(169 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 designed to remove thrombus from large intracranial vessels by aspirating the proximal side of the thrombus using the Penumbra Reperfusion Catheter, Penumbra Separator, 3D Revascularization Device, Penumbra Aspiration Tubing, and Penumbra Aspiration Pump. The Penumbra System was most recently cleared under K162901.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The 3D Revascularization Device is used with the 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 I.D. of 0.054in 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 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Separator is advanced and retracted through the 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 Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
The Penumbra Engine Pump and Canister
The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Penumbra System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stopflow filter to prevent excess fluid from entering the patient port on the lid is sized to accept the Suction Connector on the Penumbra Aspiration Tubing.
The Penumbra System is designed to remove thrombus from large intracranial vessels. The provided text outlines the acceptance criteria and the study conducted for the Penumbra Engine Pump and Canister, which are components of the Penumbra System.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Specification | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Pump - Electrical Safety | Conforms to IEC 60601-1 and IEC 60601-1-2 requirements, including international worldwide variants (CB Scheme). Compliant with EN ISO 10079-1. | 100% Pass | 100% Pass |
| Pump - Environmental Testing | Pump performance specifications under environmental conditions. | 100% Pass | 100% Pass |
| Pump - Dimensional Inspection | Dimensional specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump - Inspection of Design Features | Design specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump - Performance | Performance specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump - Performance at variable voltage and frequency | Performance specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump and Canister - 500-hour Use Testing | Performance specifications after 500-hour use. | 100% Pass | 100% Pass |
| Pump Canister - Inspection of Design Features | Design specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump Canister - Performance | Performance specifications per Product Specification. | 100% Pass | 100% Pass |
| Pump and Canister - Simulated Use | Pump and Canister use specifications. | 100% Pass | 100% Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The sample size for most tests for the Penumbra Engine Pump and Canister was N=5. The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated in the provided text. However, the testing was conducted by Intertek, a nationally recognized test laboratory, suggesting the testing likely adheres to international standards. The studies appear to be prospective bench-top and simulated use tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluation focuses on the engineering and performance specifications of the device components (Penumbra Engine Pump and Canister) through bench-top and simulated use testing, not on clinical performance requiring expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluation involved objective engineering and performance tests with predefined acceptance criteria. There was no need for expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The provided text focuses on the device's engineering performance rather than its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone performance study was done for the Penumbra Engine Pump and Canister, as all tests listed in the table above evaluate the device's intrinsic characteristics without human intervention influencing its core function during the test.
7. Type of Ground Truth Used:
The ground truth used was based on design specifications, risk analysis, performance standards, and guidance documents for the engineering and performance characteristics of the pump and canister. For electrical safety, the ground truth was compliance with IEC 60601-1 and IEC 60601-1-2 requirements.
8. Sample Size for the Training Set:
This information is not applicable as the described studies are for verification and validation of manufactured device components and do not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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).