(161 days)
The APRO 55 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 55 Catheter to the aspiration pump.
The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 55 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 55 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 55 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 55 Catheter is available in lengths of 125 cm and 137 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 55 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.
Here's a summary based on the provided FDA 510(k) document, focusing on acceptance criteria and study details:
Device: APRO 55 Catheter and Alembic Aspiration Tubing
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria listed are primarily for non-clinical bench tests. The reported device performance uniformly states that the APRO 55 Catheter (and Alembic Aspiration Tubing where applicable) met the acceptance criteria.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. Introducer Sheath meets the visual and dimensional specifications. | The APRO 55 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 55 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 55 Catheter met the acceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 55 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 55 Catheter met the acceptance criteria. |
| Hub Compatibility | Hub meets the requirements per EN ISO 80369-7. | The APRO 55 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 55 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 55 Catheter met the acceptance criteria. |
| Fluid Leakage | Catheter must withstand pressure with methods per ISO 10555-1 Annex C. | The APRO 55 Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 55 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 55 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 55 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 55 Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 55 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 55 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
Biocompatibility Tests:
| Test | Results | Conclusions |
|---|---|---|
| Sensitization (Guinea Pig Maximization) | The APRO 55 Catheter did not elicit a sensitization response. | Non-sensitizing |
| Irritation/Intracutaneous Reactivity | The APRO 55 Catheter demonstrated no evidence of irritation. | Non-Irritant |
| Cytotoxicity (MEM Elution, L929 cells) | The APRO 55 Catheter did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| Hemolysis – Indirect | There were no significant differences between the test article extract and negative control article results. | Non-hemolytic |
| Hemolysis – Direct | There were no differences between the hemolytic index of the test article and the negative control. | Non-hemolytic |
| Partial Thromboplastin Time (PTT) | The average clotting time of the test article was greater than vehicle control and negative control. | Acceptable clotting times |
| SC5b9 Complement Activation | The Sc5b9 concentration of the test article was statistically less than the positive control and was not statistically higher than the negative control. | Acceptable |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | Non-toxic |
| Material-Mediated Pyrogenicity | All individual rabbits for both the test article and negative control showed a 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).