(87 days)
No
The description focuses on standard image processing techniques (3D/2D viewing, manipulation, calculation based on Agaston's method) and does not mention AI, ML, or related terms. The performance study compares the calcium score calculation to a predicate device using linear regression and F-tests, which are not indicative of AI/ML.
No.
The device is for review and analysis of images as an aid in cardiac analysis, calculating a calcium score, and generating reports, rather than directly treating or preventing a disease.
Yes
The CalScoR Software aids in cardiac analysis by calculating calcium scores from CT images, which is a diagnostic function used by physicians to assess patient conditions.
Yes
The device description explicitly states that CalScoR is a "Windows-compatible software program" that runs with another software program (Rapidia). There is no mention of any accompanying hardware component being part of the CalScoR device itself.
Based on the provided information, the CalScoR Software 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.
- CalScoR's Function: The CalScoR Software analyzes CT images of the heart. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for the "review and analysis of CT images as an aid in cardiac analysis." This is image-based analysis, not analysis of biological specimens.
Therefore, the CalScoR Software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CalScoR Software is intended to be used by a trained physician with the Rapidia software for the review and analysis of CT images as an aid in cardiac analysis.
Product codes
90 LLZ
Device Description
CalScoR is a Windows-compatible software program that runs with the previously cleared Rapidia Software (K012290). The Rapidia Software is a fast, practical, and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics-rendering technology.
CalScoR can specify the location of calcium in images, calculate the calcium score based on Agaston's method display the percentile of the score with the graph, and issue reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images, MRI 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
Tests were performed to compare the accuracy of the CalScoR's calcium score with that of the predicate device. A linear regression was used to demonstrate that the scores obtained from the AccuScore and CalScoR were similar. The slope was set to 1 and the intercept was set to 0. Additionally, an F-test was used to show that the two scores are essentially identical. The F-value of the experimental results was 13742853.39, which means that the two scores are identical within 0.0001(0.01%) error level
The testing demonstrated that the CalScoR performs all functions according to the functional requirements specified in the Software Requirements Specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed to compare the accuracy of the CalScoR's calcium score with that of the predicate device. A linear regression was used to demonstrate that the scores obtained from the AccuScore and CalScoR were similar. The slope was set to 1 and the intercept was set to 0. Additionally, an F-test was used to show that the two scores are essentially identical. The F-value of the experimental results was 13742853.39, which means that the two scores are identical within 0.0001(0.01%) error level. The testing demonstrated that the CalScoR performs all functions according to the functional requirements specified in the Software Requirements Specifications.
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
§ 892.2050 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).
0
6 2002 SEP
510(k) Summary for 3DMed Co., Ltd. CalScoR
1. Submitter Name and Address
Jae Choi, PhD 3DMed Co., Ltd. 940-319 Research Park SNU, San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 REPUBLIC OF KOREA
Telephone: 82-2-889-1764
Date Prepared: June 10, 2002
2. Device Name
Proprietary Name: CalScoR Software Common/Usual Name: Calcium scoring software Picture archiving and communications system Classification Name:
3. Predicate Device
Accuview/AccuScore Software (K990241)
4. Intended Use
The CalScoR Software is intended to be used by a trained physician with the Rapidia software for the review and analysis of CT images as an aid in cardiac analysis.
5. Device Description
CalScoR is a Windows-compatible software program that runs with the previously cleared Rapidia Software (K012290). The Rapidia Software is a fast,
1
practical, and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics-rendering technology.
CalScoR can specify the location of calcium in images, calculate the calcium score based on Agaston's method display the percentile of the score with the graph, and issue reports.
Technological Characteristics 6.
The CalScoR Software and the predicate device are both software programs that can be used for measuring calcium scores from CT images. The CalScoR software can be operated from a personal computer. The algorithm for calculating calcium score is based on Agaston's method.
7. Performance Testing
Tests were performed to compare the accuracy of the CalScoR's calcium score with that of the predicate device. A linear regression was used to demonstrate that the scores obtained from the AccuScore and CalScoR were similar. The slope was set to 1 and the intercept was set to 0. Additionally, an F-test was used to show that the two scores are essentially identical. The F-value of the experimental results was 13742853.39, which means that the two scores are identical within 0.0001(0.01%) error level
The testing demonstrated that the CalScoR performs all functions according to the functional requirements specified in the Software Requirements Specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.
od and Drug Administration rate Boulevard
3DMed Co., Ltd. % Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K021913
Trade/Device Name: CalScoR Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 10, 2002 Received: June 11, 2002
Dear Ms. McNamara-Cullinane:
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); 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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: CalScoR Software
Indications for Use:
The CalScoR Software is intended to be used with the Rapidia software by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Siegmann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use