VOXAR'S CALCIUM SCORING PRODUCT

K020140 · Voxar Limited · LLZ · Jan 28, 2002 · Radiology

Device Facts

• Record ID: K020140
• Device Name: VOXAR'S CALCIUM SCORING PRODUCT
• Applicant: Voxar Limited
• Product Code: LLZ · Radiology
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

Voxar Calcium Scoring is a PC-based software application for analyzing CT image data. It identifies and quantifies calcified atherosclerotic plaques in coronary arteries. The device utilizes clinically accepted calcium scoring algorithms to process input image data. It is intended for use by radiologists and clinicians in a clinical setting. The output provides quantitative data regarding coronary calcification, which assists clinicians in assessing atherosclerotic plaque burden to support clinical decision-making.

Clinical Evidence

No clinical data provided; device relies on the use of clinically accepted calcium scoring algorithms applied to CT image data.

Technological Characteristics

PC-based software application; operates on CT image data; utilizes established calcium scoring algorithms for quantification of atherosclerotic plaques.

Indications for Use

Indicated for non-invasive identification and quantification of calcified atherosclerotic plaques in coronary arteries in patients undergoing CT imaging. Intended for use by radiologists and clinicians.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

{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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 _________________________________________________________________________________________________________________________________________________________