral thermometer), though the specific accuracy metric (e.g., mean absolute difference, standard deviation of differences, clinical equivalence) and its threshold are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on benchtop and simulated use testing for the new modifications. It explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the VitalPatch. Instead, substantial equivalence is based upon benchtop performance testing."

For the new "Body Temperature" calculation: "Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers."

Sample Size: Not specified for the paired readings.
Data Provenance: Not specified (e.g., country). It was likely prospective, as it involved simultaneous measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this 510(k) clearance document. The ground truth for the new body temperature parameter was established via a hand-held oral thermometer, which serves as a widely accepted clinical standard for temperature measurement. There is no mention of human experts interpreting physiological waveforms or images to establish ground truth.

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

Not applicable. This type of adjudication is typically used in studies where human readers are interpreting complex medical data (like images) and consensus is needed. The performance assessment here involved direct comparison to an established measurement device (oral thermometer) and verification of engineering specifications.

5. 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

No, an MRMC comparative effectiveness study was not done. The device described is a physiological data sensor, not an AI-assisted diagnostic tool that would typically involve human readers. The clearance was based on substantial equivalence and benchtop testing, not on improving human reader performance.

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

For the new body temperature feature, the "algorithm only" performance was evaluated by comparing the VitalPatch's calculated body temperature to that of a hand-held oral thermometer. The exact methodology and results (e.g., specific accuracy metrics) are not detailed beyond "analyzed to verify accuracy."

For the other parameters (heart rate, respiratory rate, etc.), they remain "Identical" to the predicate, meaning their standalone performance was previously established and is considered sufficient.

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

For the new "Body Temperature" calculation, the ground truth was "paired readings, using VitalPatch and hand-held oral thermometers simultaneously." This represents a clinical measurement reference standard.
For other physiological parameters, the ground truth would have been established during the clearance of the predicate device (K163453) using appropriate reference methods for each parameter (e.g., ECG for heart rate, spirometry for respiratory rate, etc.).

8. The sample size for the training set

This document does not describe the development or training of a complex AI model requiring a large training set. The "firmware" update (Version 3.1.0.1) mentioned for the new device includes "Body temperature derivation," which implies a calculation or algorithm rather than a machine learning model that undergoes "training." Therefore, the concept of a "training set" in the context of machine learning is not applicable here.

9. How the ground truth for the training set was established

As there's no "training set" for an AI model described, this question is not applicable. The body temperature derivation is listed as a "calculated value as a function of the skin and ambient temperatures," indicating a deterministic algorithm rather than a learned model.

Summary

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March 7, 2019

VitalConnect, Inc. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K183078

Trade/Device Name: VitalConnect Platform, VitalPatch Biosensor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: November 5, 2018 Received: November 5, 2018

Dear Robert Packard:

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 mav, 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 avare 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 and Part 809; 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, vou may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Arielle Drummond -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183078

Device Name

VitalConnect Platform, 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:

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: March 6, 2019

II. DEVICE
Name of Device:	VitalConnect Platform, VitalPatch Biosensor
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:	Vital Connect, Inc.
Predicate Trade Name:	VitalConnect Platform, VitalPatch Biosensor
Predicate 510(k):	K163453

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The following modifications are proposed for the VitalPatch wearable biosensors:

. An ambient temperature sensor is added to the original VitalPatch, which was most recently cleared in K163453, to measure ambient temperature. The measured ambient temperature along with the measured skin temperature cleared in K163453 are used to calculate the body temperature.
. An updated IFU for VitalPatch has been created to reflect the temperature sensor changes.

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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 Biosensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

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.

Table 1 Comparison of Indications for Use (change is identified in bold font)

Table 2 Size Comparison of the adhesive patch

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Dimension	Predicate (K163453)	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 Proposed Devices

Component	Predicate (K163453)	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	N/A - only in subject device	Designed to monitor ambient temperatureto more accurately calculate bodytemperature using the skin temperatureinput.
Flexible Assembly	Provides a connection between the ECGelectrodes, thermistors and patchelectronics. The flexible circuit is sealedwithin the patch.	Equivalent except the addition of theambient thermistor
Firmware	Rev. 1.0.1.13 to support functions listedin Table 4 for Predicate (K163453)	Version 3.1.0.1 of firmware adds:• Support for VitalPatch 3hardware• Sense ambient temperature• Body temperature derivation• Ability to blink the LED• 30° bed-angle posture calibration• 120-hour patch-life timer (basedon K163453 clearance)• Maintenance improvements

Table 4 – Device Performance Characteristics Comparison

PerformanceCharacteristic	Predicate (K163453)	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	Identical
	FCC Part 15 Complied
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 that	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	N/A - Subject Device Only	Using an additional thermistor sensoron the Patch, which is away from theskin, the VitalConnect Biosensoraccurately measures patch ambienttemperature, reporting the temperaturein degrees Centigrade. A knownquantity of current generated by thesensor is converted to a voltage that isaccurately matched to the ambienttemperature.Range: 15°C - 50 °C (61°F - 113°F)
Body Temperature	N/A - Subject Device Only	A calculated value as a function of theskin and ambient temperatures.Range: 32°C - 42°C
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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K183078

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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.

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Biocompatibility Testing

Biocompatibility testing, previously conducted, 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)

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

Shipping validation and transit testing and was performed to demonstrate that changes to VitalPatch did not negatively affect the safety and efficacy when compared to the predicate device. Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers.

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).

Predicate (K163453)	Subject Device
The VitalConnect Platform is a wireless remote monitoring	The VitalConnect Platform is a wireless remote monitoring
system intended for use by healthcare professionals for	system intended for use by healthcare professionals for
continuous collection of physiological data in home and	continuous collection of physiological data in home and
healthcare settings. This can include heart rate,	healthcare settings. This can include heart rate,
electrocardiography (ECG), heart rate variability, R-R	electrocardiography (ECG), heart rate variability, R-R
interval, respiratory rate, body temperature, skin	interval, respiratory rate, body temperature, skin
temperature, activity (including step count), and posture	temperature, activity (including step count), and posture
(body position relative to gravity including fall). Data are	(body position relative to gravity including fall). Data are
transmitted wirelessly from the VitalConnect Sensor for	transmitted wirelessly from the VitalConnect Sensor for
storage and analysis. The VitalConnect Platform can	storage and analysis. The VitalConnect Platform can
include the ability to notify healthcare professionals when	include the ability to notify healthcare professionals when
physiological data fall outside selected parameters.	physiological data fall outside selected parameters.
The device is intended for use on general care patients who	The device is intended for use on general care patients who
are 18 years of age or older as a general patient monitor, to	are 18 years of age or older as a general patient monitor, to
provide physiological information. The data from the	provide physiological information. The data from the
VitalConnect Platform are intended for use by healthcare	VitalConnect Platform are intended for use by healthcare
professionals as an aid to diagnosis and treatment. The	professionals as an aid to diagnosis and treatment. The
device is not intended for use on critical care patients.	device is not intended for use on critical care patients.