(69 days)
The Bovic ICON GP Generator is used to deliver high frequency radiofrequency encrey in conjunction with other surgical devices for electrosurgical cutting, coagulation, or vessel sealing.
The Bovic ICON GP (the Generator) operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other clectrosurgical accessories, is used to cut, coagulate, and seal tissues or vessels. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical offect (i.e. cut, coagulation, seal). The shape and duration of waveforms are comparable between the generator and predicate devices.
The Generator functions in any of sixteen user selectable modes:
- Pure Cut 2. Blend Mode 1
- Blend Mode 2 4. Blend Mode 3
Special Cut 5. 6. Laparoscopic Cut - Pinpoint Coagulation 8. Gentle Coagulation
- Spray Coagulation 10. Laparoscopic Coagulation
- Macro Bipolar 12. Micro Bipolar
- Gentle Bipolar 14. Auto Stop Bipolar
- Vessel Seal 16. Vessel Seal and Cut
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 generator incorporates an ergonomically designed user interface screen for the selection of device settings. Although different from the user interface of the predicate devices, the difference does not affect the safety and effectiveness and may provide improved visualization of the device settings.
There are no new hazards presented with the use of the Bovie ICON GP generator as compared with the named predicate device.
This document, K082109, is a 510(k) summary for the Bovie ICON GP General Purpose Electrosurgical Generator. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical or diagnostic device submission would.
Electrosurgical generators like the Bovie ICON GP are regulated differently from diagnostic or AI-driven devices. Their "performance" is generally assessed against established electrical safety and functional standards, and their substantial equivalence to predicate devices is based on similar technological characteristics and intended use.
Therefore, the requested information about acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone studies, and training set details is not present in this 510(k) summary.
The summary focuses on:
- Device Description: What the device is and how it works (delivers high-frequency radiofrequency energy for cutting, coagulation, and sealing tissues).
- Modes of Operation: Lists 16 user-selectable modes (Pure Cut, Blend, Coagulation, Bipolar, Vessel Seal, etc.).
- Comparison to Predicate Devices: States that the device uses technology "substantially equivalent" to predicate devices (Bovie IDS-300, Bovie ICON GI, Valleylab LigaSure).
- Safety Standards: Mentions compliance with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility.
- Intended Use: For electrosurgical cutting, coagulation, or vessel sealing.
For electrosurgical devices, "proving" they meet acceptance criteria typically involves:
- Bench Testing: Verifying output power accuracy, waveform characteristics, safety features (e.g., patient return electrode monitoring), and compliance with electrical safety standards (e.g., IEC 60601 series).
- Biocompatibility Testing: If applicable, demonstrating that materials in contact with tissues are biocompatible.
- Sterilization Validation: If provided sterile.
- User Interface Validation: Ensuring the user interface is clear, intuitive, and prevents errors.
The 510(k) process for such devices primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. This is different from the rigorous clinical trial evidence or AI performance metrics required for novel diagnostic or treatment devices.
§ 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.