The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation while grasping soft tissue, including vessels up to 3mm in diameter in open surgical procedures.

Device Description

The ETHICON Non-Stick Bipolar forceps are available in various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU).

AI/ML Overview

The device under consideration is the ETHICON Non-Stick Bipolar Forceps.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device functions as intended for tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation of soft tissue, including vessels up to 3mm in diameter.	"Preclinical laboratory evaluations (complies with IEC-602-2.2) were performed to ensure that the device functions as intended."
Compliance with IEC-602-2.2 (Standard for medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment).	"complies with IEC-602-2.2"

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document refers to "preclinical laboratory evaluations" but does not detail the number of units tested or specific test cases.
Data Provenance: The data is from "preclinical laboratory evaluations". The country of origin is not specified, but the submission is to the US FDA, implying data gathered for that regulatory body. It is retrospective in the sense that the evaluations were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study relies on "preclinical laboratory evaluations" and compliance with a technical standard, rather than expert-derived ground truth from a clinical setting.

4. Adjudication method for the test set:

This information is not provided. Given the nature of preclinical laboratory evaluations for a medical device (surgical forceps), adjudication typically involves objective measurements and adherence to test protocols, rather than a human consensus method for subjective interpretation.

5. 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:

Not applicable. This document describes a traditional medical device (bipolar forceps) and its regulatory submission. It is not an AI/Software as a Medical Device (SaMD) and therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant or performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. As stated above, this is not an AI/SaMD device. Performance evaluation for this device is based on its physical and electrical functionality, not algorithm performance.

7. The type of ground truth used:

The ground truth is based on objective performance specifications and adherence to the technical standard IEC-602-2.2, which sets requirements for the safety and performance of high-frequency surgical equipment. The "ground truth" here is the device's ability to mechanically grasp tissue and effectively perform bipolar coagulation as intended, verified through laboratory testing against established specifications.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI development.

9. How the ground truth for the training set was established:

Not applicable. As stated above, this device does not involve a training set.

Summary

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DEC - 5 1997

K973384

SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS

Information supporting claims of substantial equivalence, as 510(k) Summary of defined under the Federal Food, Drug and Cosmetic Act , Safety and Effectiveness respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: ETHICON Non-Stick Bipolar Forceps PREDICATE DEVICE NAME: Kirwan Surgical Products Bipolar Forceps 510(K) SUMMARY The ETHICON Non-Stick Bipolar forceps are available in Device Description various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU). The intended use of the ETHICON Non-Stick Bipolar Forceps is Intended Use to facilitate tissue grasping/manipulation and bipolar coagulation.

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ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

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IndicationsStatement	The ETHICON Non-Stick Bipolar Forceps are non-sterile,reusable devices intended to facilitate tissue grasping/manipulating bipolar point coagulation and bipolar coagulationwhile grasping soft tissue, including vessels up to 3mm indiameter in open surgical procedures.
TechnologicalCharacteristics	The new device is technologically the same as the predicate.
Performance Data	Preclinical laboratory evaluations (complies with IEC-602-2.2)were performed to ensure that the device functions as intended.Clinical data was deemed unnecessary to support the PremarketNotification. Sufficient data has been gathered from preclinicaltesting to assess the safety and effectiveness characteristics ofthe new device.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thenew device is substantially equivalent to the Predicate Deviceunder the Federal Food, Drug and Cosmetic Act.
Contact	Gregory JonesDirector, Regulatory AffairsETHICON, Inc.Rt. #22 WestSomerville, NJ 08876-0151
Date	September 5, 1997

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 1997

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Incorporated P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K973384 Trade Name: Ethicon Non-Stick Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: September 5, 1997 Received: September 8, 1997

Dear Mr. Jones:

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 requirements , as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for

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Page 2 - Mr. Jones

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) 594-4595. 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,

sincerely yours,

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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INDICATION FOR USE

510(k) Number (if known):	K973384
Device Name:	ETHICON Non-Stick Bipolar Forceps
Indications for Use:	The ETHICON Non-Stick Bipolar Forceps are non-sterile,reusable devices intended to facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulationwhile grasping soft tissue, including vessels up to 3mm indiameter in open surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K973384 (Optional Format 1-2-9G)
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ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.