(58 days)
The Penumbra System 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.
The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.
The Penumbra System ACE 68 Reperfusion Catheter received 510(k) clearance (K161064) based on substantial equivalence to the previously cleared Penumbra System ACE 68 Reperfusion Catheter (K152541). The study conducted in support of this clearance was a Design Verification (Bench-Top Testing), alongside Shelf Life Testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging Inspection | Confirm the packaging and dimensions of the units meet all product specifications. | Pass |
| Dimensional/Visual | (Implicitly covered by Packaging Inspection - meeting product specifications) | Pass |
| Kink Resistance | No kinking when formed in a defined radius. | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible. | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal) | Simulated use testing of the Reperfusion Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. | Pass (effectiveness of devices to remove clots and no collapse under vacuum confirmed) |
| Particulate testing: ≥ 10 um | ≤ 6000 particles | Pass |
| Particulate testing: ≥ 25 um | ≤ 600 particles | Pass |
| Particulate testing: ≥ 75 um | Measured for informational purposes only (FIPO) | FIPO (results recorded, but no pass/fail criterion) |
| Particulate testing: ≥ 125 um | Measured for informational purposes only (FIPO) | FIPO (results recorded, but no pass/fail criterion) |
| Coating Integrity | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Hub Air Aspiration | No leaks detected when vacuum is pulled on the injection lumen. | Pass |
| Static Burst Pressure Test | 45 psi for 30 sec minimum. | Pass |
| ACE 68 / Sheath or 8F Guide Catheter Friction Force | Minimum value per specification. | Pass |
| ACE 68 / 0.014 in. Guidewire Friction Force | Minimum value per specification. | Pass |
| Joint sections bond strength | Minimum value per specification. | Pass |
| Hub to shaft tensile strength | Minimum value per specification. | Pass |
| Hub to hypotube tensile strength | Minimum value per specification. | Pass |
| Elongation to failure | Elongation ≥ 5%. | Pass |
| Torsion | Number of turns will be recorded for informational purposes only. | FIPO (results recorded, but no pass/fail criterion) |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after corrosion testing procedure. | Pass |
| Shelf Life Testing | Met all established requirements (after transportation conditioning per ASTM D4169 and accelerated aging equal to 8 months). | Successful testing verifies an 8-month shelf life. |
2. Sample size used for the test set and data provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for each individual bench-top test. It generally states that "The physical and mechanical properties of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria." and "The subject ACE 68 Reperfusion Catheters met all established requirements" for shelf life.
- Data Provenance: This was a non-clinical bench-top testing and shelf-life testing. The data is therefore from laboratory simulations and controlled environments, not human subjects. The country of origin for the data is not explicitly stated, but the sponsor is Penumbra, Inc. located in Alameda, CA, USA. This is retrospective in the sense that the device changes were made, and then these verification tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of bench-top engineering testing does not typically involve human experts establishing "ground truth" in the same way clinical studies do. The "truth" is established by adherence to predefined engineering specifications and standard test methods.
- For the "Simulated Use" test, while it involves an "anatomical model which simulated the tortuosity of the neurovasculature," the assessment of "effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum" would be based on objective observation and measurement against predefined criteria rather than subjective expert consensus on clinical outcomes. The document does not mention the involvement or qualifications of experts for defining the ground truth for this non-clinical testing.
4. Adjudication method for the test set
- Not applicable as this was bench-top testing against predefined specifications, not a clinical study requiring adjudication of outcomes by multiple readers or judges.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This document describes the non-clinical (bench-top) testing for a physical medical device (catheter), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used
- The "ground truth" for this non-clinical testing consisted of pre-determined, objective engineering specifications and acceptance criteria. For example, a specific burst pressure (45 psi for 30 sec minimum), specific particulate counts (≤ 6000 for ≥ 10 um), or visual confirmation (no kinking, fluoroscopically visible markerband).
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning study, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI or machine learning study.
§ 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).