Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Device Description

Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or the details of a study proving the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a device called "Voxar Colonscreen."

This letter primarily focuses on:

Correction of an earlier letter: Amending the "Indications for Use" from "patient screening" to "patient review" to clarify its scope.
Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Regulatory information: Providing guidance on general controls, classification, and other FDA regulations.
The device's intended use: As a software application for display and 3D visualization of CT/MR data to assist in patient review and detection of colon polyps, cancers, and other lesions by radiologists, clinicians, and referring physicians.

It explicitly does not include:

Quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
Details of a performance study (sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).

Therefore, I cannot fulfill your request as the necessary information is absent from the provided document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2002 AUG 7

Mr. Conrad Chin Product Director Voxar Limited Edinburgh-Corporate Headquarters Bonnington Bond, 2 Anderson Place EDINBURGH EH6 5NP, UK

Re: K012072

Trade/Device Name: Voxar Colonscreen Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: June 28, 2001 Received: July 2, 2001

Dear Mr. Chin:

This letter corrects our substantially equivalent letter of July 12, 2001 regarding the Voxar Colonscreen. The Indications for Use at that time included the phrase "patient screening," which was ambiguous. The ambiguity led to the device's being found substantially equivalent with the agency's having interpreted "patient screening" to mean screening a patient's colon, and not screening a population of patients. You have agreed to amend your Indications for Use to substitute the phrase "patient review" for "patient screening," which is acceptable to the agency. The agency also notes your change of the device's name from Voxar VC to Voxar Color:screen.

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). 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

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Page 2 - Mr. Chin

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.

This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Daniel le Sezmm

Nancy C. Brogdo Director, Division of Reproductive. Abdominal, and Radiological Devices · Office of Device Evaluation Center for Devices and Radiological Health

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Indications For Use

Applicant:

Voxar Ltd, Bonnington Bond, 2Anderson Place, Edinburgh, EH6 5NP

510(k) Number (if known):

K012072

Device Name:

Voxar Colonscreen

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymour

(Division Sign-Off Division of Reproduct and Radiological Devic 510(k) Number

Prescription Use
(21 CFR 801.109)

Over-The-counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).