AUTOCON II 400 ELECTROSURGICAL GENERATOR

K021467 · KARL STORZ Endoscopy-America, Inc. · GEI · Nov 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021467
• Device Name: AUTOCON II 400 ELECTROSURGICAL GENERATOR
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

Device Story

Autocon II 400 Electrosurgical Generator provides high-frequency electrical current for tissue cutting and coagulation. System components include generator, dual-pedal footswitch, and power cord. Operated by qualified surgeons in open and endoscopic surgical settings. Device supports both monopolar and bipolar modes. Can be linked to Karl Storz SCB system. Surgeon activates power via footswitch to perform surgical tasks. Output enables precise tissue management, facilitating surgical procedures and potentially improving patient outcomes through controlled hemostasis and tissue division.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator providing high-frequency electrical current. Supports monopolar and bipolar modes. Includes dual-pedal footswitch and power cord. Connectivity via Karl Storz SCB link.

Indications for Use

Indicated for qualified surgeons performing open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures, requiring high frequency electrical current for tissue cutting and coagulation.

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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## 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] | NOV | 4 2012 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-----|--------|
| Contact: | James A. Lee<br>Regulatory Affairs Specialist | | |
| Device Identification: | Common Name:<br>Electrosurgical Generator | | |
| | Trade Name: (optional)<br>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) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

Device Description: The Autocon II 400 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 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.

Signed:

Aullke

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

200

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2002 NOV

Karl Storz Endoscopy-America, Inc James A. Lee Senior Regulatory Affairs Specialist 600 Corporate Pointe Culver City, California 90230-7600

Re: K021467

Trade/Device Name: Autocon II 400 Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical probe Regulatory Class: Class II Product Code: GEI Dated: September 11, 2002 Received: September 12, 2002

Dear Mr. Lee:

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.

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 (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,

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Page 2 -- Mr. James A. Lec

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Muriam C. Provost

for 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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K021467

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のです。 このため、そのためになるとなるとなると、そのため、そのため、

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

BATTAL PARACT AND THE

Specifical Comments of the Comments of the Children

Device Name: Autocon II 400 Electrosurgical Generator

Indications for Use: 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 during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number K021467

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