(65 days)
Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.
This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.
This document is a 510(k) Summary for a software upgrade (Video Plus software upgrade) for an existing digital image acquisition unit, Camtronics Video Plus, cleared under K954159. The submission compares the upgraded device to a predicate device, GE Medical Systems "Advantx DLX" (K945459, K926258).
The document explicitly states:
"Performance data: Not required for determination of substantial equivalence for this class of device."
"Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from this document as no such data was required or presented for this 510(k) submission. The FDA clearance was based on substantial equivalence to a predicate device, not on specific performance data against acceptance criteria.
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Image /page/0/Picture/0 description: The image shows a logo for Camtronics Medical Systems. The logo consists of a stylized eye-like symbol on the left, followed by the company name "Camtronics" in bold letters. Below the company name, the words "MEDICAL SYSTEMS" are printed in smaller letters. The date "OCT 13 1999" is printed below the logo.
510(k) Summary
Date prepared: August 2, 1999 Name of contact person: Robert Kriedermann Device trade name: Video Plus software upgrade Common name: Digital Image Acquisition Unit Classification name: Picture Archiving and Communications System
Predicate substantially equivalent device: GE Medical Systems "Advantx DLX" K945459, K926258
Device description and intended use: This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.
Predicate device specifications comparison:
| Principal DeviceCamtronics Video Plus | Predicate DeviceGE Medical Systems"Advantx DLX" K945459,K926258 | |
|---|---|---|
| Digital video input | yes | no |
| Linked Biplane acquisition | yes | yes |
| Auto injection | yes | yes |
| Histogram equalization | yes | yes |
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Substantial equivalence summary: The Camtronics Video Plus is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Video Plus is the same as that of the predicate device "Advantx DLX", marketed by General Electric Medical Systems. No new safety or effectiveness issues are raised with the Camtronics Video Plus. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Robert Kriedermann Regulatory Specialist Camtronics, Ltd. Medical Systems 900 Walnut Ridge Drive Hartland, WI 53029
Re:
K992666 Video Plus System Series 95000 Dated: August 2, 1999 Received: August 9, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Kriederman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 10- 7-99; 9:44AM; CAMTRONICS | ; 414 369 3220 | # 2/ | |
|---|---|---|---|
| 10/07/99 | THU 09:07 FAX 301 480 4224 | CDRH DRAERD | 4002 |
| Page | 1 of 1 |
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| 510(k) Number (if known): | K992666 |
|---|---|
| Device Name: | Video Plus |
Indications For Use:
Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Siggman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 9921 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).