(28 days)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
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 document describes the Penumbra System ACE 68 Reperfusion Catheter and its substantial equivalence to a predicate device. Below is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.
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 | Meet 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) | Reperfusion Catheter does not collapse under vacuum; devices effectively remove clots in an anatomical model which simulated the tortuosity of the neurovasculature. | Pass |
| Particulate testing (≥ 10 µm) | ≤ 6000 particles | Pass |
| Particulate testing (≥ 25 µm) | ≤ 600 particles | Pass |
| Particulate testing (≥ 75 µm) | Measured for informational purposes only (FIPO) | FIPO |
| Particulate testing (≥ 125 µm) | Measured for informational purposes only (FIPO) | FIPO |
| 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 |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after corrosion testing procedure. | Pass |
| Shelf Life | Devices underwent transportation conditioning per ASTM D4169 and accelerated aging equal to 8 months; successful testing verifies 8-month shelf life. | Verified 8 months shelf life |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size for individual tests conducted as part of design verification or shelf-life testing. It merely 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 "all tests passed successfully."
The data provenance is from bench-top testing conducted by the manufacturer, Penumbra, Inc. This is prospective data generated specifically for the device submission. The country of origin of the data is not specified beyond being generated by Penumbra, Inc. in Alameda, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
No information is provided regarding the number of experts or their qualifications for establishing ground truth for the test set. The tests described are primarily physical and mechanical properties and simulated use, not diagnostic interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective physical and mechanical tests rather than subjective evaluations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this device. The study focused on the physical and mechanical performance of the device and its substantial equivalence to a predicate, not on a human-in-the-loop performance with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this device is a medical catheter system, not an AI algorithm. Therefore, an algorithm-only standalone performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth used for these tests are engineering specifications, physical measurements, and observable outcomes (e.g., no kinking, fluoroscopic visibility, no leaks, effective clot removal in a simulated environment, no corrosion, specific pressure resistance values). For "Simulated Use," the ground truth is whether the device performed as expected in the anatomical model (e.g., did not collapse, removed clots).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm requiring 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).