(64 days)
The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.
The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.
This submission (K970813) for the DIMS (Digital Imaging and Medical System) does not contain any information regarding acceptance criteria or a study proving device performance in the manner requested.
The document explicitly states:
"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The submission focuses on the device description, intended use, technological characteristics, and comparison to a legally marketed device (Wallach Digital Imaging System, K950630) for substantial equivalence. It confirms software testing was conducted as part of the development process but no performance or clinical evaluations proving efficacy or accuracy for its intended use were submitted.
{0}------------------------------------------------
(520) 889-7900 (520) 741-2200 Fax:
MAY -8 1997
510(k) SUMMARY
DenVu L.C. Submitter's name:
Date summary prepared:
February 24, 1997
Device name:
DENVU L.C.
Tucson. AZ 85714
4400 South Santa Rita Avenue
Proprietary name:
Common or usual name:
Classification name:
DIMS (Digital Imaging and Medical System), Model CL1-5110 and Model CL1-5111. Picture archiving and communications system (PACS). Proposed classification: Picture archiving and communications systems (PACS), Class II, 21 CFR 892.2050.
Legally marketed device for substantial equivalence comparison:
Wallach Digital Imaging System submitted by Wallach Surgical Devices, Inc. and cleared for marketing under 510(k) "K950630.
Description of the device:
The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.
Intended use of device:
The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.
Technological characteristics:
The DIMS device can display, process, digitize, store, and transmit images obtained during colposcopy examinations using hardware and software components.
Testing conducted:
Software testing was conducted as part of the development process.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
§ 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).