(323 days)
CryoValve® SG Pulmonary Human Heart Valve (and Conduit) are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.
The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial solution, and treated to remove the cells and cellular debris that has not already been removed during the postmonten, and harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium, cretaining a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system nonly withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room, Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.
The provided text describes a 510(k) summary for the CryoValve® SG Pulmonary Human Heart Valve (and Conduit). This submission is for a medical device and not an AI/ML powered device. As a result, the requested information (performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) specific to AI/ML device evaluations is not applicable and not present in the document.
The document focuses on:
- Intended Use: Replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, including use in the Ross Procedure.
- Predicate Devices: Mentions previous 510(k) clearances (K033484 and K083106) for similar CryoValve® SG devices.
- Device Description: Details on aseptic recovery, antimicrobial treatment, cell and cellular debris removal, cryopreservation, packaging, and supercooling process. It also mentions reduced risk for HLA class I and class II alloantibodies compared to standard-processed valves.
- Scientific Evidence and Bench Testing: States that scientific analysis and testing were conducted to change the device shelf life, including biomechanical properties testing, pulsatile flow characterization, and accelerated wear testing. It refers to "theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures."
Since this is not an AI/ML device, the specific questions related to AI/ML acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) cannot be answered from the provided text.
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