(91 days)
The VASOVIEW 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 the 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 Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW Harvesting Tool for cutting and sealing of vessel branches. The C-Ring with the built in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port.
The provided 510(k) summary for the "Harvesting Cannula" (K132743) by MAQUET Cardiovascular LLC does not describe specific acceptance criteria or a detailed study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System) based on similar intended use, operating principles, labeling, basic design, materials, sterilization processes, and packaging.
The "Safety and Performance" section broadly states that MAQUET Cardiovascular's development process required "• Performance testing" and "• Shelf life testing." It then concludes: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula."
Without concrete performance metrics or detailed study methodologies, it's impossible to fill in most of the requested fields. However, I can extract the available information.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functionality | Not specified | Comparable to currently marketed Harvesting Cannula (Predicate Device) |
| Performance | Not specified | Comparable to currently marketed Harvesting Cannula (Predicate Device) |
| Shelf Life | Not specified | Successful (implicit in "Shelf life testing" completed) |
Missing Information: Specific quantitative or qualitative acceptance criteria are not detailed in the document. The performance is described as "comparable" to the predicate, but specific metrics of what defines "comparable" are absent.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "in-vitro tests" but does not provide details on the number of devices or scenarios tested.
- Data Provenance: The tests were "in-vitro," meaning conducted in a laboratory setting. The country of origin for the data is not specified, but the device owner is in the USA. The study was part of the device development process, making it a prospective assessment of the newly designed device's performance against established benchmarks (implicitly, the predicate device).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a surgical instrument (Harvesting Cannula), not an diagnostic imaging or AI device that requires expert-established ground truth for its performance evaluation in the context of the provided document. Its performance would be evaluated against engineering specifications and functional requirements.
4. Adjudication Method for the Test Set
- Not applicable for a device of this type and the information provided. Performance demonstration would involve engineering and functional testing, not expert adjudication of outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical instrument, not an algorithm.
7. The type of ground truth used
- For a surgical instrument like the Harvesting Cannula, "ground truth" would generally refer to adherence to design specifications, functional requirements (e.g., ability to house components, operate smoothly), material properties, and safety standards. Based on the documentation, the "ground truth" for evaluating the "functionality and performance characteristics" was the performance of the currently marketed Harvesting Cannula (the predicate device).
8. The sample size for the training set
- Not applicable. This is a physical surgical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an ML algorithm.
Summary of what is present:
The 510(k) summary for K132743 focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System). The core argument is that despite minor design changes (C-Ring Tube, Blunt Tip, Scope Wash Tube length), these differences are not considered technological and do not affect the safety or effectiveness of the device.
The "Safety and Performance" section states that "Performance testing" and "Shelf life testing" were completed, and "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula." This highly generalized statement is the extent of the performance data provided in this summary. It relies on the assumption that if the new device performs "comparably" to an already cleared predicate device, it meets the necessary safety and effectiveness standards.
§ 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.