(71 days)
No
The description focuses on semi-automatic quantification and post-processing image analysis, without mentioning AI, ML, or related concepts like deep learning or neural networks.
No.
This device is for the 'review and analysis of CT images as an aid in cardiac analysis' and semi-quantifies cardiac calcifications, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is described as an "aid in cardiac analysis" and helps quantify cardiac calcifications. While it doesn't directly provide a diagnosis, it offers tools that facilitate the diagnostic process for a trained physician. The mention of "review and analysis of CT images" and "post-processing image analysis" further supports its role in interpreting medical data for diagnostic purposes.
Yes
The device is described as a "software productivity package" that runs on existing workstations and processes CT images. There is no mention of new or modified hardware being part of this submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "review and analysis of CT images as an aid in cardiac analysis." This involves analyzing images of the patient's anatomy, not analyzing samples taken from the patient (like blood, urine, or tissue).
- Device Description: It describes a software package that processes and quantifies information from CT images. This is image analysis, not laboratory testing of biological samples.
- Input Modality: The input is CT images, which are generated by scanning the patient's body, not by analyzing biological samples.
- Anatomical Site: The focus is on the cardiac anatomy, which is visualized through imaging.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device operates on images of the body itself, not on biological samples.
N/A
Intended Use / Indications for Use
The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
A software productivity package that semi-automatically quantified cardiac calcifications by a weighted number instead of manually calculating area of Regions of Interest (ROIs) and the density within each ROI.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Cardiac
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the GE logo on the left and the date AUG 1 8 1998 on the right. The GE logo is a circular design with the letters 'GE' intertwined in the center. The date is printed in a simple, sans-serif font.
K982004
GE Medical Systems
Summary of Safety & Effectivenes
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of: 21 CFR Part 807.87(h).
Identification of submitter:
Larry A. Kroger, Ph.D. (414) 544-3894 Summary prepared 29 May 1998
Product Identification:
Name: CT Coronary Artery Calcification Scoring Option for Advantage Windows
Manufacturer:
General Electric Medical Systems 16800 W. Ryerson Road New Berlin, WI 53151
Marketed Devices: The CT Coronary Artery Calcification Scoring (CACS) option for Advantage Windows is substantially equivalent to the currently marketed Elscint Cardiac Scoring Option (K970980).
Indications for Use: CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770)
Device Description: A software productivity package that semi-automatically quantified cardiac calcifications by a weighted number instead of manually calculating area of Regions of Interest (ROIs) and the density within each ROI.
Principles of Operation: The same as Advantage Windows 3D. Features:
- Tools for selecting Regions of Interest; ●
- Image Selection: manually and/or semi-automatically using EKG data; .
- Automatic computation of calcium score for individually selected ROI or group of ROIs; .
- Creation of a report with calcium score .
- Pre-formatted film output of selected images and patient information; and .
- Collection of EKG data and statistics with output of selected images with corresponding EKG. .
Accessories: A recording EKG machine is an optional accessory that aids in the review and selection of images for scoring. (i.e. Invivo Research EKG, Millennia Model 3500 Series, K950688.) The EKG device is used to record the patient's EKG during scanning. A time stamp is placed on the EKG data to show when the imaging started. This allows the operator to select images with reduced motion artifacts. Images may also be selected without the use of an EKG.
Adverse Effects on Health: The package itself will not have any adverse effects on health. This tool displays reconstructed CT images and allows the user to perform post-processing image analysis.
Conclusions: The CT Coronary Artery Calcification Scoring (CACS) option for Advantage Windows enhances the current Advantage Windows package by providing the physician a tool for analyzing cardiac images. It is substantially equivalent to analysis packages currently in the marketplace.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Larry A. Kroger, Ph.D. Senior, Regulatory Program Manager GE Medical Systems P.O. Box 414 Milwaukee, WI 53201
Re:
K982004 CT Coronary Artery Calcification Scoring (CACS) for Advantage Windows Dated: June 1, 1998 Received: June 8, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to devices that have been reclassified in accordance 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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 marketing your device as described in your 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 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) 594-4613. 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 entitled, "Misbranding 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/odrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yih
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
2
K9r2004
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Indications for Use Statement
510(k) Number (if known):
CT Coronary Artery Calcification Scoring Option for Advantage Windows Device Name:
Indications for Use:
The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vinit A. Deyon
(Division Sign-Off) DRAERD
510(k) Number: K98200
Prescription Use
(Per 21CFR801.109)
Or
Over-The-Counter Use_ (Optional Format 1-2-96)