(84 days)
The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.
Digital Video Recording System (DVRS)
The provided text discusses regulatory approval for a Digital Video Recording System (DVRS) and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) clearance letter from the FDA, which signifies that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on demonstrating equivalence in terms of safety and effectiveness, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Details about a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document merely states the intended use of the DVRS for "viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures" and that it is for use by "medical doctors or clinicians such as speech pathologists."
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Image /page/0/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
William D. Harbeson Director of R&D Kay Elemetrics Corp. 2 Bridgewater Lane Lincoln Park, New Jersey 07035-1488 Re:
K991738 Digital Video Recording System (DVRS) Dated: May 18, 1999 Received: May 21, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Harbeson:
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 redassified 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 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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510(k) Number K991738
Device Name:
Digital Video Recording System
Indications for Use:
The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K991738
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Option Format 1-2-96)
い
§ 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).