ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19

K981981 · Boston Scientific Corp · GEI · Sep 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981981
• Device Name: ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.

Device Story

System comprises electrosurgical unit (ESU), probe, and accessories; applies radiofrequency (RF) energy to tissue. ESU delivers up to 150 watts in unipolar mode; features temperature control; monitors/displays power, electrode temperature, and duration. User sets temperature, power, and time. Safety features include overvoltage, overcurrent, and overpower shutdowns. Used in open, general surgery under direct visual control by physicians. Output allows coagulation of soft tissue and hemostasis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical system; unipolar RF energy delivery; 150W max output; temperature-controlled feedback loop; integrated monitoring for power, temperature, and time; safety shutdowns for overvoltage, overcurrent, and overpower.

Indications for Use

Indicated for use by physicians during open, general surgical procedures to coagulate soft tissues and produce hemostasis.

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

• Vallev Lab Force 40
• VNUS Medical Closure™ System
• Somnus Medical Model 615
• Oratec ORA-50™
• Arthrocare Electrosurgery System
• Wappler Electrosurgical Unit
• Ximed Medical Electrode Probe
• Circon Surgical Instruments

Submission Summary (Full Text)

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3 1998 SEP

981,981/

#### 510(k) SUMMARY (as required by 21 CFR 807.87(h)) E.

May 23, 1998 Date Prepared:

Boston Scientific Corporation Sponsor: 2710 Orchard Parkway San Jose CA 95134 [phone] Telephone: Contact: Steve.Jwanouskos Senior Director, Regulatory Affairs Title: and Quality Compliance

| Trade Name: | Boston Scientific Tissue Coagulation System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical System |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II-21 CFR 878.4400 |
| Predicate Devices: | Vallev Lab Force 40, VNUS Medical Closure™ System, Somnus<br>Medical Model 615, Oratec ORA-50™, Arthrocare Electrosurgery<br>System, Wappler Electrosurgical Unit, Ximed Medical Electrode<br>Probe. and Circon Surgical Instruments |

The Boston Scientific Tissue Coagulation System is comprised of an Device Description: Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories for the application of radiofrequency energy to tissue. The ESU supplies up to 150 watts of radiofrequency energy in unipolar mode to the electrodes of the Electrosurgical Probe under temperature control while continuously monitoring and displaying actual power delivered, actual electrode temperature, and time of power duration. User controls are provided for setting desired temperature, maximum power output, and duration of power delivery. ESU safety features include overvoltage, overcurrent, and overpower shutdowns.

Intended Use: The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 1998

Mr. Steve Jwanouskos Senior Director, Regulatory Affairs and Quality Compliance Boston Scientific Corporation 2710 Orchard Parkway San Jose, California 95134

Re: K981981

Trade Name: Boston Scientific Tissue Coagulation System Regulatory Class: II Product Code: GEI Dated: June 3, 1998 Received: June 5, 1998

Dear Mr. Jwanouskos:

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 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 (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 action. In addition, FDA may publish further announcements 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.

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### Page 2 - Mr. Steve Jwanouskos

This letter will allow you to begin marketing your device as described in your 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 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 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,

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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# D. INDICATIONS FOR USE STATEMENT

1981981 510(k) Number (if known):___

Boston Scientific Tissue Coagulation System Device Name:

Indication For Use:

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The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.

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

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of General Restorative De De C 981981 J Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)