(31 days)
Not Found
No
The summary describes image processing and analysis algorithms but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as diagnostic reading software intended for viewing and analyzing cardiac CT data to determine the presence and extent of coronary plaques, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is "a non-invasive diagnostic reading software intended for use by cardiologists and radiologists" for "determining the presence and extent of coronary plaques."
Yes
The device is described as "non-invasive diagnostic reading software" and an "interactive post-processing tool for viewing and analyzing cardiac CT image data." The description focuses solely on the software's functions and outputs related to image analysis and quantification, with no mention of accompanying hardware components.
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 described device is a software tool that analyzes cardiac CT image data. This data is generated from a non-invasive imaging procedure performed on the patient's body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for "viewing and analyzing cardiac CT data" and is a "non-invasive diagnostic reading software."
Therefore, while it is a diagnostic tool, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.
Product codes
90 JAK
Device Description
The Plaque Analysis option was added to the Comprehensive Cardiac Analysis option (a.k.a. CCA) predicate device. It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.
The Plaque Analysis application calculates lumen and vessels contours, detects findings along the vessel wall by a single click algorithm and provides a set of measurements for all the detected findings. The option includes visualization and manual correction tools.
Outputs of the application include coronary findings segmentation and quantification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac CT data
Anatomical Site
coronary vessels, coronary plaques
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologists and radiologists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042293, K070226, K061370, K060779, K061624, K063762
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary Philips Medical Systems (Cleveland) Inc. Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool
This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
Submitter 1.
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
OCT - 9 2009
Contact: .
| Michael A. Chilbert, Ph.D., P.E. | |
|---|---|
| Telephone: | 440 483 3284 |
| FAX: | 440 483 4918 |
| Email: | Michael.chilbert@philips.com |
Date of Summary: March 1, 2009
2. Device Name and Classification
| Device Name: | Philips' Comprehensive Cardiac Analysis (CCA) Plaque
Assessment tool |
|----------------------|-------------------------------------------------------------------------|
| Classification Name: | Computed Tomography X-Ray System |
The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code 90 JAK)
Predicate Device Information 3.
In the opinion of Philips Medical Systems Inc., the "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:
- Philips Medical Systems (Cleveland), Inc., Brilliance CT, Private Practice . CV Configuration, K042293
- Shina Systems Ltd., CardioCT, K070226 .
- GE- CardlQ Fusion, K061370 .
- GE Advanced Vessel Analysis LI, K060779 .
- . Vital Imaging - Vitrea2 Ver. 3.9, K061624 (specifically the SUREPlaque tools)
- Siemens syngo Circulation, K063762 �
Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool
1
4. Device Description
The Plaque Analysis option was added to the Comprehensive Cardiac Analysis option (a.k.a. CCA) predicate device. It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.
The Plaque Analysis application calculates lumen and vessels contours, detects findings along the vessel wall by a single click algorithm and provides a set of measurements for all the detected findings. The option includes visualization and manual correction tools.
Outputs of the application include coronary findings segmentation and quantification.
5. Indications for Use of the device
The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.
6. Intended Use of the device
Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is a noninvasive diagnostic reading software intended to provide cardiologists and radiologists with an optimized non-invasive application to provide accurate quantification and characterization of coronary plaque. It is an interactive post-processing tool for viewing and analyzing cardiac CT image data for determining the presence and extent of coronary plaques.
7. Comparison to Predicate Devices
In the opinion of Philips Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is of comparable type and substantially equivalent to the legally marketed devices described in paragraph 3 above.
The "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool" is manufactured in accordance with the Quality System Regulations (QSR), 21 CFR Part 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards.
Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool
2
Radiation safety is assured by compliance with 21 CFR, Subchapter J Performance Standards.
Based on the above considerations, it is Philips's opinion that the "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool" CT scanner is substantially equivalent in safety and effectiveness to the predicate devices identified in paragraph 3 above.
Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool
Page III - 3
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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
UL International Germany GmbH % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
OCT = 9 2009
Re: K092747
Trade/Device Name: Philips Comprehensive Cardiac Analysis (CCA)
Plaque Assessment Tool
Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 23, 2009 Received: September 25, 2009
Dear Mr. Conry:
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.
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 of medical
4
Page 2 -
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/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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1092747 510(k) Number (if known):
Page 1 of 1
Device Name:
Philips Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool
Indications for Use:
The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.
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)
Division Sign. Off.
(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number