(74 days)
The Voyant Maryland Fusion Device with Single-Step Activation 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 coagulation for sterilization procedures, and should not be used for these procedures.
The Voyant Maryland Fusion device with Single Step 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.
The medical device in question is the Voyant® Maryland Fusion Device with Single-Step Activation. It is an electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles up to 7mm in diameter.
Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that the devices "met all acceptance criteria" or that results were "sufficient to represent the subject device is safe and effective."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| EMC, Electrical Safety, and Mechanical Testing | The predicate device met all acceptance criteria in accordance with relevant standards of the IEC 60601 series. Additional electrical safety testing on the subject device also met all acceptance criteria. |
| Simulated Repeated-Use Testing | The subject device met the predetermined acceptance criteria for continued performance over multiple device activations. |
| System Testing (Burst Pressure) | (Performed on predicate device) Representative vessels were sealed, and burst pressure was recorded. The results are considered representative of system performance for the subject device. (No specific threshold or value is provided, but implies satisfactory burst pressure). |
| System Testing (Thermal Spread) | (Performed on predicate device) Thermal spread damage was evaluated. The results are considered representative of system performance for the subject device. (No specific thermal spread limit is provided, but implies acceptable thermal effects). |
| Animal Testing (Long-term Seal Quality, Adverse Effects) | (Performed on predicate device) Evaluated long-term seal quality, device performance, and potential for adverse effects on adjacent structures in large porcine animal models. Vessels were sealed and evaluated for hemostasis and signs of hematoma. The results are sufficient to represent the subject device is safe and effective. |
| Software Verification | Unit, integration, and system level software testing were conducted to evaluate design, implementation, and performance. (Implies all tests passed the defined acceptance criteria for software). |
Note: The document generally indicates that the device "met all acceptance criteria" without specifying the exact numerical thresholds for many of these criteria. This type of summary is common in 510(k) submissions where the focus is on demonstrating substantial equivalence rather than presenting a detailed performance report.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for all test sets. However, it provides some information:
- Burst pressure testing: "vessels representative of the devices' indications" were used. (No specific number mentioned).
- Thermal spread testing: (No specific number mentioned).
- Simulated repeated-use testing: (No specific number mentioned for activations or devices).
- Animal testing: "large porcine animal models" were used. The number of animals or vessels tested is not specified.
Data Provenance:
- Country of Origin: Not explicitly stated, but typically these studies are conducted by the manufacturer or contract research organizations, often in the country where the manufacturer is based (USA, in this case).
- Retrospective or Prospective: The testing described (simulated repeated-use, system testing, animal testing, software verification) are all prospective studies, designed and executed to evaluate the new or modified device. The reference to the predicate device's data suggests that previously collected prospective data from the predicate was leveraged.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the described performance tests. For electrosurgical devices, "ground truth" often refers to objective measurements (e.g., burst pressure, thermal spread measurements, histopathological analysis in animal studies) rather than subjective expert interpretations like in imaging studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given that most of the described tests are objective measurements (e.g., electrical parameters, burst pressure, thermal spread, software testing), an adjudication method as typically understood in studies involving human interpretation (like imaging reads) would not be applicable. For animal studies, evaluation of hemostasis and hematoma would typically follow pre-defined histological or gross pathology criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a direct-use surgical instrument, not an AI-based diagnostic tool requiring human interpretation/reading. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" typically refers to AI algorithms, in the context of this electrosurgical device, the device itself is a "standalone" instrument. The performance tests (electrical, mechanical, system, animal) described are evaluating the performance of the device only (or the device in combination with its specified generator), without a human-in-the-loop actively assisting in output. The software verification tests are also standalone evaluations of the algorithm's performance within the device's control systems.
7. The Type of Ground Truth Used
The ground truth used for various tests includes:
- Objective Measurements: For burst pressure (quantifiable pressure values), thermal spread (measurable tissue damage), and electrical safety/EMC (compliance with quantifiable standards).
- Biological/Pathological Outcomes: For animal studies, this would involve macroscopic and potentially microscopic examination of sealed vessels and surrounding tissues to assess hemostasis, presence of hematoma, and tissue damage, serving as the "ground truth" for seal quality and safety.
- Software Design Specifications: For software verification, the "ground truth" is adherence to predefined design requirements and functional specifications.
8. The Sample Size for the Training Set
The document describes performance testing for an electrosurgical device, not an AI/ML product. Therefore, the concept of a "training set" (used for training machine learning models) is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" is not applicable, the question of how its ground truth was established is also not applicable.
§ 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.