(448 days)
The Voyant Fine Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures, including head and neck procedures, where the ligation and division of vessels and tissue bundles is desired.
The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.
The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Voyant Fine Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.
Here's a breakdown of the acceptance criteria and study information for the Voyant Fine Fusion Device (EB230), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| EMC, Electrical Safety, and Mechanical | In accordance with relevant IEC 60601 series standards; continued performance over multiple device activations. | Met all acceptance criteria. Simulated repeated-use testing on predicate sufficient. |
| System Testing (Burst Pressure) | Met predetermined acceptance criteria. | Subject device met predetermined acceptance criteria and substantially equivalent to predicate. |
| System Testing (Thermal Spread) | Met predetermined acceptance criteria. | Subject device met predetermined acceptance criteria and substantially equivalent to predicate. |
| Animal Testing (Acute) | Demonstrated safety and efficacy for thermal damage and cellular viability. | Confirmed substantially equivalent performance to the predicate device. |
| Animal Testing (Chronic Stability) | Demonstrated long-term seal quality, device performance, and no adverse effects on adjacent structures. | Met predetermined acceptance criteria. Confirmed substantially equivalent performance to the predicate device. |
| Software Verification | Evaluated design, implementation, and performance of device software script. | All levels of software testing conducted (unit, integration, system). |
| Biocompatibility | Met all acceptance criteria per ISO 10993-1, 10993-5, 10993-10, 10993-11. | Met all acceptance criteria for Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- System Testing (Burst Pressure): Not explicitly stated, but "vessels representative of the devices' indications" were used.
- System Testing (Thermal Spread): Not explicitly stated.
- Acute Animal Study: "Large porcine animal models" were used. The number of animals is not specified.
- Chronic Survival Study: "Large porcine animal models" were used. The number of animals is not specified.
- Data Provenance: The animal studies were conducted using porcine models, indicating prospective animal study data. The location of these studies is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Acute Animal Study: "Functional staining techniques" were used, and "Samples were sent to a qualified histopathology laboratory for evaluation." The number and specific qualifications of the histopathologists are not provided.
- Chronic Survival Study: "Vessels representative of the devices' indications were sealed and evaluated by a qualified histopathologist for hemostasis and signs of hematoma." The number and specific qualifications of the histopathologists are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for conflicting expert opinions. The evaluations were performed by "qualified histopathologists," implying a certain level of expertise, but no mention of multiple reviewers or a consensus process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The studies focus on device performance characteristics rather than human reader improvement with AI assistance. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the Voyant Fine Fusion device is an electrosurgical instrument for direct surgical use, not an AI algorithm. The software mentioned is for the device's internal control, not for diagnostic or analytical tasks that would typically involve standalone algorithm performance evaluation in the context of AI.
7. Type of Ground Truth Used
- System Testing (Burst Pressure & Thermal Spread): Objective measurements (burst pressure values, thermal spread measurements) of physical properties served as the ground truth.
- Animal Studies (Acute & Chronic): Histopathological evaluation of tissue (cellular viability, hemostasis, signs of hematoma) by qualified histopathologists served as the ground truth for biological effects.
8. Sample Size for the Training Set
No training set is mentioned in the context of this device. The software verification refers to the internal software script of the device, not an AI model that undergoes training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI model is mentioned for this electrosurgical 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.