eMurmur Heart AI

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May 31, 2022 CSD Labs GmbH % Allison Komiyama Principal Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110 Re: K220766 Trade/Device Name: eMurmur Heart AI Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC Dated: May 6, 2022 Received: May 9, 2022 Dear Allison Komiyama: 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}------------------------------------------------ statutes and regulations administered by other Federal agencies. 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Sincerely, LCDR Stephen Browning 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** | Form Approved: | OMB No. 0910-0120 | |------------------|-------------------| | Expiration Date: | 06/30/2023 | See PRA Statement below. 510(k) Number (if known) K220766 Device Name #### eMurmur Heart Al Indications for Use (Describe) The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. eMurmur Heart Al is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data. Type of Use (Select one or both, as applicable) | <div> <span style="font-size:10pt"> <span style="font-family:Wingdings">✓</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span>▢</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY #### CSD Labs' eMurmur Heart Al ## SPONSOR | Company name: | CSD Labs GmbH | |------------------|----------------------------------------| | Company address: | Nikolaiplatz 4<br>8020 Graz<br>Austria | | Phone: | +43 650 5272666 | | Contact Person: | Andreas Reinisch | | Date Prepared: | March 14, 2022 | #### CONSULTANT | Company name: | RQM+ | |------------------|--------------------------------------------------------| | Company address: | 2251 San Diego Ave. Ste B-257<br>San Diego, CA 92110 | | Phone: | (412) 816-8253 | | Contact Person: | Allison Komiyama, PhD, RAC<br>Anike Freeman, MEng, PMP | ## DEVICE | Trade Name: | <b>eMurmur Heart Al</b> | |-----------------------|----------------------------------------------------| | Common or usual name: | Computer Aided Auscultation, Heart Sounds Analyzer | | Classification name: | Electronic Stethoscope; Phonocardiograph; | | Regulation number: | 21 CFR 870.1875, 870.2390 | | Product code: | DQD, DQC | | Device class: | Class II | | Reviewing panel: | Cardiology | # PREDICATE DEVICE | Company | CSD Labs GmbH | |---------|---------------| | Product | eMurmur ID | | 510(k) | K181988 | #### INDICATIONS FOR USE The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data. {4}------------------------------------------------ # DEVICE DESCRIPTION To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur. eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes. The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review. # TECHNOLOGICAL CHARACTERISTICS The eMurmur Heart Al has the same technological characteristics as the predicate device eMurmur ID. It can be accessed via the eMurmur backend, which in turn communicates with the front-end clients, e.g., the eMurmur app and eMurmur web portal. - Both systems use the same heart sound analysis algorithm, hosted on a server, requiring 1. a 20 second digital heart sound recording and the patient's age as input. - 2. Both systems provide heart sound analysis outputs and additional supporting information to the user. - 3. Both systems provide the transfer of auscultation data and the analysis results through a secure connection. - 4. Both systems employ equivalent usability and cybersecurity features. - 5. Both systems use the electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903) for the acquisition of the heart sounds that are to be analyzed. ## PERFORMANCE DATA eMurmur Heart AI and the predicate, eMurmur ID (K181988), utilize the same heart sound analysis algorithm, hence no new performance data is required. All applicable verification measures (unit tests, system tests, inspections) that were performed for the predicate were also performed for the current device, using the same pass/fail criteria. # SUBSTANTIAL EQUIVALENCE eMurmur Heart AI and eMurmur ID differ only in scope. For the previously cleared device eMurmur ID, all components of the software system (mobile app, web portal, backend, etc.) were treated as a medical device. For eMurmur Heart AI, only the relevant component, i.e., the algorithm analyzing heart sounds, is treated as a medical device. The other components which are solely intended to transfer, store, convert and display medical data or results are excluded from the scope of the medical device. Thus, eMurmur Heart AI is substantially equivalent to eMurmur ID, see the table below. {5}------------------------------------------------ | | eMurmur Heart Al | eMurmur ID | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The 'eMurmur Heart Al' software is a<br>decision support system in the evaluation<br>of recorded patient heart sounds. The<br>automated analysis by eMurmur Heart<br>Al identifies specific heart sounds that<br>may be present, including S1, S2,<br>physiological heart murmurs, pathological<br>heart murmurs and the absence of a<br>heart murmur.<br><br>eMurmur Heart Al is indicated for use in<br>a setting where auscultation would<br>typically be performed by a healthcare<br>provider. It is not intended as a sole<br>means of diagnosis. The heart sound<br>interpretations offered by eMurmur Heart<br>Al are only significant when considered in<br>conjunction with healthcare provider over-<br>read and including all other relevant<br>patient data.<br><br>'eMurmur' is a non-medical device<br>software platform which includes the<br>eMurmur apps and eMurmur web portal.<br>The platform is used to stream, record,<br>display, replay, and store auscultation<br>data, recorded by means of supported<br>digital stethoscopes. eMurmur Heart Al<br>interacts with the 'eMurmur' software<br>platform. | The eMurmur ID software system is a<br>decision support device for the healthcare<br>provider (the user) in the evaluation of<br>patient heart sounds. eMurmur ID is used<br>to record, display, analyze, and store the<br>acoustic signal of the heart, recorded by<br>means of an electronic stethoscope. The<br>automated analysis will identify specific<br>heart sounds that may be present,<br>including S1, S2, physiological heart<br>murmurs, pathological heart murmurs and<br>absence of a heart murmur.<br><br>eMurmur ID is indicated for use in a<br>setting where auscultation would typically<br>be performed by a healthcare provider. It<br>is not intended as a sole means of<br>diagnosis. The heart sound interpretations<br>offered by eMurmur ID are only significant<br>when considered in conjunction with<br>healthcare provider over-read and<br>including all other relevant patient data. | | User Population | Identical | Healthcare provider licensed or authorized<br>to perform auscultation | | Acquires and<br>Records Heart<br>Sounds | Identical | Acquires acoustic signals of the heart by<br>means of electronic stethoscope and<br>mobile app | | Analyzes Heart<br>Sounds | Identical | Distinguishes between<br>normal/physiological and pathological<br>heart murmurs | | User Interface | The user interface is not a part of<br>eMurmur Heart Al (medical device);<br>the user interface is part of 'eMurmur',<br>a non-medical device. | Android app for recording heart sounds,<br>sending analysis requests and receiving<br>analysis results. Web portal for reviewing<br>and editing user and patient data, OS<br>independent. | | Backend | The backend is not a part of eMurmur<br>Heart AI (medical device); the backend<br>is part of 'eMurmur', a non-medical<br>device. | Server analyzes (algorithm) and stores<br>(database) patient-related data and<br>communicates with the other components<br>of eMurmur ID. The interface to the other<br>components is a REST/JSON web API. | | Accessories | Identical | Electronic stethoscope Littmann 3200 | | Safety Features | Identical | Encrypted internet traffic, data stored in<br>the database on the backend is<br>encrypted, data in the database is<br>duplicated to another database in a<br>different datacenter, no protected health<br>information is stored on the user's<br>devices, user needs to authenticate, user<br>can only access authorized data | | Clinical<br>Performance | Identical | Sensitivity: 85.0% (72.9%-92.5%)<br>Specificity: 86.7% (74.9%-93.7%) | # Table 1. Substantial Equivalence Summary Comparison Table {6}------------------------------------------------ # CONCLUSIONS The medical device eMurmur Heart Al has the same intended use, similar indications for use, and the same technological characteristics, and principles of operation as eMurmur ID. Thus, eMurmur Heart AI is substantially equivalent to eMurmur ID. eMurmur Heart AI consists of the same heart sound analysis algorithm as eMurmur ID. Other components that were part of the eMurmur ID medical device (e.g., the app and web portal) have been excluded from the eMurmur Heart Al medical device, since these components are software solely intended to transfer, store, convert and display medical data or results.