BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224

K982748 · New Deantronics Taiwan , Ltd. · GEI · Nov 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982748
• Device Name: BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
• Applicant: New Deantronics Taiwan , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.

Device Story

Model SB 223 and SB 224 BiPolar Cord Sets function as electrosurgical accessories; they conduct high-frequency electrical current from a generator to foot-switching electrosurgical instruments. Used in clinical settings by physicians to facilitate tissue removal and control bleeding during surgery. The device acts as a passive conduit for electrical energy; it does not contain active electronic components or software. Benefit to patient includes effective hemostasis and precise tissue management during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive electrosurgical accessory; cord set designed to conduct high-frequency electrical current. No active electronic components, software, or sensors. Sterilization and material specifications not detailed in provided text.

Indications for Use

Indicated for use as an electrosurgical accessory to conduct high-frequency electrical current for tissue removal and hemostasis in patients undergoing electrosurgical procedures. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

New Deantronics Taiwan, Ltd. Mr. Lewis Ward c/o L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K982748 Model SB 223 BiPolar Cord Set (1.88TR) Trade Name: Model SB 224 BiPolar Cord Set (1.88TR) Regulatory Class: II Product Code: GEI July 31, 1998 Dated: Received: August 06, 1998

Dear Mr. Ward:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Mr. Lewis Ward

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,

Cella M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K 98 274 8 Initial 510(k)

Device Name: New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.

Indications for Use:

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Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.

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Concurrence of DCRH, Office of Device Evaluation (ODE)

Prescription Use **X** OR Over-the-Counter Use **__**
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number **__**R982748