(191 days)
Not Found
Unknown
The document mentions a "proprietary algorithm" for ECG analysis but does not explicitly state whether this algorithm utilizes AI or ML. The lack of information on training and test sets, which are common in AI/ML development, further contributes to the uncertainty.
No
The device is a software application intended for the assessment of cardiac arrhythmias, providing analytical results for healthcare professionals to review. It is not directly involved in treating or alleviating a condition, but rather in providing diagnostic information.
Yes
The device is described as software for the "assessment of cardiac arrhythmias" and supports data from devices used for "arrhythmia diagnostics". It performs "ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis" to provide "supportive information for review" by healthcare professionals, all of which are diagnostic functions. Although it states its results are "not intended to be the sole means of diagnosis," it clearly contributes to the diagnostic process.
Yes
The device is described as a "software application" and consists of a web API and an algorithm. It processes data from other FDA-cleared devices or computer-based systems and provides interpretation results. There is no mention of accompanying hardware developed or included as part of this specific device submission.
Based on the provided information, RhythmAnalytics is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- RhythmAnalytics analyzes ECG data: RhythmAnalytics processes electrical signals from the heart (ECG data), which is a physiological measurement, not a biological sample.
The intended use and device description clearly state that RhythmAnalytics analyzes single-lead ECG data to assess cardiac arrhythmias. This falls under the category of a medical device that analyzes physiological signals, not an IVD.
N/A
Intended Use / Indications for Use
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 analysing 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 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. 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)
DQK, DPS
Device Description
RhythmAnalytics consists of (1) A web application programming interface (API) which an authentic user to upload single-lead ECG data and reports ECG interpretation results, and (2) An automated proprietary algorithm, i.e., cardiac beats/arrhythmias detection which measures and analyzes ECG data to provide qualified healthcare professional supportive information for review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
subjects over 18 years of age.
Intended User / Care Setting
healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result.
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)
Tests have been performed in compliance with the appropriate recognized consensus standards. Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. Performance testing included the evaluation of sensitivity, specificity, and positive and negative values. All clinical input requirements were validated against a gold standard. No residual anomalies appeared during verification and software validation tests. General usability tests, analyzing the users' ability to login, upload, review and download were performed and met all requirements. All software validation testing was completed successfully and met all requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance testing included the evaluation of sensitivity, specificity, and positive and negative values.
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
§ 870.1425 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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March 7, 2019
Biofourmis Singapore Pte. Ltd. % Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460
Re: K182344
Trade/Device Name: RhythmAnalytics Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: February 1, 2019 Received: February 5, 2019
Dear Michael Daniel:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182344
Device Name RhythmAnalytics
Indications for Use (Describe)
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 analysing 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 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 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. 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
Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K182344
Applicant Information:
| Date Prepared: | March 01, 2019 |
|---|---|
| Name: | Biofourmis Singapore Pte.Ltd. |
| Address: | Vision Exchange, #07-15 |
| 2 Venture Drive | |
| Singapore 608526 |
| Contact Person: | Michael A Daniel, Consultant
madaniel@clinregconsult.com |
|-------------------|-------------------------------------------------------------|
| Mobile Number: | (415) 407-0223 |
| Office Number: | (775) 392-2970 |
| Facsimile Number: | (610) 545-0799 |
Device Information:
| Trade Name: | RhythmAnalytics |
|---|---|
| Common Names: | ECG Analysis System |
| Classification Name(s): | Programmable Diagnostic Computer/Electrograph |
| Product Code/ Regulation: | DQK, 21 CFR 870.1425 |
| DPS, 21 CFR 870.2340 | |
| Classification: | Class II |
Predicate Device:
- . CardioLogs ECG Analysis Platform – K170568
Device Description:
RhythmAnalytics consists of (1) A web application programming interface (API) which an authentic user to upload single-lead ECG data and reports ECG interpretation results, and (2) An automated proprietary algorithm, i.e., cardiac beats/arrhythmias detection which measures and analyzes ECG data to provide qualified healthcare professional supportive information for review.
RhythmAnalytics is only intended to analyze recordings performed on adults (over the age of 18). RhythmAnalytics works in the following sequence:
- Accept uploading digital ECG files via secure API;
- Analyse the uploaded ECG using RhythmAnalytics proprietary algorithm, which detects ● cardiac beats/arrhythmias and intervals including:
- o Heart rate determination
- o RR Interval measurements
4
- ORS o
- Non-paced arrhythmias o
- Non-paced ventricular arrhythmia calls o
- Ventricular ectopic beats O
- RhythmAnalytics returns the interpretation result to be reviewed by a qualified healthcare ● professional.
Indications for Use:
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 analysing 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 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. 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.
Summary Comparison to Predicate:
The following tables provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or effectiveness.
Comparison to Predicate Device:
The following table provides a comparison of the detection features and device comparison of RhythmAnalytics and the predicate device:
Detection Features comparison:
5
| Detection Feature | RhythmAnalytics | CardioLogs
ECG Analysis
Platform |
|-----------------------------------------------------------|-----------------|----------------------------------------|
| Heart rate determination for non-paced adult | Yes | Yes |
| QRS Detection | Yes | Yes |
| Non-paced arrhythmia interpretation for adult
patients | Yes | Yes |
| Non-paced ventricular arrhythmia calls | Yes | Yes |
| Intervals measurements | Yes | Yes |
| Ventricular ectopic beat detection | Yes | Yes |
| Patient Population | Adult | Adult |
Device comparison:
| | Subject device | Predicate Device | Comparison to
predicate
device |
|----------------------|------------------------------------|-------------------------------------|--------------------------------------|
| Device Name | RhythmAnalytics | CardioLogs ECG Analysis
Platform | N/A |
| Manufacturer | Biofourmis Singapore Pte.Ltd. | CardioLogs Technologies | N/A |
| 510(k) # | K182344 | K170568 | N/A |
| Regulation
Number | 21 CFR 870.1425
21 CFR 870.2340 | 21 CFR 870.1425
21 CFR 870.2340 | Same |
| Class | II | II | Same |
| Device
Class/Name | Electrocardiograph | Electrocardiograph | Same |
6
| | Subject device | Predicate Device | Comparison to
predicate
device |
|---------------------|----------------|------------------|--------------------------------------|
| Product Code | DPS, DQK | DPS, DQK | Same |
| Level of
Concern | Major | Moderate | Different |
| | Subject device | Predicate Device | Comparison to
predicate device | Safety Impact | Effectiveness
impact |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Refer to Section
"Indications for Use" | Refer to K170568,
Section 7.2 | Both devices are
intended for the same
use. | No impact.
Same for indication
for use. | No impact.
Same for
indication for use |
| Fundamental
scientific
technology | RhythmAnalytics
consists of: | CardioLogs ECG
Analysis Platform
consists of: | RhythmAnalytics and
the predicate device
both consists of: | | |
| | 1. A web application
programming interface
(API) which allows
uploading of ECG data
and generate ECG
interpretation results. | 1. An interface
which provides
tools to measure,
analyses and
review numerous
ECGs coded in
java language
under the Angular
and D3.js
frameworks; | 1. A cloud-based API
that works the same
way. | No impact. | No impact.
Both provide
similar interface
but coded in
difference
programming
language which
should not cause
any effectiveness
impact. |
| | 2. An automated
proprietary algorithm,
i.e., cardiac
beats/arrhythmias
detection which
measures and analyses
ECG data to provide
qualified healthcare
professional
supportive information
for review. | 2. An automated
proprietary ECG
interpretation
support algorithm
which measures
and analyses
ECGs to provide
supportive
information for
ECG diagnosis,
written in Python
language. | 2. Automated
proprietary algorithm
to detect cardiac
arrhythmias, heart
rate and interval
measurements. | No impact.
Both provided
arrhythmia
interpretation are
not intended to be
the sole means of
diagnosis. The
interpretations are
offered to
physicians and
clinicians on an
advisory or
assistive basis. | No impact.
The difference in
programming
language
shouldn't make
any effect on
algorithms. |
| | Any healthcare | This application | RhythmAnalytics | | |
| Subject device | Predicate Device | Comparison to
predicate device | Safety Impact | Effectiveness
impact | |
| leveraging on our
RhythmAnalytics API
can build web or
mobile application to
let qualified healthcare
professional review
and confirmation the
analytic result. | through an
Internet
connection and a
web browser or is
directly connected
to the CardioLogs'
API. | present any major
technological
innovations compared
to the predicate
device. | | | |
7
Summary of Performance Testing
Tests have been performed in compliance with the appropriate recognized consensus standards. Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. Performance testing included the evaluation of sensitivity, specificity, and positive and negative values. All clinical input requirements were validated against a gold standard. No residual anomalies appeared during verification and software validation tests. General usability tests, analyzing the users' ability to login, upload, review and download were performed and met all requirements. All software validation testing was completed successfully and met all requirements.
Software
Biofourmis followed IEC 62304:2015 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. The Biofourmis software is classified as a "major level of concern" per the FDA guidance document.
Verification and validation testing was completed in compliance with the following standards and guidance documents:
- AAMI ANSI IEC 62304:2015, Medical device software Software life cycle processes ●
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff" . (January, 2002)
- AAMI/ANSI EC57:2012 - Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms
- IEC 62366-1 Edition 1.0 2015-02 Medical devices Application of usability ● engineering to medical devices
Conclusion
Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, RhythmAnalytics has been shown to be substantially equivalent to the legally-marketed predicate.