The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

Device Description

This device is a disposable bipolar forceps, designed for single use in electrosurgical 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, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.

AI/ML Overview

The provided text describes performance testing for the "Kogent Bipolar Forceps" as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices. The study conducted is primarily bench testing focusing on electrical safety and mechanical integrity for an electrosurgical device, rather than a clinical study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, many of the requested fields are not applicable to this type of device and study.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Criteria	Description	Lower Spec	Upper Spec	Units	Standard Reference	Result
HF Leakage Current	Leakage current	-	$I_{leakage}=1.8 \times 10^{-5} \times d \times L \times f_{test} \times U_{peak}$ [mA]	mA	201.8.8.3.102 IEC_60601-2-2_Ed5_2009	PASS
HF Dielectric Strength	Active accessory HF dielectric strength	120% of the rated accessory voltage.		KV	201.8.8.3.103 IEC_60601-2-2_Ed5_2009	PASS
Mains Frequency Dielectric Strength	The test duration shall be 30 seconds for active connectors		Pass/Fail - 3.0KV at 60HZ Frequency	KV	201.8.8.3.104 IEC_60601-2-2_Ed5_2009	PASS
Dielectric Withstand	Scan the cord of active accessory for 5 minutes.		Pass/Fail - 3.0KV at 60HZ Frequency	KV	N/A	N/A
Anchorage	Workmanship	Pass/Fail - Cable fails the test if it separates from the connectors, or termination during any phase of the test			201.8.10.4.2 IEC_60601-2-2_Ed5_2009	PASS
Resistance/Continuity			0.2	Ohms	N/A	N/A

Note: For "Dielectric Withstand" and "Resistance/Continuity", the "Result" column is empty in the original table, so it is marked as N/A here. However, since the overall summary states that "Performance" is "Identical" to predicate devices, it can be inferred that these tests also passed or met the criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. For bench testing of medical devices like forceps, the sample size usually refers to the number of devices tested. This information is typically detailed in the full test report, not in the 510(k) summary.
Data Provenance: This is bench testing data, not human patient data. It is generated during the device's manufacturing and quality control process. The country of origin of the data would be the location where Katalyst Surgical, LLC conducted its testing, likely the USA (Chesterfield, MO, as per the manufacturer's address). The data is prospective in the sense that it pertains to the newly manufactured Kogent Bipolar Forceps being submitted for clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. This study is not evaluating an AI algorithm or a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., IEC 60601-2-2).

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. This is bench testing against established engineering standards. The pass/fail criteria are objective metrics based on those standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

No. This is not an AI-enabled device, nor is it a diagnostic tool where human reader performance would be evaluated with or without AI assistance. This section is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

N/A. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Engineering Standards and Specifications: The ground truth for this device's performance is defined by established international and national standards for electrosurgical equipment, specifically IEC 60601-2-2, and the internal design specifications of the device. These standards define the acceptable limits for parameters like leakage current, dielectric strength, and anchorage.

8. The Sample Size for the Training Set

N/A. This is not an AI algorithm requiring a training set.

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

N/A. This is not an AI algorithm requiring a training set.

Summary

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Katalyst Surgical. LLC Kogent Bipolar Forceps Traditional 510(k)

510(k) Summary

DEC 2 1 2012 Manufacturer: Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 636-536-5950 (phone) 636-787-0603 (fax) Mona Dean Contact: Katalyst Surgical, LLC 636-536-5950 (phone) 636-787-0603(fax) Mona. Dean@katalystsurgical.com Date Prepared: October 5, 2012 Kogent Bipolar Forceps Device Trade Name: Bipolar Forceps Common Name: 21 CFR 878.4400; Electrosurgical cutting and coagulation device Classification: and accessories II Class: Product Code: GEI

Indications for Use:

Device Description:

p. 1/3

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Predicate Device:

The Kogent Bipolar Forceps was shown to be substantially equivalent to the previously cleared devices: Synergetics Disposable Spetzler-Malis Bipolar forceps K121426 and Synergetics 11: Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K 10924.

Performance Testing Summary:

The Kogent Bipolar Forceps performance testing is summarized below.

Test Criteria	Description	Lower Spec	Upper Spec	Units	StandardReference	Result
HF LeakageCurrent	Leakage current	-	$Ileakage=1.8x10^-5 x d x L x ftestxUpeak [mA]$	mA	201.8.8.3.102IEC_60601-2-2_Ed5_2009	PASS
HF DielectricStrength	Active accessoryHF dielectricstrength	120 % of therated accessoryvoltage.		KV	201.8.8.3.103IEC_60601-2-2_Ed5_2009	PASS
MainsFrequencyDielectricStrength	The test durationshall be 30seconds for activeconnectors		Pass/ Fail - 3.0KV at 60HZFrequency	KV	201.8.8.3.104IEC_60601-2-2_Ed5_2009	PASS
DielectricWithstand	Scan the cord ofactive accessoryfor 5 minutes.		Pass/ Fail - 3.0KV at 60HZFrequency	KV
Anchorage	Workmanship	Pass/ Fail - Cable fails the test if itseparates from the connectors, ortermination during any phase ofthe test			201.8.10.4.2IEC_60601-2-2_Ed5_2009	PASS
	Resistance/Continuity		0.2	Ohms

P. 2/3

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Substantial Equivalence:

Bench testing demonstrates that the Kogent Bipolar Forceps are substantially equivalent to the Synergetics Disposable Spetzler-Malis Bipolar forceps K121426 and Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K ! 10924.

FDA File Reference No.	510(k) No. K110924	510(k) No. 121426
TECHNOLOGICALCHARACTERISTICS	Comparison Result	Comparison Result
Indications for Use	Identical	Identical
Target Population	Identical	Identical
Design	Similar	Similar
Materials	Similar	Similar
Performance	Identical	Identical
Sterility	Identical	Identical
Biocompatibility	Identical	Identical
Anatomical Sites	Identical	Identical
Human Factors	Identical	Identical
Energy Used and/or Delivered	Identical	Identical
Compatibility with Environmentand Other Devices	Similar	Similar
Where Used	Identical	Identical
Electrical Safety	Identical	Identical
Thermal Safety	Identical	Identical
Radiation Safety	Identical	Identical

SUMMARY OF EQUIVALENCE

Conclusion

The Kogent 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.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Katalyst Surgical, LLC % Ms. Mona Dean Ouality and Regulatory Manager 754 Goddard Avenue Chesterfield, Missouri 63005

December 21, 2012

Re: K123172

Trade/Device Name: Kogent Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 05, 2012 Received: December 06, 2012

Dear Ms. Dean:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Mona Dean

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Katalyst Surgical, LLC Kogent Bipolar Forceps Traditional 510(k)

Indications for Use

510(k) Number (if known): Pre-enact

Device Name: Kogent Bipolar Forceps

The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Intended for ass in occeps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

Prescription Use ど · AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE . IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2012.12.20 12:33:10 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number K123172

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.