(59 days)
The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic sucrival procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces
The Bovie Ultimate™ High Frequency Electrosurgical Generator (BVX-100H) is a multipurpose electrosurgical device used for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces. The generator combines the features of two cleared electrosurgical generators. The device is intended to be used in the Hospital Operating Room environment.
It features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, and three (3) bipolar modes. 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 offers one (1) monopolar handpiece output, one (1) monopolar foot controlled output, one (1) bipolar handpiece output, one (1) bipolar foot controlled output, and one J Plasma (helium) gas outlet. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The padsensing feature allows the user to use either a split or solid return electrode. This feature is not required when using Helium gas mode for soft tissue coagulation. The Bovie Ultimate™ High Frequency Electrosurgical Generator contains a single software component that is solely used to support the user interface.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.
The device consists of the generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, gas flow (rate) selection buttons, pulsing, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories. The back panel consists of Helium gas access ports, footswitch ports, volume controls, a power cord outlet, and a fuse. Internal components include printed circuit boards, speakers, and cabling.
This document describes the Bovie Ultimate™ High Frequency Electrosurgical Generator (BVX-100H). The information provided pertains to its regulatory clearance via a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices.
This document does not contain details of a clinical study with acceptance criteria and reported device performance in the context of diagnostic accuracy, which is typically found in submissions for AI/ML-based medical devices or devices performing an interpretive function.
Instead, the provided text describes a safety and performance validation study (bench testing) for an electrosurgical generator, focusing on compliance with recognized electrical safety and performance standards.
Therefore, many of the requested points regarding acceptance criteria directly related to diagnostic performance metrics, sample sizes for test/training sets, expert involvement, and ground truth types are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here refer to compliance with electrical safety and performance standards, not diagnostic performance metrics.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance | Bench testing was performed to demonstrate that the generator met design specifications and established substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance. |
| IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests | Bench testing was performed to demonstrate that the generator met design specifications and established substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance. |
| IEC 60601-2-2: 2007 Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Bench testing was performed to demonstrate that the generator met design specifications and established substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance. |
| European Restriction of Hazardous Substances Directive (2011/65/EU) | The device is designed to meet the requirements of this directive. |
| Device Design Specifications (e.g., electrical waveforms, power output, safety features like NEM) | Bench testing was performed to demonstrate that the generator met design specifications. The electrical properties and duration of waveforms are comparable to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical device itself and its components undergoing bench testing, not a dataset of medical images or patient information.
- Data Provenance: Not applicable in the traditional sense of clinical data. The "data" comes from measurements and observations during bench testing of the electrosurgical generator and its functions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for an electrosurgical generator's electrical performance would be established by reference standards, calibrated equipment, and engineering specifications, not typically by medical experts in a diagnostic capacity.
4. Adjudication method for the test set
- Not applicable. This device underwent bench testing against engineering specifications and international standards, not an adjudication process involving human reviewers of data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an electrosurgical generator, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant for this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware electrosurgical generator, not a standalone algorithm. The "software component" mentioned is solely for the user interface, not for standalone diagnostic or interpretive performance.
7. The type of ground truth used
- Ground Truth Type: Engineering specifications, international electrical safety standards (IEC 60601 series), and established principles of electrosurgery for cut and coagulation effects. Comparability to predicate devices in terms of electrical properties and clinical effects served as a proxy for validating performance.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.