(28 days)
The APRO 45 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 45 Catheter to the aspiration pump.
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 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 45 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 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
The Alembic Aspiration Tubing connects the APRO 45 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 document is a 510(k) clearance letter and summary for the APRO 45 Catheter and Alembic Aspiration Tubing. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. As such, it does not contain information typically found in studies proving a device meets acceptance criteria related to clinical performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, many of the requested sections will state that the information is not available or not applicable based on the provided document.
Acceptance Criteria and Reported Device Performance
The study supporting this 510(k) clearance relied on non-clinical bench testing to demonstrate that the APRO 45 Catheter and Alembic Aspiration Tubing meet predefined specifications and perform as intended. The acceptance criteria and reported device performance are detailed in Table 2 (Summary of Non-Clinical Bench Test Results) of the 510(k) Summary.
Table of Acceptance Criteria and Reported Device Performance (from Table 2):
| 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. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip. | 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. |
| Catheter Hub 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. |
| Catheter 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. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to a predicate. | The APRO 45 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 45 Catheter and Alembic Aspiration Tubing 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. |
Additional Requested Information:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each bench test conducted. It refers to "the subject device and predicate device" for comparisons, implying relevant samples were used for laboratory testing.
- Data Provenance: The data is from non-clinical bench testing and simulated use in anatomical neurovascular models, conducted by Alembic, LLC. It is by nature prospective experimental data, not patient-derived.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical bench study. The "ground truth" was established by predefined engineering specifications and international standards (e.g., ISO), not by expert human interpretation of medical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As a non-clinical bench study, expert adjudication of medical results was not performed. Test results were assessed against predetermined engineering acceptance criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not performed. This is a medical device (catheter and tubing), not an AI diagnostic algorithm, and its clearance was based on non-clinical performance and substantial equivalence to a predicate device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant. The device's performance was evaluated through bench testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench tests, the "ground truth" was defined by established engineering and material specifications, international standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135, ISO 10993-1), and acceptable performance in simulated models (e.g., clot retrieval from an anatomical neurovascular model). This is analogous to a "reference standard" from engineering specifications rather than clinical ground truth like pathology or outcomes.
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The sample size for the training set:
- Not Applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The device development process involves design, prototyping, and iterative testing, not AI model training.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm mentioned, the establishment of ground truth for such a set is not relevant.
§ 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).