(90 days)
Not Found
No
The description focuses on user interaction for marking regions and algorithmic calculation, without mentioning AI/ML terms or concepts.
No
The device is described as a "diagnostic tool" used to "evaluate the calcified plaques" and "monitor the progression or regression overtime," providing information for diagnosis rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease."
No
The device is described as a "software package running on the 3Dvirtuoso workstation". This indicates that the software is a component of a larger system that includes hardware (the 3Dvirtuoso workstation), and the 510(k) summary does not explicitly state that the submission is for the software only.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic), although it's not a traditional IVD in the sense of analyzing biological samples.
Here's why:
- Intended Use/Indications for Use: The description clearly states it's a "diagnostic tool" used to "evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease." It also mentions monitoring progression or regression, which is related to prognosis. This aligns with the definition of a diagnostic device used to provide information about a disease state or condition.
- Device Description: It's a software package that processes medical images (CT cardiac images) to provide quantitative information (calcium scores) that is used in a diagnostic context.
- Predicate Devices: The listed predicate devices (K972903 Imatron Ultra Access Device and K960911 SCImage NetraMD Device) are also medical devices used in diagnostic imaging and analysis, further supporting the classification as a diagnostic tool.
However, it's important to note the nuances:
- Not a traditional IVD: Traditional IVDs typically analyze biological samples like blood, urine, or tissue. This device analyzes medical images.
- Software as a Medical Device (SaMD): This device falls under the category of Software as a Medical Device (SaMD), which is a specific regulatory classification. SaMD can be considered a type of medical device, and in this case, it's performing a diagnostic function.
In summary: While it doesn't fit the narrow definition of an IVD that analyzes biological samples, its intended use as a diagnostic tool to evaluate a risk factor for a disease, combined with its function of processing medical images to provide diagnostic information, strongly suggests it would be regulated as a medical device with a diagnostic purpose. In the context of regulatory bodies like the FDA, devices that provide diagnostic information based on image analysis are often considered a type of diagnostic device, even if they aren't analyzing biological samples.
Therefore, based on the provided text, it's highly probable that this device is considered a diagnostic medical device, and within the broader scope of regulatory classifications, it would likely be categorized in a way that aligns with the principles of IVDs in terms of its diagnostic function.
N/A
Intended Use / Indications for Use
The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.
From user specified sets of CT cardiac images, Calcium Scoring can be used to: -
- Allow the user to interactively indicate regions of detected calcification.
- To allow the user to allocate each detected region to one of several coronary arteries.
- To estimate algorithmically a score for the amount of detected calcification in each allocated . artery
- To prepare reports including calcium score data, imagery, ECG traces, Comparison of score to cited literature and additional relevant information
The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium sconing may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.
Product codes
90 JAK
Device Description
Calcium Scoring is a software package running on the 3Dvirtuoso workstation that allows the user to mark regions of detected calcification in CT cardiac images, to assign each region to a coronary artery, and to calculate the Agatston score and other information from the identified pixels. Film and paper reports of the results can also be prepared. Calcium Scoring is also a cost-effective alternative to Electron Beam CT (EBCT), since it produces calcium scores that correlates to the EBCT's gold standard, but at a much lower cost.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT cardiac images
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 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
MAY 1 2 1999
Attachment 11
510(k) Summary
Siemens Calcium Scoring Software Package
April 30, 1999
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- General Information. I.
- Establishment
| Address: | Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ 08830 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen M. Rutherford
Manager, Regulatory Submissions
(908) 321-4779 phone
(908) 321-4841 fax |
| Device Name | |
| Trade Name: | Calcium Scoring |
| Common Name: | |
| Classification Name: | Picture Archiving and Communication
System (PACS) |
| Classification: | Class II |
| Performance Standards: | None established under Section 514 |
II. Information Supporting Substantial Equivalence Determination.
· Device Description:
Calcium Scoring is a software package running on the 3Dvirtuoso workstation that allows the user to mark regions of detected calcification in CT cardiac images, to assign each region to a coronary artery, and to calculate the Agatston score and other information from the identified pixels. Film and paper reports of the results can also be prepared. Calcium Scoring is also a cost-effective alternative to Electron Beam CT (EBCT), since it produces calcium scores that correlates to the EBCT's gold standard, but at a much lower cost.
of the Food, Drug, and Cosmetic Act.
· Intended Use:
The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.
1
· Technological Characteristics as compared to the Predicate Device:
As in the predicate devices UltraAccess and NetraMD, the Calcium Scoring software evaluates standard CT images for pixels above a given CT number threshold. These data are evaluated to calculate the Agatston score and other information. The results may be printed out to a paper report or to film.
· Substantial Equivalence:
Siemens Calcium Scoring is substantially equivalent to the following devices:
-
- Imatron Ultra Access Device (K972903) cleared by FDA on 11/04/97
-
- SCImage NetraMD Device (K960911) cleared by FDA on 05/29/96
Kathleen Rutherford
Manager, Regulatory Submitsions Imaging Systems Group, Siemens Medical Systems
4/30/99
Date
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1999
Alicia Juergensen Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 186 Wood Avenue Iselin. New Jersey 08830
Re:
K990426 Calcium Scoring Software Package Dated: April 30, 1999 Received: April 30, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Juergensen:
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 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). 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 (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 requlations.
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/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
นนักม พรรคที่ม
Attachment 1
Indications for Use
510(k) Number (if known) Calclum Scoring Software Package Device Name:
Indications For Use:
From user specified sets of CT cardiac images, Calcium Scoring can be used to: -
- Allow the user to interactively indicate regions of detected calcification .
- To allow the user to allocate each detected region to one of several coronary arteries .
- To estimate algorithmically a score for the amount of detected calcification in each allocated . artery
- To prepare reports including calcium score data, imagery, ECG traces, Comparison of score ◆ to cited literature and additional relevant information
The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium sconing may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.
(please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Jaris G. Elynor
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990426
Prescription Use
(Per 21 CFR 801.109)