(25 days)
The InstaCine D-2000 system enables acquisition, display, electronic processing, storage and review of radiographic images generated during certain medical procedures, particularly cardiac anglographic The product is intended and radiographic/fluroscopic examinations. primarily for on-line or remore viewing of cardiac catheterization angiography studies communicated by network, or trquaporced by CD-R interchange media which have been produced in accordance with the ACC/NEMA DICOMO standard.
Not Found
The provided text is an FDA 510(k) clearance letter and an "Indications For Use" statement. It establishes the device's substantial equivalence and outlines its intended use, but it does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based solely on the input provided. The document primarily focuses on regulatory approval and the device's function rather than performance metrics or detailed study results.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SED 2 2 1998
Spencer J. Angel President Fidelity Medical, Inc. 10 Madison Rd., Unit C Fairfield, NJ 07004
Re:
K983088 Instacine D-2000 Dated: August 27, 1998 Received: August 28, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Angel:
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 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 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 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 disgnostic 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/dsmaldsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. 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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K983088 510(k Number (if known):_
Device Name: INSTACINE D-2000
Indications For Use:
The InstaCine D-2000 system enables acquisition, display, electronic processing, storage and review of radiographic images generated during certain medical procedures, particularly cardiac anglographic The product is intended and radiographic/fluroscopic examinations. primarily for on-line or remore viewing of cardiac catheterization angiography studies communicated by network, or trquaporced by CD-R interchange media which have been produced in accordance with the ACC/NEMA DICOMO standard.
:PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEI JED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pres ription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David C. Syzmm
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510. <) Number
§ 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).