(176 days)
The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.
The Bovie® J-Plasma Handpiece with Retractable Cutting Tip are single use devices designed to be compatible only with the ICON GS generator (GS100) and reusable cable (GS-807-RC) cleared under 510k K-090586. There are device models for both open and laparoscopic surgical procedures (GS-018C and GS-270C respectively). These handpieces contain a programmable memory device that requires a unique code for the generator to operate. Each handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the distal end of the device where gas molecules are excited by the high electric field resulting in a plasma stream. The handpiece that is intended for open procedures does not have an extended shaft. The handpiece intended for laparoscopic procedures has a 27 cm extended tip. Both handpieces contain a retractable cutting blade that can be extended manually for excising tissue.
This FDA 510(k) summary describes a device that is an electrosurgical tool, and therefore, the acceptance criteria and study information typically associated with AI/ML-driven diagnostics or imaging devices are not provided in this document. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of design, materials, and performance characteristics for electrosurgical functionality.
Here's a breakdown of the information that can be extracted from the document, and what cannot be found due to the nature of the device:
Device: Bovie® J-Plasma Handpiece with Retractable Cutting Blade
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI/ML diagnostic tools. Instead, it focuses on demonstrating equivalence to a predicate device through shared characteristics and compliance with electrical safety standards.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Equivalent or broader than predicate device. | "The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures. ... utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures." (Covers both plasma coagulation and blade cutting, for both open and laparoscopic procedures, expanding on the predicate's "coagulation of soft tissues during open soft tissue surgery.") |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2. | "Both named devices and the predicate are designed to comply with the following electrical standards: IEC 60601-1: ... General Requirements for Safety (2005) IEC 60601-2-2: ... Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories (2009)" |
| Output Energy (Coagulation) | Equivalent to predicate device. | "40 Watts (100% Setting on ICON GS Generator)" (Same as predicate) |
| Delivery System | Equivalent to predicate device. | "Monopolar" (Same as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. This information is relevant for studies involving data-driven algorithms (like AI/ML models). This document pertains to an electrosurgical hardware device, and thus, this type of data is not generated or tested in the same manner. The "testing" for this device would involve engineering verification and validation, performance testing (e.g., power output, safety features), and biocompatibility, not data set evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. As this is not an AI/ML diagnostic or imaging device, there is no "ground truth" in the sense of expert consensus on medical image interpretation. The ground truth for this device would relate to its physical performance and safety (e.g., does it cut tissue as intended, does it coagulate effectively, does it meet electrical safety standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods are used to resolve disagreements among human annotators or diagnosticians creating a ground truth for AI model training or evaluation. This is not relevant for an electrosurgical device.
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. An MRMC study is specific to diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. This device is a surgical tool, not an imaging or diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This device is a manual surgical tool; it does not operate as an "algorithm only" or in a "standalone" fashion without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not Applicable. As mentioned above, there isn't a "ground truth" of this nature for an electrosurgical device. The "truth" is established through engineering and performance testing against predefined specifications and safety standards (e.g., power meter readings, tissue ablation tests, sterility testing).
8. The sample size for the training set:
Not Applicable. This device does not use a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established:
Not Applicable. This device does not have a "training set" or "ground truth" to be established in the context of AI/ML.
§ 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.