(95 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) or who fail 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 3D Revascularization Device
- Penumbra Aspiration Pump
- Penumbra Aspiration Pump Canister
- Penumbra Aspiration Tubing
- Penumbra Separator
The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature 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. [1.37 mm] 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 Aspiration Pump Canister. 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.
The Penumbra System (Reperfusion Catheter RED 43) is a medical device used for the revascularization of patients with acute ischemic stroke. The device's acceptance criteria and performance were evaluated through a series of design verification tests, as detailed in the FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method Summary | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Confirms the units meet all dimensional and visual product specifications. | Met | Acceptance Criteria Met |
| Confirms units meet product specification related to friction. | Met | Acceptance Criteria Met |
| Confirms the markerband is fluoroscopically visible. | Met | Acceptance Criteria Met |
| Confirms the functionality of units using clinically relevant benchtop model. | Met | Acceptance Criteria Met |
| Particulates generated and coating integrity during simulated use (including multiple deployment cycling) were evaluated. | Met | Acceptance Criteria Met |
| Confirms units have no leaks when tested. | Met | Acceptance Criteria Met |
| Confirms units meet product specification related to tensile strength. | Met | Acceptance Criteria Met |
| Confirms units meet product specification related to pressure. | Met | Acceptance Criteria Met |
| Confirms units meet product specification related to elongation. | Met | Acceptance Criteria Met |
| Confirms there is no visible corrosion on the units when tested. | Met | Acceptance Criteria Met |
| Confirms units have sufficient torque strength. | Met | Acceptance Criteria Met |
| Confirms units can withstand sufficient pressure. | Met | Acceptance Criteria Met |
| Confirms units have appropriate distal tip stiffness. | Met | Acceptance Criteria Met |
| Confirms expiration date based on accelerated aging test studies. | Met | Acceptance Criteria Met |
| Confirms the packaging of the units meet all product specifications. | Met | Acceptance Criteria Met |
| Confirms the units are sterilized in accordance with ISO 11135+A1 and ISO 10993-7 | Met | Acceptance Criteria Met |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the design verification. It only indicates that "the subject device met all established requirements."
The data provenance is from benchtop testing, which is a prospective method of evaluation performed in a controlled laboratory setting. There is no mention of country of origin for the data as it's not a clinical study.
3. Number of Experts and their Qualifications for Ground Truth:
This information is not provided in the document as the device's performance was evaluated through benchtop testing, not through expert-reviewed clinical data. Therefore, the concept of "experts establishing ground truth" in the context of clinical outcomes or imaging interpretations does not apply here.
4. Adjudication Method for the Test Set:
The concept of an adjudication method (like 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Since the testing involved design verification and benchtop methods, such an adjudication method was not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers' improvement with AI assistance.
6. Standalone Performance:
The performance described is essentially standalone (algorithm only without human-in-the-loop performance), as it pertains to the physical and functional characteristics of the device itself as evaluated through bench testing. There is no "human-in-the-loop" component in the described verification tests.
7. Type of Ground Truth Used:
The ground truth used was based on ** predefined product specifications and established test methods** (e.g., ISO standards, internal design requirements) for each performance criterion. This is a form of technical and engineering ground truth rather than clinical, pathological, or outcomes data.
8. Sample Size for the Training Set:
A "training set" is typically associated with machine learning or AI models. Since this submission focuses on the physical device's performance through bench testing and explicitly states no animal or clinical studies were conducted, there is no mention or relevance of a training set in this context.
9. How the Ground Truth for the Training Set Was Established:
As there was no training set for an AI model, the concept of establishing ground truth for a training set is not applicable to this submission.
§ 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).