(251 days)
The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.
The U&U Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system. It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is not made with Latex.
The provided document is a 510(k) summary for the U&U Blood Collection Sets, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. As such, the "acceptance criteria" and "device performance" are typically defined by demonstrating conformance to recognized standards and through direct comparison with the predicate device, rather than explicit numerical thresholds for diagnostic performance metrics like sensitivity or specificity.
Here's an analysis of the provided information, structured as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Defined by Conformance to Standards & Predicate Comparison) | Reported Device Performance (U&U Blood Collection Sets) |
|---|---|
| Indication for Use | The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury. (Equivalent to Predicate) |
| Regulation Number | 880.5570 (Conforms) |
| Product Codes | FMI & JKA (Conforms) |
| Principle of Operation | Manual (Equivalent to Predicate) |
| Needle Gauges | 19G to 27G (Predicate: 21G to 25G. The subject device offers a wider range, but still meets safety and performance requirements as demonstrated by testing.) |
| Leakage (ISO 594-2) | No Leakage (Conforms, Equivalent to Predicate) |
| Tensile Strength | Withstand a static tensile force of not less than 15N for 15s; (Conforms, Equivalent to Predicate) |
| Tubing Transparency | The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. (Conforms, Equivalent to Predicate) |
| Materials | PVC, HDPE, ABS, RUBBER, SUS 304, PP (Equivalent to Predicate) |
| Force to Attach Connection (Sharps Injury Prevention Features) |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to 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 or an intravascular administration set.(b)
Classification. Class II (performance standards).