GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910

K061417 · Genicon · GEI · Oct 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061417
• Device Name: GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
• Applicant: Genicon
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GENICON Disposable Electrosurgical Instrumentation is indicated for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.

Device Story

GENICON Electrosurgical Instrumentation consists of single-use, sterile endoscopic instruments (graspers, dissectors, scissors) constructed from biocompatible plastic and stainless steel. Devices feature 33cm working length. Operated by surgeons during endoscopic procedures; instruments connect to an external, approved electrosurgical generator to provide high-frequency energy for tissue coagulation and cutting. Requires use of an appropriate ground electrode. Device facilitates tissue manipulation and hemostasis, benefiting patients by enabling minimally invasive surgical access.

Clinical Evidence

Bench testing only. No clinical data provided. Device design verified against voluntary standards including AAMI/ANSI HF18:2001, IEC 60601-2-2:2000, EN 12011:1998, ISO 7153-1:1991, and ISO 4957:1999.

Technological Characteristics

Materials: Biocompatible plastic and stainless steel (ISO 7153-1:1991, ISO 4957:1999). Dimensions: 33cm working length. Energy: High-frequency electrical energy via external generator. Standards: AAMI/ANSI HF18:2001, IEC 60601-2-2:2000, EN 12011:1998. Sterilization: Irradiation (EN 552:1994).

Indications for Use

Indicated for patients requiring laparoscopic surgical intervention where electrosurgical cutting, manipulating, or coagulating is required. Not indicated for fallopian tube sterilization.

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.

Predicate Devices

• Ethicon ENDOPATH (K984240)

Submission Summary (Full Text)

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510(k) Summary

OCT 1 0 2006

## (As Required By 21 CFR 807.93)

K061417

# PreMarket Notification Summary

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A 510(k) summary has been selected in lieu of a 510[k] statement.

Trade Name - GENICON Electrosurgical Instrumentation

Common Name - Electrosurgical Instrumentation

Classification Name - Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400, Product Code GEI)

Legally Marketed Device - Ethicon ENDOPATH (K984240)

Device Description - The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.

Intended Use - GENICON Disposable Electrosurgical Instrumentation is indicated for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.

Technological Characteristics - The technological characteristics of the new device are the same as the predicate device.

Performance – There are no mandatory performance standards or special controls in existence for this device at the date of submittal. GENICON electrosurgical instruments were designed to meet the following voluntary standards:

AAMI/ANSI HF18:2001, Electrosurgical Devices

IEC 60601-2-2:2000, Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment

EN 12011:1998, Instrumentation to be used in association with non-active surgical implants - General requirements

ISO 7153-1:1991, Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel

ISO 4957:1999, Tool Steels

EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Conclusion - Based on the indications for use and technological characteristics, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OC1 1 0 2006

Genicon % Mr. Gary Haberland 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792

Re: K061417

Trade/Device Name: Genicon Disposable Electrosurgical Instrumentation Regulation Number: 21 CFR 878.4400 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: GEI Dated: September 13, 2006 Received: September 14, 2006

Dear Mr. Haberland:

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. Gary Haberland

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). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buettm

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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# Indications for Use

### 510(k) Number (if known): K061417

## Device Name: Genicon Disposable Electrosurgical Instrumentation

### Indications for Use:

Endoscopic surgical procedures. It is a family of instruments which includes graspers, Linsectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.

#### Target population definition

Patients requiring laparoscopic surgical intervention where use of an electro-surgical cutting, manipulating, and/or coagulating device is indicated.

### Anatomical sites

Where laparoscopic surgical techniques are indicated, but not for fallopian tube sterilization.

Prescription Use YES X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buettner

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

510(k) Number K191417