(64 days)
Not Found
Not Found
No
The summary describes a simple electrosurgical cable and makes no mention of AI or ML technology.
No.
The device is a cable that transmits electrical power from a generator to a surgical instrument; it does not directly provide therapy.
No
The device is described as an electrosurgical cable for transmitting electrical power from a generator to an instrument, not for diagnosing medical conditions.
No
The device is described as a physical cable made of polyvinyl chloride, intended for transmitting electrical power. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide transmission of electrical power from an electrosurgical generator to a bipolar instrument" during electrosurgical procedures. This describes a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description focuses on its function in transmitting electrical power and the materials used, which are consistent with a surgical accessory.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other characteristics typically associated with IVD devices.
Therefore, the DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
MAY 2 2 1997
DeRoyal Industries, Inc.
DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
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: | (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
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 |
1
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.
2
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
3
Page of
510(k) Number (if known):
Device Name:
DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable
11
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)
(Division Sign-Off)
Division of General Restorative Devices [