(80 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 intravenous tissue plasminogen activator (IV t-PA 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA 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 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 describes the acceptance criteria and study proving the performance of the Penumbra System® (Reperfusion Catheter RED™ 72). It is a 510(k) summary, indicating that the device is being cleared based on substantial equivalence to a legally marketed predicate device, rather than requiring a full premarket approval (PMA) with extensive clinical trials.
It's important to note that because this is a 510(k) submission based on substantial equivalence to an existing device (the Penumbra System (Reperfusion Catheter JET 7)), the studies primarily focus on engineering and biocompatibility performance data against established requirements, rather than clinical efficacy studies often seen with novel AI devices. There are no AI/ML components described in this document, thus the requested information regarding MRMC studies, standalone AI performance, human expert ground truth for imaging, and training/test set sample sizes for AI models are not applicable.
Here's the breakdown of the acceptance criteria and study details provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a series of design verification tests and biocompatibility tests. The acceptance criteria for each test are stated, and the conclusion is consistently that the "Acceptance Criteria Met" or "Pass."
Design Verification Testing:
| Test | Test Method Summary | Acceptance Criteria Met (Reported Performance) |
|---|---|---|
| Dimensional/Visual Test | Confirms the units meet all dimensional and visual product specifications. | Yes |
| Friction Test | Confirms units meet product specification related to friction. | Yes |
| Fluoroscopy Test | Confirms the markerband is fluoroscopically visible. | Yes |
| Simulated Use Test | Confirms the functionality of units using clinically relevant benchtop model. | Yes |
| Particulate Test | Particulates generated during simulated use (including multiple deployment cycling) were evaluated. | Yes |
| Hub/Air Test | Confirms units have no leaks when tested. | Yes |
| Tensile Test | Confirms units meet product specification related to tensile strength. | Yes |
| Pressure Test | Confirms units meet product specification related to pressure. | Yes |
| Elongation Test | Confirms units meet product specification related to elongation. | Yes |
| Corrosion Resistance Test | Confirms there is no visible corrosion on the units when tested. | Yes |
| Torque Strength Test | Confirms units have sufficient torque strength. | Yes |
| Burst Pressure Test | Confirms units can withstand sufficient pressure. | Yes |
| Shelf-Life | Confirms expiration date based on accelerated aging test studies. | Yes |
| Sterilization Test | Confirms the units are sterilized in accordance with ISO 11135 and ISO 10993-7. | Yes |
Biocompatibility Testing (Based on predicate/reference devices):
| Tests | Acceptance Criteria | Pass/Conclusion (Reported Performance) |
|---|---|---|
| Cytotoxicity: MEM Elution (ISO 10993-5) | Sample extracts must have a cytotoxic reactivity score of grade 2 or lower. | Pass (Non-cytotoxic) |
| Sensitization: Magnusson-Kligman Method (ISO 10993-10) | Test Group shall yield Grade 10% in 3 or more animals. | Pass (Non-toxic) |
| Systemic Toxicity: Material Mediated Pyrogen (ISO 10993-11) | Sample extracts must not cause a total rise in body temperature of ≥ 0.5°C. | Pass (Non-pyrogenic) |
| Hemocompatibility: Thrombogenicity (ISO 10993-4) | The test article must have similar or less thrombus formation than predicate. | Pass (Non-thrombogenic) |
| Hemocompatibility: Partial Thromboplastin Time (PTT) (ISO 10993-4) | Clotting times of test article must be similar to predicate values. | Pass (Hemocompatible) |
| Hemocompatibility: Complement Activation (ISO 10993-4) | The concentration of SC5b-9 of test article must be similar to predicate values. | Pass (Hemocompatible) |
| Hemocompatibility: Hemolysis, indirect contact (ISO 10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Pass (Non-hemolytic) |
| Hemocompatibility: Hemolysis, direct contact (ISO 10993-4) | Sample must be non-hemolytic (≤ 2% hemolytic index). | Pass (Non-hemolytic) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units) used for each design verification bench test, as is typical for 510(k) summaries of mechanical devices. However, it indicates that units were tested. The data provenance would be from internal testing conducted by Penumbra, Inc. (the manufacturer). This is a retrospective evaluation of the device's physical and functional properties. There is no indication of country of origin for specific test data beyond the manufacturer being in Alameda, California, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission is for a mechanical medical device (catheter system), not an AI/ML device that requires human expert annotation for ground truth in image analysis. The "ground truth" for this device's performance is established by objective physical and chemical testing against engineering specifications and international standards (e.g., ISO, USP).
4. Adjudication Method for the Test Set
Not applicable. As there are no human expert readings or interpretations involved in the performance data presented (it's benchmark and material testing), there is no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a mechanical catheter system for stroke intervention, not an AI/ML diagnostic tool. Therefore, no such study was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This refers to the standalone performance of an AI algorithm. Since this is a mechanical device, this concept is not applicable. The standalone "performance" refers to the device meeting its physical and functional specifications during bench testing.
7. The Type of Ground Truth Used
The "ground truth" used for this device's performance evaluation comes from engineering specifications, international standards (e.g., ISO 10993 series), and validated test methods. This includes:
- Pre-defined dimensional and visual product specifications.
- Measured physical properties (friction, tensile strength, pressure, elongation, torque, burst pressure).
- Chemical and biological properties (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) determined through laboratory assays adhering to GLP (Good Laboratory Practices) and ISO standards.
- Functionality in simulated clinical use benchtop models.
8. The Sample Size for the Training Set
Not applicable. This refers to a training set for an AI model. This device is a mechanical medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI training set, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles, materials science, and medical device regulations.
§ 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).