NELSON ELECTROSURGICAL UNIT, MODEL GN640

K014172 · Aesculap, Inc. · GEI · Mar 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014172
• Device Name: NELSON ELECTROSURGICAL UNIT, MODEL GN640
• Applicant: Aesculap, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's Nelson delix® Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

Device Story

Electrosurgical unit (ESU) generates high-frequency electrical current for monopolar and bipolar cutting and coagulation; used in microsurgery and macrosurgery. Device features two monopolar and two bipolar outlets; housed in metallic and thermoplastic enclosure; includes universal power cord (100-240V). Operated via foot control or hand piece. Software-based program manages electrical output. Healthcare providers use device to perform tissue cutting and coagulation during surgery; output affects surgical site management and hemostasis.

Clinical Evidence

Bench testing only. The device conforms to applicable IEC standards and Canadian Standards Association (CSA) requirements for medical electrical equipment.

Technological Characteristics

Metallic and thermoplastic enclosure; monopolar and bipolar outlets; universal power cord (100-240V). Software-based control of high-frequency electrical current. Conforms to IEC and CSA standards for medical electrical equipment.

Indications for Use

Indicated for use in surgical procedures, including microsurgery and macrosurgery, requiring monopolar or bipolar cutting and coagulation. Intended for prescription use.

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

• Conmed / Aspen Laboratories' System 7500 ABC Electrosurgical Unit (K981220)
• Erbe's Erbotom ICC 300 (K953738)
• Erbe's Erbotom ICC 350 (K933002)
• ValleyLab's Force FX (K944602)

Submission Summary (Full Text)

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Nelson deluxe Electrosurgical Unit Page 1 of 1

| MAR 1 9 2002 | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS<br>in Accordance with SMDA of 1990 |
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K014172

## Nelson goluxe Electrosurgical Unit

December 18, 2001

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate<br>800-258-1946 (phone)<br>610-231-3713 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Nelson deluxe Electrosurgical Unit |
| COMMON NAME: | Monopolar / Bipolar Coagulator, Electrosurgical Unit |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 79 GEI |
| CLASSIFICATION: | 878.4400 - Electrosurgical Cutting & Coagulation Device & Accessories |
| REVIEW PANEL: | General & Plastic Surgery |

#### INTENDED USE

Aesculap's Nelson delix® Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

### DEVICE DESCRIPTION

Aesculab's Nelson dollar Electrosurgical Unit is an Electrosurgical unit (ESU) capable of generating high frequency electrical current, driven through a software based program, for use in monopolar and bipolar electrosurgery. The Nelson asunt Electrosurgical Unit is equipped with two monopolar and two biopolar outlets. All software and electrical components are housed within a combination metallic and thermoplastic enclosure and the product is provided with a universal power cord, which automatically adapts to voltages ranging from 100-240 volts. A monopolar or bipolar cord connects the instruments to the coagulator. The unit is activated by means of a foot control or hand piece.

### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Nelson deliver Electrosurgical Unit conforms to applicable IEC standards and the requirements of the Canadian Standards Association (CSA), for medical electrical equipment.

#### SUBSTANTIAL EQUIVALENCE

The Nelson ellectrosurgical Unit described in this premarket notification share similar features and functions such as intended use, labeling, and basic operating principles to the following predicate devices: Conmed / Aspen Laboratories' System 7500 ABC Electrosurgical Unit (#K981220), Erbe's Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602).

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of thick, curved lines that give it a modern and abstract appearance. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2002

Ms. Lisa Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

> K014172 Trade/Device Name: Nelson Electrosurgical Unit, Model GN640 Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation Device and accessories Regulatory Class: II Product Code: GEI Dated: December 18, 2001 Received: December 20, 2001

Dear Ms. Millington:

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 for are basedon 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 - Ms. Lisa Millington

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to orgin maxioning of substantial equivalence of your device to a legally premail.cr notification: "The Pro Pression 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 If you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0671. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1 1891 - 1852 - 15 - 15 - 1639. 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 Other general information on your respational 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

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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510(k) Premarket Notification

Nelson deluxe Electrosurgical Unit Page 1 of 1

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

014172

Nelson deluxe Electrosurgical Unit. Device Name:

Indication for Use:

Aesculap's Nelson deluxe Electrosurgical is intended to be used in surgery to Accenter electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

Miriam C. Provost

on Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

or Over-the-Counter Use Prescription Use (per 21 CFR 801.109)