Aesculap's Bipolar Irrigation Forceps are designed to be used with Aesculap's current Jet Irrigation System (#K971310) and Bipolar Coagulator (#K952524). The Bipolar Irrigation Forceps are intended for use in electrosurgery for coagulation and irrigation of selected tissue.

Device Description

The bipolar irrigation forceps (GK842R, GK845R, and GK848R) are a "Bayonet" style forceps, similar to Aesculap's currently marketed bipolar irrigation forceps (#K971310). The irrigation channel runs inside the right-hand prong, with an outlet 2.5mm above the tip of the forceps. The new bipolar irrigation forceps are available in lengths ranging from 180mm - 230mm with a tip size of 1.3mm.

AI/ML Overview

The submitted text describes the Bipolar Irrigation Forceps and its 510(k) submission, not a study evaluating a device against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance cannot be extracted from the provided text.

Specifically, the document states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new bipolar irrigation forceps conform to applicable ASTM and ISO standards. The bipolar irrigation forceps do meet the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment)."

This indicates that the device's performance is demonstrated through adherence to recognized industry standards rather than a specific clinical study with predefined acceptance criteria for a novel algorithm or diagnostic performance.

Here's what can be extracted based on the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
N/A (No specific performance standards promulgated under Section 514 of the FD&C Act.)	Conforms to applicable ASTM and ISO standards.
Meets requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment).	Meets requirements of IEC 601-2-18.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes compliance with standards, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

No. The document describes an electrosurgical device, not an AI-powered diagnostic tool, and thus no MRMC study was conducted.

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

No. This is an electrosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The device's performance is demonstrated through compliance with engineering standards, not through comparison to a ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a hardware device.

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

Not applicable. There is no mention of a training set or ground truth establishment for a training set.

Summary

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OCT - 3 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

BIPOLAR IRRIGATION FORCEPS

August 21, 2001

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Lisa M. Millington, Regulatory Associate800-258-1946 (phone)610-231-3713 (fax)lisa.millington@aesculap.com (email)
TRADE NAME:	Bipolar Irrigation Forceps
COMMON NAME:	Jet Irrigation Forceps
DEVICE CLASS:	Class II
PRODUCT CODE:CLASSIFICATION:	79 GEI878.4400 -- Electrosurgical Cutting & Coagulation Device & Accessories
REVIEW PANEL:	General & Plastic Surgery

INTENDED USE

Aesculap's Bipolar Irrigation Forceps are designed to be used with Aesculap's currentJet Irrigation System (#K971310) and Bipolar Coagulator (#K952524). The Bipolar Irrigation Forceps are intended for use in electrosurgery for coagulation and irrigation of selected tissue.

DEVICE DESCRIPTION

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new bipolar irrigation forceps conform to applicable ASTM and ISO standards. The bipolar irrigation forceps do meet the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment).

SUBSTANTIAL EQUIVALENCE

The new Bipolar Irrigation Forceps described in this premarket notification are substantially equivalent to those in Aesculap's current Bipolar Forceps product lines (subjected to K971310, K944955, and pre-amendment devices) with regard to intended use, fundamental scientific technology, design and material.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three curved lines forming its wings and body, giving it a modern and abstract appearance.

OCT - 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K012986

Trade/Device Name: Jet Irrigation Forceps Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 21, 2001 Received: September 6, 2001

Dear Ms. Millington:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lisa M. Millington

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

/2986

Device Name: Jet Irrigation Forceps

Indication for Use:

(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 and Neurological Devices

Prescription Use

✓

510(k) Number_ko12986

or Over-the-Counter Use

(per 21 CFR 801.109)

(Optional Format 3-10-98)

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.