MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2

K982749 · New Deantronics Taiwan , Ltd. · GEI · Sep 14, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982749
• Device Name: MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
• Applicant: New Deantronics Taiwan , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Device Story

Monopolar Foot Control Pencil (Model SB 112-2) is an electrosurgical accessory; operates by delivering high-frequency electrical current to target tissue. Device features foot-activated control mechanism; allows surgeon to initiate tissue cutting or coagulation. Used in clinical/surgical settings by physicians to remove tissue and control bleeding. Output is electrical energy delivered to the surgical site via the pencil tip. Benefits include precise tissue management and hemostasis during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrosurgical pencil; foot-activated control; high-frequency electrical current delivery. Form factor: handheld pencil with integrated foot switch. No software or complex electronics described.

Indications for Use

Indicated for use as an electrosurgical accessory for tissue removal and hemostasis via high-frequency electrical current. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

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

Re: K982749

Trade Name: Monopolar Foot Control Pencil, Model # SB 112-2 Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 6, 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 legally marketed predicate 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 Current Good Manufacturing Practice requirements, 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 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 - 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/dsma/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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## K982749 Initial 510(k)

Device Name: New Deantronics, Inc. Model SB 112-2 Monopolar Foot Control Pencil.

Indications for Use:

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Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

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Concurrence of DCRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982749