(39 days)
Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Monopolar Foot Control Pencil, Model # SB 112-2
The provided text is a Scan of an FDA 510(k) clearance letter for a medical device called the "Monopolar Foot Control Pencil, Model # SB 112-2." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than performance studies with defined acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text.
The document indicates that the device is an "electrosurgical accessory" intended "to remove tissue and control bleeding by use of high-frequency electrical current." The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are deemed comparable without requiring new clinical trials or performance studies to establish de novo acceptance criteria.
Therefore, for each of the requested points, the answer is that the information is not available in the provided document.
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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 (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/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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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
§ 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.