(12 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as using "clinically accepted calcium scoring algorithms," which typically refers to established, non-AI methods.
No
Explanation: This device is a diagnostic tool for identifying and quantifying calcified atherosclerotic plaques, not for treating any condition.
Yes
The software non-invasively identifies and quantifies calcified plaques for diagnostic purposes.
Yes
The device is explicitly described as a "PC based software only application" in both the Intended Use and Device Description sections.
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 description: The description clearly states "PC based software only application" that uses "IST image data" to analyze "coronary arteries". This involves processing medical images, not analyzing biological samples.
- Intended Use: The intended use is for "non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data". This is a diagnostic process based on imaging, not on in vitro analysis of biological specimens.
Therefore, this device falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.
Product codes
90 LLZ
Device Description
PC based software only application
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
IST image data
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and other clinicians
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.
Not Found
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.
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
§ 892.2050 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Voxar, Ltd. % Mr. Jeff D. Rongero Project Engineer Conformity Assessment Services Underwriters Labortories, Inc. 12 Labortory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995
Re: K020140 Trade/Device Name: Voxar Calcium Scoring Product (Gold Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: January 14, 2001 Received: January 16, 2001
Dear Mr. Rongero:
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.
1
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
Applicant:
Voxar Ltd, Bonnington Bond, 2Anderson Place, Edinburgh, EH6 5NP
510(k) Number (if known):
Unknown
Device Name:
Voxar Calcium Scoring Product
Indications For Use:
Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Severson
(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number
Prescription Use
(21 CFR 801.109)
OR
Over-The-counter Use _________________________________________________________________________________________________________________________________________________________