(84 days)
Bovie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.
Bovie Resistick II Electrosurgical Electrodes ("electrodes") consist of coated blade, needle, and ball configured electrodes, sold sterile and bulk non-sterile, and are designed for single-use. These electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and coagulate soft tissues during open surgical procedures. The intended use of these electrodes is the same as that of previously cleared Resistick II electrodes. The coating is designed to reduce friction and to minimize the buildup of burned tissue. Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety.
Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories.
Bovie Resistick II Electrosurgical Electrodes include three tip configurations; blade, needle, and ball. Within each configuration there are models that differ by length of the electrode shaft and whether the tips are partially exposed ("modified"). Eleven electrode configurations are the same shape and size as predicate devices cleared in premarket notification number K974735. There are an additional nine electrode configurations, each comprised of the same materials and having the same intended use. All electrodes are also to be available for sale as non-sterile components for subsequent placement into kits and trays.
This 510(k) summary (K093025) describes Bovie Medical's Resistick™ II Coated Electrosurgical Electrodes. The submission outlines the device's intended use for cutting and coagulating soft tissues during open surgical procedures, its components, and its operation. It also clarifies that the device includes various tip configurations and is made of the same materials as the predicate device (Resistick™ II Electrosurgical Electrode, K974735), with the key difference being a new coating designed to reduce friction and tissue buildup. The FDA's letter of December 22, 2009, indicates that the device has been found substantially equivalent to the predicate device.
Based on the provided information, the following can be extracted:
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific quantitative acceptance criteria for performance metrics such as coating effectiveness, tissue adhesion reduction, or electrical safety in a tabular format. The general acceptance appears to be based on demonstrating substantial equivalence to the predicate device, Resistick™ II Electrosurgical Electrode (K974735), and meeting general safety requirements through biocompatibility analyses and electrical safety testing.
The "reported device performance" is primarily qualitative, focusing on the claims that the new coating is "designed to reduce friction and to minimize the buildup of burned tissue." The submission states, "Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety." And, "an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories."
Given the provided text, a table of acceptance criteria and reported device performance cannot be generated with specific quantitative metrics.
2. Sample Size and Data Provenance
The document does not provide information on sample sizes for any specific tests or studies. It also does not specify the country of origin of data or whether it was retrospective or prospective.
3. Number and Qualifications of Experts
The document does not mention the use of experts to establish ground truth or for any other aspect related to the performance evaluation in this 510(k) summary.
4. Adjudication Method
The document does not specify any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the provided text. The device is an electrosurgical electrode, and such studies are typically not relevant for this type of medical device.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the device is an electrosurgical electrode, not an algorithm or AI-driven system. Therefore, no standalone algorithm performance study would have been conducted.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/image analysis studies is not relevant to this device submission. The evaluation of this device focuses on demonstrating substantial equivalence to a predicate device and meeting safety and performance standards relevant to electrosurgical electrodes (e.g., biocompatibility, electrical safety, coating effectiveness).
8. Sample Size for Training Set
This is not applicable as the device is an electrosurgical electrode, not an AI/machine learning system that requires a training set.
9. How Ground Truth for Training Set was Established
This is not applicable for the same reasons mentioned above.
§ 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.