(87 days)
provides sterile vascular access for the collection of blood utilizing a vacuum tube system or syringe. allows vascular access with a low entry angle and firm needle tip control. permits collection of blood via a flexible tubing, effectively dissociating the puncture site from the proximal end of the device.
The PUNCTUR-GUARD® Winged Set is comprised of a sharp, lubricated stainless steel front needle which is attached to a flexible winged body. A blunt inner cannula is contained inside the front needle and provides the fluid path. A third wing is provided to actuate the blunting cannula forward of the needle point. The third wing is connected to flexible tubing at the end of which is a female luer connector. The device will be available in two configurations, with a male luer cap covering the female luer connector or with a Multi-Sample Lure Adapter (MSLA) attached to the female luer connector. The MSLA is comprised of a valved needle, hub with female luer connector and threaded section for the attachment of a holder. BIO-PLEXUS manufactures a one piece Needle Holder.
This 510(k) summary (K961251) describes a PUNCTUR-GUARD® Winged Set, a single-lumen hypodermic needle for blood collection. This document is a pre-market notification for a medical device and therefore does not contain the acceptance criteria and study information typically associated with AI/ML-driven device performance evaluations.
The provided text focuses on demonstrating the substantial equivalence of the PUNCTUR-GUARD® Winged Set to already marketed devices, rather than establishing acceptance criteria and proving performance through rigorous studies in the way an AI/ML device would.
Here's why the requested information cannot be extracted from this document:
- Device Type: This is a physical medical device (a needle) with a specific mechanical function, not an AI/ML diagnostic or prognostic tool. Therefore, concepts like sensitivity, specificity, AUC, human reader improvement with AI, standalone performance, training sets, and ground truth for AI algorithms are not applicable.
- Regulatory Pathway: A 510(k) summary primarily aims to demonstrate "substantial equivalence" to a predicate device already on the market. This often involves showing similar intended use, technological characteristics, and safety/performance through bench testing and simulated use, rather than extensive clinical efficacy trials against defined performance metrics like an AI/ML device.
- Content of the Document: The document explicitly states its purpose is to show substantial equivalence to existing winged blood collection sets and focuses on descriptive comparison and basic performance testing (bench tests and simulated use) to confirm similarities.
Therefore, it is not possible to fill out the requested table and answer the study-related questions for this specific input because the document does not contain information relevant to AI/ML device evaluation.
If this were an AI/ML device 510(k) summary, the information would typically be found in sections detailing clinical studies, performance data, algorithm validation, and comparison to a gold standard.
§ 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).