RhythmAnalytics

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="font-size: 1.5em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="margin-left: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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.* #### FORM IO THE PRA STAFF 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}------------------------------------------------ # 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<br>2 Venture Drive<br>Singapore 608526 | | Contact Person: | Michael A Daniel, Consultant<br>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<br>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<br>ECG Analysis<br>Platform | |-----------------------------------------------------------|-----------------|----------------------------------------| | Heart rate determination for non-paced adult | Yes | Yes | | QRS Detection | Yes | Yes | | Non-paced arrhythmia interpretation for adult<br>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<br>predicate<br>device | |----------------------|------------------------------------|-------------------------------------|--------------------------------------| | Device Name | RhythmAnalytics | CardioLogs ECG Analysis<br>Platform | N/A | | Manufacturer | Biofourmis Singapore Pte.Ltd. | CardioLogs Technologies | N/A | | 510(k) # | K182344 | K170568 | N/A | | Regulation<br>Number | 21 CFR 870.1425<br>21 CFR 870.2340 | 21 CFR 870.1425<br>21 CFR 870.2340 | Same | | Class | II | II | Same | | Device<br>Class/Name | Electrocardiograph | Electrocardiograph | Same | {6}------------------------------------------------ | | Subject device | Predicate Device | Comparison to<br>predicate<br>device | |---------------------|----------------|------------------|--------------------------------------| | Product Code | DPS, DQK | DPS, DQK | Same | | Level of<br>Concern | Major | Moderate | Different | | | Subject device | Predicate Device | Comparison to<br>predicate device | Safety Impact | Effectiveness<br>impact | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | Refer to Section<br>"Indications for Use" | Refer to K170568,<br>Section 7.2 | Both devices are<br>intended for the same<br>use. | No impact.<br>Same for indication<br>for use. | No impact.<br>Same for<br>indication for use | | Fundamental<br>scientific<br>technology | RhythmAnalytics<br>consists of: | CardioLogs ECG<br>Analysis Platform<br>consists of: | RhythmAnalytics and<br>the predicate device<br>both consists of: | | | | | 1. A web application<br>programming interface<br>(API) which allows<br>uploading of ECG data<br>and generate ECG<br>interpretation results. | 1. An interface<br>which provides<br>tools to measure,<br>analyses and<br>review numerous<br>ECGs coded in<br>java language<br>under the Angular<br>and D3.js<br>frameworks; | 1. A cloud-based API<br>that works the same<br>way. | No impact. | No impact.<br>Both provide<br>similar interface<br>but coded in<br>difference<br>programming<br>language which<br>should not cause<br>any effectiveness<br>impact. | | | 2. An automated<br>proprietary algorithm,<br>i.e., cardiac<br>beats/arrhythmias<br>detection which<br>measures and analyses<br>ECG data to provide<br>qualified healthcare<br>professional<br>supportive information<br>for review. | 2. An automated<br>proprietary ECG<br>interpretation<br>support algorithm<br>which measures<br>and analyses<br>ECGs to provide<br>supportive<br>information for<br>ECG diagnosis,<br>written in Python<br>language. | 2. Automated<br>proprietary algorithm<br>to detect cardiac<br>arrhythmias, heart<br>rate and interval<br>measurements. | No impact.<br>Both provided<br>arrhythmia<br>interpretation are<br>not intended to be<br>the sole means of<br>diagnosis. The<br>interpretations are<br>offered to<br>physicians and<br>clinicians on an<br>advisory or<br>assistive basis. | No impact.<br>The difference in<br>programming<br>language<br>shouldn't make<br>any effect on<br>algorithms. | | | Any healthcare | This application | RhythmAnalytics | | | | Subject device | Predicate Device | Comparison to<br>predicate device | Safety Impact | Effectiveness<br>impact | | | leveraging on our<br>RhythmAnalytics API<br>can build web or<br>mobile application to<br>let qualified healthcare<br>professional review<br>and confirmation the<br>analytic result. | through an<br>Internet<br>connection and a<br>web browser or is<br>directly connected<br>to the CardioLogs'<br>API. | present any major<br>technological<br>innovations compared<br>to the predicate<br>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.