(184 days)
Not Found
Yes
The device description explicitly states that the software "applies machine learning algorithms to process echocardiography images".
No.
The device is a software tool that processes previously acquired medical images to provide a measurement (ejection fraction) to assist clinicians in cardiac evaluation, rather than directly treating or diagnosing patients.
Yes
The device assists the clinician in a cardiac evaluation by providing an automated estimation of left ventricular ejection fraction from ultrasound images. This measurement is used to assess a patient's cardiac function, which is a diagnostic purpose.
Yes
The device is described as software that processes previously acquired images and operates between DICOM source and destination, with no mention of accompanying hardware components or hardware-specific functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EchoMD Automated Ejection Fraction software processes previously acquired transthoracic cardiac ultrasound images. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to process images and provide an automated estimation of left ventricular ejection fraction based on those images. This is a form of image analysis and measurement, not a diagnostic test performed on a biological specimen.
Therefore, while it is a medical device used in a cardiac evaluation, it falls under the category of image processing and analysis software, not an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text."
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The EchoMD Automated Ejection (AutoEF) software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.
The software applies machine learning algorithms to assess image quality and provides this information as qualitative and quantitative user feedback.
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.
Input Imaging Modality
transthoracic cardiac ultrasound images
Anatomical Site
left ventricular
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Test datasets were strictly segregated from algorithm training datasets.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Root Mean Square Deviation (RMSD) = 8.290%
p-value = 0.00052
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name is in blue text. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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). 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 medical devices and radiation-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,
Michael D. 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
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| 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)
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 ( 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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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.
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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
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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
Fraction Software Application | DiaCardio, Ltd, LVivo EF Software
Application (K130779, Predicate) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ |
| Intended Use | 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 fraction. This measurement can be
used to assist the clinician in a cardiac
evaluation. | DiaCardio's L Vivo EF Software
Application is intended for non-invasive
processing of already acquired
echocardiographic images in order to
detect, measure, and calculate the left
ventricular wall for left ventricular
function evaluation. This measurement
can be used to assist the clinician in a
cardiac evaluation. |
| Machine Learning-
Based Algorithm | Yes | Yes |
Comparison Table: EchoMD AutoEF versus Predicate
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| | Bay Labs EchoMD Automated Ejection
Fraction Software Application | DiaCardio, Ltd, LVivo EF Software
Application (K130779, Predicate) |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Operates on DICOM
clips | Yes | Yes |
| Automation level | Fully automated, including clip selection | Fully automated (with manually-
selected clips) |
| EF Method | Biplane (non-segmentation/non-
endocardial trace) | Biplane Method of Disks
Segmentation (endocardial trace) |
| Offline EF evaluation
using clips from multiple
ultrasound scanners | Yes | Yes |
| Image Clip Selection | Automated | Manual |
| Automated Ejection
Fraction Calculation | Yes | Yes |
| Ejection Fraction
reported | Whole number estimate (percentage) | Whole number estimate
(percentage) |
| Algorithm Confidence | Qualitative and quantitative user
feedback on transthoracic cardiac
ultrasound image quality | Display of endocardial border tracing |
| EF Result shown with
video clip | Yes | Yes |
| User confirmation/
rejection of result | Yes | Yes |
| Manual editing of
automated result by
user | Yes (on PACS workstation) | Yes (in application) |
| Left ventricular volumes
measurements | Not internal. Uses manual trace option
PACS workstation | Yes |