SYSTEM 7500 ABC ELECTROSURGICAL UNIT

K981220 · Aspen Laboratories, Inc. · GEI · Apr 21, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981220
• Device Name: SYSTEM 7500 ABC ELECTROSURGICAL UNIT
• Applicant: Aspen Laboratories, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

Device Story

System 7500 ABC Electrosurgical Unit; device used for controlled destruction of human tissue during surgical procedures. Operates via electrosurgical energy delivery to tissue; intended for use by surgeons in clinical/surgical settings. Provides therapeutic benefit through tissue destruction. Output controlled by clinician; device functions as standard electrosurgical unit.

Clinical Evidence

No clinical data provided; substantial equivalence based on intended use and technological characteristics compared to predicate devices.

Technological Characteristics

Electrosurgical unit; utilizes electrical energy for tissue destruction. Designed for use with existing marketed electrosurgical accessories. Class II device.

Indications for Use

Indicated for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit. Prescription use only.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing the snakes and a base representing the staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 1 1998

Mr. Charles M. Hart Director of Quality Assurance and Requlatory Affairs ConMed Corporation 14603 East Fremont Avenue Englewood, Colorado 80112

K981220 Re: System 7500 Electrosurgical Unit Trade Name: Requlatory Class: II Product Code: GEI March 31, 1998 Dated: Received: April 3, 1998

Dear Mr. Hart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A ... ... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 regulations.

{1}------------------------------------------------

Page 2 - Mr. Hart

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets 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 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 ene regaracion chercica) (11825anding m) 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,

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

Enclosure

{2}------------------------------------------------

### K981220 510(k) Number:

#### System 7500 ABC Electrosurgical Unit Device Name:

## Indications for Use:

Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use **__**

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices