The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

Device Description

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems:

Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module)
Life Sensor Firmware
Life Sensor Application

Life Sensor Electrode

Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart.
. Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device.
Life Sensor Firmware:

The Life Sensor Firmware is the software installed on the Life Sensor Module. The Life Sensor Firmware manages bi-directional communication between the Life Sensor Module and the Life Sensor Application. Encrypted data is transmitted to and from the Life Sensor Module and the Life Sensor Application.

. Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module.
When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process.

Life Sensor Application has visual alarms to alert clinical personnel when heart rate of the person being monitored is outside the set limits, lead off, asystole, tachycardia and bradycardia, when the battery is low, or when there is loss of communication between the Life Sensor Application and the Life Sensor Electrode.

AI/ML Overview

The provided text describes the Life Sensor Cardiac Monitor (CM) Platform and its 510(k) summary, comparing it to a predicate device, the LifeSignals WiPatch & WiApp System (K172011).

However, the document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with specific statistical results to "prove" the device meets acceptance criteria in the way a clinical trial or algorithm performance study might. The information provided is primarily related to non-clinical testing for safety and basic performance.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the form of specific quantitative thresholds in a table for most performance aspects. Instead, it states technical specifications and implies compliance with standards.

Feature / Metric	Acceptance Criteria (Explicitly Stated / Implied)	Reported Device Performance
Heart Rate Display Range	N/A (Predicate: 30 to 250 BPM)	30 to 200 BPM
Heart Rate Accuracy	N/A (Predicate: ±3/min)	±10 or ±5/min, whichever is greater
Wear Duration	N/A (Predicate: 72 hours maximum)	72 hours maximum
Biocompatibility	Compliance with ISO 10993-1:2018 recommendations (cytotoxicity, irritation, sensitization)	Complies with ISO 10993-1:2018 recommendations
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2	Complies with IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2
Software V&V	Compliance with FDA Guidance for "moderate" level of concern software	Documentation provided as recommended by FDA Guidance
Usability	Compliance with IEC 62366	Complies with IEC 62366
Shelf Life, Packaging Integrity, Operation & Storage Conditions	N/A (Bench testing was done to ensure these)	Bench testing completed

Missing Information/Detail:

Specific numerical acceptance criteria for biocompatibility, electrical safety, software V&V, and usability are not detailed, only that the device "complies" with the relevant standards.
The exact results of the shelf life, packaging integrity, and operation/storage conditions bench testing are not provided.
The document does not include any clinical performance data or studies comparing the device's accuracy in detecting medical conditions (as it states it "does not detect or diagnose medical conditions"). The focus is on accurate physiological data monitoring.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" or "training set" in the context of an algorithm's performance on patient data. The non-clinical testing mentioned (biocompatibility, electrical safety, software V&V, usability, bench testing) would have their own sample sizes (e.g., number of units tested for electrical safety, number of participants for usability) but these are not provided in the summary.

Data provenance: Not applicable in the context of algorithm performance on patient data, as no such study is described. The non-clinical tests would have been performed in a laboratory or controlled environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no algorithm performance or diagnostic study on a test set (with human-established ground truth) is described.

4. Adjudication Method for the Test Set

Not applicable, as no algorithm performance or diagnostic study on a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The device is a "monitor" and does not perform diagnostic interpretations that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study is not mentioned or described. The device's primary function is to monitor and transmit physiological data (ECG and heart rate) for review by healthcare professionals on an iOS application. It explicitly states, "The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions."

7. The Type of Ground Truth Used

For the basic physiological measurements (heart rate, ECG display), the "ground truth" would implicitly be derived from highly accurate, calibrated reference measurement devices used during "bench testing" or controlled physiological simulations, rather than pathology, expert consensus, or outcomes data, as the device is not for diagnosis. However, the details of how accuracy was measured against a reference are not provided, only the specified accuracy range.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm requiring a "training set" for diagnostic or predictive purposes is described.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no machine learning algorithm requiring a "training set" is described.

Summary of Device Purpose:
The Life Sensor Cardiac Monitor is presented as a wireless monitoring system for healthcare professionals to monitor physiological data (heart rate and ECG) in healthcare settings. It transmits data to an iOS application for review. The focus of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (LifeSignals WiPatch & WiApp System) through non-clinical testing for safety and basic performance (biocompatibility, electrical safety, software V&V, usability, bench testing), rather than through clinical trials or algorithm performance studies that would involve large patient datasets and established ground truths for diagnostic accuracy. The device monitors, but does not detect or diagnose medical conditions.

Summary

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June 12, 2019

BraveHeart Wireless, Inc. % Thomas Schorre Official Correspondent Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, Florida 33155-3708

Re: K191331

Trade/Device Name: Life Sensor Cardiac Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG, DRT, DRX Dated: May 14, 2019 Received: May 16, 2019

Dear Thomas Schorre:

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,

for Nicole Goodsell Assistant 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)

K191331

Device Name Life Sensor Cardiac Monitor

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 510(k) Summary for Life Sensor Platform

(As required by 21 CFR 807.92)

Submitter Information l.

Date Prepared:

Submitter	BraveHeart Wireless, Inc.11 Perimeter RoadNashua, NH 03063
Contact Person:	Balaji SudabattulaVP, Quality and Regulatory AffairsPhone: 385-988-0625Email: balaji.sudabattula@braveheart.life

April 10, 2019

II. Device Identification and Classification

Device Trade Name:Model Name:Common Name:	Life Sensor PlatformLife Sensor Cardiac MonitorWireless Remote Monitoring System
Classification Name:	Transmitters and Receivers, Physiological Signal,Radiofrequency
Classification Panel:	Cardiovascular
CRF Section:	870.2910, 870.2300, 870.2360
Device Class:
Product Code:	DRG, DRT, DRX

III. Predicate Device

Manufacturer:	Life Signals, Inc
Model Name:	LifeSignals WiPatch & WiApp System
510(k) #:	K172011

This predicate has not been subject to a design-related recall.

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IV. Device Description

Life Sensor Electrode

Bluetooth

iPad installed with Life Sensor App

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems:

Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module) Life Sensor Firmware Life Sensor Application

Life Sensor Electrode

Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart.
. Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device.
Life Sensor Firmware:

. Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module.
When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process.

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V. Indications for Use

Comparison	Life Sensor Platform(subject)	WiPatch & WiApp System
Sponsor	BraveHeart Wireless, Inc.Nashua, NH	LifeSignalsFremont, CA
Intended use	The Life Sensor Platform is awireless monitoring systemintended for use by healthcareprofessionals for surveillance ofphysiological data withinhealthcare settings. This includesheart rate andelectrocardiography (ECG). Datais transmitted wirelessly from LifeSensor Patch to an application oniOS device where it is displayedfor review by healthcareprofessionals. The device isintended for use on general care	The LifeSignals WiPatch &WiApp system is intended forspot check and short-termmonitoring of ECG & heartrate of patients at rest orpatients who can betransported within the rangeof the antenna network. TheWiPatch & WiApp system hasvisual and audio alarms toalert clinical personnel whenheart rate falls outside the setlimits. The device is intendedfor use on general carepatients of 18 years or older.The device is not intended for

VI. Summary Table of Substantial Equivalence

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Comparison	Life Sensor Platform(subject)	WiPatch & WiApp System
	patients 18 years or older and byprescription only.	use on critical care patients.
IntendedPopulation	Adults ≥ 18	Adults ≥ 18
Intended UseEnvironment	Healthcare facility	Healthcare facility
Heart Rate	Yes	Yes
ECG Display	Single channel	ECG-A and ECG-B
Sensor	Wireless patch design -	Wireless patch design RF/Wi-Fi
	RF/Bluetooth 2.4 GHz	2.4 GHz 802.11b
Wear duration	72 hours maximum	72 hours maximum
Hardware	Standard commercial iOS tablet	Standard commercial iOS tablet
Platform
Technical Specifications
Display Range	30 to 200 BPM	30 to 250 BPM
Accuracy	±10 or ±5/min, whichever is	±3/min
	greater.
Battery	Lithium ion (non-chargeable)	Two zinc air coin cell batteries

Life Sensor CM Platform and the predicate device (LifeSignals WiPatch & WiApp System, 510(k) #: K172011) monitor and display ECG and heart rate. Healthcare professional can set limits for heart rate to alarm the healthcare provider if a patient's heart rate falls outside the set limits. Both transmit data to an iPad for review by healthcare professional.

Minor difference is that the predicate device uses Wi-Fi while the subject device uses Bluetooth Low Energy (BLE) to communicate with iPad.

VII. Summary of Performance Testing

The following non-clinical testing has been completed to demonstrate safety and effectiveness of the Life Sensor Cardiac Monitor Platform.

. Biocompatibility testing, including in-vitro cytotoxicity, irritation and sensitization, performed according to the recommendations of ISO 10993-1:2018, Biological evaluation of medical devices – Part: Evaluation and testing.
. Electrical safety and EMC testing. The device complies with IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2.

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. 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 "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.
. Bench testing, including shelf life, packaging integrity, operation and storage conditions.
Usability testing. The device complies with IEC 62366.

VIII. Conclusion

The Life Sensor Cardiac Monitor Platform is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use.

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).