POWERSTAR BIPOLAR SCISSORS

K981361 · ETHICON, Inc. · GEI · Jul 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981361
• Device Name: POWERSTAR BIPOLAR SCISSORS
• Applicant: ETHICON, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

Device Story

PowerStar Bipolar Scissors are limited-life, reusable surgical instruments; designed for use in open surgical procedures. Device connects to bipolar output mode of electrosurgical generators; enables simultaneous cutting and bipolar coagulation of soft tissue. Operated by surgeons in clinical settings (OR). Output is mechanical cutting action combined with electrical coagulation; assists in tissue management during various surgeries (e.g., general, gynecological, oncologic, vascular, plastic, thoracic, ENT, urological, cardiovascular). Benefits include improved efficiency in tissue dissection and hemostasis.

Clinical Evidence

Preclinical laboratory and clinical evaluations were performed. Sufficient data gathered from these evaluations confirm the device performs as clinically intended and meets safety and effectiveness requirements.

Technological Characteristics

Limited-life, reusable bipolar electrosurgical instrument. Dimensions and shapes similar to conventional surgical scissors. Energy source: bipolar electrosurgical generator. Connectivity: connects to electrosurgical generator output. Sterilization: non-sterile (reusable).

Indications for Use

Indicated for cutting and bipolar coagulation of soft tissue in open surgical procedures, including general, gynecological, oncologic, vascular, plastic, thoracic, ENT, urological, and cardiovascular surgeries.

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

• PowerStar Bipolar Scissors (K981361)

Submission Summary (Full Text)

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|C98136i/

### SECTION 7

JUL 1 3 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act. 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.

MODIFIED DEVICE PowerStar Bipolar Scissors NAME:

EXISTING (legally marketed) DEVICE NAME: PowerStar Bipolar Scissors

### 510(K) SUMMARY

Device Description

Intended Use

The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.

The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

Continued on next page

PowerStar Bipolar Scissors ETHICON, Inc.

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# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Indications Statement

intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

The PowerStar Bipolar Scissors are non-sterile, reusable devices

The modified device is technologically the same as the existing device.

Performance Data

Technological

Characteristics

Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended.

Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device.

Conclusions

Contact

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

Gregory R. Jones Director Regulatory Affairs ETHICON, Inc. Rt. #22 West Somerville, NJ 08876-0151

. Date

PowerStar Bipolar Scissors ETHICON, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles a human figure or a bird in flight, composed of curved lines and shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 1 3 1998

Mr. Gregory R. Jones Director Regulatory Affairs Ethicon, Inc. A Johnson & Johnson Company P.O. Box 151 Somerville, New Jersey 08876

Re: K981361 Trade Name: PowerStar Bipolar Scissors Regulatory Class: II Product Code: GEI Dated: April 10, 1998 Received: April 14, 1998

Dear Mr. Jones:

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 (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Mr. Gregory R. Jones

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.

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,

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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K981361

510(k) Number (if known):

Device Name:

Indications for Use:

## INDICATION FOR USE

## PowerStar Bipolar Scissors

"The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".

Surgical procedures would include, among others, the following:

General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy

OB/GYN Surgery Hysterectomy

Myomectomy

Endometriosis

Salpingo-oophrectomy

Ovariohysterectomy

Oncological Surgery Mastectomy Axillary Node Dissection

Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial

Urological Surgery Nephrectomy Prostatectomy Cystotomy

Ear. Nose & Throat Surgery Neck Mass Mastoidectomy

Tympanoplasty Tonsillectomy

Cardiovascular/Thoracic_Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | Over-The Counter Use _______ (Optional Format 1-2-9G) |

PowerStar Bipolar Scissors
ETHICON, Inc.

| (Division Sign-Off) | <img alt="Signature" src="signature.jpg"/> |
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| Division of General Restorative Devices | |
| 510(k) Number | |

iii

And And Andrew States