(105 days)
The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation of vessels and tissue bundles is desired.
The device can seal and divide vessels up to and including 5mm 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 Open Sealer/Divider 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 5mm 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.
This document is a 510(k) premarket notification for the Voyant Open Sealer/Divider Device. It does not contain information about acceptance criteria and device performance in the format requested. The document describes the device, its intended use, and summaries of performance testing conducted to demonstrate substantial equivalence to a predicate device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information on a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data) in a quantifiable manner for specific performance metrics.
- Sample size for a training set or how ground truth for a training set was established.
Instead, the document focuses on:
- Device Description and Intended Use: The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device for use with the Voyant electrosurgical generator in open procedures for the ligation and division of vessels and tissue bundles up to 5mm in diameter.
- Predicate Device: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider (K123444).
- Performance Testing Summary (Non-clinical & Preclinical):
- Non-clinical (Bench Testing): Mechanical strength, durability, destructive testing (per IEC 60601-1, IEC 60601-2-2), electrical safety, electromagnetic compatibility, and safety systems testing.
- Preclinical (ex vivo porcine vessels/tissue and in vivo canine model): Evaluated system safety and efficacy. Side-by-side testing against the predicate focused on:
- Seal evaluation
- Thermal damage
- Burst pressures (ex vivo)
- Acute animal study (in vivo): Seal evaluation and thermal damage.
- Chronic Study: An in vivo canine model was used to evaluate seal quality and chronic hemostasis for the subject device.
- Conclusion: The device is substantially equivalent in performance to the predicate device with respect to intended use (vessel sealing performance and local tissue effects).
- Clinical Data: The premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text, as this document outlines a traditional medical device 510(k) submission, not an AI/ML-based device submission that would typically have such detailed information about acceptance criteria, test sets, ground truth, and reader studies.
§ 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.