The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.

Device Description

The OSCAR™ Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the OSCAR™ Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows between the electrodes in the cartridges and the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.

The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the OSCAR™ Bipolar Scissors is 20-30 watts.

AI/ML Overview

Acceptance Criteria and Device Performance Study for OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges (K981219)

Based on the provided 510(k) summary, the device's acceptance criteria and the study proving its performance are primarily established through a demonstration of substantial equivalence to legally marketed predicate devices. The document does not describe a traditional performance study with specific quantitative acceptance criteria for the OSCAR™ device itself, but rather relies on the equivalency to already approved devices.

Here's a breakdown of the requested information, reflecting the nature of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (as demonstrated by substantial equivalence)
Intended Use	To cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.	The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery, which is stated to be substantially equivalent to predicate devices.
Function	Electrosurgical cutting and coagulation using bipolar technology.	Operates by electric current flowing between electrodes in cartridges and stainless steel cutting surfaces of blades, enabling simultaneous cutting and coagulation. This function is presented as substantially equivalent to predicate devices.
Physical Characteristics	Reusable handle, disposable cartridge containing scissors blades, connected to electrosurgical generator. Overall length between 4 and 11 inches, blades between 1 and 2 inches, power cord approx. 120 inches.	Device description matches these characteristics, and these are deemed substantially equivalent to predicate devices' physical characteristics.
Materials	Materials suitable for electrosurgical cutting and coagulation devices.	The materials used are considered substantially equivalent to those of predicate devices. (Specific material types are not detailed in the summary).
Sterilization Method	A validated sterilization method appropriate for surgical instruments.	The sterilization method is stated to be substantially equivalent to predicate devices' methods. (Specific method is not detailed in the summary).
Power Range	Operable with electrosurgical generators, typically in the 20-30 watts range.	The device operates with electrosurgical generators and uses a power setting of 20-30 watts, consistent with similar power ranges used by predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k) summary. The submission relies on the existing safety and effectiveness profiles of the predicate devices rather than new performance data for a dedicated test set designed to establish new performance metrics for the OSCAR™ device.
Data Provenance: Not applicable. The "data" here refers to the established performance and safety profiles of the cited predicate devices (e.g., Symbiosis Bipolar Scissors, Everest Medical Bipolar Scissors, CardioThoracic Systems MIDCAB/SVH Bipolar Scissors, Ethicon PowerStar Bipolar Scissors, ENABLE Bipolar Scissors), which were legally marketed prior to this submission. Information regarding their specific testing or data provenance is not provided here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. There was no specific "test set" in the traditional sense for the OSCAR™ device in this 510(k) submission, and therefore no ground truth established by experts specifically for the OSCAR™ device to meet new performance benchmarks. The ground truth is effectively the regulatory acceptance of the predicate devices.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no specific test set requiring adjudication was used for the OSCAR™ device's performance claims.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or interpretation tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Study: Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The OSCAR™ Bipolar Scissors are shown to be substantially equivalent in intended use, function, physical characteristics, materials, and sterilization method to these pre-existing devices. This equivalency implicitly means that if the predicate devices are safe and effective, then a substantially equivalent new device will also be safe and effective.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The device is not based on machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

Summary

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K981219
OSCAR
TM Bipolar Scissors 510(k)

JUN 2 9 1998

510(k) SUMMARY OSCAR™ BIPOLAR SCISSORS WITH OSCAR™ BIPOLAR DISPOSABLE CARTRIDGES 981219 510(k) NOTIFICATION K

GENERAL INFORMATION

Manufacturer:

ENABLE Medical Corporation 6345 Centre Park Drive West Chester, OH 45069-3863 (513) 755-7600 (513) 755-7676 Est. Reg. No. 1530251

Contact Person:

Mark L. Friedman, PhD Directory, Ouality Assurance/Regulatory Affairs ENABLE Medical Corporation

Date Prepared:

DEVICE DESCRIPTION

Classification:

Trade Name:

OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges

Generic/Common Name:

Electrosurgical cutting and coagulation device and accessories 21CFR878.4400

PREDICATED DEVICES

1. Symbiosis Bipolar Scissors (K951387)
Everest Medical Bipolar Scissors (K945975 and K955001) 2.
CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 3.

Class II

1. Ethicon PowerStar Bipolar Scissors (K960476 and K973173)
1. ENABLE Bipolar Scissors (K972558)

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INTENDED USE

The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.

PRODUCT DESCRIPTION

The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are substantially equivalent to the above-identified predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method. ENABLE, CardioThoracic, Symbiosis, Everest and Ethicon devices are all bipolar scissors that cut tissue and coagulate soft tissue through the use of bipolar technology. All the bipolar scissors are connected to the same or similar electrosurgical generators and use similar power ranges for operation.

SUMMARY

As contained in this 510(k) summary, the OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are substantially equivalent to the predicate devices identified.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 29 1998

Mark L. Friedman, Ph.D. Director Ouality Assurance and Regulatory Affairs Enable Medical Corporation 6345 Centre Park Drive West Chester, Ohio 45069-3863

Re: K981219

Trade Name: Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges Regulatory Class: II Product Code: GEI Dated: March 27, 1998 Received: April 3, 1998

Dear Dr. Friedman:

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 (OS) 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 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 - Dr. Friedman

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) 594-4648. Additionally, for questions on the promotion and advertising of your 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.

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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OSCAR™ Bipolar Scissors 510(k) Premarket Notification

STATEMENT OF INDICATIONS OF USE

The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.

Prescription Use
(Per 21 CFR 801.109)

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510k

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.