PUNCTUR-GUARD WINGED SET

K961251 · Bio-Plexus, Inc. · FMI · Jun 27, 1996 · General Hospital

Device Facts

• Record ID: K961251
• Device Name: PUNCTUR-GUARD WINGED SET
• Applicant: Bio-Plexus, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

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.

Device Story

Sterile, single-use blood collection set; provides vascular access for blood collection via vacuum tube or syringe. Device features sharp, lubricated stainless steel front needle with internal blunt cannula; flexible winged body; third wing actuates blunt cannula forward of needle point to cover tip. Flexible tubing connects to female luer connector; available with male luer cap or Multi-Sample Luer Adapter (MSLA). Used by clinicians in clinical settings for venipuncture; blunting mechanism reduces needle-stick risk. Output is blood sample collected into vacuum tube or syringe.

Clinical Evidence

Bench testing only; simulated use tests confirmed performance similarities to equivalent marketed products.

Technological Characteristics

Stainless steel needle; flexible winged body; blunt inner cannula mechanism; female luer connector; optional Multi-Sample Luer Adapter (MSLA). Sterile, single-use.

Indications for Use

Indicated for sterile vascular access for blood collection via vacuum tube system or syringe in patients requiring venipuncture.

Regulatory Classification

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.

Predicate Devices

• Vacutainer® Brand Blood Collection Set (reorder number 7250)
• SurFlo® Winged Infusion Set (reorder number SV*21BLK)
• Butterfly® Infusion Set (reorder number 4492)

Reference Devices

• PUNCTUR-GUARD® Blood Collection Needle

Submission Summary (Full Text)

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K961251

JUN 27 1996

# 510(k) SUMMARY

| Proprietary Name: | PUNCTUR-GUARD® Winged Set |
| --- | --- |
| Classification Name: | Single Lumen Hypodermic Needle |
| Regulation #: | 880.5570 |
| Class: | II |
| Panel Code: | 80 |
| Product Code: | FMI |
| Reason for submission: | 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:

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:

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.