(81 days)
Yes
The device description explicitly states that "EchoGo Core 2.0 utilizes artificial intelligence (AI)" and mentions "Machine learning-based algorithm: Yes".
No.
The device is intended to provide quantification and reporting of results to support physician diagnosis, and aid in diagnostic decision-making, rather than directly treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that EchoGo Core is intended to "support physician diagnosis" and the "Device Description" section elaborates that it aids "interpreting physicians with diagnostic decision-making process."
Yes
The device description explicitly states "EchoGo Core 2.0 is a software application manufactured by Ultromics". It processes existing ultrasound images and outputs reports, without mentioning any associated hardware components included with the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- EchoGo Core's Function: EchoGo Core processes images (echocardiograms) of the heart, which are acquired in vivo (within the living body). It does not analyze biological specimens.
- Intended Use: The intended use is to quantify and report on cardiovascular function based on these images to support physician diagnosis. This is a form of medical image analysis, not in vitro testing.
While the device provides information to support diagnosis, the method by which it obtains that information (analyzing images rather than biological samples) places it outside the definition of an In Vitro Diagnostic.
No
The input text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.
Product codes
QIH
Device Description
EchoGo Core 2.0 is a software application manufactured by Ultromics to provide a report of left ventricular cardiac function, in the form of secondary capture DICOM files and/or as a structured DICOM report, to aid interpreting physicians with diagnostic decision-making process. EchoGo Core 2.0 applies to ultrasound images of the heart (echocardiograms).
EchoGo Core 2.0 utilizes artificial intelligence (AI) for the operator-assisted automatic quantification of commonly measured echocardiographic metrics . Independent training, test and validation datasets were used for training and performance assessment of the device.
Mentions image processing
Medical image management and processing system
Mentions AI, DNN, or ML
EchoGo Core 2.0 utilizes artificial intelligence (AI) for the operator-assisted automatic quantification of commonly measured echocardiographic metrics.
Machine learning-based algorithm: Yes
Input Imaging Modality
ultrasound images of the heart (echocardiograms).
Anatomical Site
Cardiovascular structures
Indicated Patient Age Range
adult populations
Intended User / Care Setting
Accredited echocardiographers and sonographers
Description of the training set, sample size, data source, and annotation protocol
Independent training, test and validation datasets were used for training and performance assessment of the device.
Description of the test set, sample size, data source, and annotation protocol
Independent training, test and validation datasets were used for training and performance assessment of the device.
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 214 previously unseen studies. Left ventricle volume and metrics subsequently derived, such as ejection fraction, were calculated. For global longitudinal strain and segmental strain at peak and end-systole, LV contour Euclidean distances were calculated. The performance dataset used was representative of the intended patient population over a clinically representative range of measures. The population was gender-balanced over clinically typical age, weight, and height ranges. Performance testing included acquisitions from multiple ultrasound system manufacturers to validate essential performance across multiple scanner platforms and settings. Root mean square error was calculated as the primary endpoint. The primary endpoint was met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Left Ventricular Metric | % Root Mean Square Error |
|---|---|
| Length | 3.06 - 4.59 |
| Volume at End Diastole and End Systole | 8.57 - 16.59 |
| Ejection Fraction | 6.69 - 8.50 |
| Stroke Volume | 10.57 - 13.68 |
| Global Longitudinal Strain | 3.36 - 4.79 |
| Systolic Segmental Longitudinal Strain | 5.51 - 9.98 |
Three operators processed a total of 214 TTE studies, respectively. Inter-operator variability demonstrated acceptable performance with a Deming RMSE of 0 for all report metrics. Similarly, intra-operator variability demonstrated acceptable performance with a Deming RMSE of 0 for all report metrics. The repeatability results for EchoGo Core 2.0 demonstrated acceptable performance.
Predicate Device(s)
Reference Device(s)
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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Ultromics Limited % Jaco Jacobs Chief Regulatory and Compliance Officer 4630 Kingsgate, Cascade Way Oxford Business Park South Oxford, Oxfordshire OX4 2SU UNITED KINGDOM
December 20, 2021
Re: K213275
Trade/Device Name: EchoGo Core (2.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: September 27, 2021 Received: September 30, 2021
Dear Jaco Jacobs:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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
Submission Number (if known)
Device Name
EchoGo Core (2.0)
Indications for Use (Describe)
EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.
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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K213275
510(K) SUMMARY
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1 Submitter
| Company | Ultromics Limited
4630 Kingsgate Cascade Way, Oxford Business Park South, Oxford,
Oxfordshire, United Kingdom, OX4 2SU |
|---------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Jaco Jacobs |
| Date Prepared | 27 November 2021 |
2 Subject Device
| Product Trade Name | EchoGo Core |
|---|---|
| Model Number | 2.0 |
| Medical Speciality | Radiology |
| Regulation | 892.2050 – Picture Archiving and Communications System |
| Product Code | QIH - Automated Radiological Image Processing Software |
| Regulatory Class | II |
EchoGo Core is the product trade name and 2.0 is the model number. For the avoidance of doubt, in this submission we combine the product trade name and model number and refer to the subject device as EchoGo Core 2.0.
3 Predicate and Reference Devices
| Predicate Device | EchoGo Core |
|---|---|
| 510(k) | K191171 |
| Manufacturer | Ultromics Limited |
| Reference Device | TomTec Arena TTA2 |
|---|---|
| 510(k) | K150122 |
| Manufacturer | TomTec Imaging Systems GmbH |
Device Description বা
EchoGo Core 2.0 is a software application manufactured by Ultromics to provide a report of left ventricular cardiac function, in the form of secondary capture DICOM files and/or as a structured DICOM report, to aid interpreting physicians with diagnostic decision-making process. EchoGo Core 2.0 applies to ultrasound images of the heart (echocardiograms).
EchoGo Core 2.0 utilizes artificial intelligence (AI) for the operator-assisted automatic quantification of commonly measured echocardiographic metrics . Independent training, test and validation datasets were used for training and performance assessment of the device.
ECHOGO CORE 2.0
510(k) SUMMARY
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EchoGo Core 2.0 requires an operator at key steps to confirm or relabel automatically labeled acquisition views (if required) and approve the left ventricle segmentations (contours) proposed by the Al.
EchoGo Core 2.0 operates in a sequential workflow manner, that includes:
-
- Automatic view classification and labeling
-
- Operator confirmation or relabeling of view classifications
-
- Contouring of the left ventricle in apical chamber views
-
- Automated heart cycle identification and end-diastolic and end-systolic frame selection
-
- Operator confirmation or rejection of left ventricle contouring and frame selection
-
- Calculation of clinical report metrics
To identify a heart cycle, the heart rate must be known. If an ECG was not taken during acquisition of the echocardiogram, the heart rate may be inferred. The operator is selecting a contoured image clip for each view and approving the selected cycle (and the key end-diastolic (ED) and end-systolic (ES) frames). The operator will review the report produced and may be asked to approve cautions that are added to the report. EchoGo Core 2.0 supports the production of reports for any combination of the three processible views (A2C, A3C and A4C), either embedded as image files in one or more multi-frame true color secondary capture DICOM files, and/or as a DICOM structured report.
5 Indications for Use
EchoGo Core 2.0 is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core 2.0 is indicated for use in adult populations.
Both the intended use and indications for use statement for the subject and predicate devices are identical. Both the subject and predicate devices are indicated for use in quantification and reporting of cardiovascular function to support the physician's diagnosis in an adult population.
Comparison of Technological Characteristics o
A comparison of technological differences between the subject and predicate devices follows.
| Characteristic | Subject Device
EchoGo Core 2.0 | Predicate Device
EchoGo Core 1.0 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Identical | Quantification of cardiovascular function from an echocardiogram |
| Indications for use | Identical | Quantification and reporting of results of cardiovascular function
to support physician diagnosis.
EchoGo Core is indicated for use
in adult populations |
| Anatomical site | Identical | Cardiovascular structures |
| Users | Identical | Accredited echocardiographers
and sonographers at Ultromics |
| Machine learning-based algorithm | Yes | Yes |
| Algorithms | Auto-Contouring DICOM Handling | Auto-Contouring DICOM Handling |
| Characteristic | Subject Device
EchoGo Core 2.0 | Predicate Device
EchoGo Core 1.0 |
| | • Technical QC | • Technical QC |
| | • Auto-View Classification | • Manual Labelling UI |
| | • Manual Labelling UI | • Contour Selection and
Approval |
| | • Contour Selection and
Approval | • Metrics Calculation |
| | • Metrics Calculation | • Auditing |
| | • Auditing | • Reporting |
| | • Service Webhooks | |
| | • Reporting | |
| Operates on DICOM clips | Yes | Yes |
| Average GLS A2C/A4C views | Yes | Yes |
| Average GLS A2C/A4C/A3C views | Yes | No |
| Per view GLS, EF and LV volume | Yes | No |
| Segmental LS | Yes | No |
| Echocardiogram images on device
report | Yes | Yes |
| Horseshoe and bullseye
representations | Yes | No |
| Mechanical dispersion plot | Yes | No |
| Strain temporal intensity
plot/CAMM plot | Yes | No |
| Contours overlayed on
echocardiogram images | Yes | No |
| Auto-view classification | Yes | No |
| Automatic ED/ES frame detection | Yes | Yes |
| EF Reported | Yes | Yes |
| Automated EF calculation | Yes | Yes |
| Simpson's biplane LV volume
calculation | Yes | Yes |
| Non-Simpson's bi-plane LV
volume calculation methods | Yes | No |
| LV ED/ES volume indexed values | Yes | No |
| EF results shown with video clip | Yes | Yes |
| User confirmation / rejection of
result | Yes | Yes |
| Manual editing of automated
result by user | No | No |
| LV stroke volume | Yes | No |
| LV length | Yes | No |
| Operating system | Windows | Windows |
| Operating platform | Single software application
platform | Single software application
platform |
| Software | Complies with IEC 62304:2015
and developed under an EDA QSR | Complies with IEC 62304:2006
and developed under an EDA QSR |
| Characteristic | Subject Device
EchoGo Core 2.0 | Predicate Device
EchoGo Core 1.0 |
| | compliant QMS incorporating risk
management per ISO 14971:2019 | compliant QMS incorporating risk
management per ISO
14971:2007 |
| Usability | Complies with IEC 62366-1:2020
and general use of FDA guidance
on usability engineering | General use of FDA guidance on
usability engineering |
| Performance testing | Equivalent to reference
comparator TomTec Arena TTA2
(K150122) | Equivalent to reference
comparator TomTec Arena TTA2
(K150122) |
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Both the subject and predicate devices have similar technological characteristics and principles of operation. Any technological differences between the subject and predicate devices raise no new concerns with regards to safety and efficacy.
Consensus Standards 7
The following consensus standards were used in the design and manufacture of EchoGo Core 2.0.
| Standard | Recognition
Number |
|-------------------------------------------------------------------------------------------------|-----------------------|
| ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | 5-125 |
| IEC 62304:2015 – Medical Device Software - Software Life Cycle Processes | 13-79 |
| IEC 62366-1:2020 – Medical Devices – Application of Usability Engineering to Medical
Devices | 5-129 |
| NEMA PS 3.1 – PS 3.20 (2016) – Digital Imaging and Communications in Medicine (DICOM)
Set | 12-300 |
| IEC ISO 10918-1:1994 – Digital Compression and Coding of Continuous-tone Still Images | 12-261 |
Ultromics Limited cites conformity to the voluntary standards above. In addition, EchoGo Core 2.0 was designed and manufactured under a QMS that fully conforms to ISO 13485:2016.
8 Performance Data
8.1 Software Verification and Validation
EchoGo Core software was developed and tested in accordance with Ultromics' 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. Formative usability assessments were conducted during formal development. Cybersecurity 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.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is considered as a moderate level of concern, since a failure or latent design flaw could indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider.
510(k) SUMMARY
8
EchoGo Core 2.0 passed all software verification and validation tests.
Essential Performance 8.2
Performance testing was conducted to demonstrate substantial equivalence to the predicate device, EchoGo Core 1.0, via a reference comparator device, TomTec Arena TTA2. Pre-determined acceptance criteria were formalised in terms of Root Mean Square (RMS) error against reference values generated using the comparator device, for each reported metric. The acceptance criteria were formalised such that EchoGo Core 2.0 would produce measures of left ventricular (LV) length, volume at end diastole (ED), and end systole (ES), ejection fraction (EF), stroke volume, cardiac output, global longitudinal strain (GLS) and segmental longitudinal strain (SLS) with an RMS error below a set, pre-determined threshold.
A formal retrospective, non-interventional validation study was conducted using 214 previously unseen studies. Left ventricle volume and metrics subsequently derived, such as ejection fraction, were calculated. For global longitudinal strain and segmental strain at peak and end-systole, LV contour Euclidean distances were calculated. The performance dataset used was representative of the intended patient population over a clinically representative range of measures. The population was gender-balanced over clinically typical age, weight, and height ranges. Performance testing included acquisitions from multiple ultrasound system manufacturers to validate essential performance across multiple scanner platforms and settings. Test datasets were strictly segregated from algorithm training datasets. Root mean square error was calculated as the primary endpoint. The primary endpoint was met. Performance against the comparator device is summarised as follows.
| Left Ventricular Metric | % Root Mean Square Error |
|---|---|
| Length | 3.06 - 4.59 |
| Volume at End Diastole and End Systole | 8.57 - 16.59 |
| Ejection Fraction | 6.69 - 8.50 |
| Stroke Volume | 10.57 - 13.68 |
| Global Longitudinal Strain | 3.36 - 4.79 |
| Systolic Segmental Longitudinal Strain | 5.51 - 9.98 |
Three operators processed a total of 214 TTE studies, respectively. Inter-operator variability demonstrated acceptable performance with a Deming RMSE of 0 for all report metrics. Similarly, intra-operator variability demonstrated acceptable performance with a Deming RMSE of 0 for all report metrics. The repeatability results for EchoGo Core 2.0 demonstrated acceptable performance.
All measurements produced by EchoGo Core 2.0 were deemed to be substantively equivalent to the predicate device and met acceptable levels of performance. We therefore consider EchoGo Core 2.0 to be substantively equivalent to the predicate device and is therefore deemed to be safe and effective.
9 Conclusions
The subject device, EchoGo Core 2.0 is as safe and as effective as the predicate device, EchoGo Core 1.0, previously cleared under K191171. The subject and predicate devices have identical intended uses and indications for use, and similar technological characteristics and principles of operation. Any minor differences raise no new concerns with regards to safety and effectiveness. Essential performance of both the subject and predicate devices were evaluated against a comparator reference device, TomTec Arena TTA2, previously
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cleared under K150122. Performance data demonstrate that EchoGo Core 2.0 and EchoGo Core 1.0 have similar essential performance.
It follows that EchoGo Core 2.0 is substantially equivalent to EchoGo Core 1.0.