(40 days)
Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.
Not Found
The provided document is an FDA 510(k) clearance letter for the Horizon Ligation Clips, dated August 10, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the input document. The document is primarily a regulatory approval letter and does not include the detailed technical study information that would be necessary to answer your questions.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Mr. Brian J. Young Requlatory Affairs Manaqer Weck Closure Systems One Weck Drive P.O. Box 12600 27709 Research Triangle Park, North Carolina
K982313 Re: Trade Name: Horizon Ligation Clips Regulatory Class: II Product Code: FZP Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Young:
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 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 requirement, 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 Reqister. 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.
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Page 2 - Mr. Brian J. Young
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/dsmamain.html".
Sincerely yours,
Colvin M. Whitten, Ph.D., M.
- Celya M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2 Statement of indications for use
INDICATIONS FOR USE
INDICATIONS FOR USE
Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.
\prescription
device
(Division)Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.