MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR by KARL STORZ ENDOSCOPY-AMERICA, INC.

The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue.

Device Description

The Autocon II 400 consists of a generator, a foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.

AI/ML Overview

This 510(k) submission describes an electrosurgical generator, which is a hardware device. For such devices, acceptance criteria and performance are typically evaluated based on electrical and safety standards, rather than the metrics used for AI/software devices (e.g., sensitivity, specificity, AUC).

Therefore, the following information regarding acceptance criteria and studies for AI/software devices is not applicable to the provided document:

A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative performance metrics like sensitivity, specificity, or AUC, as these are not relevant for an electrosurgical generator's evaluation. Its performance is assessed against electrical safety and functional standards.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Explanation Based on Document Content:

The provided document, K062464 for the Karl Storz Endoscopy Autocon II 400 Electrosurgical Generator, is a 510(k) summary indicating substantial equivalence to predicate devices. The evaluation of this device focuses on:

Intended Use: "to provide a high frequency (HF) electrical current for cutting and coagulating tissue."
Device Description: "consists of a generator, a foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB."
Substantial Equivalence: The document states that the device is "substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences... raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

For electrosurgical generators, "performance" and "acceptance criteria" are typically demonstrated through:

Bench testing: Verifying electrical output parameters (e.g., power, voltage, current) across various modes and settings, often adhering to international standards like IEC 60601-2-2 (for high-frequency surgical equipment).
Safety testing: Ensuring electrical safety (e.g., insulation, leakage currents, grounding) as per standards like IEC 60601-1.
Electromagnetic Compatibility (EMC) testing: Conforming to EMC standards (e.g., IEC 60601-1-2).
Functional testing: Confirming that the device performs its intended functions (cutting and coagulation) reliably.
Biocompatibility testing (if applicable to patient-contacting components): Ensuring materials are safe for patient contact.

The 510(k) process for such a device relies on comparing these aspects to a legally marketed predicate device, ensuring that any differences do not introduce new questions of safety or effectiveness. The summary provided outlines the basis for substantial equivalence but does not detail the specific test results or acceptance criteria from those underlying studies, as is typical for 510(k) summaries which focus on demonstrating equivalence rather than providing full study protocols and results.

Summary

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Ko6 2464

FEB 6 2007

Page 111

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100
Contact:	James A. LeeSenior Regulatory Affairs Specialist
Device Identification:
Common Name:	Electrosurgical Generator
Trade Name: (optional)	The KSEA Autocon II 400 Electrosurgical Generator

Indication: The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) clectrical current for cutting and coagulating tissue.

Device Description: The Autocon II 400 consists of a generator, a foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.

Substantial Equivalence: The KSEA Autocon II 400 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences between the KSEA Autocon II 400 Electrosurgical Generator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

gned:
James A. Lee, Ph.D.

Signed:

James A. Lee, Ph.D.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy-America, Inc. % Mr. James A. Lec Senior Regulatory Affairs Specialist 600 Corporate Points 5th Floor Culver City, California 90230-7600

FEB 1 6 2007

Re: K062464

K002404
Trade/Device Name: Modified AUTOCON II 400 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 25, 2007 Received: January 29, 2007

Dear Mr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your Section 910(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure, to regars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices mail have been recadssiriou in accession of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that to hot require of the general controls provisions of the Act. The Y ou may, merelore, market the device, soojeer es use as annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) this existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controlio. "Entroling component" be found in the Oods of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other matt that TDA has made a decommances and regulations administered by other Federal agencies. You must of ally if cuchal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. James A. Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and will you to ough finding of substantial equivalence of your device to a legally prematice notification. "The started 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), please 11 you a some office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

mluh N. Mlleken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kobz464

510(k) Number (if known): K62464

Device Name: Modified AUTOCON II 400 Electrosurgical Generator

Indications for Use:

The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeous to provide a high frequency (HF) electrical current for cutting and coagulating tissue.

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

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Concurrence of CDRK, Office of Device Evaluation (ODE)

V.O.

(Division Sign-C

Division of Gene al, Restorative,

and Neurological Devices

510(k) Nur

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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.