(153 days)
The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.
This document pertains to the Access25™ Delivery Microcatheter by Penumbra, Inc. This is a medical device and not an AI/ML powered device, therefore some relevant sections of the query will not be applicable.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Inspection Test | Catheter outer diameter, inner diameter, length, and coating length meet specifications. | Acceptance Criteria met |
| Simulated Use Test | Device performs as intended under simulated use conditions in a clinically relevant anatomical model. | The device performs as intended under simulated use conditions |
| Tensile Test | Peak tensile force meets ISO 10555-1 requirements after preconditioning in a simulated use model. | Acceptance Criteria met |
| Particulate Test | Particulate generation during simulated use is comparable to the predicate device. | Particulate generation was comparable to predicate device |
| Burst Pressure Test | Units can withstand sufficient pressure per ISO 10555-1 after simulated use. | Acceptance Criteria met |
| Radiopacity Test | Markerband(s) are fluoroscopically visible. | Acceptance Criteria met |
| Flow Rate Test | Contrast media can be delivered through the catheter lumen. | Acceptance Criteria met |
| Friction Test | Units meet product specification related to friction. | Friction results were comparable to the predicate |
| Corrosion Resistance Test | No visible corrosion on units when tested per ISO 10555-1. | Acceptance Criteria met |
| Torque Strength Test | Device can withstand a specified number of catheter rotations until failure. | Acceptance Criteria met |
| Elongation Test | Units meet product specification related to elongation. | Acceptance Criteria met |
| Hub/Air Test | Units have no leaks when tested per ISO 10555-1. | Acceptance Criteria met |
| Distal Tip Stiffness Test | Maximum compressive force to cause catheter tip buckling is comparable to the predicate. | Distal tip stiffness was comparable to the predicate. |
| Kink Resistance Test | Units have appropriate kink resistance. | Acceptance Criteria met |
| Liquid Leakage Test | Units can withstand sufficient pressure. | Acceptance Criteria met |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (in accordance with ISO 10993-5). | Pass: Non-cytotoxic |
| Biocompatibility: Sensitization | Non-sensitizing (in accordance with ISO 10993-10). | Pass: Non-sensitizing |
| Biocompatibility: Irritation | Non-irritating (in accordance with ISO 10993-23). | Pass: Non-irritating |
| Biocompatibility: Systemic Toxicity | Non-toxic (in accordance with ISO 10993-11). | Pass: Non-toxic |
| Biocompatibility: Material-Mediated Pyrogen | Non-pyrogenic (in accordance with USP ). | Pass: Non-pyrogenic |
| Biocompatibility: Hemolysis (direct contact) | Non-hemolytic (in accordance with ISO 10993-4). | Pass: Non-hemolytic |
| Biocompatibility: Hemolysis (indirect contact) | Non-hemolytic (in accordance with ISO 10993-4). | Pass: Non-hemolytic |
| Biocompatibility: In-vitro Thrombogenicity | Non-thrombogenic (in accordance with ISO 10993-4). | Pass: Non-thrombogenic |
| Biocompatibility: Complement Activation | Non-activator of complement system (in accordance with ISO 10993-4). | Pass: Non-activator of complement system |
| Biocompatibility: Partial Thromboplastin Time (PTT) | Hemocompatible (in accordance with ISO 10993-4). | Pass: Hemocompatible |
| Sterilization | Sterilized using a validated EO sterilization process in accordance with ISO 11135-1. | Validated EO sterilization process per ISO 11135-1. |
| Pyrogenicity | Non-pyrogenic, meeting and ANSI/AAMI ST72. | Non-pyrogenic based on material mediated rabbit pyrogen biocompatibility testing per USP and LAL testing per ANSI/AAMI ST72 to meet , ANSI/AAMI ST72) and internal product specifications. These standards and specifications define what constitutes safe and effective performance for such a device. |
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/ML algorithm, there is no training set or its associated ground truth establishment process. The "ground truth" in the device development context refers to the established performance requirements and standards against which the device is tested.
§ 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).