FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Penumbra System is intended 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. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

Device Description

The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance	Pass / Fail
Biocompatibility Testing
In Vitro Cytotoxicity	Sample extracts must yield cell lysis grade 2 or lower	Grade 1: Slight	Pass
Sensitization	Test Group shall yield Grade 10% weight loss in 3 or more test animals, Mortality of 2 or more test animals, Abnormal behavior in 2 or more test animals	No evidence of systemic toxicity from sample extracts: No weight loss (all gained weight), No death, All test animals appeared normal	Pass
Rabbit Pyrogen Study	Sample Extracts must not cause a total rise in body temperature of ≥ 0.5°C	Non-pyrogenic: No evidence of material-mediated pyrogenicity; no single animal had a total body temperature rise of ≥ 0.5°C	Pass
Hemocompatibility In Vitro Hemolysis	Sample extracts must be non-hemolytic (≤ 2% hemolytic index)	Non-hemolytic: Hemolytic Index = 0.70%, Corrected Hemolytic index = 0.00%	Pass
Complement Activation	The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate (Exposure Control & Ref Material) control and statistically lower than the positive control for all exposure times	The test sample concentrations of C3a and SC5b-9 were statistically similar or lower than the predicate control sample concentrations, and statistically lower than the positive control sample concentrations at all three exposure times	Pass
Dog Thrombogenicity	The device must be non-thrombogenic after 4 hours in vivo when compared to a control device (Boston Scientific Excelsior SL-10 microcatheter)	No significant thrombosis with a Grade of 0 was observed in 2 out 2 test site and 2 out of 2 control sites. Based on the evaluation criteria, the amount of thrombosis was not considered significant	Pass
Bench-top Testing
Dimensional/Visual Inspection	Units meet all inspection criteria for release of finished goods (clinically acceptable) product.	Pass	Pass
Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal)	Effectiveness of devices to remove clots and that Reperfusion Catheter does not collapse under vacuum.	100% Pass	Pass
Coating Integrity	Coating has not delaminated, peeled, or flaked after simulated use.	100% Pass	Pass
Particulate Testing (Hydrophilic Coating)	Max particles: ≥ 10 um ≤ 6000 particles; ≥ 25 um ≤ 600 particles.	10um 100% Pass; 25 um 100% Pass	Pass
Particulate Testing (Catheter/Separator)	Max particles: ≥ 10 um ≤ 6000 particles; ≥ 25 um ≤ 600 particles.	10μm 100% Pass; 25 um 100% Pass	Pass
Coating Integrity (after particulate testing)	Coating is not grossly damaged after undergoing particulate testing.	100% Pass	Pass
Hub/Catheter Air Aspiration	When negative pressure is pulled, no air may leak into hub.	100% Pass	Pass
Pressure Test	45 psi for 30 sec MIN	100% Pass	Pass
Reperfusion Catheter/Sheath or 8F Guide & 0.014" Guidewire compatibility (Friction Force)	Maximum value per specification.	100% Pass	Pass
Markerband Section Bond Strength	Minimum value per specification.	100% Pass	Pass
Joint Sections Bond Strength	Minimum value per specification.	100% Pass	Pass
Hub to Shaft & Hub to Hypotube Bond Strength	Minimum value per specification.	100% Pass	Pass
Steam-Shaped Distal Tip Tensile	Minimum value per specification.	100% Pass	Pass
Elongation to Failure	% Elongation ≥ 5%	100% Pass	Pass
Kink Resistance	No kinking when formed in a defined radius.	100% Pass	Pass
Corrosion	No visible corrosion on Reperfusion Catheter immediately after Corrosion Testing procedure.	100% Pass	Pass
Animal Study
Vessel Injury	No vessel injury on final angiograms.	No vessel injury was noted.	Pass
Gross/Histology Findings	No abnormal gross or histology findings in test vessel segments.	No abnormal gross or histology findings were noted.	Pass
Vascular Response	No significant vascular response.	No significant vascular response.	Pass

2. Sample Size and Data Provenance (for test sets, where applicable)

Biocompatibility Testing:
- In Vitro Cytotoxicity: Not specified in terms of sample size for the test itself, but implies multiple samples for extract testing.
- Sensitization: "Test Group" - size not specified.
- Acute Intracutaneous Reactivity: "mean test article and mean control score" - implies multiple samples, size not specified.
- Acute Systemic Toxicity: "3 or more test animals" (for weight loss criteria), "2 or more test animals" (for morality/behavior) - implies at least 3 animals for each extract/test (likely mice or rats, as common for this test).
- Rabbit Pyrogen Study: "No single animal" suggests multiple rabbits, specific number not stated.
- Hemocompatibility In Vitro Hemolysis: Sample extracts, size not specified.
- Complement Activation: "test samples" compared to "predicate (Exposure Control & Ref Material) control" and "positive control" at "all three exposure times." Specific number of samples not stated.
- Dog Thrombogenicity: "2 out of 2 test site and 2 out of 2 control sites" - suggests at least two test animals (dogs) for the in-vivo evaluation.
- Data Provenance: Retrospective, conducted by the manufacturer, or by external labs following GLP. Country of origin not specified, but following EN ISO 10993 guidelines.
Bench-top Testing:
- Sample sizes are not explicitly stated for all individual tests, but most indicate "100% Pass," which suggests the testing was performed on a sample of devices and all met the criteria. For particulate testing, the maximum number suggests a specific measurement from a sample.
- Data Provenance: Retrospective, conducted by the manufacturer.
Animal Study:
- Sample Size: A "swine model" was used. The number of individual animals (swine) is not explicitly stated, but the conclusions "No vessel injury was noted on the final angiograms following the vessel response procedure," "No abnormal gross or histology findings were noted in test vessel segments," and "The use of the Penumbra System ACE devices resulted in no significant vascular response in these experimental conditions," suggest sufficient animal subjects were used to support the claim.
- Data Provenance: Prospective, animal study (GLP Animal Testing).

3. Number of Experts Used and Qualifications (for ground truth establishment)

Biocompatibility Testing: Experts in toxicology, microbiology, and animal studies would have been involved in the design and interpretation of these studies. Their specific number and qualifications are not detailed in this summary.
Bench-top Testing: Engineers and material scientists within the manufacturer's R&D and Quality departments would have developed the specifications and assessed the results.
Animal Study: Veterinarians, interventionalists (to perform the procedures), pathologists (for gross and histology findings), and researchers expert in animal models for vascular devices.
Note: This document does not pertain to AI/ML or image data, so the concept of experts establishing ground truth for a test set (e.g., radiologist for image interpretation) as typically understood in AI studies is not directly applicable here. The "ground truth" here is physical/biological measurements and observations.

4. Adjudication Method (for the test set)

Not applicable in the context of this device's non-clinical testing. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation where there is subjective assessment by multiple human readers (e.g., radiologists) that needs to be reconciled to establish a ground truth. The tests described are objective physical, chemical, or biological measurements.

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

No, a MRMC comparative effectiveness study was not done. This document describes the pre-market non-clinical testing of a physical medical device (catheter), not an AI/ML algorithm for diagnostic imaging or similar applications where human reader performance is augmented.

6. Standalone (Algorithm Only) Performance Study

No, this is not an AI/ML device. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

Biocompatibility Testing: The ground truth is objective biological and chemical reactions/measurements (e.g., cell lysis grade, inflammation scores, weight changes, temperature changes, hemolytic index, C3a/SC5b-9 concentrations, histopathology for thrombogenicity).
Bench-top Testing: The ground truth is objective physical and mechanical measurements against technical specifications (e.g., dimensions, force measurements, flow rates, visual integrity, particulate counts).
Animal Study: The ground truth is direct in-vivo observation and pathological assessment (e.g., angiographic evidence of injury, gross pathology findings, histological examination of vessel segments).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves engineering design, material selection, and iterative prototyping based on established engineering principles and prior knowledge.

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

Not applicable, as there is no "training set" in the AI/ML sense for this device. The development process relies on engineering specifications, material science data, and established test methods, rather than a labeled dataset for algorithm training.

Summary

Regulation Number and Section

§ 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).