(553 days)
The MedMate™ Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The device features a shield that prevents accidental needle sticks.
The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.
Advanced Medical Innovations Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules.
This submission pertains to the MedMate™ Guarded (18g) Needle. The provided document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria. Instead, it is a 510(k) summary and an FDA clearance letter, indicating that the device was found substantially equivalent to a predicate device based on its technological characteristics and function.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states:
- "No non-clinical tests were performed."
- "Clinical testing was not performed."
The clearance was based on substantial equivalence to the BD Eclipse Hypodermic Needle (K010188).
§ 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).