(23 days)
The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the 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 sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.
This FDA 510(k) summary for the Voyant 5mm Fusion Device and Voyant Maryland Fusion Device (K193292) does not contain information about a study with acceptance criteria and observed device performance in the way a clinical trial or algorithm performance study would.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K141288, K172624, K182653). The core argument for safety and efficacy relies on the fact that the subject devices are identical in material and technological characteristics to the predicates, and thus, the existing performance, sterility, shelf life, and electrical testing of the predicate devices are leveraged.
Therefore, the requested tables and details regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific submission as it's not a de novo study for a novel device or AI algorithm.
However, I can extract the acceptance criteria and "results" as presented in the document based on the performance testing of the predicate devices, which are deemed sufficient for the subject devices due to identical design.
Here's a breakdown of the information that is available (or not available) based on your request, framed within the context of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission based on identical design, the "acceptance criteria" are implied by the standards and successful results achieved by the predicate devices. The document states that the predicate devices "met all acceptance criteria" for the listed tests.
| Test Method (as performed on Predicate Devices) | Implied Acceptance Criteria (Met "Pass") | Reported Device Performance (for Predicate Devices) |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (per ISO 10993-5) | Met ISO 10993-5 criteria | Pass |
| Intracutaneous Reactivity (per ISO 10993-10) | Met ISO 10993-10 criteria | Pass |
| Sensitization (per ISO 10993-10, ASTM F2148) | Met ISO 10993-10 / ASTM F2148 criteria | Pass |
| Electrical: | ||
| IEC 60601-1 (General requirements for basic safety and essential performance) | Met IEC 60601-1 standards | Pass |
| IEC 60601-1-2 (Electromagnetic compatibility) | Met IEC 60601-1-2 standards | Pass |
| IEC 60601-2-2 (Particular requirements for the safety of high frequency surgical equipment) | Met IEC 60601-2-2 standards | Pass |
| Mechanical Testing: | ||
| Simulated repeated use testing (jaw force, electrical continuity) | Maintained jaw force and electrical continuity | Pass |
| Destructive jaw force testing (mechanical functionality and integrity of the jaw) | Maintained mechanical functionality and integrity | Pass |
| Bench Testing: | ||
| Burst pressure testing on representative vessels | Achieved satisfactory burst pressure | Pass |
| Thermal spread testing (evaluate thermal spread damage) | Satisfactory thermal spread damage profile | Pass |
| Animal Testing: | ||
| Chronic survival study (chronic hemostasis and signs of hematoma) | Demonstrated chronic hemostasis; no signs of hematoma | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document for any of the tests. The document refers to "representative vessels" and "surgical sites" for the bench and animal testing, respectively, but does not provide numbers.
- Data Provenance: The data comes from prior testing associated with the predicate devices (K141288, K172624, K182653). The document does not specify the country of origin or if the studies were retrospective or prospective, though animal and bench testing are typically prospective experiments.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This submission is not evaluating an AI algorithm or diagnostic device requiring expert interpretation of results to establish ground truth. The tests are laboratory-based (biocompatibility, electrical, mechanical, bench) and animal studies, which have objective endpoints.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, no expert consensus or adjudication process is described for these types of engineering and biological tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not describe any MRMC study. The device is an electrosurgical tool, not a diagnostic imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
- No. The device is a surgical instrument. This concept is not applicable.
7. Type of Ground Truth Used:
- For biocompatibility tests: Standardized laboratory assays based on cell viability, immune response, etc.
- For electrical tests: Measurement against established IEC standards.
- For mechanical tests: Objective measurements of force, integrity, and electrical continuity.
- For bench testing: Measurements of burst pressure and thermal spread, which are objective physical parameters.
- For animal testing: Histological examination, observation of hemostasis, and absence of hematoma, likely evaluated by veterinary pathologists or study investigators based on established criteria.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI or machine learning device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable.
In summary: This 510(k) submission explicitly states that the subject devices are identical to predicate devices and therefore leverages the prior testing data of those predicates. It does not present new studies with a detailed breakdown of acceptance criteria and performance for a novel device or AI algorithm, but rather relies on the successful historical performance of prior substantially equivalent devices.
§ 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.