HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults. HeartKey Rhythm analyses a single ECG lead recorded from compatible devices used for arrhythmia diagnostics such as Holters, Extended Holters, ECG Patches, Event Recorders, or other similar devices when assessment of the rhythm is necessary.

The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities:

ECG signal conditioning,
ECG signal quality assessment,
QRS beat detection,
Ventricular ectopic beat detection,
ECG rhythm analysis

HeartKey Rhythm is not intended for use in life supporting, or sustaining systems, or real-time ECG monitors, or cardiac alarm devices, or OTC-use only devices. HeartKey Rhythm analysis results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Device Description

HeartKey Rhythm is intended to automatically analyse ECG data and provide ECG signal processing and assessment of cardiac arrhythmias. The software processes the following types of ambulatory ECGs:

Standard Holter: Lead I, II, III electrode configuration using gel electrodes e.g., Ag/AgCl,
Patch: Modified Lead II, Lead III, sternum using gel electrodes e.g., Ag/AgCl .

HeartKey Rhythm is capable of analysing both continuous ECGs as well as event recorders. The device provides the following analysis:

Feature	Description
ECG Signal Processing Engine (SPE)	Signal Conditioning (SC): Reduce the noise artefact present in the input ECG signal for physician review of NSR, AF and VE beats. Beat Detector (BD): Detect the QRS complexes of the input ECG signal. Signal Quality (SQ): Identify and classify the ECG segments' signal quality from the input ECG signal.
ECG Arrhythmia Analysis (AA)	Rhythm Analysis: Normal Sinus Rhythm, Atrial Fibrillation, Cardiac Pause, Tachycardia, Bradycardia, Inconclusive, Unreadable. Beat Analysis: Normal (N), Ventricular (V) Ectopic. Beat Clustering: Beat Cluster Template, Beat Cluster Count, QRS Location, Beat Classification, Heart Rate

The Software Library may be integrated into ECG management systems, ECG analysis platforms or remote patient monitoring platforms. The filtered and enhanced ECG is not intended to be used by other automated analysis algorithms.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the HeartKey® Rhythm device.

Here's a breakdown of the requested information:

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

The document states that "Performance testing included the evaluation of metrics such as sensitivity, specificity, and positive values. These outputs were evaluated against a clinically relevant acceptance criteria to demonstrate HeartKey Rhythm's effectiveness." However, the exact numerical values for the acceptance criteria and the reported device performance for these metrics (sensitivity, specificity, positive values for different arrhythmias) are not explicitly provided in a table within the provided text.

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

Test Set Sample Size: "B-Secur evaluated HeartKey Rhythm against a large independent proprietary set of ECGs and standard databases." It specifies a proprietary dataset including more than 1200 ECGs.
Data Provenance:
- Country of Origin: Approximately 66% of ECGs recorded in the US. The origin of the remaining 34% is not specified but implied to be non-US or unknown.
- Retrospective or Prospective: Not explicitly stated, but "recorded ECGs" suggests a retrospective dataset.

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

The document mentions that the device's analysis output was compared "against a known reference." It does not specify the number of experts used or their qualifications (e.g., radiologist with 10 years of experience) for establishing this ground truth.

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

The document does not specify the adjudication method used for the test set's ground truth.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described in the provided text. The performance testing appears to be a standalone (algorithm only) evaluation against ground truth.

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

Yes, a standalone (algorithm only) performance evaluation was done. The text states: "B-Secur evaluated HeartKey Rhythm against a large independent proprietary set of ECGs and standard databases, comparing its analysis output against a known reference." This indicates the algorithm's performance was assessed independently.

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

The ground truth was established by "a known reference," and the context of evaluating ECG analysis suggests this refers to expert consensus interpretation of ECGs, although the specifics of how this consensus was reached (e.g., multiple experts, adjudication) are not detailed.

8. The sample size for the training set:

The document does not specify the sample size for the training set used for the AI/ML model. It only describes the test set.

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

The document does not specify how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

B-Secur Limited Cameron Moore Quality Assurance Manager 11th Floor, City Quays 3 92 Donegall Quay Belfast, BT1 3FE United Kingdom

Re: K233755

Trade/Device Name: HeartKey® Rhythm Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: July 19, 2024 Received: July 22, 2024

Dear Cameron Moore:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Kimberly N. Crowley -S

For: Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices

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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) K233755

Device Name HeartKey® Rhythm

Indications for Use (Describe)

The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities:

· ECG signal conditioning,
· ECG signal quality assessment,
· QRS beat detection,
· Ventricular ectopic beat detection,
ECG rhythm analysis

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

Date Prepared:	19 July 2024
Submitter/Applicant:	B-Secur LtdCity Quays 392 Donegall QuayBelfastBT1 3FEUnited Kingdom
Official Contact:	Cameron Moore, Quality Assurance Manager
Primary Contact Person:	Cameron MooreQuality Assurance Manager, B-Secur Limited.Email: cameron.moore@b-secur.comPhone: +44 (0)28 9568 5489
Secondary Contact Person:	Prabhu RaghavanRegulatory Consultant for B-Secur Limited.Email: prabhu@mdqr.solutionsPhone: 408-316-5707
Proprietary or Trade Name:	HeartKey® Rhythm
Common/Usual Name:	Electrocardiograph
Classification Name:	21CFR 870.1425DQK - Programmable diagnostic computerClass II
Predicate Device:	K210822 - Medicalgorithmics S.A. - DeepRhythmAI

Device Description:

HeartKey Rhythm is intended to automatically analyse ECG data and provide ECG signal processing and assessment of cardiac arrhythmias. The software processes the following types of ambulatory ECGs:

Standard Holter: Lead I, II, III electrode configuration using gel electrodes e.g., Ag/AgCl,
Patch: Modified Lead II, Lead III, sternum using gel electrodes e.g., Ag/AgCl .

HeartKey Rhythm is capable of analysing both continuous ECGs as well as event recorders. The device provides the following analysis:

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Feature	Description
ECG SignalProcessing Engine(SPE)	Signal Conditioning (SC): Reduce the noise artefact present inthe input ECG signal for physician review of NSR, AF and VEbeats.Beat Detector (BD): Detect the QRS complexes of the inputECG signal.Signal Quality (SQ): Identify and classify the ECG segments'signal quality from the input ECG signal.
ECG ArrhythmiaAnalysis (AA)	Rhythm Analysis:Normal Sinus RhythmAtrial FibrillationCardiac PauseTachycardiaBradycardiaInconclusiveUnreadableBeat Analysis:Normal (N)Ventricular (V) EctopicBeat Clustering:Beat Cluster TemplateBeat Cluster CountQRS LocationBeat ClassificationHeart Rate

Principle of Operation:

It is intended that the library is integrated into other software such as ECG management systems, ECG analysis platforms or remote patient monitoring platforms. Such applications could be written to run on a PC or server. All features are accessed via a documented rest application programming interface (API).

HeartKey Rhythm analyses the input ECG using a combination of rules-based calculations and AI / ML technology. The software is compiled and remains static, with no further modification of the code carried out once deployed.

Indications for Use:

HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults. HeartKey Rhythm analyses a single ECG lead recorded from compatible

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devices used for arrhythmia diagnostics such as Holters, Extended Holters, ECG Patches, Event Recorders, or other similar devices when assessment of the rhythm is necessary.

The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities:

ECG signal conditioning, ●
ECG signal quality assessment,
QRS beat detection, ●
. Ventricular ectopic beat detection,
ECG rhythm analysis

HeartKey Rhythm is not intended for use in life supporting, or sustaining systems, or real-time ECG monitors, or cardiac alarm devices, or OTC-use only devices. HeartKey Rhythm analysis results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Patient Population:

Adults.

Environments of use: Home or hospital environment.

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Table 3.1. outlines the proposed device vs. the predicate.

As part of the comparison, the following shall be presented & discussed:

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

Table 3.1 is a comparison - Subject Device vs. the Predicate, K210822 - Medicalgorithmics S.A. - DeepRhythmAl.

Note: The comparison to the predicate is based upon available technical specifications vs. comparative testing.

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	Predicate	Subject device
	DeepRhythmAl	HeartKey® Rhythm
K#	K210822	K233755
Product Code	DQK and DPS	DQK and DPS
CFR	870.1425	870.1425
Classification	Class II	Class II
Regulation Number(s)	21 CFR §870.1425	21 CFR §870.1425
	21 CFR §870.2340	21 CFR §870.2340
Classification name	ProgrammableDiagnostic Computer,Electrocardiograph	ProgrammableDiagnostic Computer,Electrocardiograph
Intended Use	DeepRhythmAI is a cloud-basedsoftware for the assessment ofcardiac arrhythmias using twolead ECG data in adult patients.It is intended for use by ahealthcare solution integrator tobuild web, mobile or anothertypes of applications to letqualified healthcareprofessionals review andconfirm the analytic result.	HeartKey Rhythm is intendedfor use for signal processing andanalysis of ambulatory ECGs. Itis intended for non-activepatient monitoring or for non-urgent clinical decision making.
Indications for Use	DeepRhythmAI is acloud-based software for theassessment ofcardiac arrhythmiasusing two lead ECG data inadult patients.It is intended for use by ahealthcare solution integrator tobuild web, mobile or anothertypes of applications to letqualified healthcareprofessionals review andconfirm the analytic result. Theproduct supports downloadingand analyzing datarecorded in thecompatible formats fromdedicated ambulatory ECGdevices such as	HeartKey Rhythm is intendedfor use by qualified healthcareprofessionals for analysing ECGdata from adults. HeartKeyRhythm analyses a single ECGlead recorded from compatibledevices used for arrhythmiadiagnostics such as Holters,Extended Holters, ECG Patches,Event Recorders, or othersimilar devices when assessmentof the rhythm is necessary.The HeartKey Rhythmapplication program interface(API) is intended to beintegrated into other devicesoftware to provide thefollowing capabilities: ECGsignal conditioning, ECG signal
	similar devices when theassessment of the rhythm isnecessary.The product can beelectronically interfacedand perform analysiswith data transferredfrom other computer based ECGsystems, such as an ECGmanagement system.DeepRhythmAI can beintegrated into medical devices.In this case, the medical devicemanufacturer will identify theindication for use depending onthe application of their device.DeepRhythmAI is not for use inlife-supporting or sustainingsystems or ECG Alarm devices.Interpretation results are notintended to be the sole means ofdiagnosis. It is offered tophysicians and clinicians on anadvisory basis only inconjunction with the physician'sknowledge of ECG patterns,patient background, clinicalhistory, symptoms and otherdiagnostic information.	beat detection, ECG rhythmanalysis.HeartKey Rhythm is notintended for use in lifesupporting, or sustainingsystems, or real-time ECGmonitors, or cardiac alarmdevices, or OTC-use onlydevices. HeartKey Rhythmanalysis results are not intendedto be the sole means ofdiagnosis. It is offered tophysicians and clinicians on anadvisory basis only inconjunction with the physician'sknowledge of ECG patterns,patient background, clinicalhistory, symptoms, and otherdiagnostic information.
Level ofConcern/DocumentationLevel	Moderate	Enhanced
Components	Software only: 1) A web API 2)An automated proprietaryalgorithm.	Software only: 1) A web API 2)An automated proprietaryalgorithm.
Interface	Web applicationprogramming interface(API)	Web applicationprogramming interface(API)
Part responsiblefor ECG signalanalysis	The automatedproprietary deep-learningalgorithm, whichmeasures and analyzes ECGdata to providequalified healthcareprofessional withsupportive information	The automatedproprietary machine-learningalgorithm, whichmeasures and analyzes ECGdata to providequalified healthcareprofessional withsupportive information
	for review.	for review.
Number of leadsfor a receivedECG signal	Two lead ECG data	A single lead from one of thefollowing leads:Wet Electrode Lead I, II, and IIIWet Electrode Modified Leads IIand IIIWet Electrode Sternum Lead
Display orGraphical UserInterface (GUI)	No primary display orGUI	No primary display orGUI

Table 3.1 – Comparison – Subject vs. Predicate

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Substantial Equivalence Discussion

HeartKey Rhythm has the same general intended use and similar indications, technological characteristics, and principles of operation as the predicate Medicalgorithmics DeepRhythmAI, K210822.

Intended Use/ Indications for Use

The indications for use for HeartKey Rhythm and the predicate Medicalgorithmics DeepRhythmAI, K210822 both are rest API based software libraries which are intended to be integrated into computer-based ECG systems. Both devices allow for the processing and extraction of beats from an ECG signal, providing an accurate heart rate measurement, in an ambulatory environment.

Both the proposed and the predicate allow for ECG rhythm analysis and beat classification. The indications for use are substantially equivalent.

Environment of Use and Target Population

HeartKey Rhythm is intended for prescriptive use and for adults over 18. The predicate DeepRhythmAl has the same environment of use and population.

Both HeartKey Rhythm and DeepRhythmAl are intended for use in a home or hospital environment.

Technological Characteristics and Principles of Operation

HeartKey Rhythm is a library collection of callable functions that have been compiled into native machine code of the computer on which they will execute. A rest application programming interface (API) calls some or all the available functions within the library to securely exchange information. This can be deployed to a variety of cloud platforms or to a virtual or physical machine.

HeartKey Rhythm is intended to be integrated into different ECG platforms such as ECG management systems, ECG analysis platforms or remote patient monitoring platforms. Medicalgorithmics DeepRhythmAl software has the same intended use and users as the predicate.

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HeartKey Rhythm provides the applications/platforms it is intended to be deployed in, with ECG signal processing and beat extraction in order to provide a heart rate reading and arrhythmia analysis to the device user. The predicate DeepRhythmAI (K210822) software assesses ambulatory electrocardiogram (ECG) rhythms from adult subjects.

HeartKey Rhythm and DeepRhythmAI are based on the following technological characteristics:

Process ECG signals ●
. Detect peaks in ECG signals
. Output heart rate measurements to the user
. Rhythm analysis
. Beat classification

HeartKey Rhythm and the predicate are substantially equivalent in relation to their technological characteristics.

Non-clinical Testing

Nonclinical performance testing was conducted in compliance with the appropriate recognised consensus standards, to demonstrate that HeartKey Rhythm satisfies its design and software requirements as well as demonstrate that the ECG analysis performance is substantially equivalent to the predicate device (DeepRhythmAI, K210822). Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. B-Secur evaluated HeartKey Rhythm against a large independent proprietary set of ECGs and standard databases, comparing its analysis output against a known reference. The proprietary dataset included more than 1200 ECGs with approximately 25% females, 25% males and 50% gender unknown, approximately 16% whites, 24% non-whites, and 60% race unknown, and approximately 66% of ECGs recorded in the US. Performance testing included the evaluation of metrics such as sensitivity, specificity, and positive values. These outputs were evaluated against a clinically relevant acceptance criteria to demonstrate HeartKey Rhythm's effectiveness. Unit, integration and system level testing conducted identified no residual anomalies during verification software tests. Cybersecurity testing was conducted in which no vulnerabilities were identified and all software requirements were satisfied. Overall, the software verification & validation testing was completed successfully and met all requirements. Testing demonstrated that the subject device performance was deemed to be acceptable.

Verification and validation testing was completed in compliance with the following standards and guidance documents:

ANSI/AAMI EC57:2012, Testing and Reporting Performance Results of Cardiac Rhythm . And ST-Segment Measurement Algorithms.
ANSI/AAMI/IEC 60601-2-47:2012. Medical electrical equipment Part 2-47: Particular . requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
IEC 62304:2006+A1:2015, Medical device software Software life cycle processes. ●

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. IEC 81001-5-1:2022, Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle.
. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January, 2002)
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Final Guidance for Industry and FDA Staff (September, 2023)

Substantial Equivalence Conclusion

In conclusion, HeartKey Rhythm has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Differences between the subject device and the predicate have been tested to ensure that the device meets its intended use. Therefore, HeartKey Rhythm is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).