(128 days)
This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.
The covers are offered sterile, single use. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.
The provided document describes the acceptance criteria and testing summary for the International Medsurg Connections Piston Syringe and Needles, submitted for 510(k) clearance (K022159).
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Syringe Column Sealing (Positive Pressure) | No leakage at 300 Kpa | No leakage |
| Syringe Column Sealing (Negative Pressure) | No leakage at 88 Kpa | No leakage |
| Volume | ± 4% | Met criteria (implied) |
| Tip Sealing Property | No Leakage | No Leakage |
| Indicating Ruler - 0 level line | Within ¼ range | Met criteria (implied) |
| Tip size, Draw Strength | No separation at 25N | No separation at 25N |
| Residue Contents |
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).