The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

Device Description

These devices are disposable bipolar forceps, designed for single use in general surgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, irrigate and illuminate, when applicable, selected tissues. The irrigation tube is designed to carry sterile fluid to the tips of the instrument. The illumination style forceps contain illumination fibers on each tine to deliver light to the surgical site. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The forceps are provided sterile by ethylene oxide and in sterile pouches.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about a study that would include acceptance criteria and device performance in the context of an AI/human reader study or clinical trial as you've outlined.

The document is a 510(k) summary for medical devices (Kogent Disposable Copper Forceps, Irrigating, and Illuminating Bipolar Forceps), which focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing and adherence to recognized standards, rather than clinical efficacy trials involving human readers or AI.

Here's why none of your requested information can be extracted:

No AI component: The devices described are electrosurgical forceps, not AI-powered diagnostic or assistive tools.
No human reader component: The evaluation is for physical medical devices and their performance characteristics (e.g., sterilization, biocompatibility, electrical safety, thermal conductivity, non-stick ability), not for human interpretation of data.
No clinical study: The document explicitly states, "Clinical Testing was not required to prove substantial equivalence." The evaluation is based on bench testing.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance related to AI or human interpretation.
Sample size for a test set in a human-in-the-loop or standalone AI study.
Number and qualifications of experts for ground truth establishment.
Adjudication method.
MRMC study results or effect size for AI assistance.
Standalone AI performance.
Type of ground truth (expert consensus, pathology, outcomes data) for AI/diagnostic purposes.
Training set sample size (as there's no AI model to train).
How ground truth for a training set was established.

The provided document describes the following performance data and tests for the physical medical device:

Medical Electrical Equipment Standards: IEC 60601-1 (various editions), IEC 60601-2-2, IEC 60601-1-6.
Biocompatibility: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-11 (Systemic Toxicity).
Sterilization: ISO 11135 (Ethylene oxide sterilization).
Shelf Life: ASTM F1980 (Accelerated Aging).
Bench Testing: Thermal Conductivity, Non-Stick Ability, Average Flow Rate (for irrigating forceps), Average Illumination Output (for illuminating forceps), Average Temperature Rise due to Illumination Output, Thermal Effects on Tissue.

These tests are designed to show that the new forceps are as safe and effective as existing legally marketed predicate devices, not to evaluate an AI or human interpretive performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 7, 2022

Katalyst Surgical, LLC Liz Morgan Ouality and Regulatory Specialist 754 Goddard Ave Chesterfield, Missouri 63005

Re: K213610

Trade/Device Name: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 6, 2022 Received: September 6, 2022

Dear Liz Morgan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213610

Device Name Kogent Disposable Copper Bipolar Forceps Kogent Disposable Irrigating Copper Bipolar Forceps Kogent Disposable Illuminating Copper Bipolar Forceps

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Manufacturer:	Katalyst Surgical, LLC754 Goddard AvenueChesterfield, MO 63005636-536-5950 (phone)636-787-0603 (fax)
Contact:	Liz MorganKatalyst Surgical, LLC636-536-5950 (phone)636-787-0603(fax)e.morgan@katalystsurgical.com
Date Prepared:	November 4, 2021
510(k) Number:	K213610
Device Trade Name:	Kogent Disposable Copper Bipolar ForcepsKogent Disposable Irrigating Copper Bipolar ForcepsKogent Disposable Illuminating Copper Bipolar Forceps
Common Name:	Bipolar Forceps
Classification:	21 CFR 878.4400
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Class:	II
Product Code:	GEI

Indications for Use:

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Device Description:

Predicate Device:

The Kogent Disposable Copper Bipolar Forceps was shown to be substantially equivalent to the previously cleared devices: Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K110924, Synergetics Spetzler Malis Dual Illuminating Bipolar Forceps K160103, and Kogent Bipolar Forceps K123172.

	Subject Device	Predicate Device
Device Name	Kogent Disposable CopperBipolar Forceps	Kogent Bipolar Forceps
Company	Katalyst Surgical, LLC	Katalyst Surgical, LLC
K Number	K213610	K123172
Classification	Class II	Class II
Product Code	GEI	GEI
Indications for Use	Single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue	Single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue
Forceps Design	Bayonet Style	Bayonet Style
Patient Contact Material	Silver Plated copper base with PVDF insulation	Silver Plated aluminum base with PVDF insulation
Electrical Safety Testing	IEC 60601-1IEC 60601-1-6IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2
Size Offerings Overall Length	6.25, 7, 8, and 9 inches	7, 8, and 9 inches
Size Offerings Distal Tip	0.5mm, 1.0mm, 1.5mm	0.5mm, 1.0mm, 1.5mm
Packaging Configuration	Double Tyvek/Poly pouches	Double Tyvek/Poly pouches
Biocompatibility	Biocompatible per test reports	Biocompatible per test reports
Method of Sterilization	ETO	ETO
Sterility Assurance Level	10-6	10-6

Comparison of Technical Characteristics:

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	Subject Device	Predicate Device
Device Name	Kogent Disposable CopperIrrigating Bipolar Forceps	Synergetics DisposableSpetzler Malis DualIrrigating Bipolar Forceps
Company	Katalyst Surgical, LLC	Synergetics, Inc
K Number	K213610	K110924
Classification	Class II	Class II
Product Code	GEI	GEI
Indications for Use	Single use product soldsterile and are intended foruse in electrosurgery forcoagulation and irrigation oftissue	Sterile single use, for use inelectrosurgery forcoagulation and irrigation oftissue
Forceps Design	Bayonet Style	Bayonet Style
Patient Contact Material	Silver Plated copper basewith PVDF insulation	Silver Plated aluminum basewith PVDF insulation
Electrical Safety Testing	IEC 60601-1IEC 60601-1-6IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2
Size Offerings Overall Length	7,8 and 9 inch handles	7,8 and 9 inch handles
Size Offerings Distal Tip	0.5mm, 1.0mm, 1.5mm	0.5mm, 1.0mm, 1.5mm
Packaging Configuration	Double Tyvek/Poly pouches	Rigid PETG Tray withTyvek 1073B Lid
Biocompatibility	Biocompatible per testreports	Biocompatible per testreports
Method of Sterilization	ETO	ETO
Sterility Assurance Level	10-6	10-6

	Subject Device	Predicate Device
Device Name	Kogent Disposable CopperIlluminating BipolarForceps	Synergetics Spetzler MalisDual Illuminating BipolarForceps
Company	Katalyst Surgical, LLC	Synergetics, Inc
K Number	K213610	K160103
Classification	Class II	Class II
Product Code	GEI	GEI
Indications for Use	Single use product soldsterile and are intended foruse in electrosurgery forcoagulation and to providelight for surgical procedures	Single use devices soldsterile and are intended foruse in electrosurgery forcoagulation of tissue and to

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		supply light for surgicalprocedures
Forceps Design	Bayonet Style	Bayonet Style
Patient Contact Material	Silver Plated copper basewith PVDF insulation	Silver Plated aluminum basewith PVDF insulation
Electrical Safety Testing	IEC 60601-1IEC 60601-1-6IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2
Size Offerings OverallLength	7,8 and 9 inch handles	8 and 9 inch handles
Size Offerings Distal Tip	0.5mm, 1.0mm, 1.5mm	0.5mm, 1.0mm, 1.5mm
Packaging Configuration	Double Tyvek/Poly pouches	Rigid PETG Tray withTyvek 1073B Lid
Biocompatibility	Biocompatible per testreports	Biocompatible per testreports
Method of Sterilization	ETO	ETO
Sterility Assurance Level	10-6	10-6

Performance Data:

Clinical Testing was not required to prove substantial equivalence. Bench testing performed between the candidate device and the predicate devices that the Kogent Copper Bipolar Forceps are substantially equivalent to predicate devices.

The product required the following other tests which were completed successfully:

Medical Electrical Equipment:

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 IEC 60601-2-2: 2017 for use in conjunction with IEC 60601-1:2005, COR1:2006, COR 2:2007, AMD1:2012 or IEC 60601-1:2012 IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012

Biocompatibility:

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity

Sterilization:

ISO 11135:2014 Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices

Shelf Life:

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K213610

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Bench Testing Thermal Conductivity Non-Stick Ability Average Flow Rate Average Illumination Output Average Temperature Rise due to Illumination Output Thermal Effects on Tissue

Conclusion

The Kogent Disposable Copper Bipolar Forceps were shown to be substantially equivalent to previously cleared devices with respect to intended use, indications for use, technological characteristics, performance characteristics, and biocompatibility.

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.