(67 days)
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.
The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a regulatory approval summary for the "VACUETTE® PREMIUM Safety Needle System Tube-Touch." It establishes substantial equivalence to a predicate device (VACUETTE® PREMIUM Safety Needle System, K072602) for its intended use and materials. This type of submission typically relies on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring a detailed clinical study with specific acceptance criteria and performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the regulatory process for clearance, not on a detailed performance study of the device against specific acceptance criteria.
§ 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).