(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.
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JUN 2 7 1996
510(k) SUMMARY
Proprietary Name: Classification Name: Regulation #: Class: Panel Code: Product Code: Reason for submission:
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PUNCTUR-GUARD® Winged Set Single Lumen Hypodermic Needle 880.5570 II 80 FMI new device
This document demonstrates the substantial equivalence of the PUNCTUR-GUARD® Winged Set to currently marketed Winged Blood Collection Sets, such as the Vacutainer® Brand Blood Collection Set, reorder number 7250, manufactured by Becton Dickinson, the SurFlo® Winged Infusion Set, reorder number SV *21BLK, manufactured by Terumo, and the Butterfly® Infusion Set, reorder number 4492, manufactured by Abbott Laboratories.
This summary provides the following safety and effectiveness information upon which a determination of substantial equivalence is based.
The PUNCTUR-GUARD® Winged Set is a sterile, single use blood collection set that performs the following functions.
- (i) provides sterile vascular access for the collection of blood utilizing a vacuum tube system or syringe.
- (ii) allows vascular access with a low entry angle and firm needle tip control.
- (iii) permits collection of blood via a flexible tubing, effectively dissociating the puncture site from the proximal end of the device.
Device Description:
(2005)
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.
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Labels and Labeling:
( 122
Labeling meets the requirements of the 21 CFR Part 801 as relates to the indications for use of the device.
Descriptive Comparison to Legally Marketed Devices:
The comparison of the intended use, technological features and specifications (including material) of the PUNCTUR-GUARD® Winged Set to currently marketed winged blood collection sets demonstrates the device's substantial equivalence. The blunting feature is compared to the PUNCTUR-GUARD® Blood Collection Needle as they utilize a similar technology.
Performance Testing:
The bench tests and the simulated use tests confirmed the similarities of the PUNCTUR-GUARD® Winged Set to the equivalent currently marketed products.
Accessories to the Device:
The PUNCTUR-GUARD® Winged Set with a MSLA is by design compatible with PUNCTUR-GUARD® Needle Holders.
§ 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).