(183 days)
The indications for the use of the DuoClip Titanium Clips are the same as those for a Hemostatic Clips (Product Code 79MCH, Class1, Regulation# 878.4300). The indications is for ligating blood vessels.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding the "DuoClipper Titanium Clips" (later referred to as DuoClip Titanium Clips). It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices for the indication of "ligating blood vessels." Substantial equivalence means that the device is as safe and effective as a legally marketed device that is not subject to premarket approval.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI. (This device is a physical clip, not an AI or imaging device).
- A standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 27 1998
Mr. Stephen Chakoff President SCION International, Incorporated 5200 Blue Lagoon Drive, Suite 890 Miami, Florida 33126
Re: K973652 Trade Name: DuoClipper Titanium Clips Regulatory Class: II Product Code: FZP Dated: December 29, 1997 December 31, 1997 Received:
Dear Mr. Chakoff:
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, qood 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 Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Chakoff
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) 594-4595. 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,
Celia M. Witten, Ph.D.
Celia 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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Image /page/2/Picture/0 description: The image shows a series of bold, black numbers and letters. The sequence appears to be 'K93652'. Below the numbers, there is some smaller text that is difficult to read, but it seems to say 'Page 1 of 1'. The image is high contrast, with the black text standing out against a white background.
510(k) Number (if known):
DuoClip Titanium Clips Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The indications for the use of the DuoClip Titanium Clips are the same as those for a Hemostatic Clips (Product Code 79MCH, Class1, Regulation# 878.4300).
The indications is for ligating blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K973652 |
| Prescription Use(Per 21 CFR 801.109) | X OR Over-The-Counter Use |
| (Optional Format 1-2-96) |
§ 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.