(84 days)
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 70 Catheter to the aspiration pump.
The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 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 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 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 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 performance data for the APRO 70 Catheter and Alembic Aspiration Tubing. However, it does not contain information about a study proving device performance in the context of AI/ML or human reader performance. The device described is a medical catheter and aspiration tubing, not an AI/ML diagnostic or assistive device. Therefore, questions related to AI/ML specific acceptance criteria, test set characteristics (ground truth, expert adjudication, sample size for test/training sets with medical images), and MRMC studies are not applicable this document.
Here's the relevant information based on the provided text, focusing on the mechanical and biological aspects of the device, and addressing the applicable parts of your request.
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. | |
| Introducer Sheath meets the visual and dimensional specifications. | ||
| Aspiration Tubing meets the visual and dimensional specifications. | The APRO 70 Catheter met the acceptance criteria. | |
| The Introducer Sheath met the acceptance criteria. | ||
| The Alembic Aspiration Tubing 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 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter with Aspiration Tubing is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 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 Catheter met the acceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimum required number of rotations without breakage. | The APRO 70 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Catheter met the acceptance criteria. |
| Fluid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Catheter met the acceptance criteria. |
| Static Burst (Rupture) | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Aspiration Tubing | Aspiration Tubing junction must meet tensile strength specification. | The Alembic Aspiration Tubing met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Usability | The Catheter and Aspiration Tubing were used per the Instructions for Use with accessory devices in an anatomical neurovascular model and compared to a predicate. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Corrosion Resistance | Catheter must be corrosion resistant per ISO 10555-1, Annex A. | The APRO 70 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 Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Catheter met the acceptance criteria. |
| Sensitization (Guinea Pig) | Did not elicit a sensitization response. | Non-sensitizing |
| Irritation/Intracutaneous Reactivity | Demonstrated no evidence of irritation. | Non-Irritant |
| Cytotoxicity (MEM Elution, L929 cells) | Did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| Hemolysis - Indirect | No significant differences between the test article and the negative control. | Non-Hemolytic |
| Hemolysis - Direct | 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 | Acceptable - during use, the circulating blood dilutes by over 800X the exposure during the test, providing assurance that the use of the APRO 70 Catheter will not constitute a complement activation safety concern. | Acceptable |
| Thrombogenicity | No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential. | Non-thrombogenic |
| 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).