(55 days)
The KSEA Monopolar Coagulating and Needle Electrodes are designed to be used by qualified surgeons and physicians to cut, coagulate, and/or fulgurate tissue via high-frequency electrical current wave forms, during endoscopic general and plastic surgical procedures.
The Monopolar Coagulating Electrodes are indicated for use in cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical procedures.
The KSEA Monopolar Coagulating and Needle Electrodes are reusable surgical devices. The body-contact portions of the electrodes are composed of AISI series 420 surgical-grade stainless steel. The shafts are composed of AISI series 303 and 304 surgical-grade stainless steel, and are insulated with polytetrafluoroethylene (PTFE).
The provided document is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. Monopolar Coagulating and Needle Electrodes. This type of regulatory submission is for medical devices that are substantially equivalent to a predicate device and generally does not include detailed clinical study data or acceptance criteria for device performance. It focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise new safety or effectiveness concerns.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment for either test or training sets.
The core of this submission is to establish "substantial equivalence," not to prove specific performance metrics against pre-defined acceptance criteria through a clinical study. The safety and effectiveness are inferred from the predicate device.
What the document does state regarding substantial equivalence:
- Claim: "The KSEA Monopolar Coagulating and Needle Electrodes are substantially equivalent to the predicate devices since the basic designs and intended uses are the same. The minor difference between the K.SEA Monopolar Coagulating and Needle Electrodes and the predicate devices raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function, or intended uses of the devices."
- Basis for Equivalence: The document highlights the similarity in basic designs, intended uses, and material composition of the body-contact portions and shafts (surgical-grade stainless steel) and insulation (PTFE) with the predicate devices.
In summary, none of the requested information regarding acceptance criteria and performance study details is present in the provided 510(k) summary.
§ 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.