ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES

K972008 · European Surgical, Inc. · GEI · Sep 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972008
• Device Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES
• Applicant: European Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Select-Sutter Electrosurgical Instruments are reusable surgical instruments which have applications in but not limited to; laparoscopic, general, neurologic and thoracic procedures The Forcens and Hierrories are designed to provide surgeons with an electrosurgical technique for coagulation.

Device Story

Select-Sutter Electrosurgical Instruments consist of reusable forceps and electrodes used in surgical settings (laparoscopic, general, neurologic, thoracic). Devices function by delivering electrosurgical energy to tissue to achieve coagulation. Operated by surgeons during surgical procedures. Benefits include providing a controlled method for tissue coagulation. Instruments are constructed from medical-grade materials capable of withstanding steam sterilization.

Clinical Evidence

Bench testing only. Testing includes dimensional verification, functional testing, visual inspection, bioburden assessment, stress/destructive testing, accelerated aging/shelf-life testing, and sterilization validation.

Technological Characteristics

Reusable electrosurgical forceps and electrodes. Materials: Surgical grade stainless steel (CrNiMo-alloy) per ISO 3832/1 and ASTM 899; Teflon and medical-grade plastics. Standards: cGMP, MIL-STD 105E, AAMI, ASTM, IEC 601 (2-2). Sterilization: Steam autoclavable.

Indications for Use

Indicated for use in laparoscopic, general, neurologic, and thoracic surgical procedures requiring electrosurgical coagulation. Intended for use by surgeons.

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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K972008
Sept. 19, 1997

972008

## SAFETY & EFFECTIVENESS DATA SUMMARY

( instituation Name Electrosurgical Cutung and Coagulation Device and Accessories I ommord sual Name: Electrosurgical Forceps and Electrodes N/A at this ume Propretary Name

Classification: Class II Electrosurgical cutting and coagulation Device and Accessories # 79GEI Reg. # 878.4400 Electrosurgical Electrodes # 79JOS Reg. # 878.4400

Performance Standards: Devices are manufactured according to cGMP's. MIL-STD 105E. AAMI and ASTM requirements, IEC 601 (2-2) and applicable Harmonized Standards

Material Composition

Material Composition: Surgical grade Stainless Steel (CrNiMo-alloy) certified according IC ISO 3832/1 and ASTM 899. Tefinn and plastics are identical to the materials used on modicale devices All of our products are manufactured from medical grade materials.

All materials were selected because of their stability to withstand Steam sterilization.

Testing conducted to assure safety and effectiveness include but is not limited to:

Note: This testing will be completed. reviewed and approved prior to release and mistribution I this product.

> Dimensional Venfication I Pak lesting Functional Testing Visual Inspection Bioburden Stress/desiructive testing Accelerated Aging - Shelf Life Sterilization

Intended Uses:

The Select-Sutter Electrosurgical Instruments are reusable surgical instruments which have applications in but not limited to; laparoscopic, general, neurologic and thoracic procedures The Forcens and Hierrories are designed to provide surgeons with an electrosurgical technique for coagulation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ellen Henke-Knupp European Surgical, Inc. 73 Eagles Nest Road Duxbury, Massachusetts 02332

SEP 1 9 1997

K972008 Re: Trade Name: Electrosurgical Forceps and Electrodes Regulatory Class: II Product Code: GEI Dated: July 18, 1997 Received: July 24, 1997

Dear Ms. Henke-Knupp:

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 800 to 895. A substantially 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 regulations.

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Page 2 - Ms. Ellen Henke-Knupp

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.

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,

focallfo

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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> !0(k) Number (it known)

Electrosurgical Forceps and Electrodes Device Name

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Indications For Use

The Select - Sutter Electrosurgical Forceps and Electrodes are reusable Electrosurgical Forceps and Electrodes which have applications in laparoscopic, general, Neurologic and Thoracic applications in laparosoppid are designed to provide surgeons with an electrosurgical technique for coagulation. The accessories provide a method for aiding in electrosurgical rie accessories provice a migues and medical literature relative
procedures. Surgical techniques and medical to tache consulted procedered. Complications, and hazards are to be consulted proceded the performance of any surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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of General Restorative D

Prescription Use
(21 CFR 801.109)
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Over-The-Counter Use

(Optional Format 1-2-96)