The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is indicated for use during electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.

Device Description

The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.
Device Design/ Materials Used/Physical Properties: The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is made of materials commonly used for their purpose. The primary material components are made of polyvinyl chloride.

AI/ML Overview

This is a 510(k) premarket notification for a disposable bipolar electrosurgical cable. Such submissions for devices of this nature typically do not include detailed studies on performance metrics like accuracy, sensitivity, or specificity, as they are not AI/algorithm-driven devices with diagnostic or predictive functions. Instead, the focus is on demonstrating substantial equivalence to predicate devices through design, material, and intended use comparisons, often supported by bench testing to ensure basic functionality and safety.

Therefore, the provided text does not contain information on acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a study proving device performance in that regard. The "study" here is essentially the comparison to predicate devices and the inherent understanding that the device will function as expected given its materials and design, similar to existing products on the market.

However, I can extract the relevant information that is present or implied by the nature of such a submission:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (DeRoyal Device)
Length of Cable	12 ft. (366 cm.)	12 ft. (366 cm.)
Material of Outer Cable Insulation	PVC	PVC
Disposable	Yes	Yes
Sterility	Sterile	Sterile
Intended Use	To provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.	To provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.
Function	Functions in the same manner as predicate devices.	Functions in the same manner as predicate devices.
Materials	Commonly used for their purpose.	Made of materials commonly used for their purpose.

Explanation: The "acceptance criteria" for a device like this in a 510(k) submission are typically not explicitly stated as numerical targets for accuracy, but rather as meeting the established characteristics and performance profile of legally marketed predicate devices. The "reported device performance" demonstrates that the DeRoyal cable matches these characteristics, establishing substantial equivalence.

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

Not applicable. This device is a disposable electrosurgical cable, not an AI/algorithm-driven device requiring a test set of data (e.g., medical images, patient records). The "test" for this type of device involved comparing its physical and functional specifications to those of existing devices. The data provenance is the design and manufacturing specifications of the DeRoyal device and the characteristics of the predicate devices.

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

Not applicable. Ground truth, in the context of AI/algorithm performance, refers to independently verified labels for data. For this device, "ground truth" relates to existing standards for electrosurgical cables. Establishing this would involve engineering and regulatory expertise, not medical experts for a "test set" of cases.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of cases or "adjudication method" in the AI sense for this device. The evaluation is based on engineering specifications and comparison to predicate devices.

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

Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-driven device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is the established safety, functionality, and performance of existing, legally marketed predicate electrosurgical cables. This is based on:

Engineering design principles and material specifications.
Compliance with general controls for medical devices (e.g., good manufacturing practices).
The history of use and regulatory acceptance of similar devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. If a comparison to predicate devices can be considered a form of "training" for regulatory review, the "ground truth" for such a comparison is based on the known, accepted characteristics of these predicate devices, established through their own regulatory pathways and market experience.

Summary

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MAY 2 2 1997

DeRoyal Industries, Inc.

DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE

510(k) Summary

K970993

Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based

SUBMITTER INFORMATION

NAME:	DeRoyal Industries, Inc.
ADDRESS:	200 DeBusk LanePowell, TN 37849
TELEPHONE:	(423) 938-7828
CONTACT:	Maria Ebio
DATE OF PREPARATION:	March 18, 1997

DEVICE NAMES

NAME:

DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable COMMON/USUAL NAME: Bipolar Cable/Cord Electrosurgical Cutting & Coagulation Device and Accessories CLASSIFICATION NAME (if known): (79 GEI)

PREDICATE OR LEGALLY MARKETED DEVICES

American Biosurgical, Apple Medical, Birtcher Medical Systems, Codman, Conmed, Kirwan, Olsen, Pilling Weck, and Valleylab

DEVICE DESRIPTION

Device Design/ Materials Used/Physical Properties: The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is made of materials commonly used for their purpose. The primary material components are made of polyvinyl chloride.

DEVICE INTENDED USE

The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is intended for use in electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLYMARKETED DEVICE(S)

Characteristic	DeRoyal Device	Other Devices
Length of Cable	12 ft. (366 cm.)	12 ft. (366 cm.)
Material of Outer Cable Insulation	PVC	PVC
Disposable	Yes	Yes
Sterility	Sterile	Sterile

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing, with a staff and two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1997

Ms. Maria Ebio Regulatory Affairs DeRoval Industries. Inc. ... 200 DeBusk Lane Powell, Tennessee 37849

Re: K970993

Trade Name: DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable Regulatory Class: II Product Code: GEI Dated: March 18, 1997 Received: March 19, 1997

Dear Ms. Ebio:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Maria Ebio

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, 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 yours.

Apisella

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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Page of

510(k) Number (if known):

Device Name:

DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices [<470993]
510(k) Number

Prescription Use
(Per 21 CFR §801.109)

Over-The-Counter Use

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.