(98 days)
This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.
The GRIPPER® Micro needle is compromised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. Fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.
The provided document is a 510(k) Premarket Notification for a medical device (GRIPPER® Micro Needle), not an AI/ML device. Therefore, none of the requested information regarding acceptance criteria, study details, ground truth, or expert involvement for an AI/ML product is present in the document.
The document states:
- "The GRIPPER® Micro needle met all established acceptance criteria for performance testing and design verification testing." (Section IX.A)
- "Based upon the information provided; the GRIPPER® Micro needle meets all acceptance criteria for performance testing and design verification testing. Therefore, this product is considered acceptable for human use." (Section IX.C)
- "Clinical studies for the GRIPPER® Micro needle was deemed not necessary due to its similarity in materials, design and function to current Smiths Medical MD, Inc. devices." (Section IX.B)
This indicates that the acceptance criteria are related to "performance testing and design verification testing" for the physical device, and these criteria were met. However, the specific details of these criteria (e.g., fluid flow rate, needle strength, resistance to bending, etc.) and the studies proving they were met are not included in this summary.
Therefore, I cannot populate the requested table and answer the study-specific questions as they pertain to AI/ML device evaluations. The document focuses on the regulatory submission for a physical medical device based on substantial equivalence to a predicate device.
§ 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).