(65 days)
The Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.
The Bovie ICON GI (the Generator) operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other electrosurgical accessories, is used to cut and coagulate tissue. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The Generator functions in any of seven user selectable modes: Cut, Blend, Smart Cut, Pinpoint Coagulation, Soft Coagulation, Bipolar Coagulation, Gentle Bipolar Coagulation. The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. The Generator uses technology substantially equivalent to the predicate devices, the Aaron IDS-300 (K022856) and the ERBE USA ERBOTOM ICC 200 (K933157). The generator incorporates an ergonomically designed user interface screen for the selection of device settings.
The provided text describes the Bovie ICON GI Electrosurgical Generator and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It describes the device's operation, compares it to predicate devices, and outlines its intended use.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving their achievement. The provided text does not include any of the following details:
- Table of acceptance criteria and reported device performance
- Sample size for the test set or its provenance
- Number of experts and their qualifications for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
- Standalone algorithm performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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.