(178 days)
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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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) 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.
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra System® is comprised of the following devices:
- Penumbra Reperfusion Catheter .
- . Penumbra Aspiration Pump
- Penumbra Aspiration Pump/Canister Tubing .
- . Penumbra Aspiration Tubing
- Penumbra Separator .
- Penumbra 3D Revascularization Device .
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
This document is a 510(k) Summary for the Penumbra System (Reperfusion Catheter RED 62). It asserts substantial equivalence to predicate devices based on bench testing. The information provided is characteristic of a Class II medical device submission, which generally focuses on non-clinical performance data unless clinical data is deemed necessary to establish substantial equivalence.
Based on the provided text, the device in question is a physical medical device (catheter) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device performance, such as ground truth establishment with experts, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
Here's an analysis of the provided document regarding acceptance criteria and study proof:
1. A table of acceptance criteria and the reported device performance:
The document provides a table of "Design Verification Tests" and their conclusions. The "Acceptance Criteria" themselves are not explicitly detailed in numerical or categorical form within this table, but the "Conclusion" column consistently states "Acceptance Criteria Met," implying that internal, predefined criteria were satisfied.
| Test | Test Method Summary | Reported Performance / Conclusion |
|---|---|---|
| Dimensional/Visual Test | Confirms the units meet all dimensional and visual product specifications. | Acceptance Criteria Met |
| Friction Test | Confirms units meet product specification related to friction. | Acceptance Criteria Met |
| Fluoroscopy Test | Confirms the marker band is fluoroscopically visible. | Acceptance Criteria Met |
| Simulated Use Test | Confirms the functionality of units using clinically relevant benchtop model. | Acceptance Criteria Met |
| Particulate Test | Particulates generated during simulated use (including multiple deployment cycling) were evaluated. | Acceptance Criteria Met |
| Hub Air Test | Confirms units have no leaks when tested. | Acceptance Criteria Met |
| Tensile Test | Confirms units meet product specification related to tensile strength. | Acceptance Criteria Met |
| Pressure Test | Confirms units meet product specification related to pressure. | Acceptance Criteria Met |
| Elongation Test | Confirms units meet product specification related to elongation. | Acceptance Criteria Met |
| Corrosion Resistance Test | Confirms there is no visible corrosion on the units when tested. | Acceptance Criteria Met |
| Torque Strength Test | Confirms units have sufficient torque strength. | Acceptance Criteria Met |
| Burst Pressure Test | Confirms units can withstand sufficient pressure. | Acceptance Criteria Met |
| Distal Tip Stiffness Test | Confirms units have appropriate distal tip stiffness. | Acceptance Criteria Met |
| Shelf-Life | Confirms expiration date based on accelerated aging test studies. | Acceptance Criteria Met |
| Packaging Validation Test | Confirms the packaging of the units meet all product specifications | Acceptance Criteria Met |
| Sterilization Test | Confirms the units are sterilized in accordance with ISO 11135 and ISO 10993-7. | Acceptance Criteria Met |
| Biocompatibility Tests | ||
| Cytotoxicity: MEM Elution (ISO 10993-5) | No evidence of cell lysis or toxicity (Grade = 0, Reactivity None). | Pass |
| Sensitization: Magnusson-Kligman Method (ISO 10993-10) | Both Test Group & Control Group Grade = 0. None of the treated or negative control animals exhibited any reaction at the challenge. The positive control article elicited discrete reactions in all animals. | Pass |
| Irritation: Intracutaneous Reactivity (ISO 10993-10) | None of the animals exhibited overt signs of toxicity at any of the observation points. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. | Pass |
| Systemic Toxicity: Acute Systemic Injection (ISO 10993-11) | No evidence of systemic toxicity from sample extracts. (No deaths; No signs consistent with toxicity; No weight loss > 10%). | Pass |
| Systemic Toxicity: Material Mediated Pyrogen (ISO 10993-11) | Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5 °C. | Pass |
| Hemocompatibility: In-vitro Thrombogenicity (ISO 10993-4) | Device non-thrombogenic in vitro when compared to a predicate device. | Pass |
| Hemocompatibility: Partial Thromboplastin Time (PTT) (ISO 10993-4) | Test article coagulation times are statistically similar to predicate. | Pass |
| Hemocompatibility: Complement Activation (ISO 10993-4) | Test article concentrations of Sc5b-9 are statistically similar to predicate. | Pass |
| Hemocompatibility: Hemolysis, indirect contact (ISO 10993-4) | Hemolytic Index = 0.00%. | Pass |
| Hemocompatibility: Hemolysis, direct contact (ISO 10993-4) | Hemolytic Index = 0.00%. | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact sample size (number of units tested) for each of the design verification and biocompatibility tests. It broadly states "the units" were tested. This is common for bench testing summaries where detailed test reports would contain specific sample sizes.
- Data Provenance: The data is from "Design Verification Testing" and "Biocompatibility" studies, which are typically performed in a laboratory setting by the manufacturer (Penumbra, Inc., Alameda, CA, USA). The studies are retrospective from the perspective of this 510(k) submission, meaning they were completed prior to the submission. The document does not specify the country of origin of where the testing itself was performed, but it references ISO standards and FDA GLP, implying internationally recognized practices. This is 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):
This question is Not Applicable to this submission. This is a submission for a physical medical device (catheter) based on bench testing (performance and biocompatibility), not an AI/ML device that requires human expert review for establishing ground truth on image or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is Not Applicable. As stated above, this is bench testing of a physical device. There is no "ground truth" to be adjudicated by multiple readers or experts in the context of diagnostic agreement. The "acceptance criteria met" indicates that the device met pre-defined engineering and safety specifications.
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:
This question is Not Applicable. This is not an AI/ML device, and no MRMC study was conducted or required. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This question is Not Applicable for the type of device and studies presented. The "ground truth" for this device is its adherence to engineering specifications, material properties, and biological safety standards, verified through objective bench tests (e.g., measurements for dimensions, leak tests, tensile strength tests, chemical analysis for biocompatibility). There is no "expert consensus" on imaging or clinical outcomes data required to validate the device's fundamental performance.
8. The sample size for the training set:
This question is Not Applicable. This is not an AI/ML device, so there is no training set mentioned or used.
9. How the ground truth for the training set was established:
This question is Not Applicable. As there is no training set (being a physical medical device and not an AI/ML device), no ground truth was established for it.
§ 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).