It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.

The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation 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.

Device Description

The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.

DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.

DeepRhythmAl is not for use in life supporting or sustaining systems or ECG Alarm devices. Interpretation 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.

AI/ML Overview

The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA regarding the DeepRhythmAI device. It outlines the FDA's decision but does not contain detailed performance study data such as specific acceptance criteria and reported numeric device performance, sample sizes used for test and training sets, the number and qualifications of experts for ground truth, adjudication methods, MRMC study details, or the specific type of ground truth used.

The document states that "DeepRhythmAI has been subjected to performance testing according to the recognized consensus standards, ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012." It also mentions "Moreover, to enable robust device validation, the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population." However, the specific results of these tests are not provided in this letter.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document generaly states that the device was tested against mentioned standards and that "Test results confirm that DeepRhythmAl meets its intended use." However, specific numerical acceptance criteria and the corresponding reported performance values (e.g., sensitivity, specificity, accuracy for specific arrhythmias) are not provided in this document.

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

Test Set Sample Size: "the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population." The exact number (sample size) is not specified.
Data Provenance: The data is from a "proprietary database (MDG validation db)." The country of origin and whether it's retrospective or prospective data are not specified.

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

This information is not provided in the document.

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

This information is not provided in the document.

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:

This type of study is not mentioned in the document. The device is described as "cloud-based software for the assessment of cardiac arrhythmias... It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result." This suggests an AI-assisted workflow, but no MRMC study details are given.

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

The document states that "DeepRhythmAl is a cloud-based software for automated analysis of ECG data. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review." And the performance testing was done for "arrhythmia detection and automated analysis of ECG data," which implies standalone performance was evaluated against the mentioned standards. Specific standalone performance metrics are not provided.

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

While it's implied that ground truth was established to validate the algorithm against standards, the specific type of ground truth (e.g., expert consensus of specific cardiologists, adjudicated clinical events) is not explicitly stated.

8. The sample size for the training set:

This information is not provided in the document. The document only mentions "proprietary deep-learning algorithm" implying a training process, but no details of the training set.

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

This information is not provided in the document.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 4, 2024

Medicalgorithmics S.A. Joanna Dabala Product Compliance Leader Aleje Jerozolimskie 81 Warsaw, 02-001 Poland

Re: K241197

Trade/Device Name: DeepRhythmAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS, OYX Dated: November 7, 2024 Received: November 7, 2024

Dear Joanna Dabala:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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).

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Sincerely,

Jennifer W. Shih -S

Jennifer 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

Submission Number (if known)

K241197

Device Name

DeepRhythmAl

Indications for Use (Describe)

DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.

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)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for MEDICALgorithmics. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, lighter font. The logo is simple and professional, and it conveys the company's focus on medical technology.

510(k) Summary

. Submitter's name and address:

Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland

Contact Person: Joanna Dabała Phone: (+48) 733 888 448 Email: j.dabala@medicalgorithmics.com

Date Prepared:

2024-11-07

ll. Device
Trade name:

DeepRhythmAl

870.1425 870.2340 870.1025

Class II

Common name: ECG Analysis System

Classification name: Programmable Diagnostic Computer/

Electrocardiograph/ Outpatient Cardiac Telemetry

Requlation number:

Regulatory Class:

DQK, DPS, QYX Classification Product code:

Substantial Equivalence lll.

The selected predicate device is:

1. DeepRhythmAI, K210822 (Predicate Device),

IV. Device description

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Image /page/5/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICALgorithmics" is written in a bold, sans-serif font, with the first part of the word in a dark blue color and the second part in a slightly lighter blue. Below the main logo, there is a tagline that reads "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, sans-serif font.

V. Indications for use

DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.

VI. Comparison to predicate device

The following tables provide a comparison of the detection features and device comparison of DeepRhythmAI and the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICAL" is in large, bold, blue letters, with a blue square to the left of the word. The word "gorithmics" is in a smaller, but still bold, blue font. Below the company name is the phrase "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, lighter font.

Detection Features comparison:

Device functionality	Subject device(K241197)	Predicate device(K182344)
	DeepRhythmAl	DeepRhythmAl
QRS detection	YES	YES
Heart rate determination fornon-paced adult	YES	YES
R-R interval detection	YES	YES
Non-paced arrhythmiasinterpretation	YES	YES
Non-paced ventriculararrhythmias calls	YES	YES
Atrial fibrillation detection	YES	YES
Cardiac beats detection(Ventricular ectopic beats,Supraventricular ectopicbeats)	YES	YES
Patient populations	Adult	Adult

Device comparison:

Devicefunctionality	Subject device	Predicate device	Similarities/Differences
	DeepRhythmAl(DRAI)	DeepRhythmAl(DRAI)
Manufacturer	Medicalgorithmics S.A.	Medicalgorithmics S.A.	N/A
510(k) Number	K241197	K182344	N/A
Classification	Class II	Class II	Equivalent
RegulationNumber(s)	21 CFR §870.142521 CFR §870.234021 CFR §870.1025	21 CFR §870.142521 CFR §870.2340	Equivalent
Classificationname	ProgrammableDiagnostic Computer,Electrocardiograph.Outpatient CardiacTelemetry	ProgrammableDiagnostic Computer,Electrocardiograph	Equivalent
Product Code	DOK, DPS, QYX	DOK, DPS	Equivalent
Devicefunctionality	Subject device	Predicate device	Similarities/Differences
	DeepRhythmAl(DRAI)	DeepRhythmAl(DRAI)
Indications forUse	DeepRhythmAl is acloud-based software forthe assessment ofcardiac arrhythmiasusing two lead ECG datain adult patients.It is intended for use bya healthcare solutionintegrator to build web,mobile or another typesof applications to letqualified healthcareprofessionals review andconfirm the analyticresult. The productsupports downloadingand analyzing datarecorded in thecompatible formats fromdedicated ambulatoryECG devices such asHolter, event recorder,Outpatient CardiacTelemetry devices orother similar recorderswhen the assessment ofthe rhythm is necessary.The product can beelectronically interfacedand perform analysiswith data transferredfrom other computer-based ECG systems,such as an ECGmanagement system.DeepRhythmAI can beintegrated into medicaldevices. In this case, themedical devicemanufacturer will identifythe indication for usedepending on theapplication of theirdevice.	DeepRhythmAl is acloud-based software forthe assessment ofcardiac arrhythmiasusing two lead ECG datain adult patients.It is intended for use bya healthcare solutionintegrator to build web,mobile or another typesof applications to letqualified healthcareprofessionals review andconfirm the analyticresult. The productsupports downloadingand analyzing datarecorded in thecompatible formats fromdedicated ambulatoryECG devices such asHolter, event recorder,Mobile CardiacTelemetry or othersimilar devices when theassessment of therhythm is necessary.The product can beelectronically interfacedand perform analysiswith data transferredfrom other computer-based ECG systems,such as an ECGmanagement system.DeepRhythmAl can beintegrated into medicaldevices. In this case, themedical devicemanufacturer will identifythe indication for usedepending on theapplication of theirdevice.	Equivalent
Devicefunctionality	Subject device	Predicate device	Similarities/Differences
	DeepRhythmAI(DRAI)	DeepRhythmAI(DRAI)
	DeepRhythmAI is not foruse in life-supporting orsustaining systems orECG Alarm devices.Interpretation results arenot intended to be thesole means of diagnosis.It is offered to physiciansand clinicians on anadvisory basis only inconjunction with thephysician's knowledge ofECG patterns, patientbackground, clinicalhistory, symptoms andother diagnosticinformation.	DeepRhythmAI is not foruse in life-supporting orsustaining systems orECG Alarm devices.Interpretation results arenot intended to be thesole means of diagnosis.It is offered to physiciansand clinicians on anadvisory basis only inconjunction with thephysician's knowledge ofECG patterns, patientbackground, clinicalhistory, symptoms andother diagnosticinformation.
Level of Concern	Moderate	Moderate	Equivalent
Components	Software only:1) A web API2) An automatedproprietary algorithm.	Software only:1) A web API2) An automatedproprietary algorithm.	Equivalent
Interface	Web applicationprogramming interface(API)	Web applicationprogramming interface(API)	Equivalent
Part responsiblefor ECG signalanalysis	The automatedproprietary deep-learning algorithm, whichmeasures and analyzesECG data to providequalified healthcareprofessional withsupportive informationfor review.	The automatedproprietary deep-learning algorithm, whichmeasures and analyzesECG data to providequalified healthcareprofessional withsupportive informationfor review.	Equivalent
Display orGraphical UserInterface (GUI)	No primary display orGUI	No primary display orGUI	Equivalent

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Image /page/7/Picture/0 description: The image shows the logo for MEDICALgorithmics. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical technology.

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Image /page/8/Picture/0 description: The image shows the logo for MEDICALgorithmics. The text "MEDICALgorithmics" is in a bold, blue font. Below the company name is the text "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, thinner font, also in blue.

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Image /page/9/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICAL" is in bold, blue letters, and the word "gorithmics" is in a smaller font size and is also blue. Below the logo, the words "INNOVATIVE SOLUTIONS IN MEDICINE" are written in a smaller font size.

Device comparison summary:

The algorithm responsible for arrhythmia detection has been changed. Performance data was evaluated on the same requirements according to the

international standards ANSI/AAMI EC57:2012 and ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 as the predicate device. Patient population and monitoring environments for devices are equivalent.

The subject device is considered substantially equivalent to the predicate devices.

VII. Summary of performance data

The DeepRhythmAl software for arrhythmia detection and automated analysis of ECG data has been subjected to performance testing according to the recognized consensus standards, ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012, Moreover, to enable robust device validation, the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population. MDG validation database allowed for validation of additional compatible hardware configurations (MLII and MLIII leads)

Medicalgorithmics followed ANSI/AAMI/IEC 62304 and the FDA Guidance Document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation.

All necessary testing was conducted on the DeepRhythmAl to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAl meets its intended use.

VIII. Conclusion

In conclusion, DeepRythmAl has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, DRAI 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).