AUTOCON II 200 ELECTROSURGICAL GENERATOR

K023924 · Karl Storz Endoscopy · GEI · Feb 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023924
• Device Name: AUTOCON II 200 ELECTROSURGICAL GENERATOR
• Applicant: Karl Storz Endoscopy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Autocon II 200 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, ENT, gynecologic, and arthroscopic procedures.

Device Story

The Autocon II 200 is an electrosurgical generator providing high-frequency (HF) electrical current for tissue cutting and coagulation. The system comprises the generator unit, a dual-pedal footswitch for activation, and a power cord. It supports both monopolar and bipolar operating modes. The device is intended for use by qualified surgeons in clinical settings, including operating rooms for open and endoscopic procedures. It can be integrated with the Karl Storz SCB (Storz Communication Bus) system. By delivering controlled HF current, the device enables surgeons to perform precise tissue management, potentially reducing intraoperative bleeding and improving surgical efficiency.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Electrosurgical generator providing monopolar and bipolar HF current. Includes dual-pedal footswitch. Capable of linking to Karl Storz SCB. Class II device (Product Code GEI).

Indications for Use

Indicated for qualified surgeons performing cutting and coagulation of tissue in open and endoscopic surgeries, including general, plastic, urological, ENT, gynecologic, and arthroscopic procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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## K023924 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.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Susie S. Chen<br>Director, Regulatory & Product Legal Affairs |
| Device Identification: | <b>Common Name:</b><br>Electrosurgical Generator |
| | <b>Trade Name:</b> (optional)<br>The KSEA Autocon II 200 Electrosurgical Generator |

Indication: The Autocon II 200 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, ENT, gynecologic, and arthroscopic procedures.

Device Description: The Autocon II 200 consists of a generator, a dual pedal foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 200 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 200 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 200 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.

Signed:
Susie S. Chen

Director, Regulatory & Product Legal Affairs

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three horizontal lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

Karl Storz Endoscopy Susie S. Chen Director, Regulatory & Product Legal Affairs 600 Corporate Pointe Drive Culver City, California 90230

Re: K023924

Trade/Device Name: Autocon II 200 Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical Generator Regulatory Class: Class II Product Code: GEI Dated: November 20, 2002 Received: November 25, 2002

Dear Ms. Chen:

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. Iisting 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

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Page 2 - Ms. Susie S. Chen

(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. 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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

(0) 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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510(k) Number (if known): Not yet assigned.

K023924

Device Name: Autocon II 200 Electrosurgical Generator

Indications for Use: The Autocon II 200 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, ENT, gynecologic and arthroscopic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

Muriam C. Provost

vision Sign-Off) Division of General, Restorative and Neurological Devices

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510(k) Number K023924