(495 days)
Yes
The device description explicitly states that the main component is an "automated proprietary deep-learning algorithm," which is a type of machine learning.
No
The device is a diagnostic tool that provides analysis of cardiac arrhythmias to aid healthcare professionals, but it does not directly treat or provide therapy to patients.
Yes
The device, DeepRhythmAI, is intended for "assessment of cardiac arrhythmias" and provides "supportive information for review" to "qualified healthcare professionals." It analyzes ECG data to detect cardiac beats/arrhythmias and intervals, generating "interpretation results." While these results are not the sole means of diagnosis and are offered on an advisory basis, the device's function of analyzing medical data to provide information for the identification or monitoring of a disease (cardiac arrhythmias) falls under the definition of a diagnostic device.
Yes
The device is explicitly described as "cloud-based software" and its primary component is a "deep-learning algorithm." It functions as an API for integration with other systems and does not include or require specific hardware components for its core functionality.
Based on the provided information, DeepRhythmAI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DeepRhythmAI's Function: DeepRhythmAI analyzes ECG data, which is an electrical signal recorded from the body's surface. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for the assessment of cardiac arrhythmias using two lead ECG data. This is a physiological measurement, not an in vitro test.
Therefore, DeepRhythmAI falls under the category of a medical device that analyzes physiological signals, not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for 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 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.
Product codes
DOK, DPS
Device Description
The DeepRhythmAI 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 DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.
DeepRhythmAI 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. DeepRhythmAI 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
DeepRhythmAI returns the interpretation result to be reviewed by a qualified healthcare professional. DeepRhythmAI 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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm
Input Imaging Modality
ECG data
Anatomical Site
Cardiac
Indicated Patient Age Range
adult patients.
Intended User / Care Setting
healthcare solution integrator, qualified healthcare professionals, physicians, clinicians
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
The DeepRhythmAI 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.
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 DeepRhythmAI to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAI meets its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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) |
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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:
-
- RhythmAnalytics, K182344 (Predicate Device),
-
- Zio AT ECG Monitoring System, K181502 (Reference Device).
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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.
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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.
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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: |
- A web API
- An automated
proprietary algorithm. | Software only: - A web API
- An automated
proprietary algorithm. | 1) Zio AT Patch
Recorder Device - Zio AT Wireless
Gateway Device with
Bluetooth and Cellular
Technology - 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 |
| | DeepRhythmAl | RhythmAnalytics | Zio AT ECG Monitoring
System |
| ECG data to provide
qualified healthcare
professional with
supportive information
for review. | detection which
measures and analyzes
ECG data to provide
qualified healthcare
professional supportive
information for review. | electrocardiogram
(ECG) analysis and
reporting software,
designed to process
continuously recorded
single-lead ECG data.
The ZEUS Software
downloads, stores,
analyzes and sorts the
ECG data to allow
iRhythm's Certified
Cardiographic
Technicians (CCTs) to
generate and distribute a
report of the findings
contained within the
data, thereby enabling
the provision of a
complete ECG
processing and analysis
service. The ZEUS
Software contains a
rhythm classification
algorithm utilizing deep-
learning technology. | |
| Number of leads
for a received
ECG signal | two lead ECG data | single-lead ECG data | single-lead ECG data |
| Display or
Graphical User
Interface (GUI) | No primary display or
GUI | No primary display, it
has a GUI | Has display and GUI |
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Device comparison summary:
- Similarities: -
-
- The subject device, predicate and reference devices have the same fundamental scientific technology and intended use.
-
- The subject device, predicate and reference devices analyze ECG signals, detect and classify arrhythmias for compatible formats from FDA -cleared devices.
-
- The subject device and predicate device are software only with callable Application Programming Interface (API) used for interaction with clients.
-
- The subject device and the predicate device are not for use in patients requiring life-supporting or life-sustaining systems or ECG Alarm devices.
-
- The subject device and the predicate device provide arrhythmia analysis that are not intended to be the sole means of diagnosis. In both devices, the ECG analytics results are returned to be reviewed and interpreted by a physician or other qualified healthcare professional to make a diagnosis.
-
- The subject device, predicate and reference devices have the same patient population.
-
- Differences: -
-
- The predicate and reference devices have Graphical User Interface (GUI), while DeepRhythmAl doesn't have GUI. This is minor difference, and it does not impact either safety or effectiveness of the product. Analysis results are made available for the user through GUI of the third-party software integrated with DeepRhythmAl, but it does not cause neither safety nor effectiveness impact. GUI just makes it easier for users.
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- The predicate device and reference device have different Levels of Concern . The Level of Concern of the subject device has been determined according to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medica Devices, May 11, 2005
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Summary of performance data VII.
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.
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
The Medicalgorithmics' DeepRhythmAl is substantially equivalent to the predicate and reference devices as supported by the descriptive information and the performance testing. The subject device complies with all applicable FDA requirements, recognized standards and guidance documents. Any differences consensus in technological characteristics have been analyzed and addressed through performance testing that demonstrated that the DeepRhythmAl meets its intended use and that any differences between the subject device and the predicate and reference devices do not raise any new issues of safety or effectiveness.