KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES

K972497 · KARL STORZ Endoscopy-America, Inc. · GEI · Aug 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972497
• Device Name: KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Monopolar Coagulating and Needle Electrodes are designed to be used by qualified surgeons and physicians to cut, coagulate, and/or fulgurate tissue via high-frequency electrical current wave forms, during endoscopic general and plastic surgical procedures.

Device Story

Reusable electrosurgical electrodes used in endoscopic general and plastic surgery. Device delivers high-frequency electrical current to cut, coagulate, or fulgurate tissue. Operated by surgeons/physicians in clinical settings. Output is thermal tissue effect controlled by surgeon via electrosurgical generator. Benefits include precise tissue management during minimally invasive procedures.

Clinical Evidence

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

Technological Characteristics

Body-contact portions: AISI 420 stainless steel. Shafts: AISI 303 and 304 stainless steel. Insulation: PTFE. Monopolar electrosurgical energy delivery.

Indications for Use

Indicated for use by qualified surgeons and physicians for cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical 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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Karl Storz Endoscopy-America, Inc

Culver City, California 90230-760 Phone [phone]

上できる(800) 4.21 13

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K972+97

## 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 are accurate to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy-America, Inc.<br>600 Corporate Pointe<br>Culver City, California 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Marlena Allen Piercy, Ph.D.<br>Senior Clinical Affairs Specialist |
| Device Identification: | <b>Common Name:</b><br>Electrosurgical Coagulating Electrodes<br>Electrosurgical Needle Electrodes |
| | <b>Trade Name (optional):</b> |

KSEA Monopolar Coagulating Electrodes KSEA Monopolar Coagulating Needle Electrode

Indication: The KSEA Monopolar Coagulating and Needle Electrodes are designed to be used by qualified surgeons and physicians to cut, coagulate, and/or fulgurate tissue via high-frequency electrical current wave forms, during endoscopic general and plastic surgical procedures.

Device Description: The KSEA Monopolar Coagulating and Needle Electrodes are reusable surgical devices. The body-contact portions of the electrodes are composed of AISI series 420 surgical-grade stainless steel. The shafts are composed of AISI series 303 and 304 surgical-grade stainless steel, and are insulated with polytetrafluoroethylene (PTFE).

Substantial Equivalence: The KSEA Monopolar Coagulating and Needle Electrodes are substantially equivalent to the predicate devices since the basic designs and intended uses are the same. The minor difference between the K.SEA Monopolar Coagulating and Needle Electrodes and the predicate devices raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function, or intended uses of the devices.

Signed: Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1997

Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 92030-7600

K972497 Re:

> Trade Name: Karl Storz Monopolar Coagulating Electrodes and Karl Storz Monopolar Coagulating Needle Electrodes Regulatory Class: II Product Code: GEI Dated: July 2, 1997 Received: July 3, 1997

Dear Dr. Piercy:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 300 to 895. A substanially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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## Page 2 - Marlena Allen Piercy, Ph.D.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. " " w

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "Karl Storz Endoscopy" in a smaller font. The logo is simple and modern, and it is likely used to represent the company's brand.

Karl Storz Endoscopy-America, Inc.

500 Corporate Porne Culver City, California 90230-7600 Phone [phone]

01 Free 800 421 08.13 Fax [phone]

K9124997

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

Device Name: Monopolar Coagulating Electrodes for General and Plastic Surgery

Indications for Use:

The Monopolar Coagulating Electrodes are indicated for use in cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical procedures.

CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: (Per 21 CFR 801.109) | <div> <table style="border: none;"><tr><td><div> <img alt="Signature" src="signature.png" style="width: 200px;"/> </div> <div>(Division Sign-Off)</div></td></tr></table> </div> | <div> <img alt="Signature" src="signature.png" style="width: 200px;"/> </div> <div>(Division Sign-Off)</div> | OR Over-the-Counter Use: | (Optional Format 1-2-96) |
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| <div> <img alt="Signature" src="signature.png" style="width: 200px;"/> </div> <div>(Division Sign-Off)</div> | | | | |
| | Division of General Restorative Devices | | | |
| | 510(k) Number K972497 | | | |

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