ETHICON NON-STICK BIPOLAR FORCEPS

K973384 · ETHICON, Inc. · GEI · Dec 5, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973384
• Device Name: ETHICON NON-STICK BIPOLAR FORCEPS
• Applicant: ETHICON, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation while grasping soft tissue, including vessels up to 3mm in diameter in open surgical procedures.

Device Story

The ETHICON Non-Stick Bipolar Forceps are reusable surgical instruments used in open surgical procedures. The device functions by grasping soft tissue or vessels (up to 3mm diameter) and delivering electrical energy from an electrosurgical generator to perform bipolar coagulation or bipolar point coagulation. The forceps connect to an electrosurgical generator via the ETHICON Bipolar Cable (K960476). Operated by a surgeon, the device facilitates hemostasis by coagulating tissue between the forceps tips. The non-stick design is intended to reduce tissue adhesion during the coagulation process, potentially improving surgical efficiency and patient outcomes by minimizing tissue trauma.

Clinical Evidence

Bench testing only. Preclinical laboratory evaluations were performed to ensure device functionality and safety. Clinical data was deemed unnecessary to support the Premarket Notification.

Technological Characteristics

Reusable, non-sterile bipolar forceps. Designed for use with electrosurgical generators. Complies with IEC-602-2.2. Mechanical design features non-stick properties for coagulation.

Indications for Use

Indicated for tissue grasping, manipulation, and bipolar coagulation of soft tissue, including vessels up to 3mm in diameter, during open surgical procedures.

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

• Kirwan Surgical Products Bipolar Forceps

Reference Devices

• ETHICON Bipolar Cable (K960476)

Submission Summary (Full Text)

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DEC - 5 1997

K973384

### SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

Information supporting claims of substantial equivalence, as 510(k) Summary of defined under the Federal Food, Drug and Cosmetic Act , Safety and Effectiveness respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: ETHICON Non-Stick Bipolar Forceps PREDICATE DEVICE NAME: Kirwan Surgical Products Bipolar Forceps 510(K) SUMMARY The ETHICON Non-Stick Bipolar forceps are available in Device Description various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU). The intended use of the ETHICON Non-Stick Bipolar Forceps is Intended Use to facilitate tissue grasping/manipulation and bipolar coagulation.

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ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.

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# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

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| Indications<br>Statement | The ETHICON Non-Stick Bipolar Forceps are non-sterile,<br>reusable devices intended to facilitate tissue grasping/<br>manipulating bipolar point coagulation and bipolar coagulation<br>while grasping soft tissue, including vessels up to 3mm in<br>diameter in open surgical procedures. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The new device is technologically the same as the predicate. |
| Performance Data | Preclinical laboratory evaluations (complies with IEC-602-2.2)<br>were performed to ensure that the device functions as intended.<br>Clinical data was deemed unnecessary to support the Premarket<br>Notification. Sufficient data has been gathered from preclinical<br>testing to assess the safety and effectiveness characteristics of<br>the new device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>new device is substantially equivalent to the Predicate Device<br>under the Federal Food, Drug and Cosmetic Act. |
| Contact | Gregory Jones<br>Director, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22 West<br>Somerville, NJ 08876-0151 |
| Date | September 5, 1997 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 1997

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Incorporated P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K973384 Trade Name: Ethicon Non-Stick Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: September 5, 1997 Received: September 8, 1997

Dear Mr. Jones:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Mr. Jones

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

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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# INDICATION FOR USE

| 510(k) Number (if known): | K973384 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ETHICON Non-Stick Bipolar Forceps |
| Indications for Use: | The ETHICON Non-Stick Bipolar Forceps are non-sterile,<br>reusable devices intended to facilitate tissue grasping/<br>manipulation, bipolar point coagulation, and bipolar coagulation<br>while grasping soft tissue, including vessels up to 3mm in<br>diameter in open surgical procedures. |

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

| Prescription Use | <div style="text-align:left;">✓</div> | OR | Over-The Counter Use | |
|----------------------|---------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K973384 (Optional Format 1-2-9G) |
|---------------|----------------------------------|
|---------------|----------------------------------|

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ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.