(28 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 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 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 is a 510(k) summary for the APRO 70 Catheter and Alembic Aspiration Tubing. This type of submission is for medical devices, not AI/ML-based software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and study data typical for AI/ML performance (e.g., ground truth establishment, expert adjudication, MRMC studies, training set details) are not applicable to this document.
The document describes the device, its intended use, and demonstrates substantial equivalence to a predicate device through non-clinical bench testing. The performance data is focused on the physical characteristics and functional integrity of the catheter and tubing.
Here's an analysis based on the information provided for this medical device:
1. Table of Acceptance Criteria and 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 | 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. |
| 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. |
| 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. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each non-clinical bench test. It states "Alembic performed non-clinical bench testing in accordance with design controls, protocol, and test methods". The data provenance is non-clinical bench testing; it's not patient-derived data, so country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as understood in AI/ML is not relevant for this type of medical device bench testing. The "ground truth" for these tests is defined by established engineering and material science specifications, and ISO standards (e.g., ISO 10555-1), not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described for these bench tests. The results are based on quantitative measurements and observations against pre-defined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device, not an AI/ML-based software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The study presented here is focused on demonstrating the physical and functional performance of the catheter and tubing, and its substantial equivalence to a predicate device through non-clinical bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance documented is that of the physical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this medical device is based on:
- Pre-defined engineering and material specifications.
- Compliance with recognized standards (e.g., ISO 10555-1).
- Functional performance criteria observed during bench testing (e.g., freedom from kinking, maintaining vacuum).
- Comparison to the performance of a legally marketed predicate device in some tests (e.g., Particulate, Delivery and Retrieval Force, Tip Buckling Force sections mention comparison to a predicate).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 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).