(28 days)
The VasoView® 6 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring wire, endoscope washer tube and Bipolar Bisector for ligation and division of vessel branches. The C-Ring/endoscope washer is independently controlled by a C-Ring Slider on the handle of the device for retraction of the vessel as well as washing of the distal tip of the Endoscope. The Bipolar Bisector can be extended/retracted/rotated with the Bisector Carriage, and mechanical cutting is achieved with the toggle located on the Bisector Carriage. Bipolar coagulation is achieved using electrosurgical energy. Positioning of the device, coagulation, and mechanical cutting are performed under endoscopic visualization. This device is intended for use with the bipolar outputs of compatible generators.
The Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with a 7 mm Endoscope for minimally invasive vessel harvesting.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The provided document summarizes that the Guidant VasoView® 6 Harvesting Cannula "meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria are not explicitly detailed in the provided text. The document refers to "the established acceptance criteria" but does not define them. Similarly, the "reported device performance" is not quantitatively presented, but rather asserted to be equivalent to predicate devices.
Therefore, for the request, a table of acceptance criteria and reported device performance cannot be fully populated with specific metrics directly from the input. Instead, what can be stated is the general claim of equivalence.
| Acceptance Criteria (Not explicitly detailed, inferred from claims) | Reported Device Performance (Summary statement) |
|---|---|
| Functional equivalence to predicate devices (VV4, VV5, VV6) | The Guidant VasoView® 6 Harvesting Cannula meets established acceptance criteria and performs in a manner equivalent to the predicate devices. |
| Safety equivalence to predicate devices | No new safety or effectiveness issues were raised during the testing program. |
| Effectiveness equivalence to predicate devices | Performs in a manner equivalent to predicate devices for indications such as cutting tissue, controlling bleeding through coagulation, and blunt dissection of tissue. |
Study Details:
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Sample Size used for the Test Set and Data Provenance:
- The document does not specify the sample size used for the test set (number of devices tested, number of procedures simulated, or number of patients if applicable).
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. The testing appears to be verification testing, likely conducted in a lab environment rather than a clinical trial.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention using experts to establish ground truth for a test set. The performance data refers to "verification testing," which typically involves engineering or lab-based assessments against specifications, rather than clinical ground truth established by expert review.
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Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Since no expert review or clinical assessment for ground truth is indicated, there is no mention of an adjudication method.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done or mentioned. The device is a surgical instrument, not a diagnostic imaging device that would typically involve human readers.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable/Not mentioned. This device is a surgical tool, not an algorithm. Its performance is intrinsically tied to human operation.
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Type of Ground Truth Used:
- Not explicitly stated in terms of clinical ground truth. The "Performance data" section refers to "verification testing," suggesting the ground truth was based on engineering specifications, design requirements, and performance characteristics compared to predicate devices, rather than clinical outcomes, pathology, or expert consensus on clinical findings.
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Sample Size for the Training Set:
- Not applicable/Not mentioned. The device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As it's not an AI/ML algorithm, there is no training set or associated ground truth.
§ 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.