(336 days)
Not Found
Yes
The document explicitly states that the device "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection" and is "compatible with an external AI service for ECG analysis, Medicalgorithmics' DeepRhythmAI". While the AI service itself is described as "not a part of the subject device", the subject device's functionality is dependent on and integrates with this AI service for core analysis tasks.
No.
The device is intended for assessment of arrhythmias using ECG data and provides analysis, visualization, review, and reporting, which are diagnostic functions, not therapeutic. It explicitly states it is "not for use in life supporting or sustaining systems or ECG monitor and Alarm devices" and its results are "not intended to be the sole means of diagnosis."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for the assessment of arrhythmias using ECG data" and "for the arrhythmia diagnostics". The "Device Description" also mentions "It provides arrhythmia diagnosis process". These phrases clearly indicate that the device is used for diagnosing medical conditions.
Yes
The device description explicitly states it is a "cloud-based software with microservice architecture and browser-based user interface." While it interacts with external hardware (ambulatory ECG recording devices) and an external AI service, the device itself, as described, is solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are specifically designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes ECG data: The DeepRhythm Platform analyzes electrical signals from the heart (ECG data) recorded by external devices. This is a physiological measurement, not the analysis of a biological sample.
- The intended use focuses on ECG analysis: The intended use clearly states the device is for "assessment of arrhythmias using ECG data."
Therefore, while it is a medical device used for diagnosis, it falls under the category of devices that analyze physiological signals rather than biological samples, which is the defining characteristic of an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section states 'Not Found'.
Intended Use / Indications for Use
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in adult patients.
The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arrhythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary.
The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arrhythmias. The DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.
The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI.
The DeepRhythm Platform 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS, DQK
Device Description
The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities.
The DeepRhythm Platform's functionality consists of:
- enrolling a patient for an ECG monitoring session in a medical facility (performed by Healthcare Professionals users),
- receiving the signal from a compatible monitoring device worn by the patient,
- using an external AI service for signal analysis and classification (not a part of the subject device),
- processing signal and annotations received from the external AI service, including statistics computation,
- reviewing the signal and annotations by an ECG Technician user,
- generating and publishing a report for a single ECG episode (Urgent report) and for the entire monitoring session (End of Study report), performed by an ECG Technician user,
- reviewing a published report back at the medical facility that ordered the monitoring session in the first place (performed by a Physician user).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
- using an external AI service for signal analysis and classification (not a part of the subject device),
- The DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Qualified healthcare professionals / medical facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing were conducted and documented. The DeepRhythm Platform has been subjected to evaluation according to the applicable clauses of recognized consensus standard, ANSI/AAMI/IEC 60601-2-47:2012 /(R)2016 and IEC EN 60601-2-25 Edition 2.0 2011-10.
The Medicalgorithmics S.A. 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 DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use.
The software was considered an Enhanced Level of Documentation as a design flaw or failure could directly or indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of care provider.
Usability Engineering: The DeepRhythm Platform went under the usability engineering study. It was performed according to the FDA guidance and standards: Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Administration Staff (February 3, 2016) and ANSI AAMI Drug IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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June 20, 2024
Medicalgorithmics S.A. % Joanna Dabala Product Compliance Leader Medicalgorithmics US Holding Corporation Corporation Service Company 251 Little Falls Drive Wilmington, Delaware 19808
Re: K232161
Trade/Device Name: DeepRhythm Platform Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK Dated: February 29, 2024 Received: February 29, 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" (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).
1
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,
Jennifer W. Shih -S
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
2
Indications for Use
510(k) Number (if known) K232161
Device Name DeepRhythm Platform
Indications for Use (Describe)
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients.
The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary.
The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.
The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI.
The DeepRhythm Platform 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.
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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3
510(k) Summary
1 Submitter's name and address
Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland
Contact Person: Joanna Dąbała Phone: (+48) 733888448 Email: j.dabala@medicalgorithmics.com
Date Prepared: June 14, 2024
N Device
| Trade name | DeepRhythm Platform |
|---|---|
| Common name | DR Platform, DRP |
| Classification name | Electrocardiograph |
| Programmable Diagnostic Computer | |
| Regulation number | 21 CFR § 870.2340 |
| 21 CFR § 870.1425 | |
| Regulatory Class | Class II |
| Product Codes: | DPS, DQK |
3 Predicate device
The selected predicate device is:
- Cardiologs Holter Platform (K212112) -
4 Device description
The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities.
4
The DeepRhythm Platform's functionality consists of:
- enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users),
- receiving the signal from a compatible monitoring device worn by the patient, .
- using an external AI service for signal analysis and classification (not a part of the . subject device),
- processing signal and annotations received from the external Al service, including . statistics computation,
- · reviewing the signal and annotations by an ECG Technician user,
- generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user,
- reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).
5 Indications for use
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in adult patients.
The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when retrospective assessment of the rhythm is necessary.
The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arrhythmias.
The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.
The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAl.
The DeepRhythm Platform 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
Guidance documents 6
The following guidance documents have been taken into account during the preparation of this submission:
-
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Guidance for Industry and Food and Drug Administration Staff (July 28, 2014):
- Content of Premarket Submissions for Software Contained in Medical Devices, 2. Guidance for Industry and Food and Drug Administration Staff (May 11, 2005);
- Content of Premarket Submissions for Management of Cybersecurity in 3. Medical Devices, Guidance for Industry and Food and Drug Administration Staff (October 2, 2014);
-
- Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act., March 30,2023
-
- Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (September 27, 2019);
-
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff (September 6, 2017);
- General Principles of Software Validation, Guidance for Industry and Food and 7. Drug Administration Staff (January 11, 2002);
- Applying Human Factors and Usability Engineering to Medical Devices, 8. Guidance for Industry and Food and Drug Administration Staff (February 3, 2016);
- Multiple Function Device Products: Policy and Considerations, Guidance for 9. Industry and Food and Drug Administration Staff (July 29, 2020),
-
- Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (December 28, 2016);
Referenced standards 7
The DeepRhythm Platform meet the requirements of the following performance standards in accordance with FDA recognized consensus standards:
-
- AAMI/ANSI/IEC 60601-2-47:2012 /(R)2016, Medical Electrical Equipment -Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems;
-
- IEC EN 60601-2-25 Edition 2.0 2011-10, Medical electrical equipment -Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs;
-
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life cycle processes [Including Amendment 1 (2016)];
6
-
- ANSI AAMI ISO 14971 :2019 Medical devices Applications of risk management to medical devices;
-
- ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices.
8 Performance data
Software Verification and Validation Testing 8.1
Software verification and validation testing were conducted and documented.
The DeepRhythm Platform has been subjected to evaluation according to the applicable clauses of recognized consensus standard, ANSI/AAMI/IEC 60601-2-47:2012 /(R)2016 and IEC EN 60601-2-25 Edition 2.0 2011-10.
The Medicalgorithmics S.A. 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 DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use.
The software was considered an Enhanced Level of Documentation as a design flaw or failure could directly or indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of care provider.
8.2 Usability Engineering
The DeepRhythm Platform went under the usability engineering study. It was performed according to the FDA guidance and standards: Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Administration Staff (February 3, 2016) and ANSI AAMI Drug IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices.
Substantial Equivalence Conclusion 8.3
The DeepRhythm Platform is substantially equivalent to the marketed predicate device - Cardiologs Holter Platform, which already has the 510(k) clearance -K212112.
Both devices - DeepRhythm Platform and Cardiologs Technologies are software products intended for use by a qualified and trained professionals for assessment of arrhythmias. Differences between the proposed device and predicate device are minor and have no impact on the safety and the effectiveness of the product. Descriptive characteristics and performance testing were used to demonstrate substantial equivalence.
7
In the tables below are demonstrated similarities and differences between the proposed and predicate device.
| Characteristics | DeepRhythm Platform
(Proposed device) | Cardiologs Holter
Platform
(Predicate device) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medicalgorithmics S.A. | Cardiologs Technologies |
| 510(k) number | K232161 | K212112 |
| Classification | Class II | Class II |
| Regulation Number(s) | 21 CFR 870.2340
21 CFR § 870.1425 | 21 CFR 870.2340
21 CFR § 870.1425 |
| Classification name | Electrocardiograph
Programmable Diagnostic
Computer | Electrocardiograph
Programmable Diagnostic
Computer |
| Product code | DPS, DQK | DPS, DQK |
| Components | Software only | Software only |
| Display Options | Computer | Computer |
| Algorithm | Proprietary algorithm | Proprietary algorithm |
| Multiple
monitoring
mode options | Holter, Event recorder | Holter, event recorder,
12 lead ECG device |
| Intended users | Qualified and trained
healthcare professionals | Qualified healthcare
professionals |
| Alarm function | No | No |
| Characteristics | DeepRhythm Platform
(Proposed device) | Cardiologs Holter
Platform
(Predicate device) |
| Manufacturer | Medicalgorithmics S.A. | Cardiologs Technologies |
| Level of concern | Major | Moderate |
| Patient population | Adult | Adult and Pediatric |
| Fundamental
scientific
technology | DeepRhythm Platform
consists of:
A software interface
intended for analysis,
review, assessment and
reporting of arrhythmias
using ECG data acquired
from a compatible device,
coded in C# and
Typescript languages,
under the React and .NET
frameworks.
DeepRhythm Platform
is compatible with an
external Al service for
ECG analysis,
Medicalgorithmics'
DeepRhythmAl, which
performs QRS complexes
and arrhythmia detection
on the ECG signal.
Additionally, DeepRhythm
Platform performs
statistical processing of
results of data analysis
received from
DeepRhythmAI. | The Cardiologs Holter
Platform consists of:
An interface which
provides tools to
measure, analyze and
review numerous ECGs
coded in java language
under the Angular and
D3.js frameworks;
An automated proprietary
ECG interpretation
support algorithm which
measures and analyzes
ECGs to provide
supportive information for
ECG diagnosis, written in
Python language. This
application can be
accessed through an
Internet connection and a
web browser, or is directly
connected to the
Cardiologs' Application
Programming Interface
(API). |
| Characteristics | DeepRhythm Platform
(Proposed device) | Cardiologs Holter
Platform
(Predicate device) |
| Compatible devices | The DeepRhythm
Platform supports
downloading and
analyzing data recorded
in compatible formats
from 1-channel and
2-channel ambulatory
ECG recording devices
used for the arrhythmia
diagnostics such as
Holter, event recorder, or
other similar devices
when assessment of the
rhythm is necessary. | The product supports data
recorded in compatible
formats from any device
used for the arrhythmia
diagnostics such
as Holter, event recorder,
12 lead ambulatory ECG
devices, or other similar
devices when assessment
of the rhythm is
necessary. |
Table 1 Similarities – between proposed and predicate device
8
Table 2 Differences – between proposed and predicate device
9
Conclusion 9
The DeepRhythm Platform is substantially equivalent to the predicate device as supported by the descriptive information and the performance testing. The nonclinical data support the safety of the device and software verification and validation demonstrate that the DeepRhythm Platform should perform as intended in the specified use conditions.