Who is the manufacturer of DeepRhythmAI?

Medicalgorithmics S.A. filed the 510(k) submission for DeepRhythmAI (K210822).

What is the FDA product code for DeepRhythmAI?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for DeepRhythmAI?

510(k) clearance (submission type: Traditional).

Does DeepRhythmAI use AI or machine learning?

Yes. DeepRhythmAI (K210822) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like DeepRhythmAI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like DeepRhythmAI get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

DeepRhythmAI

K210822 · Medicalgorithmics S.A. · DQK · Jul 27, 2022 · Cardiovascular

Device Facts

Record ID	K210822
Device Name	DeepRhythmAI
Applicant	Medicalgorithmics S.A.
Product Code	DQK · Cardiovascular
Decision Date	Jul 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. 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, Mobile Cardiac Telemetry or other similar devices 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. DeepRhythmAI 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. DeepRhythmAI 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 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 Story

DeepRhythmAI is cloud-based software for automated ECG analysis. It ingests two-lead ECG data from ambulatory devices (Holter, event recorders, MCT) or ECG management systems via API. A proprietary deep-learning algorithm processes the signal to detect cardiac beats, arrhythmias, and intervals (QRS, heart rate, RR intervals, ventricular/supraventricular ectopic beats). The device lacks a native UI; it integrates into third-party web/mobile applications used by healthcare professionals. The system provides advisory analysis results to clinicians, who must review and confirm all algorithm annotations. It supports clinical decision-making by providing automated rhythm assessment, but is not a diagnostic tool on its own. Benefits include efficient, automated screening of large volumes of ECG data, assisting physicians in identifying arrhythmias.

Clinical Evidence

Bench testing only. Performance validated according to ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012. Software validation conducted per ANSI/AAMI/IEC 62304 and FDA guidance.

Technological Characteristics

Cloud-based software; API-based integration; proprietary deep-learning algorithm for ECG signal processing. Supports two-lead ECG data. Complies with ANSI/AAMI/IEC 60601-2-47 and AAMI/ANSI/EC57. Software development follows ANSI/AAMI/IEC 62304.

Indications for Use

Indicated for adult patients requiring assessment of cardiac arrhythmias using two-lead ECG data. Not for use in life-supporting/sustaining systems or ECG alarm devices.

Regulatory Classification

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.

Predicate Devices

RhythmAnalytics (K182344)

Reference Devices

Zio AT ECG Monitoring System (K181502)

Related Devices

K253141 — DeepRhythmAI · Medicalgorithmics S.A. · Dec 11, 2025
K241197 — DeepRhythmAI · Medicalgorithmics S.A. · Dec 4, 2024
K250932 — DeepRhythmAI · Medicalgorithmics S.A. · May 27, 2025
K232161 — DeepRhythm Platform · Medicalgorithmics S.A. · Jun 20, 2024
K170568 — CardioLogs ECG Analysis Platform · Cardiologs Technologies · Jun 26, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". July 27, 2022 Medicalgorithmics S.A. % Agnieszka Romowicz Operations & Product Compliance Director Medicalgorithmics US Holding Corporation 2711 Centerville Road, Suite 400 Wilmington, DE 19808 Re: K210822 Trade/Device Name: DeepRhythmAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: June 24, 2022 Received: June 27, 2022 Dear Agnieszka Romowicz: 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 {1}------------------------------------------------ 542 of the Act); 21 CFR 1000-1050. 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- 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210822 Device Name DeepRhythmAI ### Indications for Use (Describe) DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. 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, Mobile Cardiac Telemetry or other similar devices when tof 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. DeepRhythmAI 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. DeepRhythmAI 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 on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information. | 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) | ## 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 displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MedicAlgorithms. The logo has the word "MEDIC" in gray and the word "Algorithms" in red. Below the words is the phrase "Innovative Solutions in Medicine" in a smaller font. June 24, 2022 ## 510(k) Summary 2022-06-24 #### l. Submitter's name and address: Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland Contact Person: Agnieszka Romowicz Phone: (+48) 733 888 448 Email: a.romowicz@medicalgorithmics.com Date Prepared: - ll. Device | Trade name: | DeepRhythmAl | |------------------------------|--------------------------------------------------------| | Common name: | ECG Analysis System | | Classification name: | Programmable Diagnostic Computer Electrocardiograph | | Regulation number: | 870.1425 870.2340 | | Regulatory Class: | Class II | | Classification Product code: | DQK, DPS | #### lll. Substantial Equivalence The selected predicate and reference devices are: - 1. RhythmAnalytics, K182344 (Predicate Device), - 2. Zio AT ECG Monitoring System, K181502 (Reference Device). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "Algorithms" in red. Below the words is the phrase "Innovative Solutions in Medicine". #### Device description IV. 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 the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when the assessment of the rhythm is necessary. DeepRhythmAI 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 a User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting. 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. . DeepRhythmAI algorithm detects cardiac beats/arrythmias and intervals including: - . QRS - Heart rate determination - RR Interval measurements - Non-paced arrhythmias - Non-paced ventricular arrhythmia calls - Ventricular ectopic beats - Supraventricular ectopic beats DeepRhythmAl returns the interpretation result to be reviewed by a qualified healthcare professional. DeepRhythmAl when integrated with the other computer-based ECG systems, creates a semi-autonomous system for analysis of ECG recordings. All algorithm annotations must be analyzed and confirmed by a qualified healthcare professional. The subject device can only be integrated with the display product used by the monitoring center that allows for verification of the algorithm output, its correction and confirmation. 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Medical Algorithms. The word "MEDICAL" is in gray, and the word "Algorithms" is in red. Below the company name is the text "Innovative Solutions in Medicine." #### Indications for use V. DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. 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, Mobile Cardiac Telemetry or other similar devices 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "ALGORITHMS" in red. Below the words is the phrase "INNOVATIVE SOLUTIONS IN MEDICINE" in gray. #### Comparison to predicate device VI. The following tables provide a comparison of the detection features and device comparison of DeepRhythmAI and the predicate devices. Detection Features comparison: | Device functionality | DeepRhythmAl | RhythmAnalytics | Zio AT ECG Monitoring System | |----------------------------------------------------------------------------------------------|--------------|---------------------------------------|---------------------------------| | QRS detection | YES | YES | No information | | Heart rate determination for non-paced adult | YES | YES | YES | | R-R interval detection | YES | YES | No information | | Non-paced arrhythmias interpretation | YES | YES | YES | | Non-paced ventricular arrhythmias calls | YES | YES | YES | | Atrial fibrillation detection | YES | No information | YES | | Cardiac beats detection (Ventricular ectopic beats, Supraventricular ectopic beats) | YES | YES (Ventricular ectopic beats) | YES | | Patient populations | Adult | Min 18 years old | Min 18 years old | Device comparison: | Device functionality | Subject device | Predicate device | Reference device | |-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | DeepRhythmAl | RhythmAnalytics | Zio AT ECG Monitoring System | | Manufacturer | Medicalgorithmics S.A. | Biofourmis Singapore Pte. Ltd. | iRhythm Technologies, Inc. | | 510(k) Number | K210822 | K182344 | K181502 | | Classification | Class II | Class II | Class II | | Regulation Number(s) | 21 CFR §870.1425 21 CFR §870.2340 | 21 CFR §870.1425 21 CFR §870.2340 | 21 CFR §870.1425 21 CFR §870.2800 21 CFR §870.2920 21 CFR §870.1025 | | Device functionality | Subject device | Predicate device | Reference device | | | DeepRhythmAl | RhythmAnalytics | Zio AT ECG Monitoring System | | Classification name | Programmable Diagnostic Computer, Electrocardiograph | Programmable Diagnostic Computer, Electrocardiograph | Programmable Diagnostic Computer; | | | | | Medical Magnetic Tape Recorder; | | | | | Telephone electrocardiograph transmitter and receiver; | | | | | Arrhythmia detector and alarm | | Product Code | DQK, DPS | DQK, DPS | DQK, DSH, DXH, DSI | | Indications for Use | DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. 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, Mobile Cardiac Telemetry or other similar devices 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 | RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when assessment of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal | The device is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. While continuously recording patient ECG, both patient triggered and automatically-detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on the beat-to- beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light- headedness, pre- syncope, syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on | | Device functionality | Subject device | Predicate device | Reference device | | | DeepRhythmAl | RhythmAnalytics | Zio AT ECG Monitoring System | | | 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. | processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product 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. RhythmAnalytics interpretation results are not intended to be the sole means of diagnosis. Itis 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. | clinical judgment and experience. It is not intended for use on critical care patients. | | Level of Concern | Moderate | Major | No information | | Components | Software only: 1) A web API 2) An automated proprietary algorithm. | Software only: 1) A web API 2) An automated proprietary algorithm. | 1) Zio AT Patch Recorder Device 2) Zio AT Wireless Gateway Device with Bluetooth and Cellular Technology 3) ZEUS System for analysis and reporting. | | Interface | Web application programming interface (API) | Web application programming interface (API) | PC / Server Mix to Clinician & Patient Websites | | Part responsible for ECG signal analysis | The automated proprietary deep- learning algorithm, which | The automated proprietary algorithm, i.e., cardiac beats/arrhythmias | The ZEUS System (component of the Zio AT ECG Monitoring System) | | Device functionality | Subject device | Predicate device | Reference device…