(246 days)
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
This document is a 510(k) Summary for a medical device called the "Neurovascular Access System Family." It details the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Name | Objective | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|---|
| Visual Surface Requirements | To demonstrate that the device meets the visual surface requirements. | ISO 10555-1 2013, Section 4.4 | Device meets visual surface requirements. | Pass |
| Dimensional Verification | To demonstrate that the device meets the dimensional requirements. | ISO 10555-1 2013, Section 4.5 | Device meets dimensional requirements. | Pass |
| Liquid Leakage Under Pressure | To demonstrate that the device passes the liquid leakage under pressure test. | ISO 10555-1 2013, Section 4.7.1, Annex C | Device passes liquid leakage test. | Pass |
| Hub Aspiration Air Leakage | To demonstrate that the device passes the hub aspiration air leakage test. | ISO 10555-1 2013, Section 4.7.2, Annex D | Device passes hub aspiration test. | Pass |
| Simulated Use and Usability | To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes simulated use and usability protocols. | Pass |
| Flex Fatigue | To demonstrate that the device passes the flex fatigue test. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes flex fatigue test. | Pass |
| Torque Test | To demonstrate the torque strength of the device. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Device demonstrates adequate torque strength. | Pass |
| Tip Deflection | To demonstrate that the tip deflection is comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Tip deflection is comparable to predicate. | Pass |
| Device Removal Forces | To demonstrate that the removal forces are comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Removal forces are comparable to predicate. | Pass |
| Peak Tensile Strength Testing | To demonstrate that the device passes the peak tensile strength testing including all bonds and joints. | ISO 10555-1 2013, Section 4.6, Annex B | Device passes peak tensile strength testing. | Pass |
| Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | ISO 10555-1 2013: Section 4.9 | Flow rate is comparable to predicate. | Pass |
| Corrosion Resistance | To demonstrate that the device has no visual evidence of corrosion. | ISO 10555-1 2013, Section 4.5, Annex A | No visual evidence of corrosion. | Pass |
| Radiopacity | To demonstrate that the distal marker band is clearly visible under typical fluoroscopic imaging conditions. | ISO 10555-1 2013, Section 4.2; ASTM F640-12 | Distal marker band is clearly visible. | Pass |
| Kink Resistance | To demonstrate that shaft kink resistance is comparable to the predicate device and clinically relevant for the intended anatomical locations for use. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Shaft kink resistance is comparable to predicate and clinically relevant. | Pass |
| Particulates and Coating Integrity | To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicates and reference devices. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Particulates and coating integrity are comparable to predicates. | Pass |
| Dynamic Burst | To demonstrate that the device withstands dynamic burst strength. | ISO 10555-1 2103, Annex G | Device withstands dynamic burst strength. | Pass |
| Static Burst | To demonstrate that the device passes static burst pressure as specified in the test protocol. | ISO 10555-1 2013, Section F | Device passes static burst pressure. | Pass |
| Shelf Life | Repeated bench tests after accelerated aging to demonstrate that the device performance is maintained over the proposed shelf-life (6 months). | ASTM D4332-22, ASTM D4169-22, ASTM F1980-21, ASTM F1886 / F1866M-16, ASTM 2096-11 (2019), ASTM F88/F88M:21 | Device performance maintained over 6-month shelf-life. | Pass |
Biocompatibility Tests:
| Test Name | Objective (Implied) | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Results") | Reported Device Performance |
|---|---|---|---|---|
| Cytotoxicity | Assess cell toxicity. | ISO 10993-5 | No reactivity observed. | Non-cytotoxic |
| Sensitization | Assess potential for allergic reactions. | ISO10993-10 | No evidence of delayed dermal contact sensitization. | Non-sensitizing |
| Intracutaneous Reactivity | Assess localized irritation. | ISO 10993-23 | Scores from test article extracts were acceptable ( |
§ 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).