(90 days)
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.
By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.
By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.
The provided document is a 510(k) premarket notification letter from the FDA for an electrosurgical pencil. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. This document is a regulatory approval letter, not a study report or technical specification.
Therefore, I cannot provide the requested information from the given text.
To address your request, I would need a different type of document, such as:
- A clinical study report
- A validation study protocol or report
- A performance specification document
- A 510(k) summary (which might contain a brief summary of performance data, though often not in the detail you're asking for).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 8 2010
Wickimed (HuiZhou) Medical Equipment Manufacturing Co., Ltd. % Mr. Kipson Fung Room 25, 11th Floor 19 Shing Yip Street Kwun Tong, Kowloon Hong Kong, People's Republic of China
Re: K100258
Trade/Device Name: Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 28, 2009 Received: January 28, 2010
Dear Mr. Fung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Kipson Fung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Electrosurgical pencil Device Name:
Indications For Use:
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.
By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.
Concurrence of CDRH, Office of Device Evalu
(Division Sign-Off)
Division of Surgical, Orthopedic
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100258
Prescription Use · X OR (Per 21 CFR 801.109)
Over-The-Counter-Use
§ 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.