(72 days)
Not Found
No
The description explicitly states the software is based on the Agaston scoring method, a traditional, rule-based algorithm, and there are no mentions of AI, ML, or related concepts.
No
The device is described as a software option for quantifying calcified tissues in coronary arteries from CT scans, which is a diagnostic function, not a therapeutic one. It analyzes data to help identify a condition, but does not treat or alleviate it.
Yes
The device quantifies calcified tissues in coronary arteries using the Agaston scoring method for cardiac scoring from CT scans, which is a measurement used to aid in diagnosis and risk assessment.
Yes
The device is described as a "software option" that performs cardiac scoring based on computed tomography data. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is "Cardiac scoring from whole body computed tomography derived measurements." This involves analyzing images of the body itself, not specimens taken from the body (like blood, urine, or tissue samples).
- The device description focuses on analyzing images. It describes a "software option based on the Agaston scoring method for the quantification of high density structures... in the coronary arteries." This is a form of medical image analysis.
Therefore, this device falls under the category of medical imaging software or a medical device accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cardiac scoring from whole body computed tomography derived measurements
Product codes
90 JAK
Device Description
The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography
Anatomical Site
coronary arteries
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Summary of Safety and Effectiveness
1. Device Name
MAY 2 9 1997
Cardiac Scoring option
2. Submitter
Elscint Inc., 505 Main Str. Hackensack, NJ 07601.
3. Description of Main Features
The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.
4. Predicate Devices
CT Twin flash, K945512,
5. Safety
The Level of Concern of the Cardiac Scoring was determined to be minor.
The safety of this software option is assured by the company procedures that conform to accepted practices. The key process stages are:
- · Definition of Requirements
- · Design
- · Implementation
- Verification and Validation .
Good quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.
6. Effectiveness
The Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use.
7. Substantial Equivalency Statement
Based on the above considerations, it is Elscint's opinion that the Cardiac Scoring option is substantially equivalent in safety and effectiveness to the Histogram and ROI functions of the predicate device, CT Twin flash, K945512.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three curved lines that resemble a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Thomas J. Spackman, M.D., F.A.C.R. President and Chief Executive Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601
Re: K970980 Cardiac Scoring for CT Scanners Dated: March 11, 1997 Received: March 18, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Dr. Spackman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in scoordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device and be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification some affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin markeing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation ensided, "Misbonading by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrtv/dsmamain.html".
Sincerely yours,
Williamy
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K970980
Device Name: Cardiac Scoring for CT Scanners
Indications For Use: Cardiac scoring from whole body computed tomography derived measurements
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation(ODE)
Vinh h. Saygon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K970980 510(k) Number
Prescription Use X
(Per 21 CFR 801.109)
OR
- 4 . . Over-The-Counter Use