(28 days)
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 MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The Penumbra System® MAX components are additional components of the currently available Penumbra System. The summary of non-clinical data details the testing that substantiates the safe and effective performance of the Neuron MAX System and its substantial equivalence to predicate devices. This includes Biocompatibility testing, Design Verification (Bench-Top Testing), and an Animal study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria for each test were "Pass," meaning the device met the established requirements for each attribute.
| Test / Test Subject | Attribute | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity | No evidence of cell lysis or toxicity | No evidence of cell lysis or toxicity |
| Acute Intracutaneous Reactivity (Irritation) | No evidence of irritation | No evidence of irritation |
| Acute Systemic Toxicity | No evidence of systemic toxicity | No evidence of systemic toxicity |
| Rabbit Pyrogen Study | No evidence of material-mediated pyrogenicity | No evidence of material-mediated pyrogenicity |
| Sensitization | Non-Sensitizing | Non-Sensitizing |
| Hemo-compatibility - In Vitro Hemolysis | Non-hemolytic | Non-hemolytic |
| Hemo-compatibility - In Vitro Coagulation (PT, PTT) | Coagulation times are within the normal range; Non-Thrombogenic | Within normal range; Non-Thrombogenic |
| Hemo-compatibility - Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Bench-top Testing (Reperfusion Catheters) | ||
| Pouch Seal | Pouch Seal Strength | Pass |
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use [Intracranial Access & Thrombus Removal] | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Hub /Shaft & Hub / HypotubeTensile Strength | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Joint Tensile Strength | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Hub Air Aspiration | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Burst Test | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Particulate Testing (Hydrophilic Coating) | Pass |
| Reperfusion Catheter4MAX / Sheath or 8F Guide compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 4MAX / 0.014" Guidewire compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 054 (Friction Force) | Friction Force | Pass |
| Reperfusion Catheter 3MAX / 0.014" Guide wire compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Flow Rate | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Elongation to Failure | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Corrosion | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Torsion | Pass |
| Bench-top Testing (Separator 3MAX) | ||
| Dimensional / Visual Inspection (all sizes) | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use: Hub Transition | Pass | |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Tracking | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX & Reperfusion Catheter Compatible | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX / Reperfusion Catheter / Pump and accessories / Aspiration Tubing (Aspiration Remove Clot) | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX and Reperfusion Catheter Compatibility (Separator Advance / Retract) | Pass |
| Separator Bond Joint Test | Separator 054 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 041 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 032 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 026 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 3MAX and Wire Joint Break Force | Pass |
| Animal Study | ||
| Safe use of Penumbra System MAX in swine model | No vessel injury noted on final angiograms following the vessel response procedure. No abnormal gross or histology findings in test vessel segments. No significant vascular response. | No vessel injury; No abnormal findings; No significant vascular response |
2. Sample Size Used for the Test Set and the Data Provenance
- Bench-top Testing: Sample sizes for individual tests ranged from 3 to 30 units (e.g., N=30 for Pouch Seal Strength, N=10 for Particulate Testing, N=3 for Flow Rate). The data provenance is internal laboratory testing ("All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements."). This is considered retrospective data from a manufacturing/design verification process.
- Biocompatibility Testing: The document does not specify exact sample sizes for each biocompatibility test but states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," which implies standard laboratory animal testing where applicable (e.g., Rabbit Pyrogen Study, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization). This data is from controlled laboratory experiments.
- Animal Study: The document mentions "An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model." The exact sample size for the animal study is not explicitly provided in the summary, but it refers to "experimental conditions" and "test vessel segments," suggesting a controlled study within a lab setting. This is prospective animal data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. The studies described are non-clinical (bench-top, biocompatibility, animal studies) and do not involve human diagnostic or treatment decision-making where expert consensus would establish ground truth for a test set. The "ground truth" here is determined by objective physical, mechanical, biological, or physiological measurements against predefined engineering and biological safety standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are non-clinical studies. The results are objective measurements/observations (e.g., "Pass," "No evidence of toxicity," "No vessel injury") rather than interpretations requiring adjudication among human experts.
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 the safety and effectiveness testing of a physical medical device (catheter system) for mechanical thrombus removal, not an AI or imaging-based diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these non-clinical studies was established by:
- Predefined engineering specifications and performance parameters for mechanical and physical properties.
- Established international and national standards for biocompatibility (e.g., ISO 10993, USP, ASTM, 21 CFR Part 58).
- Physiological observations, angiographic evaluations, gross pathology, and histology in the animal model.
8. The Sample Size for the Training Set
Not applicable. This document refers to the testing of a physical medical device. There is no "training set" in the context of machine learning or AI. The design verification and biocompatibility testing involved various "test units" or "samples" for specific tests, as detailed in the table, to ensure the device met its design specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as #8. Ground truth in this context refers to the defined specifications and standards the device was designed to meet and was tested against.
§ 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).