(197 days)
Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
Semkin Insulated Bipolar Forcep
The provided document is a 510(k) clearance letter from the FDA for the Semkin Insulated Bipolar Forcep. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter only states that the device is substantially equivalent to legally marketed predicate devices for its intended use, which is "Intended to remove tissue and control bleeding by use of high frequency electrical current." It also mentions general controls provisions and compliance with Good Manufacturing Practice.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from this document. This typically would be found in the 510(k) summary or a more detailed technical submission, which is not provided here.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1998
Mr. Donald Seavey ·Titan Manufacturing, Inc. 6 Jamie Lane Phoenixville, Pennsylvania 19460
Re: K974593 Trade Name: Semkin Insulated Bipolar Forcep Regulatory Class: II Product Code: GEI Dated: March 20, 1998 Received: May 27, 1998
Dear Mr. Seavey:
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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 53.1 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.
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Page 2 - Mr. Seavey
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,
S.J. M. Witten, Ph.D., M.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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Titan Manufacturing, Inc.
6 Jamie Lane Phoenixville, PA 19460 Tel/Fax: 610.933.9771
INDICATIONS FOR USE STATEMENT
974593
510(k) Number (if known):
Device Name:
Semkin Insulated Bipolar Forcep
Indications For Use:
Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
(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 | K974593 |
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------------------------------ | --- | ---- | ---------------------- | -- |
(Optional Format 1-2-96)
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.