(64 days)
The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.
The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.
The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.
The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.
This FDA 510(k) clearance letter pertains to the CARESTREAM Vue PACS system, including its Lesion Management Application. The document itself does not contain specific acceptance criteria or details of a study proving device performance against such criteria.
The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices. This means that, based on the information provided by the manufacturer, the FDA believes the device is as safe and effective as a device already on the market.
Information NOT present in the provided document:
The provided document (an FDA 510(k) clearance letter) does not include any of the requested information regarding acceptance criteria, device performance results, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Explanation of the document's content:
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Page 0 & 1: These pages are the official FDA clearance letter. They state:
- The device name: CARESTREAM Vue PACS.
- Regulation Number and Name: 21 CFR 892.2050, Picture archiving and communications system.
- Regulatory Class: II.
- Product Code: LLZ.
- The crucial statement that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the basis for its clearance, not a new performance study proving acceptance criteria.
- General regulatory requirements for devices.
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Page 2: This page outlines the "Indications for Use" for the CARESTREAM Vue PACS, including the Lesion Management Application.
- The PACS system is intended for archiving, distributing, retrieving, and displaying images and data from hospital modalities.
- The Lesion Management Application is described as a module for "measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings."
- Crucially, it explicitly states: "Lesion Management Application is not to be used for mammography."
- It also confirms that it is a prescription-use device.
To answer your request, one would need to refer to the original 510(k) submission document (K122523) filed by Carestream Health, Inc., which would contain detailed information on performance testing, comparison to predicate devices, and any specific acceptance criteria used for that comparison. The clearance letter itself is the FDA's decision based on that submission, not the submission's content.
§ 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).