(264 days)
The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.
The ERBE Hybrid Knife™ is used with the Water Jet Model ERBEJET® 2 and an ERBE ElectroSurgical Unit (ESU), VIO Model. The Water Jet delivers pressurized sterile normal saline through the Hybrid Knife to cut and dissect soft tissue. The ESU supplies High Frequency (HF) energy through a retractable electrode of the Hybrid Knife for the cutting and coaqulation of tissue. The ERBE Hybrid Knife™ consists of tubing to the Water Jet, a cable to the ESU, a handle, probe tubing, and an electrode. Clinicians would assemble the device and attach it respectively to the Water Jet and ESU. For endoscopic procedures, the Hybrid Knife is placed down the channel of an endoscope that has a working channel greater than 2.8 mm. Upon the set up of the Water Jet and ESU, the Hybrid Knife is ready for use. The pedal of the ERBEJET 2 Footswitch activates its water-jet cutting capabilities. To activate cautery, the recessed electrode is extended out its tip (up to 5 mm) and the ESU's Footswitch is depressed. The ERBE Hybrid Knife™ is provided sterile and is single use.
The provided document is a 510(k) summary for the ERBE Hybrid Knife™, a medical device. It describes the device, its intended use, and a comparison to predicate devices, along with the FDA's clearance letter. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information regarding device performance, sample sizes, ground truth establishment, or expert involvement.
The document states:
- "biocompatibility of the specific materials for the Hybrid Knife was demonstrated. See Biocompatibility Study, III-18 to III-27."
- "performance testing demonstrated the functionality of the Hybrid Knife. See Performance Testing, III-28 to III-31."
These references indicate that studies were conducted and reported in a separate part of the 510(k submission (III-18 to III-31), but the details of those studies, including acceptance criteria and results, are not present in the provided text.
Therefore, I cannot provide the requested information from the given input. The document is a summary of the device for regulatory clearance, not a detailed technical report of the studies performed.
§ 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.