(155 days)
Not Found
Yes.
The device description clearly states it is an "automated machine learning-based decision support system" and specifically uses a "machine learning process" to identify cardiac amyloidosis.
No.
The device is indicated as a screening tool to alert a physician for referral to confirmatory investigations; it does not directly treat or alleviate a condition.
Yes
The device is described as a "screening tool" and "decision support system" that "provides information alerting the physician for referral to confirmatory investigations," and "assists clinicians in the diagnosis of cardiac amyloidosis," all of which are functions of a diagnostic device. It processes echocardiogram videos to output a report "suggestive or not suggestive of cardiac amyloidosis."
Yes
The device explicitly states in its description that it "has no physical form" and is a "Software as a Medical Device (SaMD) machine-learning screening algorithm." It integrates into an institution's PACS system and "inputs images and videos from echocardiogram studies, and it outputs a report," indicating a purely software-based function.
No.
An IVD is used for in-vitro examination of specimens derived from the human body. This device processes echocardiogram videos, which are in-vivo images, not in-vitro specimens.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text explicitly says "Control Plan Authorized (PCCP) and relevant text Not Found".
Intended Use / Indications for Use
InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography.
When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations.
InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.
Product codes
SDJ
Device Description
The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The device assists clinicians in the diagnosis of cardiac amyloidosis.
The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis. The device inputs images and videos from echocardiogram studies, and it outputs a report suggestive or not suggestive of cardiac amyloidosis.
The device has no physical form and is installed as a third-party application to an institution's PACS system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system
The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm
The InVision PCA algorithm uses a machine learning process
Input Imaging Modality
echocardiogram videos, echocardiogram studies, transthoracic cardiac ultrasound images
Anatomical Site
Cardiovascular
Indicated Patient Age Range
adult patients aged 65 years and over
adult populations over 65 years of age.
Intended User / Care Setting
interpreting physician, Interpreting clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The ML model performance validation study was conducted using a total of 1221 unique echocardiogram studies that fulfilled the inclusion and exclusion criteria. The data were selected from three geographically different U.S. sites. The ratio of cardiac amyloidosis cases to non-suspicious non-CA control cases was 1:2. The study compared the device's performance in analyzing previously acquired transthoracic cardiac ultrasound images and identifying cases of Cardiac Amyloidosis compared to confirmatory reference data, such as diagnostic imaging or pathology.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ML model performance validation study was conducted using a total of 1221 unique echocardiogram studies. The validation study met all its predefined endpoints, demonstrating a sensitivity of 0.607 and a specificity of 0.990. Subgroup analysis was performed across age, gender, BMI, race/ethnicity, CA type, sites, and imaging manufacturers. The device successfully passed the acceptance criteria across all subgroups.
Additionally, a human factors validation was conducted to evaluate users can safely and effectively interact with the device. The HF validation consisted of intended users (16 non-cardiologists and 15 cardiologists) and was conducted under simulated-use conditions in the United States. The HF validation concluded that all users were able to comprehend the output report of the device, and the existing use-related errors have been mitigated as far as possible.
Cybersecurity testing - including Dynamic Code Analysis, Vulnerability Scanning, Fuzz Testing, and Penetration Testing - was conducted to evaluate the security of the device. There were no vulnerabilities identified, demonstrating that the InVision PCA's cybersecurity controls are effective and that there are no new cybersecurity-related risks for the InVision PCA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity of 0.607 and a specificity of 0.990
PPV and NPV at various prevalences based on the device's sensitivity (Se) and specificity (Sp).
Prevalence: 0.5%, PPV: 0.237, NPV: 0.998
Prevalence: 1%, PPV: 0.384, NPV: 0.996
Prevalence: 2%, PPV: 0.558, NPV: 0.992
Prevalence: 3%, PPV: 0.656, NPV: 0.988
Prevalence: 5%, PPV: 0.765, NPV: 0.980
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2200 Adjunctive cardiovascular status indicator.
(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 21, 2025
InVision Medical Technology Corporation
Golnaz Moeini
Medical Device and Regulatory Consultant
9702 Cisco Street
Los Angeles, California 90034
Re: K243866
Trade/Device Name: InVision Precision Cardiac Amyloid
Regulation Number: 21 CFR 870.2200
Regulation Name: Adjunctive Cardiovascular Status Indicator
Regulatory Class: Class II
Product Code: SDJ
Dated: April 15, 2025
Received: April 16, 2025
Dear Golnaz Moeini:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K243866 - Golnaz Moeini Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K243866 - Golnaz Moeini Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Stephen C. Browning -S
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
Page 4
Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243866
Device Name: InVision Precision Cardiac Amyloid
Indications for Use (Describe)
InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography.
When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations.
InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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"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."
Page 5
InVision Medical Technology 510(k) Summary
Submitter
InVision Medical Technology Corporation
9702 Cisco St. Los Angeles, CA 90034
Contact person: Golnaz Moeini, Medical Device and Regulatory Consultant
Email: golnaz.moeini@gmail.com
Phone: 408-504-3187
Date prepared: April 11, 2025
Subject Device
Proprietary name: InVision Precision Cardiac Amyloid
Common name: InVision Precision Cardiac Amyloid
Regulation: 21 CFR 870.2200; Adjunctive cardiovascular status indicator.
Regulatory class: II
Product code: SDJ
Predicate Device
Proprietary name: Ultromics EchoGo Amyloidosis (K240860)
Device Description
The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The device assists clinicians in the diagnosis of cardiac amyloidosis.
The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis. The device inputs images and videos from echocardiogram studies, and it outputs a report suggestive or not suggestive of cardiac amyloidosis.
The device has no physical form and is installed as a third-party application to an institution's PACS system.
K243866 Page 1 of 6
Page 6
Intended Use
InVision Precision Cardiac Amyloid is intended to provide adjunctive information on a patient's cardiovascular condition (diagnostic aid for cardiac amyloidosis).
Indications for Use
InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography.
When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations.
InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.
Summary of Technological Characteristics
A comparison of technological similarities and differences between the subject and predicate devices is as follows:
| Feature | Subject Device: InVision Precision Cardiac Amyloid | Predicate Device: Ultromics EchoGo Amyloidosis K240860 |
|---|---|---|
| Regulation | 21 CFR 870.2200 | Same |
| Generic Device Type | Adjunctive cardiovascular status indicator | Same |
| SaMD | Yes | Same |
| Indications for Use | InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography. | EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system, indicated as a screening tool for adult patients over 65 years of age with heart failure undergoing routine cardiovascular assessment using echocardiography. |
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| Feature | Subject Device: InVision Precision Cardiac Amyloid | Predicate Device: Ultromics EchoGo Amyloidosis K240860 |
|---|---|---|
| When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid. | When utilised by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. EchoGo Amyloidosis 1.0 is indicated in adult populations over 65 years of age with heart failure. Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis 1.0 analysis. | |
| Anatomical Site | Cardiovascular | Same |
| Users | Interpreting clinician | Same |
| Machine Learning-Based Algorithm | Yes | Same |
| Operating Platform | Hosted on InVision's platform or third party infrastructure | Same |
| Interoperability | Compatible with devices compliant with DICOM Standard | Same |
| Software | Complies with IEC 62304 | Same |
| Risk Management | In accordance with ISO 14971 | Same |
| Cybersecurity | Post-market Management of Cybersecurity in Medical Devices. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Cybersecurity for Networked Medical Devices Containing Off The-Shelf (OTS) Software: Guidance for Industry. | Same |
| Human Factors | Human factors validation with intended users | Same |
| Pre-Clinical | No animal studies were conducted | Same |
K243866 Page 3 of 6
Page 8
| Feature | Subject Device: InVision Precision Cardiac Amyloid | Predicate Device: Ultromics EchoGo Amyloidosis K240860 |
|---|---|---|
| Bench Performance Testing | Technical validation, numerical stability, and regression testing. | Same |
| Clinical Performance Testing | Validated on a validation cohort representative of the intended use population. | Same |
Both subject and predicate devices have the same intended use, similar principles of operations, and technological characteristics. Any differences do not raise different questions of safety and effectiveness.
Performance Data
The InVision PCA software was developed and tested in accordance with InVision Medical Technology's Design Control processes and has been subjected to extensive safety and performance testing. Verification and validation testing were conducted to establish the substantial equivalence of the subject device to the predicate. Software verification and validation were conducted in accordance with IEC 62304 - Medical device software – Software life cycle process. The testing demonstrated that software requirements were properly implemented and that the software functions as intended.
The ML model performance validation study was conducted using a total of 1221 unique echocardiogram studies that fulfilled the inclusion and exclusion criteria. The data were selected from three geographically different U.S. sites. The ratio of cardiac amyloidosis cases to non-suspicious non-CA control cases was 1:2. The study compared the device's performance in analyzing previously acquired transthoracic cardiac ultrasound images and identifying cases of Cardiac Amyloidosis compared to confirmatory reference data, such as diagnostic imaging or pathology. The validation study met all its predefined endpoints, demonstrating a sensitivity of 0.607 and a specificity of 0.990. Subgroup analysis was performed across age, gender, BMI, race/ethnicity, CA type, sites, and imaging manufacturers. The device successfully passed the acceptance criteria across all subgroups.
PPV and NPV at various prevalences based on the device's sensitivity (Se) and specificity (Sp).
K243866 Page 4 of 6
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Se=60.7% Sp=99.0% (Actual)
| Prevalence | PPV | NPV |
|---|---|---|
| 0.5% | 0.237 | 0.998 |
| 1% | 0.384 | 0.996 |
| 2% | 0.558 | 0.992 |
| 3% | 0.656 | 0.988 |
| 5% | 0.765 | 0.980 |
Additionally, a human factors validation was conducted to evaluate users can safely and effectively interact with the device. The HF validation consisted of intended users (16 non-cardiologists and 15 cardiologists) and was conducted under simulated-use conditions in the United States. The HF validation concluded that all users were able to comprehend the output report of the device, and the existing use-related errors have been mitigated as far as possible.
Cybersecurity testing - including Dynamic Code Analysis, Vulnerability Scanning, Fuzz Testing, and Penetration Testing - was conducted to evaluate the security of the device. There were no vulnerabilities identified, demonstrating that the InVision PCA's cybersecurity controls are effective and that there are no new cybersecurity-related risks for the InVision PCA.
Conclusions
Performance testing demonstrated InVision Precision Cardiac Amyloid performs as expected and in a manner that is substantially equivalent to the predicate device. InVision PCA has the same intended use and similar indications for use, principles of
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operation, and technological characteristics as the predicate device. The differences do not raise new concerns of safety and effectiveness. Therefore, InVision Precision Cardiac Amyloid is substantially equivalent to the predicate device.
K243866 Page 6 of 6