The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive.

The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.

The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.

Device Description

The B-Secur HeartKey Software Library is an "object library". An object library is a collection of callable functions that have been compiled into native machine code of the computer on which they will execute. The HeartKey Software Library includes a basic application for viewing and analyzing electrocardiogram (ECG) data. The source code for the library is not available and cannot be modified by the end user.

The B-Secur HeartKey Software Library provides ECG signal processing and QRS detection for a single lead ECG 30s spot check. System input lead is configurable based on the application, but the typical application is arrhythmia screening from a Lead I stainless steel dry electrode device capable of carrying out periodic spot checks.

The software library is designed to accept a digital ECG stream and produce several metrics.

AI/ML Overview

Acceptance Criteria and Study Details for B-Secur HeartKey Software Library (K200884)

The B-Secur HeartKey Software Library is intended for medical device manufacturers to assess single-lead ECG spot checks from adult patients. It processes ECG signals to provide heart rate and classify ECG rhythms as normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, unreadable, or inconclusive.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. However, it indicates that the algorithm's performance was assessed to ensure it "performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device."

The study compared the HeartKey Software Library's performance against its specifications and those implied by its equivalence to the predicate device. The performance focused on:

Heart Rate Validation
Tachycardia and Bradycardia Validation
Atrial Fibrillation Validation
Arrhythmia Detection Validation

While specific numerical performance metrics for the HeartKey Software Library are not provided, the document states: "The results of the testing demonstrate that the HeartKey® Software Library performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device."

2. Sample Size and Data Provenance for Test Set

The document states that algorithm performance testing was assessed using:

ECG databases from ANSI/AAMI EC57:2012: This standard outlines requirements for ambulatory electrocardiographs. These are likely established, publicly available databases.
B-Secur proprietary datasets: The specifics of these datasets are not detailed, so information on their country of origin or whether they are retrospective or prospective is not available in this document.

The exact sample size used for the test set is not explicitly mentioned.

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the "number of experts" used to establish ground truth for the test set or their "qualifications." It generally refers to using "ECG databases from ANSI/AAMI EC57:2012 and other proprietary datasets," which would typically have expert-derived ground truth.

4. Adjudication Method for Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The submission focuses on the standalone performance of the algorithm and its equivalence to a predicate, not on human-in-the-loop performance improvement.

6. Standalone Performance (Algorithm Only) Study

Yes, a standalone performance study was conducted. The document states: "Non-clinical testing was conducted to assess algorithm performance and to verify that the HeartKey® Software Library performs as intended including Heart Rate Validation, Tachycardia and Bradycardia Validation, Atrial Fibrillation Validation and Arrhythmia Detection Validation." This indicates that the algorithm's performance was evaluated inherently, without human intervention in the interpretation process.

7. Type of Ground Truth Used

The ground truth for the performance assessment was derived from "ECG databases from ANSI/AAMI EC57:2012 and other proprietary datasets." While not explicitly stated, such databases typically involve expert consensus or board-certified cardiologist interpretations to establish the definitive rhythm classifications and heart rate measurements.

8. Sample Size for Training Set

The document does not explicitly state the sample size used for the training set. It only mentions the databases used for performance testing.

9. How Ground Truth for Training Set Was Established

The document does not explicitly detail how the ground truth for the training set was established. However, given that performance testing used "ECG databases from ANSI/AAMI EC57:2012 and other proprietary datasets," it is reasonable to infer that similar methods (likely expert consensus or interpretations from cardiologists) would have been used for any training data derived from these or similar sources.

Summary

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December 7, 2020

B-Secur Ltd. % Paul Dryden Consultant B-Secur Ltd. c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K200884

Trade/Device Name: B-Secur HeartKey Software Library Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: October 30, 2020 Received: November 2, 2020

Dear Paul Dryden:

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 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)

K200884

Device Name

B-Secur HeartKev Software Librarv

Indications for Use (Describe)

The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.

Type of Use (Select one or both, as applicable)
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XX Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (6/20)

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K200884

	Page 1 of 7
Date Prepared:	7-Dec-20
Sponsor:B-Secur Ltd20 Queens RoadBelfast BT3 9DT United KingdomTel - + 44 2890 737800
Sponsor Contact:	David Brown, Head of Operations
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	HeartKey Software Library
Common/Usual Name:	Electrocardiograph
Classification Name:Product Classification:Regulation:Class:	Programmable diagnostic computerDQK21CFR 870.1425Class II
Classification Name:Product Classification:Regulation:Class:	ElectrocardiographDPS21CFR 870.2340Class II
Predicate Device:	K181823 – AliveCor, Inc. - KardiAI

Device Description:

The software library is designed to accept a digital ECG stream and produce several metrics.

Feature	Description
Signal filtering	The removal of noise from the input ECG
QRS detection	Identification of QRS complexes
Heart rate	Report calculated heart rate (40 bpm - 200 bpm)from the input ECG
RR interval	Report of time between QRS complexes

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Feature	Description
Signal Quality	Analysis and output of the quality of incoming signal
Arrhythmia analysis	Normal Sinus RhythmBradycardiaTachycardiaAtrial FibrillationInconclusiveUnreadable

510(k) Summary Page 2 of 7

All features are accessed via an application programming interface (API).

The device is only intended to analyze ECG from:

(1) "wet" lead I-or II electrodes, or
(2) lead I handheld stainless-steel dry electrodes from devices intended for automated ECG analysis.

B-Secur will compile the HeartKey library for the ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into their product for their ECG analysis.

It is the responsibility of the device manufacturer to integrate HeartKey correctly and to obtain the necessary regulatory approval/clearance for the final device integrating the HeartKey. It is also the responsibility of the device manufacturer to ensure their ECG device has the correct regulatory approvals and meets the required standards for their intended use; any regulatory clearance and tests that HeartKey has does not apply to an ECG device integrating HeartKey, and these processes and tests should be repeated at the system level.

Principle of Operation:

It is intended that the library is integrated into other device software. An application software program is written that calls some or all of the available functions within the software library. The application which forms the device software could be written to run on a PC, server or embedded microcontroller. All features are accessed via a documented application programming interface (API).

Indications for Use:

The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.

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Patient Population:

Adults (over 18)

Environments of use:

Home or healthcare environment

We present the proposed device vs. the predicate in Table 1.

As part of the comparison we will present and discuss the:

Indications for Use ●
Technology and Principle of Operation
. Performance and Specifications

Table 1 is a comparison - Subject Device vs. the Predicate, K181823 - AliveCor, Inc. - KardiAI. Note that the comparison to the predicate is based upon available technical specifications vs. comparative testing.

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K200884 510(k) Summary Page 4 of 7

Table 1 - Comparison - Subject vs. Predicate
----------------------------------------------	--

	Predicate - KardiAI	Subject device - HeartKey® Software Library	Comparison
K#	K181823	K200884	-
Product Code	DQK and DPS	DQK and DPS	Same
CFR	870.1425 / 870.2340	870.1425 / 870.2340	Same
Classification	Programmable Diagnostic Computer	Programmable Diagnostic Computer	Same
Indications for Use	KardiaAI is a software analysis library intended	The B-Secur HeartKey Software Library is intended	Similar
	to assess ambulatory electrocardiogram (ECG)rhythms from adult subjects. The device supportsanalyzing data recorded in compatible formats fromany ambulatory ECG devices such as event recorders,or other similar devices. The library is intended to beintegrated into other device software.	to be used by medical device manufacturers inmedical devices to assess a single lead ECG spotchecks from adult patients. The product allows theprocessing and extraction of beats from an ECGsignal to provide a heart rate reading and ECGrhythm analysis. The library will classify a 30 secondECG spot check recording as normal sinus rhythm,atrial fibrillation, bradycardia, and tachycardia,unreadable or inconclusive.	The predicate device may beimplemented in a device withOTC and/or prescriptive use.The medical devicemanufacturer integrating thelibrary, or select features ofthe library, into an ECGmonitoring device willdetermine the type of usefor their specific application.
	The library is not intended for use in lifesupporting, or sustaining systems, or ECGmonitors, or cardiac alarm, or OTC use onlydevices.	The library is intended to be integrated into otherdevice software. All interpretations must bereviewed by a medical professional for clinicaldecision making, and the user of the device shouldnot make changes to their medication withoutconsulting a physician.
	KardiaAI provides the following capabilities:• ECG noise filtering,• heart rate measurement from ECGs,• detection of noisy ECGs, and• ECG rhythm analysis for detecting the presence ofnormal sinus rhythm, atrial fibrillation, bradycardia,and tachycardia (when prescribed or used under thecare of a physician).	The library is not intended for use in life supportingor sustaining systems, or cardiac alarm systems.
Target Population	Adults (over 18)	Adults (over 18)	Same
Components	Software only	Software only	Same

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K200884 510(k) Summary Page 5 of 7

	Predicate - KardiAI	Subject device - HeartKey® Software Library	Comparison
Software FunctionalComparisons	An interface that provides tools to process andanalyze ECGs through various algorithmsThe automated proprietary ECG algorithmsprovide supportive information for ECGdiagnosis.The library can be accessed by directly connecting tothe KardiaAI's Application Programming Interface	An interface that provides tools to process andanalyze ECGs through various algorithms.An application software library can be written toinvoke some or all of the functions in an objectlibrary.The library can be accessed by directly calling theHeartKey Application Programming Interface.	SimilarAn object library is acollection of callable functionsthat have been compiled intonative machine code of thecomputer on which they willexecute. It is intended that anapplication software programis written that calls some or allof the available functionswithin the library.
Parameters measured	ECG Signal ProcessingBeat DetectionHeart Rate determination for non-paced adultsArrhythmia determination for adults including AtrialFibrillation, Tachycardia and Bradycardia	ECG Signal ProcessingBeat DetectionHeart Rate determination for non-paced adultsArrhythmia determination for adults including AtrialFibrillation, Tachycardia and Bradycardia	Same
Performance Testing	Algorithm performance testing was assessed usingECG databases from ANSI/AAMI EC57:2012 andother proprietary datasets	Algorithm performance testing was assessed usingECG databases from ANSI/AAMI EC57:2012 andother proprietary datasets	Same
Biocompatibility	No patient contact materials	No patient contact materials	Same

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Substantial Equivalence Discussion

The HeartKey® Software Library has the same general intended use and similar indications, technological characteristics, and principles of operation as the predicate AliveCor KardiaAI, K181823.

Intended Use/ Indications for Use

The indications for use for the B-Secur HeartKey® Software Library and the predicate AliveCor KardiaAI, K181823 both are software libraries which are intended to be integrated into medical devices. Both devices allow for the processing and extraction of beats from an ECG signal, providing an accurate heart rate measurement, in either an ambulatory or non-ambulatory environment.

Both the proposed and the predicate allow for ECG rhythm analysis in order to detect Sinus Rhythm, Atrial Fibrillation, Tachycardia and Bradycardia. The indications for use are similar.

Environment of Use and Target Population

The HeartKey® Software Library is intended for prescriptive and for adults over 18. The predicate KardiaAI library has the same environment of use and population.

Both the HeartKey® Software Library and the KardiaAI library are intended for home use.

Technological Characteristics and Principles of Operation

The HeartKey® Software Library is an "object library" - a collection of callable functions that have been compiled to native machine code of the computer on which they will execute. The HeartKev® Software Library is intended to be implemented into medical devices by medical device manufacturers. The HeartKey® library has the same intended use and users as the predicate.

The HeartKey® Software Library provides the medical devices it is intended to be used in, with real time ECG signal processing and beat extraction in order to provide a heart rate reading and arrhythmia analysis to the device user. The predicate KardiaAI (K181823) software analysis library assesses ambulatory electrocardiogram (ECG) rhythms from adult subjects. The HeartKey® Software Library and KardiaAI are based on the following technological characteristics:

Process ECG signals ●
. Detect peaks in ECG signals
o Output heart rate measurements to the user
Rhythm analysis to detect Sinus Rhythm, Atrial Fibrillation, Bradycardia and Tachycardia

The HeartKey® Software Library and the predicate are substantially equivalent in relation to their technological characteristics.

Non-clinical Testing

Non-clinical testing was conducted to assess algorithm performance and to verify that the HeartKey® Software Library performs as intended including Heart Rate Validation, Tachycardia and Bradycardia Validation, Atrial Fibrillation Validation and Arrhythmia Detection Validation assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as B-Secur

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proprietary databases. The results of the testing demonstrate that the HeartKey® Software Library performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.

Differences and Substantial Equivalence Conclusion

The results of nonclinical testing demonstrate that the HeartKey® Software Library meets its intended use which is equivalent to that of the predicate device. Testing also ensured that differences in technological characteristics perform as intended and do not raise different questions of safety or effectiveness.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).