(182 days)
The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded ... .
This Origin Cardiac Stabilizer Occluder is a single use sterile device. It consists of a stabilizer foot, and occluders. The Origin Cardiac Stabilizer Occluder may be used by attaching the stabilizer foot to the Origin Cardiac Stabilizer Clamp; then this assembly is attached to a self retaining rib retractor or sternal retractor or other stationary platform. The Origin Cardiac Stabilizer Occluder may also be used by suturing the stabilizer foot to the desired area of the heart. The stabilizer foot rests against the epicardium. Forceps may be used to position the occluder over the desired vessel. Once in position the occluder may be advanced toward the vessel and locked in place; to cause the vessel to be temporarily occluded. Following completion of the surgical procedure , the Origin Cardiac Stabilizer Occluder is removed.
The provided text is a 510(k) Summary for the "Origin Cardiac Stabilizer Occluder." This type of document is a premarket notification for new medical devices, aiming to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Key Observation: The document does not describe any clinical studies, performance data, or acceptance criteria for the device's technical performance. Instead, it focuses on the device's description, intended use, and its substantial equivalence to existing predicate devices.
Therefore, I cannot provide the requested information from the given text alone. The document is a regulatory submission for market clearance based on substantial equivalence, not a report of a performance study.
To answer your request, if such information were available, it would typically be found in:
- A separate clinical study report.
- A section within the 510(k) submission detailing specific performance testing (e.g., bench testing, animal studies, or clinical data if substantial equivalence cannot be entirely based on predicate devices without it).
- Post-market surveillance data.
Since the provided text does not contain this information, I must state that the acceptance criteria and studying proving the device meets them are not present in this document.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).