Search Results

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)

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.

Ask a specific question about this device

The Penumbra System™ is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The Penumbra System consists of four devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator, and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump (K051758). Materials used in the Penumbra System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or report a direct device performance metric in a quantifiable manner (e.g., a specific percentage of primary endpoint success that the device had to meet). Instead, it states that the device "met the specifications and the outcome measures of the clinical protocol."

The document focuses on demonstrating substantial equivalence to predicate devices. This means the acceptance criteria are implicitly linked to the performance and safety profile of the predicate devices. The "performance" reported is that the device was found to be substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed..." However, it does not specify the sample size used for the clinical study (test set).

Regarding data provenance, the document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely to be a prospective clinical study, though this is not explicitly confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications. It only refers to a "clinical study" without detailing its design or evaluation methodology.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. This is logical as the device is a medical device (catheter system) for mechanical thrombectomy, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone (algorithm-only) performance study. The Penumbra System is a physical medical device (catheter) used in a medical procedure, not an algorithm.

7. Type of Ground Truth Used

The document refers to a "clinical study" and "outcome measures of the clinical protocol." For a device like the Penumbra System, the ground truth for revascularization would typically be established by:

• Imaging results: Post-procedure angiographic assessments (e.g., TIMI score, mTICI score) to determine the degree of reperfusion.
• Clinical outcomes data: Such as modified Rankin Scale (mRS) scores at 90 days to assess functional independence, and potentially NIHSS scores to assess neurological deficit.

However, the document does not explicitly state the specific type of ground truth used, beyond implying it followed clinical protocol outcomes.

8. Sample Size for the Training Set

The document does not mention a "training set" as it is describing a physical medical device and its clinical evaluation, not an AI model.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), this information is not applicable to the provided document.

Ask a specific question about this device