(312 days)
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
The subject device is a microcatheter available in three versions: a 150 cm length microcatheter with a 15 cm length distal segment; a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 42 cm length distal segment. The distal segment of the catheter is flexible to facilitate access into tortuous anatomy, and the distal tip of the catheter is formable, allowing the physician to shape it according to the needs of the procedure at the point of use. The CerusEndo Microcatheter has a hydrophilic coating, radiopaque marker, Luer hub on the proximal end, polymer tapered shaft construction, stainless steel reinforced shaft, and Teflon lined inner lumen. The subject device is controlled by user manipulation to access discrete locations within the vascular anatomy. It is intended to deliver other interventional or therapeutic devices through its inner lumen. It is designed to be used in peripheral, coronary, and neurovascular locations.
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature. No specific acceptance criteria for "device performance" (e.g., accuracy, sensitivity, specificity) were provided. Instead, the document summarizes various bench tests and biocompatibility tests conducted to ensure the device's safety and substantial equivalence to a predicate device. The results consistently state "Device met acceptance criteria" or similar affirmations for each test, implying the device performed as expected by the manufacturer for the specific test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list numerical acceptance criteria. Instead, it indicates that "Device met acceptance criteria" or similar positive outcomes for all tests. The table below summarizes the tests performed and the reported performance.
| Test Description | Reported Device Performance & Rationale |
|---|---|
| Bench Testing | |
| Tensile Strength | Device met acceptance criteria. (Measures tensile strength of catheter bonds). |
| Shaft Flexibility (stiffness) | Device met acceptance criteria. (Measures bending stiffness of distal and proximal catheter shaft segments). |
| Shape Retention | Device met acceptance criteria. (Measures ability of the catheter tip to form and retain a steam shape). |
| Kink Resistance | Device met acceptance criteria. (Measures distal and proximal catheter shaft resistance to kinking). |
| Static Burst | Device met acceptance criteria. (Measures resistance to burst failure by pressurizing the lumen with a high-pressure injector while the distal tip is occluded). |
| Simulated Use | Device met acceptance criteria. (Device used in accordance with Instructions for Use). |
| Particulate | Device met acceptance criteria. (Assesses coating integrity by measuring quantity and size of particles generated during simulated use in an anatomical model). |
| Coating Friction and Durability | Device met acceptance criteria. (Measures lubricity of the coating and durability after repeated abrasion cycles). |
| Sterilization Validation | Device met acceptance criteria. (Confirms minimum 6 log sterility assurance level, assesses ethylene oxide sterilant residual levels, and detects pyrogens). |
| Biocompatibility Testing | |
| Cytotoxicity (MEM Elution) | Non-cytotoxic. The test article is considered non-cytotoxic to cells. (Extracts exposed to mouse fibroblast cells). |
| Sensitization (ISO Kligman Guinea Pig Maximization Test) | Non-sensitizing. The test article did not elicit a sensitization response. (Samples extracted in saline and cotton seed oil). |
| Irritation/ISO Intracutaneous Toxicity in Rabbits | Non-irritant. No evidence of irritation. (Samples extracted in saline and cotton seed oil). |
| Systemic Toxicity (ISO Systemic Injection) | Non-cytotoxic. No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to mice. (Samples extracted in saline and cotton seed oil). |
| Systemic Toxicity (Rabbit Material-Mediated Pyrogenicity) | Non-pyrogenic. All individual rabbits for both the test article and negative control showed a total rise in temperature of |
§ 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).