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510(k) Data Aggregation
(108 days)
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.
The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:
- Gauge
- 20 Ga (Touhy only)
- 21 to 24 Ga
- Lengths
- 35 mm to 150 mm
- Point style
- Bevel tip
- Pencil point
- Touhy tip
- Cannula echogenicity
- The cannula is naturally echogenic but the addition of grooves on the cannula enhance the echogenicity
The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.
Here's an analysis of the acceptance criteria and study information for the ARROW UltraQuik Peripheral Nerve Block Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (Non-Inserted Regions) | > 15 N force to break | Injection Tubing to Needle Hub: mean 27 N |
| Injection Tubing to Luer Lock: mean 27 N | ||
| Tensile Strength (Needle Cannula to Hub joint) | > 40 N force to break | All have a mean > 99 N |
| Needle Sharpness (Penetration Force) | None (Pass/fail criteria not explicitly stated) | All have a mean > 3.17 N |
| Injection Leakage | No leak at 50 psi for 30 sec | No leakage observed |
| Resistance to Leakage (Aspiration/Vacuum) | No internal leakage at -25 mmHg for 120 sec | No leakage observed |
| Corrosion Resistance | No visible sign of corrosion | No observed corrosion |
| Needle Stiffness (Deflection) |
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