(107 days)
No
The description focuses on image processing, storage, and management, without mentioning AI, ML, or related concepts like algorithms for automated analysis or diagnosis.
No
The device processes and stores images for visualization, but it does not directly treat or alleviate a disease or condition. Its function is to facilitate the review and management of retinal image data.
No
The "Summary of Performance Studies" explicitly states that "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." This indicates it is not a diagnostic device. Its purpose is for importing, processing, storing, and visualizing images.
Yes
The device description explicitly states "CARA is a software platform" and describes its functions as collecting, enhancing, storing, and managing images through computerized networks and an internet-browser-based interface. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, CARA is likely NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is focused on importing, processing, storing, and visualizing color fundus images. It does not mention analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Device Description: The description reinforces the focus on image management and enhancement, not on analyzing biological specimens.
- Lack of Biological Sample Analysis: The core function described is handling images, not performing tests on biological materials.
- Performance Study Summary: The statement "does not make any diagnostic claims and does not replace the existing retinal images or the treating physician" strongly suggests it's a tool for managing and enhancing images for physician review, not a diagnostic test itself.
- Predicate Device: The predicate device (Topcon IMAGEnet Professional PC Software System) is also likely a system for managing and viewing ophthalmic images, not an IVD.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment. CARA's function is centered around image handling and presentation, which falls outside the typical scope of an IVD.
Therefore, based on the provided text, CARA appears to be a medical image management and processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
NFJ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
color fundus images
Anatomical Site
retinal (implied from fundus images)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
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.
1
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 Device | ||
| Images Processing | √ | √ |
| Image Data Management | √ | √ |
| Fundus Image Only | √ | √ |
| File Import | √ | √ |
| Color Fundus Image | ||
| Enhancement | x | √ |
| Black & White Fundus Image | ||
| Enhancement | √ | x |
| Linear Distance and Area | ||
| Measurement | √ | 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.
2
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.
3
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
4
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
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