(51 days)
The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.
The Smith & Nephew Tumescent Catheter Inversion System provides a system for removal of incompetent greater saphenous veins. The system also provides the capability to flush the tunnel left behind from the removal of the vein with tumescent solution.
The provided text is a 510(k) summary for the Smith & Nephew Tumescent Catheter Inversion System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed performance metrics commonly associated with such studies (like sample sizes, ground truth establishment, or expert qualifications).
The document explicitly states:
H. Summary Performance Data
"There are no known performance standards or special controls promulgated under section 514 of the Act for this device has been tested and found to be in compliance with ISO 10993-1 and at the time of commercialization will be in compliance with applicable sterilization standards. This device has been tested and found to be safe and effective for its intended use."
This statement indicates that while the device was tested for safety and effectiveness and compliance with ISO 10993-1 (biocompatibility) and sterilization standards, the submission does not include a detailed study with acceptance criteria and reported performance data in the manner typically seen for complex diagnostic or AI-based devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a pre-amendment device based on similar design, materials, function, and intended use, rather than presenting a detailed performance study against quantified acceptance criteria.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).