(334 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 AB1 Instrument, when used with the Creo Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The AB1 Instrument is not intended for use in cardiac procedures.
The Creo Medical (Creo) Electrosurgical System with AB1 Accessory includes the following:
- . AB1 Instrument
- . Electrosurqical 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 (ablating) tissue. Only the microwave output is used to power the AB1 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 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 AB1 soft tissue ablation accessory (Instrument) consists of a flexible, movable handle and a 0.95 m long x 4.3 mm diameter shaft that terminates in a 38 mm long x 1.9 mm diameter distal antenna with conical tip. Two metallic washers separated by dielectric materials couple microwave energy to target tissue when AB1 is only compatible for use with the Creo Electrosurgical System, and the Creo Electrosurgical System is only intended for use with compatible Creo instruments and accessories.
The provided text describes the Creo Electrosurgical System with AB1 Accessory, which is intended for soft tissue coagulation (ablation) using microwave energy. The 510(k) summary (K200298) primarily focuses on demonstrating substantial equivalence to a predicate device (K163105 Emprint Ablation System) through various performance data, rather than outlining specific clinical acceptance criteria for diagnostic performance.
Therefore, the requested information categories related to diagnostic performance (e.g., effect size of human readers with AI, standalone performance, MRMC study, expert qualifications for ground truth) are not applicable to this submission, as it is for an electrosurgical device and not an AI/diagnostic software.
However, the document does contain information about performance testing and acceptance criteria related to its operational safety and effectiveness as a medical device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (as implied by testing) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Assurance Level: Maintain required sterility for single-use instruments. (Implied: SAL of 10^-6) | The AB1 Sterility Assurance Level is 10^-6, per ISO 11135 and AAMI TIR28 standard evaluation. |
| Shelf-life: Maintain device integrity and functionality over time. | The shelf-life for the AB1 Instrument is 6 months. The shelf life for the Interface Sheath is 3 years. |
| Biocompatibility: Acceptable biological risk for patient-contacting materials. (Implied compliance with ISO 10993-1 and FDA guidance) | Biocompatibility evaluation conducted in accordance with ISO 10993-1:2009 and FDA guidance. The antenna assembly of AB1 and distal portion of its shaft are categorized as externally communicating with limited ( |
§ 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.