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The AB1 Instrument, when used with the Creo Medical 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 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 Creo Medical (Creo) AB1 soft tissue microwave ablation instrument (electrosurgical instrument, accessory or instrument, also referred to as AB1) is designed for use with the Creo electrosurgical system, previously cleared under K200298. No changes have been made to the Creo generator, footswitch, or interface cable with sterile sheaths that comprise the electrosurgical system, nor are any changes proposed to the AB1 instrument in this 510k. AB1 is provided as a sterile, single-use instrument that is 0.95 m long with a 4.3 mm diameter shaft that terminates in a distal antenna that is 38 mm long and less than 2.00 mm in diameter (nominally, 1.9 mm) with a conical tip. The AB1 instrument is provided with a flexible, removable (distal) handle. The outer sheath of the flexible shaft may be removed. This 510k provides instructions to the end user on how to remove the outer extrusion and distal handle to create a configuration that has an outer diameter less than 2.00 mm. The instrument may be used to access target tissue directly, e.q. in open surgical procedures, or, with the handle and outer sheath removed, through a compatible trocar in minimally invasive procedures. The antenna couples microwave energy to target tissue when AB1 is powered by the Creo Electrosurqical System. 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 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 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 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.

The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories. The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: - · Peptic Ulcers - · Dieulafoy Lesions - · Mallory-Weiss Tears - · Bleeding Polyp Stalks - · Arteriovenous Malformations (AVMs) - · Angiomata The HS1 also has irrigation capability. Any other use is not recommended.

The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following: - . HS1 hemostasis surgical accessory - . Electrosurgical Generator - Footswitch - Interface Cable The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut: 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 Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory. HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.