The AccurECG Analysis System is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.

The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG Analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).

The AccurECG Analysis System is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.

The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.

The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.

Device Description

The AccurECG Analysis System ("AccurECG" or the "System") consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.

AccurECG is intended to analyze recordings performed on adults over the age of 22 and works in the following sequence:

i. The web interface allows the user to select files and upload to the AccurECG secure database.
ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- o Delineation detection of ORS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- · Abnormality labels automated arrhythmia interpretation and statistical classification.
iii. AccurECG Analysis System displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
iv. AccurECG Analysis System allows for preliminary comments summarizing the review before generating a report.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the AccurECG® Analysis System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for specific metrics (e.g., sensitivity, specificity, accuracy). However, it indicates that performance tests were conducted in conformance with specific FDA-recognized consensus standards. The "Summary of Performance Data" section implies that the device met the requirements of these standards without detailing specific quantitative metrics.

The standards mentioned are:

AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
IEC 60601-2-47:2012 Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems (Section 201.12.1.101 -Algorithm Testing).

The "Conclusion" section states, "Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the AccurECG® Analysis System has been shown to be substantially equivalent to the cited predicate." This indicates that the device's performance, as evaluated against these standards, was deemed sufficient for substantial equivalence.

Without specific performance metrics from the document, a table of acceptance criteria and reported device performance cannot be fully constructed.

Study Details

The document provides limited information regarding the specifics of the performance study.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The document mentions "clinical input requirements were validated against a gold standard," which implies a dataset, but details on its origin (e.g., country, retrospective/prospective) are absent.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document refers to "gold standard" but doesn't specify how this was established or by whom.
Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The mention of "gold standard" suggests a defined ground truth, but the method (e.g., 2+1, 3+1 consensus) is not described.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any evaluation of human readers with vs. without AI assistance. The focus seems to be on the standalone performance of the algorithm against standards and a "gold standard."
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Yes, a standalone performance evaluation of the algorithm was done. The "Summary of Performance Data" refers to performance tests "in conformance with the following FDA-recognized consensus standards" and "All clinical input requirements were validated against a gold standard." This indicates an assessment of the algorithm's capabilities without direct human-in-the-loop interaction for performance measurement. The "Software verification and validation" section also notes verification and validation tests.
The Type of Ground Truth Used:
- Ground Truth Type: "Gold standard." The specific nature of this "gold standard" (e.g., expert consensus on ECGs, pathology, outcomes data) is not detailed. However, given the context of ECG analysis, it would typically involve expert-annotated ECG waveforms.
The Sample Size for the Training Set:
- Training Set Sample Size: Not explicitly stated. The document focuses on the validation aspect and does not provide details about the training data used for the algorithm.
How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth Establishment: Not explicitly stated. This information is typically proprietary to the developer's methodology and is often not fully disclosed in 510(k) summaries.

Summary

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June 23, 2023

AccurKardia, Inc. % Adrienne Lenz Principle Medical Device Regulation Expert Hyman, Phelps & McNamara, PC 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005-5929

Re: K223013

Trade/Device Name: AccurECG® Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK Dated: May 26, 2023 Received: May 26, 2023

Dear Adrienne Lenz:

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 statutes and regulations administered by other Federal agencies.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,

Shruti N. Mistry -S

for

Jennifer Shih Kozen 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K223013

Device Name

AccurECG® Analysis System

Indications for Use (Describe)

The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCI) electrodes (wet leads).

The AccurECG Analysis System is not for use in life-supporting or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.

The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurEGG Report is an adjunct intended to facilitate health care decision with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.

The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.

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

区 Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displaysa currently valid OMB number."

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SECTION 5 : 510(k) Summary

5.1 Applicant/Submitter

Company Name	:	AccurKardia, Inc.
Street Address	:	101 Avenue of the Americas, FL 8
City	:	New York
State	:	New York
Zip Code	:	10013
Phone Number	:	646-334-5728

5.2 Contact Person

Full Name	: Juan C. Jiménez
Phone	: 646-334-5728

5.3 Correspondent Information

Full Name	: Juan C. Jiménez
Phone	: 646-334-5728

5.4 Date of Preparation

Date of Preparation

: 05/26/2023

5.5 Device Information

Device Name	AccurECG® Analysis System
Model Number
Common Name	ECG Analysis System
Regulation	21 CFR 870.2340, 21 CFR 870.1425
Product Code	DPS;DQK
Reviewing Panel/Branch	Cardiovascular
Submission Number	K223013

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5.6 Predicate Device(s)

	Table - 5.1 Predicate Device(s)
--	----------------------------------	--

Predicate Type	510(k) Number	Device Name	Manufacturer	Product Code
Primary	K212112	Cardiologs Holter Platform	Cardiologs Technologies	DPS,DQK

5.7 Device Description

AccurECG is intended to analyze recordings performed on adults over the age of 22 and works in the following sequence:

i. The web interface allows the user to select files and upload to the AccurECG secure database.
ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- o Delineation detection of ORS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- · Abnormality labels automated arrhythmia interpretation and statistical classification.
iii. AccurECG Analysis System displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
iv. AccurECG Analysis System allows for preliminary comments summarizing the review before generating a report.

5.8 Intended Use/Indications for Use

The System provides single-lead analysis on a beat-by-beat basis. Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG Analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).

The AccurECG Analysis System is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.

The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.

5.9 Comparison of Technological Characteristics with Predicate

The subject device has the same intended use and substantially equivalent technological characteristics that do not raise questions of safety or effectiveness. Table - 5.2 Feature Comparison: AccurECG System to the predicate device illustrates a comparison of detection features between the AccurECG system and the cited predicate.

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Feature	AccurECG	CardioLogs ECG Analysis Platform
Heart rate determination for non-pacedadult	Yes	Yes
QRS Detection	Yes	Yes
Non-paced arrhythmia interpretation foradult patients	Yes	Yes
Non-paced ventricular arrhythmia calls	Yes	Yes
Intervals measurements	Yes	Yes
Ventricular ectopic beat detection	Yes	Yes
Patient Population	Adult	Adult & Pediatric

Table - 5.2 Feature Comparison: AccurECG to the predicate device

Table - 5.3 Comparison of technological characteristics: AccurECG to the predicate device provides a comparison of the technological characteristics of the AccurECG System with the cited predicate.

Table - 5.3 Comparison of technological characteristics: AccurECG System to the predicate device

	AccurECG(this submission)	CardioLogs ECG Analysis Platform(K170568)	Comparison topredicate device
Device TradeName	AccurECG® Analysis System	CardioLogs ECG Analysis Platform	N/A
Manufacturer	AccurKardia, Inc.	CardioLogs Technologies	N/A
510(K) No.	(this submission)	K212112	N/A
RegulationNumber	21 CFR 870.234021 CFR 870.1425	21 CFR 870.234021 CFR 870.1425	Same
Product Code	DQK, DPS	DQK, DPS	Same
Class	2	2	Same
DeviceClass/Name	Electrocardiograph	Electrocardiograph	Same
Software Level ofConcern	Major	Moderate	Same

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Indications forUse	The AccurECG Analysis System is	The Cardiologs Platform (Also knownas Cardiologs ECG Analysis Platform)	The predicate device is
	intended for use by qualified healthcareprofessionals("HCP") in the assessment of a patient'srecorded ambulatory ECG data.Analysis results are provided in astandard report for review and printing.The System provides single-lead analysison a beat-by-beat basis, VentricularEctopic Beat and SupraventricularEctopic Beat detection, heart ratemeasurement, and rhythm analysis. TheAccurECG Analysis System iscompatible with ECG recordings takenwith silver/silver chloride (Ag / AgCl)electrodes (wet leads).The AccurECG Analysis System is notfor use in life-supporting or sustainingsystems or ECG monitor and alarmdevices. The System is not intended tobeused with cardiac telemetry monitors.The AccurECG Analysis System'sautomated interpretation results are notintended to be the sole means ofdiagnosis. The AccurECG Report is anadjunct intended to facilitate health caredecision making in conjunction with thephysician's knowledge of ECG patterns,patient background, clinical history,symptoms, and other diagnosticinformation to arrive at a diagnosticconclusion.The AccurECG Analysis System doesnot interface with data managementsystems or hardware and is deviceindependent.	is intended for use by qualifiedhealthcare professionals for theassessment of arrhythmias using ECGdata in the adult and pediatricpopulation. The product supportsdownloading and analyzing datarecorded in compatible formats fromany device used for the arrhythmiadiagnostics such as Holter, eventrecorder, 12 lead ambulatory ECGdevices, or other similar devices whenassessment of the rhythm is necessary.The Cardiologs Platform can also beelectronically interfaced and performanalysis with data transferred fromother computer-based ECG systems,such as an ECG management system.The Cardiologs Platform provides ECGsignal processing and analysis, QRSand Ventricular Ectopic Beatdetection, QRS feature extraction,interval measurement, heart ratemeasurement and rhythmanalysis.The Cardiologs Platform is not for usein life supporting or sustaining systemsor ECG monitor and Alarm devices.The product can be integrated intocomputerized ECG monitoring devices.In this case, the medical devicemanufacturer will identify theindication for use depending on theapplication of their device.The product can be integrated intocomputerized ECG monitoring devices.In this case, the medical devicemanufacturer will identify theindication for use depending on theapplication of their device.Cardiologs Platform interpretationresults are notintended to be the sole means ofdiagnosis. It is offered to physiciansand clinicians on an advisory basis onlyin conjunction with the physician'sknowledge of ECG patterns, patientbackground, clinical history,	indicated for pediatric aswell as adult patients.
Fundamentalscientifictechnology	The AccurECG Analysis Systemconsists of:	The Cardiologs Holter Platformconsists of:	The AccurECG AnalysisSystem does not presentany major technologicaldifferences compared tothepredicate device.
	An interface which provides tools toupload, analyze, review ECG data codedin Java.	An interface which provides tools tomeasure, analyze and review numerousECGs coded in java language under theAngular and D3.js frameworks;	Substantially equivalent:Bothdevices provide a webinterface which providestools to upload, analyze,review ECG data, but arecoded in a differentprogramming language,which should not haveany effect on intended usor performance and doesnot introduce new issuesof safety or effectiveness
	An automated proprietary ECGinterpretation supportalgorithm which measures and analysesECGs to providesupportive information for ECGdiagnosis, written in LabVIEW usingthe G Programming language.	An automated proprietary ECGinterpretation supportalgorithm which measures and analyzesECGs to provide supportiveinformation for ECG diagnosis, writtenin Python language.	Both are accessed througaninternet connection and aweb browser, but thepredicate device can alsobe accessed through adirect connection to theAPI. This connectiondifference should nothave any effect onintended use orperformance and does nointroduce new issues ofsafety or effectiveness.
	This application is accessed through anInternet connection and a web browserconnected to the AccurECG ApplicationProgramming Interface (API).	This application can be accessedthrough an Internetconnection and a web browser, or isdirectly connected to the Cardiologs'Application Programming Interface(API).

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5.10 Summary of Performance Data

Performance tests have been conducted in conformance with the following FDA-recognized consensus standards.

· AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
· IEC 60601-2-47:2012 Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems (Section 201.12.1.101 -Algorithm Testing).

5.11 Software verification and validation

Testing described in this premarket notification consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard. There are 2 residual anomalies appeared during verification and software validation tests. The Anomalies can be found in the APPX 44 PRJ-21-059 v05 Software Anomalies Listing, AccurECG.

Usability of the AccurECG Analysis System was tested throughout development, validating the effectiveness of risk control measures associated with the user interface. AccurKardia conducted usability tests of the AccurECG user interface with Certified Cardiovascular Technicians to evaluate the effectiveness of the design, labeling and risk. The protocols cover the testable technical requirements relevant to the user interface as described in the User Interface Specification.

5.12 Conclusion

Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the AccurECG® Analysis System has been shown to be substantially equivalent to the cited predicate.

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).