The Dexide Bipolar Forceps II** device is a laparocopic grasping, coagulating, and transecting bipolar forceps, which is intended to be passed down a laparoscopic cannula. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.

AI/ML Overview

Acceptance Criteria and Study for Dexide Bipolar Forceps II** Device

This document describes the acceptance criteria and the study performed for the Dexide Bipolar Forceps II** device, based on the provided 510(k) Summary.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993.	The Dexide Bipolar Forceps II** device is in compliance with ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993.
Component materials are in accordance with ISO Standard # 10993-1 (Biocompatibility).	All component materials of the Dexide Bipolar Forceps II** device are comprised of materials which are in accordance with ISO Standard # 10993-1.
Substantial equivalence to the predicate device: Minisite* Bipolar Forceps** device (K972415), for indications of use in laparoscopic bipolar procedures to grasp, coagulate, and transect tissues.	The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

Note: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards rather than establishing specific quantitative performance metrics beyond these compliance statements.

2. Sample Size and Data Provenance

The provided document does not specify a sample size used for a test set in the context of clinical performance evaluation (e.g., patient data, in vitro or ex vivo samples for comparative testing). The evaluation primarily relies on compliance with standards and substantial equivalence to a predicate device.

The data provenance for the reported performance is from device testing against specified standards and material biocompatibility assessments, rather than clinical trial data.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. The evaluation is based on engineering and material compliance standards.

4. Adjudication Method

Not applicable. The evaluation does not involve an adjudication method for a test set, as no clinical performance study with human-interpreted outcomes is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The 510(k) summary does not describe any human-in-the-loop performance studies or comparisons of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument (bipolar forceps), not an algorithm or AI-based system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth used for this submission is primarily based on:

Compliance with recognized industry standards: ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993.
Compliance with material biocompatibility standards: ISO Standard # 10993-1.
Demonstration of substantial equivalence to a predicate device (Minisite* Bipolar Forceps** device K972415) based on design, materials, intended use, and performance claims.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument and does not involve a training set as would be used for an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI or machine learning model, the establishment of ground truth for such a set is not relevant.

Summary

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JUN 23 1999

Dexide Bipolar Forceps II** Device

KG918Sq

IX. 510(k)_Summary of Safety and Effectiveness

SUBMITTER:	United States Surgical150 Glover AvenueNorwalk, CT 06856
CONTACT PERSON:	Christopher A. Graham
DATE PREPARED:	May 27, 1999
CLASSIFICATION NAME:	Electrosurgical cutting and coagulation device and accessories
COMMON NAME:	Bipolar Forceps
PROPRIETARY NAME:	Dexide Bipolar Forceps II** device
PREDICATE DEVICES:	Minisite* Bipolar Forceps** device (K972415)
DEVICE DESCRIPTION:	The Dexide Bipolar Forceps II** device is a laparocopicgrasping, coagulating, and transecting bipolar forceps, which isintended to be passed down a laparoscopic cannula. Thedevice is intended to be used with the bipolar outputs ofcompatible electrosurgical generators.
INTENDED USE:	The Dexide Bipolar Forceps II** device is indicated for use inlaparoscopic bipolar procedures, to grasp, coagulate andtransect tissues.
MATERIALS:	All component materials of the Dexide Bipolar Forceps II**device are comprised of materials which are in accordance withISO Standard # 10993-1.
PERFORMANCE DATA:	The Dexide Bipolar Forceps II** device is in compliance withANSI/AAMI American National Standard for ElectrosurgicalDevices HF-18/1993.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corp. 150 Glover Avenue Norwalk, Connecticut 06856

Re: K991859 Trade Name: Dexide Bipolar Forceps II Regulatory Class: II Product Code: GEI Dated: May 27, 1999 Received: June 1, 1999

Dear Mr.Graham:

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.

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Page 2 - Mr. Christopher A. Graham

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., M.D.
Director
Division of General and
Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dexide Bipolar Forceps II** Device

IV. Indications For Use:

ﺰ

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Name: Dexide Bipolar Forceps II** device

Indications For Use:

The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

OR Over-The-Counter Use:_ Prescription Use: (Per 21 CFR §801.109)

Pocotalo

Sign-Off) (Division Division of General Restorative Devices 510(k) Number .

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.