(21 days)
Not Found
No
The summary describes image processing and segmentation algorithms but does not mention AI, ML, or related terms like deep learning or neural networks. The performance validation is based on comparison to radiologists and a predicate device, not on training or test sets typically associated with ML model development.
No
The device is a software application that assists physicians in visualizing coronary anatomy and pathology from CT angiographic images. It processes images and displays information, but it does not directly treat or diagnose a disease or condition, nor does it restore, modify, or correct body function or structure. Its function is to assist in analysis, which is a diagnostic support function, not a therapeutic one.
Yes
The device is described as assisting a trained physician in analyzing CT Angiographic images to visualize coronary anatomy and pathology, identifying lesions, segmenting vessels, and detecting deviations from expected values, all of which are diagnostic functions.
Yes
The device is described as a "post processing software application which runs on a standalone server, work-station" and its input is "Computed Tomography (CTA) set of images." It performs analysis and visualization of these images. There is no mention of accompanying hardware being part of the device itself, only the platform it runs on.
Based on the provided information, the COR Analyzer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The COR Analyzer analyzes images of the human body (CT Angiographic images).
- IVDs provide information about a patient's health status based on the analysis of these samples. The COR Analyzer assists a physician in visualizing and analyzing anatomical structures and potential abnormalities within the coronary arteries based on imaging data.
The COR Analyzer is a medical image processing software intended to aid physicians in interpreting imaging data, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.
Product codes
LLZ
Device Description
The COR Analyzer (unmodified) device is a post processing software application which runs on a standalone server, work-station. The device input is Computed Tomography (CTA) set of images. The Device Software provides the location and segmentation of the (RCA, LM, LAD & LCX) coronary arteries. The software also labels these arteries and displays them uniquely colored in a 3D view. Artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view. The device has been modified to include also the location, segmentation & processing of major branches (of the RCA, LM, LAD & LCX) arteries. The device reliability & user interface have been modified to improve convenience of use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CTA)
Anatomical Site
major coronary vessels and lesions, coronary anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been designed, verified and validated complying with 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparison the processing results to experienced radiologists' interpretation of the same data and to the processing results of the predicate device. The comparison results demonstrate that the COR Analyzer meets the required specifications for use. No adverse affects have been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: COR Analyzer
JAN 3 1 2011 .
Establishment Name and Registration Number of Submitter
Name: RCADIA Medical Imaging Ltd. (RCADIA hereafter) Registration: 3006850219 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
| Product Code: | LLZ |
|---|---|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |
Reason for 510(k) Submission
Modification of legally marketed device - Special 510(K)
Identification of Legally Marketed Predicate (un modified) Device
K072242 COR Analyzer II Manufacturer : RCADIA
Description of the Device Modifications
The COR Analyzer (unmodified) device is a post processing software application which runs on a standalone server, work-station. The device input is Computed Tomography (CTA) set of images. The Device Software provides the location and segmentation of the (RCA, LM, LAD & LCX) coronary arteries. The software also labels these arteries and displays them uniquely colored in a 3D view. Artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view. The device has been modified to include also the location, segmentation & processing of major branches (of the RCA, LM, LAD & LCX) arteries. The device reliability & user interface have been modified to improve convenience of use.
Indications for use
The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing
Safety & Effectiveness
The device has been designed, verified and validated complying with 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparison the processing results to experienced radiologists' interpretation of the same data and to the processing results of the predicate device. The comparison results demonstrate that the COR Analyzer meets the required specifications for use. No adverse affects have been detected.
Substantial Equivalency
It is Rcadia Medical Imaging Ltd. opinion that the COR Analyzer is substantially equivalent in terms of indications for use, safety and effectiveness to the unmodified predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Dan Laor Quality & Regulatory affairs Advisor Rcadia Medical Imaging Ltd. 6 Sireni Haifa 32972 ISRAEL
JAN 3 1 201
Re: K110071
Trade/Device Name: COR Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 5, 2011 Received: January 10, 2011
Dear Mr. Laor:
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 includions for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dryine to
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
proceed to the market.
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Indications for Use
510(k) Number (if known): K110071
Device Name: COR Analyzer
Indications For Use:
The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510K