(388 days)
The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices
The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethanc exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal risk of arterial those Catheter is hydrophilic coated to enhance lubricity. The portion of the OrossDoos Canieternal stainless steel hypotube stiffener that provides the additional tolerance to push. A torque device, coaxially positioned over the proximal additional the CrossBoss Catheter, provides a comfortable user interface for device manipulation. The CrossDose (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.
The provided document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of analytical or clinical performance.
The document is a 510(k) summary for the BridgePoint Medical CrossBoss Catheter, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria.
Here's what the document does state regarding evaluation:
- Device Evaluation Information Provided: "A variety of in vitro and in vivo information has been provided demonstrating substantial equivalence."
This statement indicates that some testing was performed to support the claim of substantial equivalence, but it does not detail:
1. Specific acceptance criteria for performance metrics.
2. The results of those tests against such acceptance criteria.
3. Sample sizes for tests.
4. Details about expert involvement, ground truth, or MRMC studies.
5. Details on training sets for any algorithms (which are not mentioned in this device's description).
Therefore, I cannot populate the table or provide the requested information based on the provided text. The document is a regulatory submission for pre-market notification, not a detailed study report.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).