EchoMD Automated Ejection Fraction Software

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June 14, 2018 Bay Labs, Inc. % Yarmela Pavlovic Partner Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 SAN FRANCISCO CA 94111 Re: K173780 Trade/Device Name: EchoMD Automated Ejection Fraction Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 22, 2018 Received: May 22, 2018 Dear Yarmela Pavlovic: 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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: 06/30/2020 See PRA Statement below 510(k) Number (if known) K173780 Device Name Bay Labs, Inc. EchoMD Automated Ejection Fraction Software #### Indications for Use (Describe) The Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection. This measurement can be used to assist the clinician in a cardiac evaluation. The EchoMD Automated Ejection Fraction Software is indicated for use in adult patients. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <b> </b> <span style="font-size:14px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:14px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | CONTINUE ON A SEPARATE PAGE IF NEEDEDThis 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 # Bay Labs, Inc. EchoMD Automated Ejection Fraction Software #### Submitter's Name, Address, Telephone Number, Contact Person Bay Labs, Inc. 290 King Street, Suite 9 San Francisco, CA 94107 Contact Person: Charles Cadieu, CEO Phone: 415 671 4711 email: charles@baylabs.io Date Prepared: May 21, 2018 ## Name of Device Common or Usual Name: Picture Archival and Communications Systems Workstation Proprietary Name: EchoMD Automated Ejection Fraction Software Classification Name: 21 CFR § 892.2050 Regulatory Class: II Product Code: LLZ, System, Image processing, Radiological ## Predicate Device Diacardio, Ltd. LVivo EF Software (K130779) #### Intended Use / Indications for Use The Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection. This measurement can be used to assist the clinician in a cardiac evaluation. The EchoMD Automated Ejection Fraction Software Application is indicated for use in adult patients. The intended use/indications for use statement is worded slightly differently than that of the predicate device, but the minor differences do not alter the intended diagnostic effect of the subject device; both products are intended to process echocardiogram images and produce ejection fraction calculations. The minor differences also do not raise different questions of safety or effectiveness, as in both instances the key question is whether the software can both produce ejection fraction calculations acceptable for clinical use. {4}------------------------------------------------ #### Device Description The EchoMD Automated Ejection (AutoEF) software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction. The software operates in between the DICOM source and the DICOM destination. EchoMD AutoEF performs left ventricular ejection measurements using both the apical four chamber and apical two chamber cardiac ultrasound views. The software selects the image clips to be used, performs the AutoEF calculation, and forwards the results to a destination PACS server for clinician viewing. The output of the Ejection Fraction estimate stated as a percentage, which is displayed via the destination PACS system. The software applies machine learning algorithms to assess image quality and provides this information as qualitative and quantitative user feedback. By automating the estimation of ejection fraction, the EchoMD software is designed to streamline the clinician's calculation of the measurement. #### Summary of Technological Characteristics The technological principle underlying both the EchoMD AutoEF and the predicate device is the calculation of ejection fraction (EF) on previously acquired cardiac scans using machine learning-based algorithms and biplane apical echocardiographic images. Ultimately, the key question for both products is whether the EF calculation provides adequate information for the clinician. While the two products use slightly different approaches to achieving their shared purpose, these differences do not raise different questions of safety or effectiveness. EchoMD AutoEF operates as a microservice background function communicating with ultrasound systems and PACS workstation systems, which provide the user interface. The predicate device may operate in this manner but also is configurable to provide its own user interface. EchoMD AutoEF automates the selection of image video clips on which to operate. The predicate device includes manual user selection of image video clips. EchoMD AutoEF utilizes a convolutional network design which operates on the image data in order to estimate ejection fraction without creating endocardial traces. The predicate generates endocardial traces. Other minor differences arise due to the design of the EchoMD running as part of a PACS system, rather than as a fully stand-alone application like the predicate. A tabular comparison of the key features of the subject and predicate devices is provided at the end of this Summary. ## Performance Data EchoMD EF software was developed and tested in accordance with Bay Labs' Design Control processes and has been subjected to extensive safety and performance testing. Non-clinical verification and validation test results established that the device meets its design requirements and intended use. Specifically, software verification was conducted at unit, module, and system integration levels. Risk management analysis generated multiple risk mitigation measures and verification activities. A Cybersecurity Analysis and data security testing were conducted to verify that data and patient protected health information security measures are included in the software. Verification and validation testing was conducted to demonstrate the substantial equivalence of EchoMD AutoEF. In both tests, the success criterion was that the EchoMD AutoEF would produce an {5}------------------------------------------------ ejection fraction number with a Root Mean Square Deviation below a set threshold as compared to the reference ground truth EF. A formal retrospective, non-interventional validation study was conducted using over 300 previously-acquired studies where the biplane method of disks ejection fraction was reported. This patient dataset was constructed to provide a balanced range of gender, ejection fraction values, and body mass index levels. Testing included a wide array of ultrasound system manufacturers to verify that EchoMD AutoEF performs acceptably across multiple scanner platforms. Variability testing was also performed to demonstrate that EchoMD AutoEF performs acceptably with a variety of image clips and frames from the same patient. Test datasets were strictly segregated from algorithm training datasets. EchoMD AutoEF ejection fraction measurements were compared to the biplane method ejection fraction, and a root mean square deviation was calculated and used as the primary endpoint. The primary endpoint was met (results: 8.290% RMSD, p-value 0.00052). An additional study was performed with a different set of cardiologists on a subset of the validation patient studies to further demonstrate the generalizability of the software. Based on the clinical performance as documented in this pivotal clinical study, the device has a safety and effectiveness profile that is similar to the predicate Diacardio LVivo EF Software device. # Conclusion The EchoMD AutoEF Software is as safe and effective as the Diacardio LVivo EF Software. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the EchoMD AutoEF and its predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that the subject device is as safe and effective as the identified predicate. Thus, the EchoMD Automated Ejection Fraction Software is substantially equivalent. | | Bay Labs EchoMD Automated Ejection<br>Fraction Software Application | DiaCardio, Ltd, LVivo EF Software<br>Application (K130779, Predicate) | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | LLZ | | Intended Use | The Bay Labs, Inc. EchoMD Automated<br>Ejection Fraction software is used to<br>process previously acquired transthoracic<br>cardiac ultrasound images, to store images,<br>and to manipulate and make<br>measurements on images using a personal<br>computer or a compatible DICOM-<br>compliant PACS system in order to provide<br>automated estimation of left ventricular<br>ejection fraction. This measurement can be<br>used to assist the clinician in a cardiac<br>evaluation. | DiaCardio's L Vivo EF Software<br>Application is intended for non-invasive<br>processing of already acquired<br>echocardiographic images in order to<br>detect, measure, and calculate the left<br>ventricular wall for left ventricular<br>function evaluation. This measurement<br>can be used to assist the clinician in a<br>cardiac evaluation. | | Machine Learning-<br>Based Algorithm | Yes | Yes | ## Comparison Table: EchoMD AutoEF versus Predicate {6}------------------------------------------------ | | Bay Labs EchoMD Automated Ejection<br>Fraction Software Application | DiaCardio, Ltd, LVivo EF Software<br>Application (K130779, Predicate) | |---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Operates on DICOM<br>clips | Yes | Yes | | Automation level | Fully automated, including clip selection | Fully automated (with manually-<br>selected clips) | | EF Method | Biplane (non-segmentation/non-<br>endocardial trace) | Biplane Method of Disks<br>Segmentation (endocardial trace) | | Offline EF evaluation<br>using clips from multiple<br>ultrasound scanners | Yes | Yes | | Image Clip Selection | Automated | Manual | | Automated Ejection<br>Fraction Calculation | Yes | Yes | | Ejection Fraction<br>reported | Whole number estimate (percentage) | Whole number estimate<br>(percentage) | | Algorithm Confidence | Qualitative and quantitative user<br>feedback on transthoracic cardiac<br>ultrasound image quality | Display of endocardial border tracing | | EF Result shown with<br>video clip | Yes | Yes | | User confirmation/<br>rejection of result | Yes | Yes | | Manual editing of<br>automated result by<br>user | Yes (on PACS workstation) | Yes (in application) | | Left ventricular volumes<br>measurements | Not internal. Uses manual trace option<br>PACS workstation | Yes |