(271 days)
The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.
RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and electrode tip, the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.
- Electrosurgical Unit Main body
- Five different handpieces
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (SILKRO), primarily focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to various safety and performance standards. It mentions non-clinical ex vivo animal testing for histological data but does not present this data as acceptance criteria or a study proving device performance against such criteria. The document explicitly states, "No clinical test was performed."
Therefore, I cannot extract the requested information.
§ 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.