(10 days)
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No
The summary describes image processing and visualization software but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is a software application for displaying and visualizing medical image data to assist in detection and workflow, not for directly treating a condition or disease.
Yes
The software "assists in patient review and detection of colon polyps, cancers and other lesions," which indicates a diagnostic purpose.
Yes
The device description explicitly states it is a "software application" and its function is the display and visualization of medical image data. While it utilizes standard PC hardware, the device itself is the software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Voxar Colonscreen's Function: Voxar Colonscreen processes and visualizes medical image data (CT and MR scans) from within the body. It assists in the interpretation of these images, not in the analysis of samples taken from the body.
Therefore, while it's a medical device used for diagnosis, it falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
90 LLZ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT and MR scans
Anatomical Site
colon
Indicated Patient Age Range
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Intended User / Care Setting
radiologists, clinicians and referring physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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):
Device Name:
Voxar Colonscreen
Indications For Use:
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.
(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)
OR
Over-The-counter Use _________________________________________________________________________________________________________________________________________________________