(29 days)
The APRO 45 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 45 Catheter is also indicated for use as a conduit for retrieval devices.
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 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 45 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 45 Catheter is provided with an Introducer Sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
The provided FDA 510(k) clearance letter and summary for the APRO 45 Catheter focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. It does not present information related to an AI/ML-driven medical device, a multi-reader multi-case (MRMC) study, or acceptance criteria for algorithmic performance.
Therefore, based solely on the provided text, it's not possible to fulfill most of the requested information points, as they pertain to the evaluation of AI/ML diagnostic or assistive devices. The document describes a physical medical device (catheter) and its non-clinical testing.
However, I will extract and present the acceptance criteria and performance information that is available from the provided text, primarily from the "Performance Data" section.
Acceptance Criteria and Device Performance for APRO 45 Catheter
The APRO 45 Catheter is a physical medical device, not an AI/ML driven diagnostic or assistive device. The acceptance criteria and performance data provided in the FDA 510(k) summary pertain to the physical and biological characteristics of the catheter, supporting its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 45 Catheter met the acceptance criteria. |
| Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 45 Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 45 Catheter met the acceptance criteria. |
| Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to the predicate. | The APRO 45 Catheter met the acceptance criteria. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to the predicate. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| Corrosion Resistance | Catheter shall show no signs of corrosion when tested in accordance with ISO 10555-1, Annex A. | The APRO 45 Catheter met the acceptance criteria. |
| Sterilization (Ethylene Oxide) | Verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. | Met acceptance criteria. |
| Shelf-Life (Aging Studies) | Subject device and packaging remain functional for the labeled expiration date; packaging integrity, seal strength, and device functionality met acceptance criteria. | Met acceptance criteria. (1-year shelf life established) |
| Biocompatibility: Sensitization | Did not elicit a sensitization response. | Non-sensitizing |
| Biocompatibility: Irritation/Intracutaneous Reactivity | No evidence of irritation. | Non-irritant |
| Biocompatibility: Cytotoxicity | Did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| Biocompatibility: Hemolysis - Indirect | No significant differences between the test article extract and negative control. | Non-hemolytic |
| Biocompatibility: Hemolysis - Direct | No differences between the hemolytic index of the test article and negative control. | Non-hemolytic |
| Biocompatibility: Thrombogenicity (PTT) | Average clotting time not significantly different from vehicle and negative control. | Non-thrombogenic |
| Biocompatibility: Thrombogenicity (Platelet Leukocyte Count) | Test article performed similar to comparator and negative controls. | Met acceptance criteria (performed similar) |
| Biocompatibility: Thrombogenicity (Comparative Surface and Geometry Assessment) | Similar surface morphology as the predicate device, no differences in roughness or defects. | Subject device has similar surface morphology as predicate. |
| Biocompatibility: SC5b9 Complement Activation | Sc5b9 concentration statistically less than positive control and not statistically higher than negative control. | Acceptable |
| Biocompatibility: Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity. | Non-toxic |
| Biocompatibility: 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).