(90 days)
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No
The description focuses on the electrosurgical pencil's basic function (cutting and coagulation) controlled by buttons and its electrical parameters, with no mention of AI, ML, or data processing for decision-making.
Yes
The device is described as performing surgical functions like cutting and coagulating tissue, which are direct medical interventions to treat a condition.
No
Explanation: The device is described as an electrosurgical pencil used to "CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly outlines a physical, handheld electrosurgical pencil with electrodes, operating at specific voltage, frequency, and power levels to perform cutting and coagulation of tissue. This involves hardware components and the application of electrical energy, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states that this electrosurgical pencil is used to "CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation." This is a direct surgical intervention performed on the patient's body (in vivo).
- Lack of Diagnostic Activity: The device's function is therapeutic (cutting and coagulating tissue), not diagnostic (analyzing samples to determine a medical condition).
Therefore, this device falls under the category of a surgical instrument used for direct treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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)
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.
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