(98 days)
The TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.
The TCS provides a complete software tool for the convenient and efficient recording, storage, review, and communication of heart catheterization and other angiographic studies In the catheterization lab environment. The TCS also creates DICOM 3.0 CDs from the cath lab procedures. The TCS operates on a WindowsNT® PC. The TCS automatically acquires the x-ray video signal and places each video inside the patient's file. The patient file may also contain single images from a video, and reports (which automatically include the full patient details and selected images from the procedure) in Microsoft® Word format. During the review of videos and single images, image enhancement tools, such as zooming, magnification, full screen view, playback loop and brightness, contrast and gamma controls may be applied. As well as creating DICOM CDs, the TCS can also import data from DICOM CDs into its database, where they are written as patient files. Data may also be introduced to the TCS via telecardiology over an ISDN line, enabling professional consultation and referral of patients from level to level of the cardiac health care system. The patient files sent and received via telecardiology may also have vocal and graphic annotations attached to them. All new patient files, whether acquired from x-ray, imported from a DICOM CD, or received via telecardiology, are logged so that their source and ownership may easily be determined.
The provided text describes a medical device, the TCS - Medcon's Telecardiology System, and its submission for 510(k) clearance. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The text is a summary of safety and effectiveness, indicating that the device is substantially equivalent to a predicate device (ComView's WriteStar and ViewStar System K964274). It describes the device's functions, such as acquiring, storing, reviewing, and communicating heart catheterization and angiographic studies, creating DICOM 3.0 CDs, and providing image enhancement tools.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided input.
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510,6' No Bit House in
Summary Of Safety And Effectiveness 5.
This summary of safety and effectiveness information is being submittee In accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Medcon Ltd. 3 Tevuot Ha'aretz Street, Tel Aviv 69546. lsrael Tel: +972 3 648 7702 Fax: +972 3 647 8593
MAR 2 3 1998
Predicate Device(s)
The TCS is substantially equivalent to ComView's WriteStar and ViewStar System (K964274).
Name of the Device:
The TCS - Medcon's Telecardiology System
Description of the Device:
The TCS provides a complete software tool for the convenient and efficient recording, storage, review, and communication of heart catheterization and other angiographic studies In the catheterization lab environment. The TCS also creates DICOM 3.0 CDs from the cath lab procedures.
The TCS operates on a WindowsNT® PC. The TCS automatically acquires the x-ray video signal and places each video inside the patient's file. The patient file may also contain single images from a video, and reports (which automatically include the full patient details and selected images from the procedure) in Microsoft® Word format. During the review of videos and single images, image enhancement tools, such as zooming, magnification, full screen view, playback loop and brightness, contrast and gamma controls may be applied.
As well as creating DICOM CDs, the TCS can also import data from DICOM CDs into its database, where they are written as patient files. Data may also be introduced to the TCS via telecardiology over an ISDN line, enabling professional consultation and referral of patients from level to level of the cardiac health care system. The patient files sent and received via telecardiology may also have vocal and graphic annotations attached to them. All new patient files, whether acquired from x-ray, imported from a DICOM CD, or received via telecardiology, are logged so that their source and ownership may easily be determined.
Mr.Uzi Blumensohn
March 16, 1998 Date
Image /page/0/Picture/18 description: The image shows the logo for Medcon Ltd. The logo is in black and white, with the company name in bold, sans-serif font. Below the company name is the phrase "Telemedicine Technology".
FDATCS//510(K)
5-1
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Summary Of Safety And Effectiveness 5.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Medcon Ltd. 3 Tevuot Ha'aretz Street, Tel Aviv 69546, lsrael Tel: +972 3 648 7702 Fax: +972 3 647 8593
Name of the Device:
The TCS - Medcon's Telecardiology System
Description of the Device:
The TCS provides a complete tool for the convenient and efficient storage, display, analysis, communication and recording of heart catheterization and other angiographic studies in the catheterization lab environment
Mr.Uzi Blumensohn
December 10, 1997
Date
Image /page/1/Picture/13 description: The image shows the logo for Medcon Ltd. The logo is black and white and features the company name in large, bold letters. Below the company name is the phrase "Telemedicine Technology" in a smaller font. The logo is simple and professional.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Medcon LTD. Eli M. Orbach c/o International Regulatory Consultants POB 6718. ERFRAT 90435 ISRAEL
Re:
TCS-Medcon Telecardiology System Dated: December 10, 1997 Received: December 15, 1997 Regulatory class: Unclassified Procode: 90 IZI
Dear Mr. Orbach:
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. Drue, 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 II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major resulations 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsmaldsmam.html".
Sincerely yours,
- Kiliai Yi~
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Dec. 17. "MS. 17754 17:34 17. 15 6000 11:10. 1972 3 6476593 ۲۰ TEL 972-2-993-4275 . ₪283 .nu2 0002 FRI 16:19 FAX 301 480 4224 CDRH DRAERD 03,06/88
| Page | ______________________________________________________________________________________________________________________________________________________________________________ |
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| 510(k) Number (if known): | K974679 |
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| Device Name: | TCS |
Indications For Use:
The TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.
(PLEA.51) DO NOT WRITE BELOW THIS LINE - CONTINUE ()N ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E/unit l.k.lymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.