(97 days)
Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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 Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] 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 Penumbra Pump MAX 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 Penumbra Pump MAX, 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 Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.
The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the KIT configuration, as that's where new testing was performed:
1. Table of Acceptance Criteria and Reported Device Performance (KIT Configuration)
| Attribute | Specification | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Products meet all inspection criteria. | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal) | Simulated use testing of the Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. | Devices effectively remove clots and catheters do not collapse under vacuum. | 100% Pass |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after simulated use. | Coating remains intact (not delaminated, peeled, or flaked). | 100% Pass |
| Gross Leak | Pouch seals, pouch front, and pouch back material do not leak. | No leaks in pouch seals, front, or back material. | 100% Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the "Design Verification testing" for the KIT configuration. It only mentions "units used in this Design Verification testing" for Visual Inspection, and implicitly for Simulated Use, Catheter Coating, and Gross Leak tests as they all report 100% Pass.
- Sample Size: Not explicitly stated as a number, but all tested units passed.
- Data Provenance: The tests are described as "additional testing performed for the KIT configuration packaging," suggesting these are prospective, benchtop tests conducted by Penumbra, Inc. The country of origin for the data generation would logically be the USA, given the company's location.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or clinicians being used to establish a ground truth for these non-clinical tests. The tests are focused on physical and mechanical properties and simulated use in anatomical models.
4. Adjudication Method for the Test Set
Not applicable, as these are non-clinical, objective tests and not based on expert review or consensus.
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
Not applicable. This document describes a medical device (Penumbra System and Penumbra Pump MAX) for treating acute ischemic stroke, not an AI-based diagnostic or treatment guidance system that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for these non-clinical tests is based on:
* Defined specifications and performance expectations: For Visual Inspection, Catheter Coating, and Gross Leak, the "ground truth" is adherence to predefined quality and integrity standards.
* Simulated physiological conditions and objective performance: For Simulated Use, the "ground truth" is the effective removal of clots and prevention of catheter collapse in an anatomical model that mimics neurovasculature.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model requiring 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).