(300 days)
The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.
The System is not intended for use in cardiac procedures.
The NP1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The NP1 Instrument is not intended for use in cardiac procedures.
The Creo Medical Electrosurgical System with NP1 Accessory 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; the other pedal activates the MW energy output for coagulation. 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 connects compatible Creo electrosurgical instruments to the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over its distal end during use to minimize the potential for contamination of the sterile field.
The sterile, single-use NP1 soft tissue ablation accessory (Instrument) consists of a handle, 1.4 m long x 2.7 mm diameter shaft, active nitinol antenna and pointed ceramic tip. Stainless-steel bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is in use. 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.
I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the Creo Medical Electrosurgical System with NP1 Accessory does not contain the specific information required to answer your request.
The document is a notification of substantial equivalence for a medical device, and while it mentions performance testing, it does not include:
- A table of acceptance criteria and reported device performance related to a specific study. It broadly states, "The system meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements." and references "Results of mechanical and ablation performance tests, including bench tests and simulated use studies conducted in ex-vivo tissue, demonstrate that the NP1 Electrosurgical System meets design specifications and performs as intended." but no specifics.
- Sample sizes used for a test set or data provenance for specific performance studies. It mentions "simulated use studies conducted in ex-vivo muscle, liver, and kidney tissue" but does not give sample sizes or specific data provenance beyond being ex-vivo tissue.
- Number of experts used or their qualifications for establishing ground truth. This information is entirely absent for any performance claims.
- Adjudication method for a test set. Not mentioned.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size. This type of study is not described or referenced.
- Details about a standalone (algorithm only) performance study. The device is an electrosurgical system, not an AI algorithm, so this concept does not apply in the typical sense of AI/ML software. Its performance is tied to its physical operation and effect on tissue.
- The type of ground truth used (e.g., pathology, outcomes data). For the ablation studies, it implies the "ablation volumes created" as a measure of performance, but it doesn't describe who established this ground truth or how precisely it was measured in terms of a clinical "ground truth."
- The sample size for a training set. As this is a hardware device with embedded software for control, not a machine learning model, the concept of a "training set" for an AI algorithm is not applicable here. The software verification and validation are mentioned but not in the context of a machine learning training set.
- How the ground truth for the training set was established. Not applicable for the reasons above.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics.
- Compliance with electrical safety, EMC, and biocompatibility standards.
- Software verification and validation (for control software, not AI/ML).
- Bench testing and simulated use testing to show the system meets design specifications and performs as intended.
Therefore, I cannot extract the requested information from the provided text.
§ 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.