(81 days)
The Vasoview Hemopro 3 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 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 3 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 3 Harvesting Tool for cutting and cauterization 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 cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
The provided text pertains to the FDA 510(k) clearance for the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield, and Vasoview Hemopro 3 Power Adapter. This clearance is based on substantial equivalence to a predicate device, which means the focus of the documentation is on demonstrating that the new device is as safe and effective as the existing, legally marketed device.
Therefore, the document describes design verification and validation testing rather than a study proving the device meets specific performance criteria in a clinical diagnostic context as one might find for an AI/ML medical device. The acceptance criteria and "device performance" in this context refer to the successful completion of various engineering and safety tests, not diagnostic metrics like sensitivity or specificity.
Based on the provided text, I can infer the following about the acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not present a single table explicitly listing quantitative acceptance criteria and corresponding reported device performance values in a diagnostic sense. Instead, it describes various tests performed and states that the device "meets the established acceptance criteria and performs in a manner substantially equivalent to the predicate device." The "acceptance criteria" for each test are implicitly the successful completion and compliance with the relevant standards or design specifications.
Test Category Acceptance Criteria (Implied) Reported Device Performance (Implied) Biocompatibility Compliance with ISO 10993-1 and FDA Guidance for externally communicating devices with limited contact. Successful completion of Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Pyrogenicity tests. Electrical Safety & EMC Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18. The subject device complies with all listed electrical safety and EMC standards. Sterilization/Shelf-Life Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ using gamma irradiation; supports a two-year shelf life. Validated to achieve SAL of 10⁻⁶ using gamma irradiation (ISO 11137). Designated shelf life of two years. Mechanical/Bench Testing Device performs as intended and claimed; comparable technological characteristics to the predicate device. Successful completion of Tool/Cannula Mechanical Evaluation, Tool Electrical Evaluation, Packaging/Sterile Barrier Evaluation, Power Adapter Evaluation, Thermal Spread Evaluation, and Vessel Burst Pressure. Animal Testing (GLP) Meets end-user needs and does not raise additional safety or performance concerns. Evaluation demonstrated the subject device meets end-user needs and did not raise additional safety or performance concerns in porcine models. Human Factors Validation Device is adequately designed, safe, and effective for intended users, interfaces, and environments; no unacceptable residual risks. Study demonstrated adequate design, safety, and effectiveness. No unacceptable residual risks from usability perspective remain. -
Sample Size used for the test set and the data provenance:
- Biocompatibility: Not specified, but typically involves laboratory testing on material samples.
- Electrical Safety & EMC: Not specified, but involves testing representative units of the device and power supply.
- Sterilization/Shelf-Life: Not specified, but involves multiple samples for validation of sterilization and aged samples for shelf-life.
- Mechanical/Bench Testing: Not specified for each individual test, but typically involves multiple units to ensure repeatability and robustness.
- Animal Testing: "porcine models" (multiple animals implied for a "study"). Data provenance is in-vivo (animal model).
- Human Factors Validation: Not specified, but typically involves a representative number of prospective users. Data provenance is prospective (participants performing tasks with the device).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in a typical diagnostic device context. For a substantial equivalence claim, the "ground truth" is often established by adherence to engineering specifications and performance comparable to the predicate device. For animal and human factors studies, the "experts" would be the study investigators and end-users, but their specific number or detailed qualifications are not listed beyond "end user evaluation" and "intended users."
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Adjudication method:
Not applicable in the context of this 510(k) submission. Adjudication methods like "2+1" or "3+1" are typical for resolving discrepancies in expert interpretations (e.g., radiologists reading images) for diagnostic algorithms.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices to measure the improvement in human reader performance. The device described, the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, is a surgical tool, not a diagnostic imaging device.
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Standalone (algorithm-only) performance:
Not applicable. This device is a physical surgical tool, not a standalone algorithm.
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Type of ground truth used:
The "ground truth" for the various tests corresponds to:
- Biocompatibility: Established scientific standards (ISO 10993-1).
- Electrical Safety & EMC: International electrical safety and EMC standards (IEC 60601 series).
- Sterilization/Shelf-Life: Sterilization validation standards (ISO 11137).
- Mechanical/Bench Testing: Engineering specifications and performance metrics compared to the predicate device.
- Animal Testing: Clinical observation and evaluation in a controlled in-vivo setting.
- Human Factors Validation: User performance metrics and subjective feedback against usability engineering standards (IEC 62366-1) and FDA guidance.
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Sample size for the training set:
Not applicable. This is a medical device, 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, as there is no "training set" for this type of medical device.
§ 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.