(36 days)
The VASOVIEW HEMOPRO 2 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 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO 2 Harvesting Tool for the cutting and sealing of vessel branches. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting, sealing and spot cautery. An area near the tip of the convex side of the Jaw can be used for spot cautery. The Activation Toggle is used to control the Jaws to activate the heating elements. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 Extension Cable, and an Adapter Cable.
This 510(k) summary describes a medical device, the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System. The document focuses on establishing substantial equivalence to a predicate device through functional characteristics and performance testing. However, it does not involve an AI/ML algorithm or a study with specific acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" and "study" refer to the verification and validation testing performed to ensure the device functions as intended and safely, and is substantially equivalent to existing devices.
Here's an breakdown based on the provided text, noting limitations due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with quantitative acceptance criteria (e.g., numerical thresholds for performance metrics) and corresponding reported performance values. Instead, it states:
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Function | Meets established acceptance criteria | "The results of verification and validation testing and Risk Analysis demonstrate that the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System data meets the established acceptance criteria and performs in a manner equivalent to the predicate devices." |
| Essential Functional Characteristics (Bench Testing) | Device functions as intended | "Bench testing was done to verify and validate essential functional characteristics of the device." |
| Thermal Spread | Acceptable extent of necrosis beyond jaws | "An example of this was thermal spread, i.e., the extent of necrosis beyond the length of the jaws." (Implied: met acceptable limits, though specific limits not provided). |
| User Needs (Non-Clinical Testing in Porcine Models) | Device meets user needs | "Non-clinical testing of the device in porcine models was done to validate that the device met user needs. In all cases the device met the acceptance criteria of the test." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "bench testing" and "non-clinical testing of the device in porcine models." The number of tests, specimens, or animals used is not provided.
- Data Provenance: The "study" (verification and validation testing) was performed internally by the manufacturer (MAQUET Cardiovascular). Data is "non-clinical" and involves "bench testing" and "porcine models." This indicates laboratory-based testing rather than human clinical data, and thus no specific country of origin is relevant in the same way as for clinical studies. It is prospective testing designed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to this type of device submission. For a physical medical device like an endoscopic vessel harvesting system, "ground truth" and "experts" are typically referred to as the engineering specifications, design requirements, and a qualified team performing the verification and validation (V&V) testing. The "ground truth" is that the device must function according to its design and safety specifications. There's no "ground truth" in the diagnostic or interpretative sense.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device where human reader performance is compared with and without AI assistance. The device is a surgical tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. There is no AI algorithm in this device. Performance is evaluated on the physical function of the device itself.
7. Type of Ground Truth Used
The "ground truth" refers to the established technical specifications, design requirements, and safety standards for an endoscopic vessel harvesting system. For instance:
- Engineering specifications for jaw movement, heating element temperature, cutting force, sealing effectiveness.
- Biocompatibility and sterilization standards.
- Safety parameters like thermal spread in tissue.
- Functional design requirements (e.g., prevention of "false turn-on's," ergonomic handle).
8. Sample Size for the Training Set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.