← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K961251 # PUNCTUR-GUARD WINGED SET (K961251) _Bio-Plexus, Inc. · FMI · Jun 27, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K961251 ## Device Facts - **Applicant:** Bio-Plexus, Inc. - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Jun 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. PAGE 6' {1} PAGE 6A' 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K961251](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K961251) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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