(266 days)
Not Found
No
The device description explicitly states that segmentation is performed using a "rule-based, non-AI/ML algorithm".
No
The device is a diagnostic tool designed to quantify and report on RV structures and function to support physicians' diagnoses. It does not directly provide therapy.
Yes
The "Indications for use" explicitly state that the software is intended "to support physicians' diagnosis."
Yes
The device is explicitly described as "The Argus Cognitive ReVISION Software" and the entire summary focuses on the software's functionality, validation, and performance. There is no mention of any accompanying hardware component that is part of the regulated device.
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 Argus Cognitive ReVISION Software analyzes imaging data (3D echocardiography) of the heart's right ventricle. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to quantify and report on the structure and function of the right ventricle based on imaging data to support diagnosis. This is a function performed on the patient's anatomy via imaging, not on a biological sample.
Therefore, while it is a medical device used to aid in diagnosis, it falls under the category of imaging analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.
Product codes
LLZ
Device Description
The Argus Cognitive ReVISION Software ("ReVISION Software") assesses global and segmental function of the right ventricle (RV) of the heart via the decomposition of longitudinal, radial, and anteroposterior motions of the RV walls and quantifies their relative contribution to global RV ejection fraction along with longitudinal, circumferential and area strains using 3D datasets obtained by echocardiography. Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments. This segmentation is then projected to all models in the corresponding cardiac cycle.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes, "Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments."
Input Imaging Modality
echocardiography
Anatomical Site
right ventricle (RV) of the heart
Indicated Patient Age Range
adults only
Intended User / Care Setting
licensed medical practitioners or assistant medical technicians.
Hospitals, clinics and physician's offices.
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
Accuracy Validation Test:
- Sample Size: 30 subjects (10 healthy adults, 10 adult subjects with established cardiac diseases but maintained right ventricular ejection fraction, and 10 adult subjects with established cardiac diseases and reduced right ventricular ejection fraction).
- Data Source: Randomly selected from a comprehensive clinical database of 811 retrospective subjects with available echocardiographic data.
- Annotation Protocol: "The accuracy of segmental volumes, EFs, and strains was evaluated by 3 expert cardiologists with expertise in 3D echocardiography who was blinded to REVISION Software results. The cardiologists manually performed segmentation and contouring on the same 3D models that were analyzed by REVISION Software." "The accuracy of global longitudinal and circumferential strains were also evaluated by the expert cardiologists who created longitudinally and circumferentially oriented contours using manual labeling." "By overlaying the decomposed end-systolic 3D surface to the end-diastolic 3D surface using the test population's 30 cases, the expert cardiologists' task was to verify visually that the decomposition direction indeed corresponds to the desired one."
Database Validation Test:
- Sample Size: 811 retrospective 3D echocardiographic clinical subjects.
- Data Source: Retrospective 3D echocardiographic clinical database.
- Annotation Protocol: "the following parameters were evaluated by the ReVISION Software and by the predicate device." (Implies comparison against predicate device's output, which would have its own annotation/measurement protocol). The evaluation was performed on:
- The entire database (n=811)
- Clinical subpopulations (Heart failure patients (n=95), Heart transplantation patients (n=86), Valvular heart disease patients (n=148), Elite athletes (n=137), Adult healthy controls (n=191), Other adult cardiovascular disease patients (n=50), Pediatric renal transplant patients (n=53), Pediatric healthy controls (n=51))
- Age category subpopulations (Child (2-12 years of age) (n=19), Adolescent (12-18) (n=55), Transitional adolescent (18-21) (n=79), Adult (21+) (n=645))
- Subpopulations based on RV dysfunction present/absent (RV dysfunction (n=107), No RV dysfunction (n=704))
cMRI Validation Test:
- Sample Size: Three (3) subjects.
- Data Source: Subjects with available retrospective Cardiac Magnetic Resonance Imaging (cMRI).
- Annotation Protocol: "evaluated by ReVISION Software by calculating right ventricular (RV) volumes and ejection fraction (EF)." (Implies comparison against cMRI data as reference).
Summary of Performance Studies
Nonclinical Testing Summary:
- Unit/Integration Testing:
- Mesh Processing: Pass (Mesh orientation parameters for apex, inflow, and outflow centers are within specifications.)
- Volume Calculation: Pass (Volume calculations are consistent with predicate device and are reproducible.)
- Motion Decomposition: Pass (Interobserver and intraobserver variability of decomposed end-systolic volumes are within specifications. Pre- and postoperative values for ejection fraction are reproducible.)
- Volumetric Segmentation: Pass (The relative volumes of each segment to the total volume fall within specifications. The sum of segmental volumes is equal to the global volume. Interobserver and intraobserver variability of segmental end-diastolic and end-systolic volumes are within specifications.)
- 3D Strain Calculation: Pass (Septal and free wall longitudinal strain, and global circumferential strain values are consistent with predicate device. Interobserver and intraobserver reliability of global longitudinal strain are within specifications.)
- Verification Tests: Pass (Global and segmental metrics are calculated in more than 99% of cases. When inadequate input is presented, the data is not analyzed and an error message is presented. Movement decomposition and volume calculations of known geometric data are accurate.)
- Mathematical Unit Tests: Pass (Various geometric and mathematical calculations are accurate.)
- Evaluation Time: Pass (Average evaluation time must be under 15 minutes.)
- System Leveling Testing:
- Response Time: Pass (Response time must be under 10 seconds.)
- Response to Stress Conditions: Pass (No delay in the ReVISION Software functionality.)
- Validation Testing:
- Accuracy Validation: Pass.
- Study Type: Accuracy validation against expert cardiologists' manual measurements.
- Sample Size: 30 subjects (10 healthy adults, 10 adult subjects with established cardiac diseases but maintained RV ejection fraction, and 10 adult subjects with established cardiac diseases and reduced RV ejection fraction).
- Key Results:
- Segmental metrics:
- Accuracy Validation: Pass.
§ 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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Argus Cognitive, Inc. % Andrea Marosan Official Correspondent Dartmouth Regional Technical Center 16 Cavendish Court LEBANON NH 03766
June 24, 2023
Re: K223322
Trade/Device Name: Argus Cognitive ReVISION Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 16, 2023 Received: June 16, 2023
Dear Andrea Marosan:
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
1
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 (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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223322
Device Name
Argus Cognitive ReVISION Software Application
Indications for Use (Describe)
Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.
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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3
510(k) Notification K223322
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Argus Cognitive, Inc. Dartmouth Regional Technical Center 16 Cavendish Court Lebanon, NH 03766 Phone: 603-400-2440 www.arguscognitive.com
Contact Person:
Attila Meretei President Argus Cognitive, Inc. (603)-400-2440 attila@arguscognitive.com
Date Prepared: June 16, 2023
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Argus Cognitive ReVISION Software Application
Generic/Common Name:
Image review and quantification software
Classification:
21 CFR 892.2050, Medical image management and processing system
Product Code:
LLZ, System, Image Processing, Radiological
4
PREDICATE DEVICE(S) [807.92(a)(3)]
K150122 - TomTec-Arena TTA2
DEVICE DESCRIPTION [807.92(a)(4)]
The Argus Cognitive ReVISION Software ("ReVISION Software") assesses global and segmental function of the right ventricle (RV) of the heart via the decomposition of longitudinal, radial, and anteroposterior motions of the RV walls and quantifies their relative contribution to global RV ejection fraction along with longitudinal, circumferential and area strains using 3D datasets obtained by echocardiography. Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments. This segmentation is then projected to all models in the corresponding cardiac cycle.
INDICATIONS FOR USE [807.92(a)(5)]
Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
Please refer to Table 2: Substantial Equivalence Table.
SUBSTANTIAL EQUIVALENCE
The proposed indications for the Argus Cognitive ReVISION Software is substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Thus, the Argus Cognitive ReVISION Software is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary software testing was conducted on the Argus Cognitive ReVISION Software to support a determination of substantial equivalence to the predicate device. The testing followed internal company procedures. Software testing was carried out at the module and system levels, following predefined test protocols.
Nonclinical Testing Summary [807.92(b)(1)]:
All necessary performance testing was conducted on the Argus Cognitive ReVISION Software to support a determination of substantial equivalence to the predicate device. Testing acceptance criteria have been predefined in all test protocols to ensure that the subject device is safe and effective. Software verification was performed according to the standard IEC 62304:2005. Medical device software - Software lifecycle processes. Usability testing was performed according to IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. The collective results of the non-clinical testing demonstrate that the Argus Cognitive ReVISION Software meets the established specifications and complies with the aforementioned standards.
The nonclinical testing is summarized in Table 1: Summary of Testing Performed.
5
| Test | Acceptance Criteria | Result |
|---|---|---|
| Unit/Integration Testing | ||
| Mesh Processing | Mesh orientation parameters for apex, inflow, and outflow centers are within | |
| specifications. | Pass | |
| Volume | ||
| Calculation | Volume calculations are consistent with predicate device and are reproducible. | Pass |
| Motion | ||
| Decomposition | Interobserver and intraobserver variability of decomposed end-systolic | |
| volumes are within specifications. | ||
| Pre- and postoperative values for ejection fraction are reproducible. | Pass | |
| Volumetric | ||
| Segmentation | The relative volumes of each segment to the total volume fall within | |
| specifications. | ||
| The sum of segmental volumes is equal to the global volume. Interobserver | ||
| and intraobserver variability of segmental end-diastolic and end-systolic | ||
| volumes are within specifications. | Pass | |
| 3D Strain | ||
| Calculation | Septal and free wall longitudinal strain, and global circumferential strain | |
| values are consistent with predicate device. | ||
| Interobserver and intraobserver reliability of global longitudinal strain are | ||
| within specifications. | Pass | |
| Verification Tests | Global and segmental metrics are calculated in more than 99% of cases. | |
| When inadequate input is presented, the data is not analyzed and an error | ||
| message is presented. | ||
| Movement decomposition and volume calculations of known geometric data | ||
| are accurate. | Pass | |
| Mathematical | ||
| Unit Tests | The area of a two-dimensional polygon is calculated accurately. | |
| The relations between a two-dimensional line or a three-dimensional plane and | ||
| a point are calculated accurately. | ||
| The closest point on a line, segment, ray, or plane to a given point is calculated | ||
| accurately. | ||
| The distance between two points, a segment and a point, a line and a point, a | ||
| ray and a point, a plane and a point is calculated accurately. | ||
| The collinearity of three points or of two lines is calculated accurately. | ||
| The relation of a point to another point, line, segment, ray, plane, or polygon is | ||
| calculated accurately. | ||
| The intersection point of two lines, a line and a triangle, a line and a plane, a | ||
| ray and a triangle, a ray and a plane is calculated accurately. | ||
| The intersection of two segments, a segment and a line, a segment and a plane, | ||
| a segment and a ray, a segment and a triangle is calculated accurately. | ||
| The points of a polygon are not duplicated and are labeled accurately. | Pass | |
| Evaluation Time | Average evaluation time must be under 15 minutes. | Pass |
| System Leveling Testing | ||
| Response Time | Response time must be under 10 seconds. | Pass |
| Response to Stress | ||
| Conditions | No delay in the ReVISION Software functionality. | Pass |
| Validation Testing | ||
| Accuracy | ||
| Validation | 30 subjects (10 healthy adults, 10 adult subjects with established cardiac | |
| diseases but maintained right ventricular ejection fraction, and 10 adult | ||
| subjects with established cardiac diseases and reduced right ventricular | ||
| ejection fraction) were randomly selected from a comprehensive clinical | ||
| database of 811 retrospective subjects with available echocardiographic data. | ||
| The accuracy of segmental volumes, EFs, and strains was evaluated by 3 | ||
| expert cardiologists with expertise in 3D echocardiography who was blinded to | ||
| REVISION Software results. The cardiologists manually performed | ||
| segmentation and contouring on the same 3D models that were analyzed by | ||
| REVISION Software. Acceptance criteria for this validation was |