(26 days)
Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.
Endovascular Dilator and Sets are manufactured from vinyl radiopaque dilator tubing and consist of either one or two dilators that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into an artery for vascular clinical applications that require percutaneous access. The serial dilator components are designed with long, gradual tapers and include hydrophilic coating, and are available in various inner and outer diameter and length combinations.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Endovascular Dilator and Sets." This type of document is a regulatory submission for medical devices, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study methodologies, or performance results that would be found in a clinical study publication.
Specifically, the document states:
"There are no device, material, or design changes to any of the devices included in the Endovascular Dilator and Sets. Since there is no design change to the device subject of this submission, the testing that was provided for the predicate device in submission K183036 remains to support this submission. No additional testing or design control activities or risk assessment are required to support substantial equivalence."
This indicates that the FDA clearance for this device (K210734) is based on its substantial equivalence to a previously cleared predicate device (K183036), meaning no new performance studies were conducted for this specific submission to demonstrate the device meets acceptance criteria. The original testing for the predicate device (K183036) would contain such information.
Therefore, I cannot provide the requested information from this document because it is not a study report. The document asserts that no new testing was performed specific to this submission (K210734) as the device itself hasn't changed.
To address your request, one would need access to the 510(k) submission for the predicate device, K183036, as that is where the original performance data and testing details would be described.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).