(87 days)
7250, SV *21BLK, 4492
Not Found
No
The summary describes a mechanical blood collection device with no mention of AI or ML components or functionality.
No
The device is used for blood collection, which is a diagnostic procedure, not a therapeutic intervention.
No
This device is designed for sterile vascular access for blood collection, not for diagnosing medical conditions. It is a tool for obtaining samples, which can then be used for diagnostic tests, but the device itself does not perform the diagnosis.
No
The device description clearly outlines physical components such as needles, tubing, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sterile vascular access for the collection of blood utilizing a vacuum tube system or syringe." This describes a device used to collect a sample from the body, not a device used to test a sample in vitro (outside the body).
- Device Description: The description details a needle, tubing, and connectors designed for blood collection. It does not mention any components or functionalities related to analyzing or testing the collected blood.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostic devices.
The device is a blood collection set, which is a tool used to obtain a sample that could then be used for IVD testing, but the collection device itself is not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The bench tests and the simulated use tests confirmed the similarities of the PUNCTUR-GUARD® Winged Set to the equivalent currently marketed products.
Key Metrics
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Predicate Device(s)
Vacutainer® Brand Blood Collection Set, reorder number 7250, manufactured by Becton Dickinson, SurFlo® Winged Infusion Set, reorder number SV *21BLK, manufactured by Terumo, Butterfly® Infusion Set, reorder number 4492, manufactured by Abbott Laboratories.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUN 2 7 1996
510(k) SUMMARY
Proprietary Name: Classification Name: Regulation #: Class: Panel Code: Product Code: Reason for submission:
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
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.
1
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.