SEMKIN BIPOLAR FORCEP by TITAN MFG., INC.

This is a letter about the substantial equivalence of a medical device (Semkin Bipolar Forcep) filed under a 510(k) premarket notification. These documents typically don't include detailed information about acceptance criteria or specific studies that prove the device meets those criteria in the way a clinical trial report or specific performance testing report would. The purpose of a 510(k) is to demonstrate that a device is as safe and effective as a legally marketed predicate device, not necessarily to re-prove its safety and effectiveness from scratch with specific performance metrics and dedicated studies.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be found in the provided text.

Based on the provided document:

A table of acceptance criteria and the reported device performance:
- The document does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) or the reported performance of the Semkin Bipolar Forcep against such criteria.
- The basis for acceptance in a 510(k) is "substantial equivalence" to a predicate device. This typically means demonstrating that the new device has the same intended use, technological characteristics, and performs as well as or better than the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The document implies the device met the requirements for substantial equivalence.
Sample size used for the test set and the data provenance:
- Not mentioned in the document. 510(k) submissions generally rely on existing predicate data, and if new testing is conducted, its details like sample size and provenance are often in supporting documentation not included here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This document is for a Bipolar Forcep, a surgical instrument. MRMC studies and AI assistance are not relevant to this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not relevant for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not mentioned in the document. For a bipolar forcep, ground truth would likely relate to its ability to remove tissue and control bleeding, demonstrated through engineering tests or pre-clinical/clinical data if deemed necessary for substantial equivalence.
The sample size for the training set:
- Not mentioned, and generally not applicable in the context of a 510(k) for a basic surgical instrument, which doesn't involve "training sets" in the AI sense.
How the ground truth for the training set was established:
- Not mentioned, and not applicable for this type of device.

Summary of available information:

The document is a 510(k) clearance letter for the "Semkin Bipolar Forcep," indicating that the FDA determined it is substantially equivalent to a legally marketed predicate device. The intended use is "Intended to remove tissue and control bleeding by use of high frequency electrical current." The acceptance criterion, implicitly met, is "substantial equivalence" to a predicate device, meaning it is as safe and effective. Details on specific performance studies (like clinical trials, test set data, expert reviews, or AI-related metrics) are not provided in this regulatory letter itself, as they would typically be part of the larger 510(k) submission which this letter is a response to.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 24 1998

Mr. Donald Seavey ·Titan Manufacturing, Inc. 6 Jamie Lane Phoenixville, Pennsylvania 19460

K974594 Re: Trade Name: Semkin 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 531 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,

tca deefa

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 Jamic Lanc Phoenixville, PA 19460 Tel/Fax: 610.933.9771

INDICATIONS FOR USE STATEMENT

974594

510(k) Number (if known):

Device Name:

Semkin 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)

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

(Division Sign Off)

Division of General Restorative and Device

510(k) Number	K974594
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Regulation Number and Section

§ 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.