(250 days)
The NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical HS1 SlypSeal Instrument, intended for coagulation (hemostasis and cauterization) of soft tissue.
The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to the compatible Creo Medical RS2 Speedboat Instrument, intended for coagulation (hemostasis and cauterization) and cutting soft tissue.
The Electrosurgical System is not intended for use in cardiac procedures.
The Creo Medical Electrosurgical System with NP1 Instrument includes the following:
- . NP1 Instrument
- . Electrosurgical Generator
- . Footswitch
- . Interface Cable with Sterile Sheaths
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. Only the microwave output is used to power the NP1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting (not active for use of NP1); the other pedal activates the MW enerqy output for coaqulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The single-use Interface Cable provides a conductive pathway between compatible Creo electrosurgical instruments and the output of the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over the cable's distal end during use to minimize the potential for contamination of the sterile field.
The sterile, single-use NP1 soft tissue ablation instrument consists of a handle, 1.6 m long x 2.7 mm diameter flexible shaft, active nitinol antenna and pointed ceramic tip. Bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is activated. NP1 is only compatible for use with the Creo Medical Electrosurgical System, and the System is only intended for use with compatible Creo instruments and accessories.
The provided document does not contain acceptance criteria or a study demonstrating device performance against such criteria in the context of typical AI/ML device evaluations. This document is a 510(k) premarket notification for a medical device (electrosurgical system) and focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and the removal of a specific contraindication for transluminal use.
Therefore, I cannot provide the requested information for an AI/ML context because the document does not discuss an AI/ML device, its performance metrics, or related studies like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.
The "Performance Data" section explicitly states: "No bench or clinical data were required to demonstrate substantial equivalence with the predicate device or to justify the elimination of the contraindication for transluminal use from the NP1 instrument IFU." It does mention a preclinical study in a porcine model to demonstrate transluminal navigation and ablation, but this is not presented as meeting specific, measurable acceptance criteria in the format requested for AI/ML performance.
In summary, the information you requested is not present in the provided document as it pertains to a different type of device clearance rather than an AI/ML device performance evaluation.
§ 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.