(210 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. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Penumbra 3D Revascularization Device
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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
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 Aspiration Pump.
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 3D Revascularization Device
- Penumbra Aspiration Pump
- . Penumbra Aspiration Pump Canister/Tubing
- Penumbra Aspiration Tubing
- Penumbra Separator .
The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. 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 Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.
The provided text describes specific acceptance criteria and performance data for the Penumbra System (Reperfusion Catheter RED 72). However, it notes that no animal or clinical studies were conducted for this particular device submission (K242104). The evidence for meeting acceptance criteria comes solely from bench and biocompatibility testing. Therefore, information regarding sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, which are typically associated with clinical or AI/algorithm performance studies, are not applicable or available in this document.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Test | Units meet all dimensional and visual product specifications. | Acceptance Criteria Met |
| Friction Test | Units meet product specification related to friction. | Acceptance Criteria Met |
| Radiopacity Test | Markerband is fluoroscopically visible. | Acceptance Criteria Met |
| Simulated Use Test | Functionality of units using clinically relevant benchtop model. | Acceptance Criteria Met |
| Particulate and Coating Integrity Test | Particulates generated during simulated use and coating integrity after simulated use (including multiple deployment cycles) were evaluated. | Acceptance Criteria Met |
| Hub/Air Test | Units have no leaks when tested. | Acceptance Criteria Met |
| Tensile Test | Units meet product specification related to tensile strength. | Acceptance Criteria Met |
| Pressure Test | Units meet product specification related to pressure. | Acceptance Criteria Met |
| Elongation Test | Units meet product specification related to elongation. | Acceptance Criteria Met |
| Corrosion Resistance Test | No visible corrosion on the units when tested. | Acceptance Criteria Met |
| Torque Strength Test | Units have sufficient torque strength. | Acceptance Criteria Met |
| Burst Pressure Test | Units can withstand sufficient pressure. | Acceptance Criteria Met |
| Distal Tip Stiffness Test | Units have distal tip stiffness comparable to the reference device. | Acceptance Criteria Met |
| Kink Resistance Test | Units meet product specification related to kink resistance. | Acceptance Criteria Met |
| Simulated Use Physician Usability Test | Usability of units in clinically relevant benchtop model. | Acceptance Criteria Met |
| Shelf Life | Expiration date based on accelerated aging test studies. | Acceptance Criteria Met |
| Packaging Validation | Packaging of the units meets all product specifications. | Acceptance Criteria Met |
| Sterilization Test | Units are sterilized in accordance with ISO 11135+A1 and ISO 10993-7. | Acceptance Criteria Met |
| Biocompatibility Tests | ||
| Cytotoxicity: MEM Elution | Sample extracts must have a cytotoxic reactivity score of Grade 2 or lower. | Pass (Non-cytotoxic) |
| Sensitization: Magnusson-Kligman Method | Test group shall yield Grade 10% in 3 or more animals. | Pass (Non-toxic) |
| Systemic Toxicity: Material-Mediated Pyrogen | Sample extracts must not cause a total rise in body temperature of ≥ 0.5 °C. | Pass (Non-pyrogenic) |
| Hemocompatibility: In-vitro Thrombogenicity | Device must not be thrombogenic in vitro when compared to a predicate device. | Pass (Comparable to the predicate) |
| Hemocompatibility: Partial Thromboplastin Time (PTT) | Clotting times of test article must be similar to predicate values. | Pass (Comparable to the predicate) |
| Hemocompatibility: Complement Activation | The concentration of SC5b-9 of test article must be similar to predicate values. | Pass (Non-activator of the complement system) |
| Hemocompatibility: Hemolysis (indirect contact) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Pass (Non-hemolytic) |
| Hemocompatibility: Hemolysis (direct contact) | Sample must be non-hemolytic (≤ 2% hemolytic index). | Pass (Non-hemolytic) |
| Hemocompatibility: Platelet and Leukocyte Count | Sample must meet the requirements of ASTM F2888-19, Standard Practice for Platelet Leukocyte Count. | Pass (Similar to the predicate) |
2. Sample size used for the test set and the data provenance: Not applicable. The document states that "No animal or clinical study was conducted as bench and biocompatibility testing were determined sufficient for verification and validation purposes." The tests listed are primarily bench (in-vitro) tests on manufactured units or material samples. The specific number of units or samples tested for each bench test is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards, and specified material properties, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable. Adjudication methods are typically employed in clinical studies or studies involving human assessment of data, which were not performed in this case.
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 MRMC study was performed as this device is a physical medical device (catheter system) and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
* Bench Testing: Engineering specifications, material properties, and functionality performance standards.
* Biocompatibility Testing: Established biological safety standards (ISO 10993 series, USP standards, 21 CFR Part 58 GLP).
8. The sample size for the training set: Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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).