(197 days)
The Penumbra System / Penumbra System MAX are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal caroiid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use for clarity.
. Added Summary of PIVITOL Trial Clinical Data
. Moved a precaution statement to the Warnings section
Added statement that the use of a Separator may not be needed for . Reperfusion Catheters with an I.D. of 0.054in or larger.
The provided 510(k) summary (K133317) for the Penumbra System / Penumbra System MAX primarily focuses on modifications to the Instructions for Use (IFU) and demonstrates substantial equivalence to predicate devices, rather than presenting a comprehensive study proving the device meets explicit acceptance criteria in a clinical or imaging performance context typically seen for AI/ML devices.
However, based on the non-clinical data provided, we can infer the implied acceptance criteria and the study that addresses these criteria for the modifications being sought. The "device" in this context refers to the Penumbra System / Penumbra System MAX with the clarified IFU.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Catheter Tip Pressure: Aspiration pressure at the distal tip of the Reperfusion Catheters equals the pressure set at the pump. | The aspiration pressure at the distal tip of the Reperfusion Catheters was equal to the pressure set at the Pump. |
| Aspiration Flow Rate: Flow rate through the Reperfusion Catheter is consistently higher without the Separator present in the lumen (for 054, 5MAX & 5MAX ACE). | The flow rate was consistently higher without the presence of the Separator in Lumen. |
| Clot Removal (without Separator): Reperfusion Catheters (054, 5MAX & 5MAX ACE) are able to completely remove clot without the use of a Separator in a simulated environment. | All Reperfusion Catheters were able to completely remove the clot without the use of a Separator. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of devices or trials beyond "All Sizes" for catheter tip pressure and "(054, 5MAX & 5MAX ACE)" for aspiration flow rate and clot removal. This suggests testing was performed on representative models of these specific catheter sizes.
- Data Provenance: The tests were non-clinical, using "a glass model" for clot removal. The data provenance is laboratory-based, performed by the manufacturer, Penumbra, Inc., located in Alameda, CA, USA. This is a retrospective analysis of device function, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This was non-clinical engineering testing. The "ground truth" was established by direct physical measurements of pressure and flow rates, and direct observation of clot removal in a simulated environment. No human expert interpretation was required for establishing these performance metrics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this was non-clinical engineering testing, not a clinical study involving human interpretation or subjective assessment.
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
Not applicable. This submission is for a physical medical device (thrombus removal catheter) and its updated instructions for use, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests was based on physical measurements and direct observation against predetermined engineering specifications and functional outcomes (e.g., complete clot removal, pressure equality, higher flow rate).
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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).