(265 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 ligation 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 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 7mm in diameter and in head and neck procedures. 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.
This document is a 510(k) premarket notification for the Voyant Fine Fusion electrosurgical device. It details the device’s indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.
Here’s a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in a quantitative format for clinical effectiveness. Instead, it describes various tests and states whether the device "passed" or demonstrated "substantial equivalence" to a predicate device.
However, based on the Discussion of Performance Testing section, we can infer some criteria and outcomes:
| Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intracutaneous Reactivity, Sensitization), ASTM F2148 (Sensitization) | "The device passed all biocompatibility testing according to the acceptance criteria contained in the respective standards." |
| Sterilization | Compliance with ISO 11137-2 and AAMI TIR 33 | "Validation of the sterilization process for this device was performed according the recognized consensus standards ISO 11137-2 and AAMI TIR 33." The packaging, sterilization method, and shelf life are "identical to that of the previously cleared Voyant Fine Fusion device (K143536)." |
| EMC | Compliance with applicable sections of IEC 60601-1-2 and IEC 60601-2-2 | "There have been no changes to the subject device that impact its electromagnetic compatibility (EMC) as presented in K143536. The device was designed and previously tested according to the applicable sections of IEC 60601-1-2 and IEC 60601-2-2." |
| Electrical Safety | Compliance with applicable sections of IEC 60601-1 and IEC 60601-2-2 | "An electrical safety evaluation... was been conducted according to the applicable sections of IEC 60601-1 and IEC 60601-2-2 and presented in K143536." "Relevant tests from these standards were repeated to confirm the safety of the updated button design." (Implies compliance was confirmed). |
| Preclinical Bench | Performance substantially equivalent to the LigaSure predicate for vessels up to 7mm and head and neck procedures, including seal evaluation and burst pressures. | "Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo ovine model) studies were performed to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device for the expanded indications including vessels up to 7mm in diameter and head and neck procedures." Specific results included "Seal evaluation" and "Burst pressures of arteries and veins." |
| Preclinical Animal | Performance substantially equivalent to the LigaSure predicate for vessels up to 7mm and head and neck procedures, including seal evaluation, thermal damage, and thermal spread metrics; chronic hemostasis and no hematomas. | "Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo ovine model) studies were performed to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device for the expanded indications including vessels up to 7mm in diameter and head and neck procedures." "Acute animal studies (in vivo) [evaluated] Seal evaluation and Thermal damage and thermal spread (Minimum, maximum, median, mode)." "In addition, chronic studies (in vivo ovine and canine model) were conducted using the subject device to evaluate long term seal quality and resulted in chronic hemostasis and no signs of hematomas." |
Key takeaway: The primary "acceptance criteria" for this 510(k) submission is showing substantial equivalence to existing, legally marketed predicate devices, particularly the LigaSure Curved, Small Jaw, Open Sealer/Divider (K113572) and the previous Voyant Fine Fusion (K143536). Performance is demonstrated by comparing the subject device against these predicates in a laboratory and animal setting.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Bench (ex vivo): "porcine vessels/tissue" were used, but a specific number is not provided.
- Acute Animal (in vivo): "ovine model" was used, but a specific number of animals or vessels is not provided.
- Chronic Animal (in vivo): "ovine and canine model" were used, but a specific number of animals is not provided.
- Data Provenance: The studies were preclinical (ex vivo and in vivo animal models). They are performed in a laboratory setting, not from human patients. The specific country of origin for the data is not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is typically not applicable to preclinical bench or animal studies where objective measurements (e.g., burst pressure, thermal spread measurements, histological examination by veterinary pathologists) establish "truth" rather than expert consensus on imaging or clinical findings. The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable. This is not a human clinical trial involving subjective assessments that would require adjudication. Preclinical studies rely on objective measurements and established scientific methodologies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical instrument, not an AI or imaging algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance is intrinsically linked to its operation by a human surgeon.
7. The Type of Ground Truth Used
- For Biocompatibility, Sterilization, EMC, Electrical Safety: Ground truth is established by adherence to recognized consensus standards (e.g., ISO 10993 series, ISO 11137-2, AAMI TIR 33, IEC 60601 series).
- For Preclinical Bench (ex vivo): Ground truth is established through objective measurements such as seal evaluation methods and quantitative burst pressure measurements of vessels.
- For Preclinical Animal (in vivo): Ground truth is established through objective measurements and observations including seal evaluation, thermal damage and spread metrics (minimum, maximum, median, mode), and histological assessment for chronic hemostasis and lack of hematomas. Comparison against the predicate device's performance also serves as a benchmark.
8. The Sample Size for the Training Set
Not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not a machine learning model. Therefore, there is no "training set" in the AI/ML sense. "Training" would refer to the engineering design and iteration process, not data-driven model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI/ML model for this device. Ground truth in the context of product development for this type of device would relate to engineering specifications, material properties, and functional requirements, all established through standard engineering and scientific principles.
§ 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.