(133 days)
Not Found
Yes
The document explicitly states that "Machine learning based view classification and border detection form the basis for this automated analysis" and that the device uses "machine learning algorithms to automate the measurement of transthoracic cardiac images."
No
The device is described as an image post-processing analysis software intended to aid diagnostic review and analysis, not to directly treat or prevent a disease.
Yes
The device "is intended to aid diagnostic review and analysis of echocardiographic data" and the data it produces "is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making." This indicates its role in the diagnostic process.
Yes
The device is described as a "fully automated software platform" and an "image post-processing analysis software device." The description focuses entirely on the software's functions, data processing, and user interface, with no mention of accompanying hardware components required for its operation beyond standard computing devices.
Based on the provided text, 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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that Us2.v1 is an "image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images". It processes and analyzes images acquired from a medical imaging modality (ultrasound), which is performed on the patient's body.
- Input Data: The input data is "acquired transthoracy cardiac ultrasound images" and "cardiovascular ultrasound images in DICOM format". These are images of the body, not biological samples taken from the body.
Therefore, Us2.v1 falls under the category of medical imaging software, not an in vitro diagnostic device.
No
The letter does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracy cardiac ultrasound images, automatically producing a full report with measurements of several and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).
Product codes
QIH
Device Description
Us2.v1 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting.
The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area and blood flow, quantitative analysis of cardiac function, and a summary report.
The software allows the sonographer to enter their markup manually. It also provides automated markup and analysis, which the sonographer may choose to accept outright, to accept partially and modify, or to reject and ignore. Additionally, the software has features for organizing, displaying and comparing to reference guidelines the quantitative data from cardiovascular images acquired from ultrasound scanners.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Machine learning based view classification and border detection form the basis for this automated analysis.
both use machine learning algorithms to automate the measurement of transthoracic cardiac images.
Input Imaging Modality
transthoracic cardiac ultrasound images, Cardiac echocardiogram
Anatomical Site
cardiac, heart
Indicated Patient Age Range
adult patients, >= 18 years of age
Intended User / Care Setting
qualified cardiologists or licensed primary care providers
Description of the training set, sample size, data source, and annotation protocol
Test datasets were strictly segregated from algorithm training datasets. (No further information provided about the training set)
Description of the test set, sample size, data source, and annotation protocol
A formal retrospective non-interventional validation study was conducted using 600 previously acquired echocardiograms to evaluate the performance of the device for each claimed measurement. The patient dataset was constructed to provide a balanced range of gender and body mass index levels. A blinded, anonymized series of 600 unique echocardiographic studies was selected for analysis. Of these, 421 are samples of patients with heart failure with reduced ejection fraction. The remaining 179 examinations were from normal subjects. Both cohorts of subjects were selected from sets of previously annotated and overread studies with robust inclusion criteria.
Two subject cohorts were used for analysis across 600 studies:
- HFrEF Subjects: 421 studies
- Normal Subjects: 179 studies
Inclusion criteria were:
HFrEF Subjects
- Written informed consent for the original study.
- Men and women >= 18 years of age.
- HFrEF subjects (heart failure with LVEF 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive
- In good health, in the opinion of the Investigator, as determined by the following:
a. A physical examination at screening and medical history with no clinically significant abnormalities
b. Not taking medications for the treatment of any chronic or episodic medical disease or condition
c. Vital signs within the ranges below measured while the subject is supine after 3 minutes rest. May re-check vital signs twice at screening.
heart rate 40-90 beats per minute; systolic blood pressure (BP) 100-140 mmHg: diastolic BP 50-95 mmHg: respiration rate 55% - Normal electrocardiogram (ECG) or, if abnormalities are present, they are deemed not clinically significant by the Investigator
The primary performance metric is the reference-scaled individual equivalence coefficient (IEC, Barnhart, 2007) across three human readers and one automated read performed by Us2.v1.
Summary of Performance Studies
A formal retrospective non-interventional validation study was conducted using 600 previously acquired echocardiograms to evaluate the performance of the device for each claimed measurement.
The primary performance metric is the reference-scaled individual equivalence coefficient (IEC, Barnhart, 2007) across three human readers and one automated read performed by Us2.v1. We define our success criterion as a non-inferiority margin, Δ= 0.25, such that Us2.v1 is deemed interchangeable with the reference if IEC + 1.96*SD(IEC)
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
eko.ai Pte. Ltd. d/b/a Us2.ai % Jared Seehafer Regulatory Consultant Enzyme Corporation 611 Gateway Blvd., Suite 120 SOUTH SAN FRANCISCO CA 94080
July 27, 2021
Re: K210791
Trade/Device Name: Us2.v1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: June 17, 2021 Received: June 24, 2021
Dear Jared Seehafer:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (Sections 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210791
Device Name Us2.v1
Indications for Use (Describe)
Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracy cardiac ultrasound images, automatically producing a full report with measurements of several and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).
Please note the following limitations:
-
Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.
-
Our software complements good patient care and does not exempt the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions.
-
If no gender is present, female referenced guideline values will be used for conclusions.
-
If Body Surface Area (BSA) is not present, indexed values cannot be provided.
-
During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
Type of Use (Select one or both, as applicable) | |
---|---|
区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
5 510(k) Summary
Submission Number: | K210791 | |
---|---|---|
Submitter's Name: | Eko.ai Pte. Ltd. (d/b/a Us2.ai) | |
Address: | 2 College Road, #02-00, Singapore 169850 | |
Contact Person: | Jared Seehafer | |
Title: | Regulatory Consultant | |
Telephone Number: | 415-857-9554 | |
Fax Number: | 415-367-1279 | |
Email: | jared@enzyme.com | |
Date Summary Prepared: | July 15, 2021 | |
Device Proprietary Name: | Us2.v1 | |
Model Number: | V 1.0.0 | |
Common Name: | Us2.v1 | |
Regulation Number: | 21 CFR 892.2050 | |
Regulation Name: | System, Image Processing, Radiological | |
Product Code: | QIH | |
Device Class: | Class II | |
Predicate Device | Trade name: EchoMD Automated Ejection Fraction | |
Software | ||
Manufacturer: Bay Labs, Inc. | ||
(now known as Caption Health, Inc.) | ||
290 King Street | ||
San Francisco, CA 94107 | ||
Regulation Number: 21 CFR 892.2050 | ||
Regulation Name: System, Image Processing, Radiological | ||
Device Class: Class II | ||
Product Code: LLZ | ||
510(k) Number: K173780 | ||
510(k) Clearance Date: June 14, 2018 |
Table 5-1. Subject Device Overview.
4
5.1 Device Description
Us2.v1 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting.
The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area and blood flow, quantitative analysis of cardiac function, and a summary report.
The software allows the sonographer to enter their markup manually. It also provides automated markup and analysis, which the sonographer may choose to accept outright, to accept partially and modify, or to reject and ignore. Machine learning based view classification and border detection form the basis for this automated analysis. Additionally, the software has features for organizing, displaying and comparing to reference guidelines the quantitative data from cardiovascular images acquired from ultrasound scanners.
5.2 Indications for Use
Us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on DICOM images produced by FDA approved ultrasound devices. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).
Please note the following limitations:
- . Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.
- . Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions.
- If no gender is present, female referenced guideline values will be used for conclusions. .
- If Body Surface Area (BSA) is not present, indexed values cannot be provided. .
- . During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
5
5.3 Summary of Technological Characteristics Comparison
Table 5-2 shows the similarities and differences between the technological characteristics of the two products. Testing demonstrates that the differences do not raise new questions of safety or effectiveness.
Topic | Predicate Device | Subject Device | ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical | ||||||||||||||||||||||||||||||||||||||||||||||||
Characteristics | Software package that operates | |||||||||||||||||||||||||||||||||||||||||||||||
utilizing off-the-shelf hardware | Same | |||||||||||||||||||||||||||||||||||||||||||||||
DICOM Standard | ||||||||||||||||||||||||||||||||||||||||||||||||
Compliance | The software processes DICOM | |||||||||||||||||||||||||||||||||||||||||||||||
compliant image data | Same | |||||||||||||||||||||||||||||||||||||||||||||||
Modalities | Cardiac echocardiogram | Same | ||||||||||||||||||||||||||||||||||||||||||||||
User Interface | The software is designed for use on | |||||||||||||||||||||||||||||||||||||||||||||||
a personal computer that has been | ||||||||||||||||||||||||||||||||||||||||||||||||
received images from a compatible | ||||||||||||||||||||||||||||||||||||||||||||||||
PACS | Same | |||||||||||||||||||||||||||||||||||||||||||||||
Automation level | Fully automated, including clip | |||||||||||||||||||||||||||||||||||||||||||||||
selection | Same | |||||||||||||||||||||||||||||||||||||||||||||||
User | ||||||||||||||||||||||||||||||||||||||||||||||||
confirmation/ | ||||||||||||||||||||||||||||||||||||||||||||||||
rejection of result | Yes | Yes | ||||||||||||||||||||||||||||||||||||||||||||||
Manual editing | ||||||||||||||||||||||||||||||||||||||||||||||||
of automated | ||||||||||||||||||||||||||||||||||||||||||||||||
result by user | Yes (on PACS workstation) | Yes (in application) | ||||||||||||||||||||||||||||||||||||||||||||||
Automated | ||||||||||||||||||||||||||||||||||||||||||||||||
calculations | Ejection Fraction | Region Measurement LV DecT LV MV-A LV MV-Adur LV MV-E LV e' lateral LV e' septal LV a' lateral LV a' septal LV s' lateral LV s' septal LV LVEDV MOD biplane LV LVEF MOD biplane LV LVESV MOD biplane LV LVSV MOD biplane LV IVSd LV LVIDd LV LVIDs LV LVPWd LV E/e' mean RV RVIDd LA LAESV MOD biplane RA Raa |
Table 5-2. Summary of Technological Characteristics Comparison.
6
5.4 Performance Data
Us2.v1 was developed and tested in accordance with Us2.ai's Design Control processes. The device has been subject to extensive safety and performance testing. Non-clinical verification and validationtest 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 managementanalysis 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 design of the software. A Human Factors/Usability Engineering study performed according to the principles of AAMI/ANSI HE75 was performed to validate device's usability within the intended user population.
A formal retrospective non-interventional validation study was conducted using 600 previouslyacquired echocardiograms to evaluate the performance of the device for each claimed measurement. The patient dataset was constructed to provide a balanced range of gender and body mass index levels. A blinded, anonymized series of 600 unique echocardiographic studies was selected for analysis. Of these, 421 are samples of patients with heart failure with reduced ejection fraction. The remaining 179 examinations were from normal subjects. Both cohorts of subjects were selected fromsets of previously annotated and overread studies with robust inclusion criteria (see below).
Additional demographic information and vital signs at the time of examination are available in Table 1.
Two subject cohorts were used for analysis across 600 studies:
- HFrEF Subjects: 421 studies -
- -Normal Subjects: 179 studies
Inclusion criteria were:
HFrEF Subjects
Subjects eligible for inclusion in this study met all of the following criteria at screening:
-
- Written informed consent for the original study.
-
- Men and women ≥ 18 years of age.
-
- HFrEF subjects (heart failure with LVEF 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive
-
- In good health, in the opinion of the Investigator, as determined by the following:
- a. A physical examination at screening and medical history with no clinically significant abnormalities
- b. Not taking medications for the treatment of any chronic or episodic medicaldisease or condition
- c. Vital signs within the ranges below measured while the subject is supine after 3 minutes rest. May re-check vital signs twice at screening.
- heart rate 40-90 beats per minute; systolic blood pressure (BP) 100-140 mmHg: diastolic BP 50-95 mmHg: respiration rate 55%
-
- Normal electrocardiogram (ECG) or, if abnormalities are present, they are deemed notclinically significant by the Investigator
Normal Cohort | HFrEF Cohort | |
---|---|---|
Age | 40.0 (± 7.5) years | 64.3 (± 12.5) years |
% Male | 72.6% | 67.4% |
Height | 168.1 (± 9.4) cm | 172.2 (± 10.3) cm |
Weight | 76.6 (± 9.2) kg | 93.4 (± 24.9) kg |
Heart Rate | 62.7 (± 7.1) bpm | 72.2 (± 11.9) bpm |
Systolic Blood Pressure | 112.0 (± 9.7) mmHg | 124.6 (± 18.1) mmHg |
Diastolic Blood Pressure | 71.2 (± 7.9) mmHg | 74.1 (± 11.5) mmHg |
Table 1. Demographics of Cohort
Test datasets were strictly segregated from algorithm training datasets. The primary performance metric is the reference-scaled individual equivalence coefficient (IEC, Barnhart, 2007) across three human readers and one automated read performed by Us2.v1.
We define our success criterion as a non-inferiority margin, Δ= 0.25, such that Us2.v1 is deemed interchangeable with the reference if IEC + 1.96*SD(IEC)