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 the following:

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

OB/GYN Surgery
Hysterectomy
Salpingo-oophrectomy
Mvomectomy
Endometriosis
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
Typanoplasty
Tonsillectomy

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

Device Description

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.

AI/ML Overview

The provided text is related to a 510(k) submission for the PowerStar Bipolar Scissors, a surgical device. The document details the device description, intended use, and a statement of substantial equivalence to an existing device.

However, the text does not contain any information regarding acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about any studies (standalone, MRMC, or otherwise) that would "prove the device meets the acceptance criteria." The document states that "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended" and "Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended," but it does not provide any specifics about these evaluations or the data.

Therefore, I cannot populate the table or answer the specific questions requested because the necessary information is not present in the provided document.

Summary of missing information:

Acceptance Criteria & Reported Performance: Not specified.
Sample size (test set) & Data provenance: Not specified.
Number of experts & qualifications: Not specified.
Adjudication method: Not specified.
MRMC comparative effectiveness study: No details provided; only a general statement about clinical evaluations.
Standalone performance study: No details provided.
Type of ground truth used: Not specified.
Sample size (training set): Not applicable, as this is a physical medical device, not an AI/algorithm-based device in the context of "training set."
How ground truth for training set was established: Not applicable.

Summary

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OCT 2 9 1997

SECTION 7

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 NAME: PowerStar Bipolar Scissors

EXISTING (legally marketed) DEVICE NAME: PowerStar Bipolar Scissors

510(K) SUMMARY

Device Description

Intended Use

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

device.

Indications Statement

Technological Characteristics

Performance Data

Conclusions

Contact

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.

The modified device is technologically the same as the existing

The PowerStar Bipolar Scissors are non-sterile, reusable devices

tissue in open surgical procedures such as general, gynecological,

intended to facilitate cutting and bipolar coagulation of soft

oncologic, vascular, plastic, thoracic, ear, nose and throat,

urological, and cardiovascular surgeries.

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

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

and the same of the same of the same of the same of

Date

PowerStar Bipolar Scissors ETHICON, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory R. Jones Director Regulatory Affairs Ethicon, Inc. PO Box 151 Somerville, New Jersey 08876-0151

OCT 2 9 1997

K973173 Re:

Trade Name: PowerStar Bipolar Scissors and Accessories Regulatory Class: II Product Code: GEI Dated: August 20, 1997 Received: August 25, 1997

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. 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

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Page 2 - Mr. Gregory R. Jones

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of vour devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

to collyp

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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510(k) Number (if known):

Device Name:

Indications 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 the following:

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

OB/GYN Surgery Hysterectomy Salpingo-oophrectomy Mvomectomy Endometriosis Ovariohysterectomy

Oncological Surgery Mastectomy Axillary Node Dissection

Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial

Nephrectomy Prostatectomy Cystotomy

Ear, Nose & Throat Surgery Neck Mass Mastoidectomy

Typanoplasty Tonsillectomy Cardiovascular/Thoracic Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The Counter Use(Optional Format 1-2-9G)
	(Division Sign-Off)
PowerStar Bipolar. ScissorsETHICON, Inc.	Division of General Restorative Devices
510(k) Number	K973173
	iii

e Flap

gical Surgery
ectomy

Urological Surgery

e the following:

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.