(112 days)
This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.
The device is comprised of the following major components: an insulated handle, an active electrode, a length of aspiration tubing, a standard foot-switch RF connector, and a standard return connector. The hand piece is designed to connect to electrosurgical generators that feature a standard foot switch controlled monopolar connector and a standard return connector.
A stainless steel electrode tip is surrounded by a ceramic thermal insulator. The product is available in a shaft diameters of 3.3mm and is available in aspirating and non-aspirating versions. The aspirating versions use suction to remove saline irrigant during the surgical procedure for the dissipation of heat and improved vision.
The device is available in electrode face angles of 50 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedgeshaped tapered tip allows access to difficult to reach locations. The working length is 160mm. The cable from the handle is 126" +/- 6" in length.
The device operates in bipolar mode. The return electrode is located on the device and does not require the use of an external grounding pad or return electrode. The device has a simple user interface that uses a footswitch to activate the device.
The primary difference between the Bovie Disposable Bipolar Ablator and the predicate device is that the Bovie Disposable Bipolar Ablator does not require the use of a dedicated electrosurgical generator but is compatible with standard electrosurgical generators.
The Bovie Disposable Bipolar Ablator has the same intended use and energy type as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.
The Bovie Disposable Bipolar Ablator is designed for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The provided document focuses on demonstrating the substantial equivalence of the Bovie Disposable Bipolar Ablator to legally marketed predicate devices rather than providing a detailed study that proves a specific quantitative acceptance criterion. The performance testing outlined primarily verifies compliance with various safety and performance standards for electrosurgical equipment.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnosis device. Instead, the acceptance criteria are implicitly that the device meets applicable standards and requirements for safety, electrical performance, biocompatibility, and functional integrity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Safety | Met: "Mechanical verification testing was conducted for the proposed device to ensure compliance with mechanical requirements of IEC-60601-1, Edition 3.1, IEC 60601-2-2: 2009, and Bovie self-enforced requirements." (Page 4-5) |
| Specific tests: Visual Inspection & Electrical Continuity, Mold Stress Relief, Cable Strain Relief, Cable Impulse, Cable Flexure/Tension, Drop Testing, Rigidity Testing of Handle and Shaft. | |
| Electrical Safety | Met: "Electrical verification testing was conducted for the relevant components of the proposed device to ensure compliance with current electrical standard requirements." (Page 5) |
| Specific tests: Visual Inspection & Electrical Continuity, Front Panel Connection Verification, Connector Insertion/Extraction Force. | |
| Electromagnetic Compatibility (EMC) | Met: "The results demonstrated compliance of the proposed device to current IEC 60601-1-2 standard requirements." (Page 5) |
| Biocompatibility | Met: "Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility." (Page 5) |
| Thermal Performance (Aspirating Model) | Met: "Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario." (Page 5) |
| Thermal Performance (Non-Aspirating Model) | Met: "Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario." (Page 5) |
| "Testing was conducted to: Assess the fluid temperature near the active electrode during activation of an ablator. The electrosurgical generator is to be set at the maximum allowable power for ablator model in order to simulate the worst case scenario." (Page 6) | |
| Aspiration Flow Rate | Met: "Testing was conducted to: Verify aspiration flow rate under specific vacuum conditions." (Page 6) |
| Thermal Performance & Clogging (Overall Ablator Function) | Met: "Testing was conducted to: Verify the performance of the Bovie Disposable Bipolar RF Arthroscopic Ablator in terms of 1) thermal performance (the temperature of irrigation fluid near the active electrode during activation of a device); 2) tissue removal, 3) clogging, and 4) ignition delay." (Page 6) |
| Compatibility with Standard Electrosurgical Generators | Met: "Testing was conducted to: Verify that the ablator is able to function as intended when connected to a compatible electrosurgical generators." (Page 5) |
| General Workmanship | Met: "Testing was conducted to: Meet general workmanship requirement. Pass electrical continuity test." (Page 5) |
2. Sample Size for Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for an AI algorithm. The performance testing described involves bench-top validation testing of the device's physical and electrical properties, as well as its functional performance. The "sample size" would refer to the number of devices or components tested. This is not explicitly stated but is implicitly sufficient to demonstrate compliance with the referenced standards.
- Sample Size: Not explicitly stated for each test, but typically several units/components would be tested for each verification.
- Data Provenance: The tests are described as bench-top validation testing performed by the manufacturer (Bovie Medical Corporation), indicating they are internal, prospective tests on manufactured devices/components. No country of origin for specific "data" is mentioned beyond the manufacturing location of the company (Clearwater, Florida, USA).
3. Number of Experts and Qualifications for Ground Truth
This question is not applicable in the context of the provided document. The device is a surgical instrument, not an AI diagnostic tool that requires expert-established ground truth from images or data. The "ground truth" for this device's performance is compliance with established engineering, electrical, and safety standards (e.g., IEC, ISO, FDA guidelines for biocompatibility) and its ability to perform its intended function in a simulated environment. The "experts" involved would be engineers, quality assurance personnel, and regulatory affairs specialists within Bovie Medical, along with the independent testing labs that certify compliance to the standards. Their qualifications are inherent in their professional roles and certifications to conduct such tests.
4. Adjudication Method
Not applicable. This is not a study assessing diagnostic performance where adjudication of disagreement among experts would be necessary. The tests are objective measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study of an AI-assisted diagnostic tool or an imaging device to compare human reader performance with and without AI assistance. The study described focuses on the standalone performance and safety of a electrosurgical ablator.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical electrosurgical tool, not an algorithm. Its "standalone performance" is what is described in the bench-top testing, demonstrating its functional capabilities without human in-the-loop diagnostic interpretation. The device's "standalone" performance means it performs its intended function (cutting, vaporization, coagulation) when activated.
7. Type of Ground Truth Used
The "ground truth" for the performance testing is based on:
- International Standards: Compliance with specific standards such as IEC-60601-1, IEC 60601-1-2, IEC-60601-2-2, ISO 10993-1, ISO 11135-1, and ISO 10993-7. These standards define acceptable limits and methodologies for testing.
- Bovie Self-Enforced Requirements: Internal specifications set by the manufacturer.
- Functional Verification: Demonstrating the device performs its intended functions (e.g., aspiration flow rate, tissue removal, temperature during use) under specified conditions.
Essentially, the "ground truth" is defined by established engineering and medical device safety requirements.
8. Sample Size for Training Set
Not applicable. The device is not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.