(88 days)
The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices.
The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath.
This document is a 510(k) Premarket Notification from the FDA regarding the APRO 70 Swift Catheter. It focuses on demonstrating the device's substantial equivalence to a predicate device, primarily through non-clinical performance data.
Here's a breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO 70 Swift Catheter particulates were comparable to the predicate device. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub Air Leakage | Catheter does not leak air into hub assembly with methods specified in ISO 10555-1, Annex D. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Torque Strength | Catheter must withstand the minimum required number of rotations without breakage and without kinking compared to legally marketed devices. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter was comparable to the predicate device. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model and during simulated clot retrieval, the Catheter must meet functionality specifications including compatibility with a stent retriever. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Sterilization (Ethylene Oxide) | Sterility assurance level of 1 x 10^-6 in accordance with ISO 11135. | Verified to a sterility assurance level of 1 x 10^-6. |
| Shelf-Life (Aging Studies) | Subject device and packaging remain functional for the labeled expiration date; packaging integrity, seal strength, and device functionality meet acceptance criteria. | Met the acceptance criteria. |
| Sensitization (Guinea Pig Maximization) | Not elicit a sensitization response. | Non-sensitizing. |
| Irritation/Intracutaneous Reactivity | No evidence of irritation. | Non-irritant. |
| Cytotoxicity (MEM Elution, L929 cells) | Not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic. |
| Hemolysis - Indirect | No significant differences between the test article extract and negative control. | Non-hemolytic. |
| Hemolysis - Direct | No differences between the hemolytic index of the test article and the negative control. | Non-hemolytic. |
| Thrombogenicity - Partial Thromboplastin Time (PTT) | Acceptable clotting times (average clotting time of test article greater than vehicle control and negative control). | Acceptable clotting times. |
| Thrombogenicity - Platelet Leukocyte Count | Performed similar to comparator and negative controls. | Non-thrombogenic. |
| Thrombogenicity - Comparative Surface and Geometry Assessment | No differences in roughness or presence of any defects compared to reference device. Same geometry as reference device. | Acceptable results. |
| SC5b9 Complement Activation | Sc5b9 concentration statistically less than positive control and not statistically higher than negative control. | Acceptable. |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity. | Non-toxic. |
| Material-Mediated Pyrogenicity | Total rise in temperature of |
§ 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).