(296 days)
The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.
Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.
I am unable to provide a description of acceptance criteria and a study proving device meets acceptance criteria, as the document does not contain information on device performance or clinical study results for the Sunmed™ Haemostatic Valves.
The document is a 510(k) premarket notification for a medical device (Sunmed™ Haemostatic Valves) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility. It explicitly states in section 8 that "Clinical Evaluation was not applicable." Therefore, there is no information about acceptance criteria for device performance or a study proving the device meets said criteria.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.