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(a) Identification. A reverse central venous recanalization system is a prescription device for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing must fulfill the following:
(i) Demonstrate the ability to safely deliver, deploy, and remove the device; and
(ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system;
(ii) Compatibility with other devices labeled for use with the device;
(iii) Tensile strengths of joints and components;
(iv) Kink resistance of system components;
(v) Radiopacity of components used to monitor procedure under fluoroscopy;
(vi) Characterization and verification of all dimensions; and
(vii) Leakage of air or fluid.
(3) All patient contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use, including a description of compatible devices;
(ii) A detailed summary of the clinical testing conducted and;
(iii) Shelf life and storage conditions.
[87 FR 26991, May 6, 2022]
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