DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE

K970993 · Deroyal Industries, Inc. · GEI · May 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970993
• Device Name: DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
• Applicant: Deroyal Industries, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Disposable bipolar electrosurgical cable; transmits electrical power from electrosurgical generator to bipolar instrument. Used in clinical electrosurgical procedures. Device consists of cable with PVC insulation. Operates as passive conduit for electrical energy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable bipolar electrosurgical cable; 12 ft (366 cm) length; PVC outer insulation; sterile; passive electrical transmission.

Indications for Use

Indicated for use during electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.

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

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

Submission Summary (Full Text)

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MAY 2 2 1997

DeRoyal Industries, Inc.

# DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE

k970893

510(k) Summary

Summary of the Safety and Effectiveness Information

Upon Which

An Equivalence Determination Could Be Based

# SUBMITTER INFORMATION

NAME: DeRoyal Industries, Inc.

ADDRESS: 200 DeBusk Lane

Powell, TN 37849

TELEPHONE: [phone]

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

CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device and Accessories (79 GEI)

# PREDICATE OR LEGALLY MARKETED DEVICES

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

# 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.

# 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 22 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Maria Ebio
Regulatory Affairs
DeRoyal 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 [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,


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): K970993

Device Name: DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable

## Indications for Use:

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.

(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 ☐