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510(k) Data Aggregation
(129 days)
APRO 70 Swift Catheter and Alembic Aspiration Tubing
The APRO 70 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.
The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Swift Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 Swift Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
The provided text describes the acceptance criteria and the study results for the APRO 70 Swift Catheter and Alembic Aspiration Tubing. It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance data, rather than a clinical trial report. Therefore, some of the requested information, particularly regarding clinical studies, human readers, and effect sizes, is not applicable or available in this document.
Here's the breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily from non-clinical bench testing.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets visual and dimensional specifications. | |
| Introducer Sheath meets visual and dimensional specifications. | The APRO 70 Swift Catheter met the acceptance criteria. | |
| The Introducer Sheath 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. | |
| Vacuum Integrity | Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak into hub assembly during aspiration, with methods specified in ISO 10555-1, Annex D. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub Compatibility | Hub meets the requirements per EN ISO 80369-7. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Catheter 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. |
| Fluid Leakage | Catheter must withstand pressure with methods per 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. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| 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. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Simulated Use including Clot Retrieval | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. Clot retrieval from various locations of the anatomical model was performed using the subject device system. | The APRO 70 Swift Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Biocompatibility (Sensitization) | Did not elicit a sensitization response. | Non-sensitizing |
| Biocompatibility (Irritation) | Demonstrated 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 article results. | Non-hemolytic |
| Biocompatibility (Hemolysis - Direct) | No differences between the hemolytic index of the test article and the negative control. | Non-hemolytic |
| Biocompatibility (Thrombogenicity - PTT) | Average clotting time of the test article was greater than vehicle control and negative control. | Acceptable clotting times |
| Biocompatibility (Thrombogenicity - Platelet Leukocyte Count) | Performed similar to comparator and negative controls. | Non-thrombogenic |
| Biocompatibility (Thrombogenicity - Comparative Surface and Geometry Assessment) | Comparative surface assessment using 40X optical microscopy at representative locations of the subject device and the reference device APRO 70 Catheter did not find any differences in roughness or presence of any defects. The subject device has the same geometry as the reference device APRO 70 Catheter. | Acceptable results |
| Biocompatibility (SC5b9 Complement Activation) | Sc5b9 concentration of the test article was statistically less than the positive control and was not statistically higher than the negative control. | Acceptable |
| Biocompatibility (Acute Systemic Toxicity) | No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | Non-toxic |
| Biocompatibility (Material-Mediated Pyrogenicity) | All individual rabbits for both the test article and negative control showed a total rise in temperature of |
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(88 days)
APRO 70 Swift Catheter
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 |
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