(107 days)
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundus images as well as visualization of original and enhanced image through computerized networks.
CARA is a software platform that collects, enhances, stores, and manages color fundus images. Through the internet, CARA software collects and manages color fundus images from a range of approved computerized digital imaging devices. CARA enables a real-time review of retinal image data (both original and enhanced) from an internet-browser-based user interface to allow authorized users to access and view data saved in a centralized database. The system utilizes state-of-the-art encryption tools to ensure a secure networking environment.
The provided text describes a 510(k) premarket notification for a device named CARA, a software platform for managing color fundus images.
Here's an analysis based on the provided information, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria or provide a table of device performance against such criteria. The document states "The results of performance and software validation and verification testing demonstrate that CARA performs as intended and meets the specifications. This supports the claim of substantial equivalence," but the specific metrics are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or sample size for evaluating performance is mentioned. The submission states, "Since the CARA system currently is not a stand-alone tool, does not make any diagnostic claims and does not replace the existing retinal images or the treating physician, the sponsor believes that the software testing and validation presented in this 510(k) are sufficient and that there is no need for a clinical trial." This indicates that no human-read test set data was used to demonstrate performance. The country of origin for any internal software testing data is not specified, but the applicant's address is in Canada.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set requiring expert ground truth was used for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done. The device is not making diagnostic claims and "does not replace the existing retinal images or the treating physician," therefore, a study on human reader improvement with or without AI assistance was not deemed necessary by the sponsor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The CARA system is explicitly stated as "not a stand-alone tool" and "does not make any diagnostic claims." The document does not describe any standalone performance testing of an algorithm making diagnostic claims. The "software testing and validation" mentioned are likely related to functional performance, security, and compatibility as a picture archiving and communication system, not diagnostic accuracy.
7. The Type of Ground Truth Used
For the purposes of this 510(k), which focuses on the device as a Picture Archiving and Communications System, the concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) is not applicable. The system's "performance" is based on its ability to import, process, store, and visualize fundus images as intended by its specifications.
8. The Sample Size for the Training Set
Not applicable. As CARA is described as a software platform for managing and enhancing images, not a diagnostic AI algorithm, there is no mention of a "training set" in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
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510(k) Premarket Notification March 25, 2011
510 ( 4 ) :
510(k) summary CARA March 2011
JUL 1 4 2011
1. Applicant Information
| Diagnos, Inc. | |
|---|---|
| 7005 Taschereau Boulevard, Suite 340 | |
| Brossard, Québec J4Z 1A7 | |
| Canada | |
| Contact Person: | Houssem Ben Tahar |
| VP Development and Business Intelligence | |
| Telephone No.: | 450.678.8882, #231 |
| Fax No.: | 450.678.8119 |
| E-mail: | houssem@diagnos.com |
2. Device Information
Classification names: Picture Archiving and Communications System Device classification: Class II Regulation numbers: 21 CFR 892.2050 Product codes: NFJ Proprietary name: CARA
3. Predicate Device
The predicate device is the Topcon IMAGEnet Professional PC Software System, cleared under K082364.
4. Description of device
CARA is a software platform that collects, enhances, stores, and manages color fundus images. Through the internet, CARA software collects and manages color fundus images from a range of approved computerized digital imaging devices. CARA enables a real-time review of retinal image data (both original and enhanced) from an internet-browser-based user interface to allow authorized users to access and view data saved in a centralized database. The system utilizes state-of-the-art encryption tools to ensure a secure networking environment.
5. Indications for use
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundus images as well as visualization of original and enhanced image through computerized networks.
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6. Substantial Equivalence
The claim of substantial equivalence to the Topcon IMAGEnet Professional PC Software System is based on similar intended uses to collect, store, enhance and transfer digital retinal images from computerized imaging devices through computerized networks.
The table below provides a comparison between the predicate device and the CARA device.
| Topcon IMAGEnet | Diagnos CARA | |
|---|---|---|
| Software Only | √ | √ |
| Web Based Platform | x | √ |
| Non-mydriatic Capture DeviceImages Processing | √ | √ |
| Image Data Management | √ | √ |
| Fundus Image Only | √ | √ |
| File Import | √ | √ |
| Color Fundus ImageEnhancement | x | √ |
| Black & White Fundus ImageEnhancement | √ | x |
| Linear Distance and AreaMeasurement | √ | x |
| Image Annotation &Measurement | √ | x |
V = present
x = absent
CARA shares many similar technological characteristics as the predicate device, both in terms of the manner in which images are captured, processed, and stored, as well as the operation of the device by the intended user.
The results of performance and software validation and verification testing demonstrate that CARA performs as intended and meets the specifications. This supports the claim of substantial equivalence
Any minor difference in operation does not raise additional new questions about safety and effectiveness. CARA raises the same issues of safety and effectiveness as the predicate device.
7. Clinical data:
Since the CARA system currently is not a stand-alone tool, does not make any diagnostic claims and does not replace the existing retinal images or the treating physician, the sponsor believes that the software testing and validation presented in this 510(k) are sufficient and that there is no need for a clinical trial.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HC" is arranged in a circular fashion. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Diagnos, Incorporated % Mr. Aron Shapiro Vice President Ora, Incorporated 300 Brickstone Square Andover. MA 01810
JUL 1 4 2011
Re: K110869
Trade/Device Name: CARA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: June 15, 2011 Received: June 16, 2011
Dear Mr. Shapiro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Keoia Alexander
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
k 110 869 510(k) Number (if known):
Device Name: CARA
Indications for Use:
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundus images as well as visualization of original and enhanced inage through computerized networks.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT/WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bob
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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number 4110869
Page I-10
§ 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).