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510(k) Data Aggregation
(448 days)
Voyant Fine Fusion Device (EB230)
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.
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(122 days)
Voyant Fine Fusion Device
The Voyant Fine Fusion is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired.
The device can seal and divide vessels up to and including 3mm 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 coagulation for sterilization procedures, and should not be used for these procedures.
The Applied Medical Voyant Fine Fusion instrument is designed for use with the Voyant ESG (cleared in K141288). This device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 3mm 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, useractuated blade for the division of sealed tissue.
Based on the provided text, the acceptance criteria and study details for the Voyant Fine Fusion device can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2. | Demonstrated compliance. |
| Mechanical Strength | Compliance with IEC 60601-1. | Tested and demonstrated. |
| Durability | Not explicitly defined, but implied through durability testing. | Tested and demonstrated. |
| Destructive Testing | Compliance with IEC 60601-2-2. | Tested and demonstrated. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Tested and demonstrated. |
| Safety Systems | Not explicitly defined, but implied through safety systems testing. | Tested and demonstrated. |
| Seal Evaluation (Bench/Ex Vivo) | To show substantial equivalence to the predicate device for vessels up to 3mm. Specific metrics (e.g., burst pressure threshold) are not detailed but are implied. | Performed a side-by-side comparison against the predicate device to evaluate seal quality. Conclusion: Substantially equivalent seal performance to the predicate device for vessels up to and including 3mm. |
| Thermal Damage (Bench/Ex Vivo) | To show substantial equivalence to the predicate device. Specific metrics (e.g., thermal spread limits) are not detailed but are implied. | Performed a side-by-side comparison against the predicate device to evaluate thermal damage. Conclusion: Substantially equivalent local tissue effects to the predicate device. |
| Burst Pressures (Bench/Ex Vivo) | To show substantial equivalence to the predicate device. Specific thresholds are not detailed. | Tested comparing the subject device to the predicate device. Conclusion: Substantially equivalent vessel sealing performance (implied by burst pressure testing) to the predicate device. |
| Seal Evaluation (Acute Animal Study) | To show substantial equivalence to the predicate device. | Performed a side-by-side comparison against the predicate device in an in vivo canine model to evaluate seal quality. Conclusion: Substantially equivalent seal performance to the predicate device. |
| Thermal Damage (Acute Animal Study) | To show substantial equivalence to the predicate device. | Performed a side-by-side comparison against the predicate device in an in vivo canine model to evaluate thermal damage. Conclusion: Substantially equivalent local tissue effects to the predicate device. |
| Seal Quality & Chronic Hemostasis (Chronic Animal Study) | To demonstrate efficacy and absence of hematomas over time. | Conducted a chronic study in an in vivo canine model to evaluate seal quality and chronic hemostasis, with no signs of hematomas. |
| Biocompatibility | Compliance with ISO 10993, FDA Blue Book Memorandum #G95-1, and 2013 FDA Draft Guidance. | Device passed all biocompatibility testing according to acceptance criteria in respective standards. |
| Sterilization | Validated to an SAL (Sterility Assurance Level) of 10⁻⁶ in accordance with ISO 11137-2 and AAMI TIR 33. | The Fine Fusion Device is validated to an SAL of 10⁻⁶. |
| Shelf Life | Maintenance of sterility and protection from damage throughout shelf life (via ship testing, environmental conditioning). | Testing conducted on aged and conditioned units met all acceptance criteria, ensuring sterility and protection from damage. |
2. Sample Sizes Used for the Test Set and the Data Provenance
- Test Set Sample Sizes:
- Bench (Ex Vivo): "ex vivo porcine vessels/tissue" - specific number of vessels/tissue samples not provided.
- Acute Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
- Chronic Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
- Data Provenance:
- The bench testing used "porcine vessels/tissue," indicating animal tissue.
- The animal studies (acute and chronic) used an "in vivo canine model," indicating animal data.
- The studies appear to be prospective as they were specifically performed to evaluate the new device and compare it against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the performance testing. The "ground truth" for these tests seems to be defined by the direct measurements and observations from the experimental procedures (e.g., burst pressure, thermal spread, visual assessment of seals and hematomas).
4. Adjudication Method for the Test Set
The document does not describe any expert adjudication methods (e.g., 2+1, 3+1). The evaluation criteria suggest direct measurement and comparison rather than subjective human assessment requiring adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so such a study would not be applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not an algorithm. Its performance is evaluated by its physical characteristics and its effect on tissue, not by an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing was primarily based on:
- Direct physical measurements: Such as mechanical strength, electrical safety parameters, burst pressures.
- Histological/Pathological observations: For thermal damage, seal quality, and absence of hematomas in animal tissue.
- Biological responses: Observed in chronic animal studies for hemostasis.
8. The Sample Size for the Training Set
There is no mention of a training set. This device is not an AI/ML-based device; therefore, the concept of a "training set" for an algorithm does not apply.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an algorithm, this question is not applicable.
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