(29 days)
The FOUNTAINTM Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient
The Fountain™ Infusion Catheter is designed to provide repeatable doses of solution with a unique spray pattern for optimal thrombolytir procedures. The side hole on the Fountain infusion catheter rotate around the catheter to create a more uniform dispersion of thrombolytic agent. The infusion sep-cent = the catheter is indicated by two radiopaque marker bands.
The Occluding Guide Wire occludes The proximal end of the occluding wire was a marker for verification of proper placement.
The provided text pertains to a 510(k) submission for a medical device (FOUNTAIN Infusion Catheter and Occluding Guide Wire) and contains an FDA clearance letter from 1999, followed by an administrative update in 2022. It includes sections on indications for use and a 510(k) summary with a device description and intended use.
However, the document does not contain information on acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for any studies.
The sections provided focus on demonstrating substantial equivalence to a predicate device based on design and intended use, rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
The information I can extract that is related to performance or testing is limited to the functional description of the device:
- Device Description mentions: "The Fountain™ Infusion Catheter is designed to provide repeatable doses of solution with a unique spray pattern for optimal thrombolytir procedures. The side hole on the Fountain infusion catheter rotate around the catheter to create a more uniform dispersion of thrombolytic agent." and "The Occluding Guide Wire occludes The proximal end of the occluding wire was a marker for verification of proper placement."
- Device Use mentions: "The use of the occluding wire enhances controlled, localized dispersion of therapeutic solution through the 0.001" to 0.005" diameter infusion holes of the infusion catheter." and "The mechanical action from pulsing the therapeutic solution helps to break down clots."
These are descriptive statements about the device's function, not quantitative performance metrics with acceptance criteria, nor are they results from a specific study designed to prove compliance with such criteria.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).