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The VASOVIEW HEMOPRO 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 perioheral 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 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. 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.

This document describes a 510(k) submission for the MAQUET VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, seeking substantial equivalence to a predicate device (K052274). The submission focuses on device modifications to address specific Medical Device Report (MDR) issues related to self-activation/overheating. Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" and "device performance" are primarily demonstrated through specific performance and safety testing, rather than novel clinical performance metrics against a medical condition.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the types of tests conducted and the conclusion that the device's functionality and performance characteristics are "comparable" to the predicate device. The document does not explicitly state numerical acceptance thresholds for these tests, but rather indicates that the tests successfully demonstrated comparable performance and addressed the identified issues.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for the "in-vitro tests" conducted. The provenance of the data is not explicitly stated beyond being "in-vitro tests." This typically implies laboratory testing using simulated conditions or excised tissue, rather than human clinical data. The document focuses on bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The study is an in-vitro engineering and performance verification study, not a clinical study requiring expert ground truth for diagnostic or clinical outcome evaluation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human subject data and multiple reviewers to reach a consensus on diagnoses or outcomes. This document describes technical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (endoscopic vessel harvesting system), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness metrics would be part of this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the performance and safety tests, the "ground truth" would be established by the test standards and specifications themselves. For example, for "burst pressure testing," the ground truth is the specified pressure the device must withstand without failure. For "electrical testing 60601-1," the ground truth is compliance with the detailed requirements of the ISO 60601-1 standard. There is no biological "ground truth" in the sense of pathology or outcomes data in this in-vitro testing context.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Training sets are relevant for machine learning or AI algorithms. This is a traditional medical device submission.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

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The VasoView® HemoPro™ 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® HemoPro™ Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the Jaws of the Harvesting Tool and then (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the

The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System (K052274) is a Class II electrosurgical cutting and coagulation device. This device is intended for use in minimally invasive surgery for vessel harvesting, primarily in endoscopic surgery for arterial bypass. It is indicated for cutting tissue, controlling bleeding through coagulation, and blunt dissection of tissue, including blood vessels, ducts, and other structures in extraperitoneal or subcutaneous spaces, as well as thoracic space.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document states that "The results of the verification testing demonstrate that the Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria (e.g., specific thresholds for sealing strength, cutting time, or tissue damage) and the reported performance values that met these criteria are not explicitly detailed in the provided text. The document broadly states equivalence to predicate devices (VV4 - K030512 and VV6 - K041981) regarding design, materials, method of delivery, and intended use.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "verification testing" and "testing program" but does not specify any sample sizes for the test set. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information is typically relevant for studies involving qualitative assessments or image-based diagnostics, which does not appear to be the primary focus of the performance data for this device.

4. Adjudication Method for the Test Set:

Since the document does not mention the use of experts or qualitative assessments for a test set, there is no information provided on any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This device is an electrosurgical cutting and coagulation device and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device, and no such study is mentioned or implied.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is a surgical instrument and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable to this device, and no such study is mentioned.

7. The Type of Ground Truth Used:

The document indicates that the performance data for the device involved "verification testing" to ensure it "meet the established acceptance criteria." Given the nature of a surgical device, the ground truth would likely be established through objective measurements and assessments of physical performance characteristics such as:

• Sealing efficacy (e.g., burst pressure, hemostasis)
• Cutting performance (e.g., clean cuts, time to cut)
• Tissue damage assessments (e.g., thermal spread, charring)
• Durability and mechanical integrity
• biocompatibility (though not explicitly mentioned in the performance data section, it would be a standard part of device testing).

This "ground truth" would be determined by engineering and biological testing rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning and AI development. As this is a medical device and not an AI algorithm, there is no mention or applicability of a training set in the provided information. The device's performance is likely validated through traditional engineering and biological testing.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for this type of device, there is no information provided on how ground truth for a training set was established.

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