(161 days)
The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.
The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.
The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.
The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.
Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.
Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Comparative Analysis | Demonstrates comparability to predicate device in: | Demonstrated comparability to predicate device in: |
| - Intended use | - Same intended use | |
| - Indications for use | - Same indications for use | |
| - Fundamental scientific technology | - Same fundamental scientific technology | |
| - Material properties (same or similar) | - Same or similar material properties | |
| - Operating principle (same or similar) | - Same or similar operating principle | |
| - Performance specifications (similar) | - Similar performance specifications | |
| - Patient-user interface (similar) | - Similar patient-user interface | |
| Functional Testing | Met pre-determined acceptance criteria for all tests. | All data met pre-determined acceptance criteria. (No specific numerical results provided in this summary) |
| Specific Functional Tests: | ||
| - Static Burst Pressure | Met criteria | |
| - Maximum Infusion Pressure | Met criteria | |
| - Maximum Flow Rate | Met criteria (e.g., 2.0Fr x 130cm: 3.0 mL/s; 2.6Fr x 130cm: 5.8 mL/s - comparable to predicate) | |
| - Kink Radius | Met criteria | |
| - Tensile Testing | Met criteria | |
| - Torque Testing | Met criteria | |
| - Coating Lubricity | Met criteria | |
| - Coating Durability | Met criteria | |
| - Fluid Leak Testing | Met criteria | |
| - Hub Assembly Air Leak | Met criteria | |
| - Physical Embolic Testing | Met criteria | |
| - Liquid Embolic Exposure Testing | Met criteria | |
| - Radiopacity | Met criteria | |
| Biocompatibility | Verified according to ISO 10993-1 and FDA guidance for an external communicating device ( |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).