(79 days)
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
The provided text is a 510(k) Summary for the CardioThoracic Systems, Inc. Vacuum Assist Stabilizer. It outlines the device's description, intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific study designs, or performance metrics that would allow for the completion of the requested table and answers.
The summary states: "Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use." This is a general statement and does not provide the detailed information needed to address your specific questions about acceptance criteria, study sizes, ground truth establishment, or clinical performance.
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory submission summary rather than a detailed study report.
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.