← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K970737 # B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE (K970737) _Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI · Mar 28, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970737 ## Device Facts - **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Mar 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The intended use for the modified device remains the same as the predicate device; for use with a pen injector device for the subcutaneous injection of insulin. ## Device Story Single-use, double-pointed 31G stainless steel needle; epoxy-bonded to polypropylene hub; protected by polyethylene shield and outer container with laminate seal. Device attaches to pen injector; penetrates insulin cartridge septum; enables subcutaneous insulin delivery. Used by patients or clinicians in home or clinical settings. Sterilized via gamma irradiation. ## Clinical Evidence Bench testing only. Evaluated needle pull-out, penetration, and insulin injection forces. Results demonstrate performance equivalent to predicate device. ## Technological Characteristics Type 304 stainless steel needle; polypropylene hub; polyethylene shield/container. Gamma irradiation sterilization (10^-6 sterility assurance level). 31G gauge size. ## 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 - B-D 30g x 5/16” pen 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} K970757 # SUMMARY OF SAFETY AND EFFECTIVENESS MAR 28 1997 ## 1.0 Submitted By: Peter Zurlo Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, NJ 07417-1883 Phone: 201-847-6447 Fax: 201-848-0457 ## 2.0 Device Name: B-D 31g x 5/16” pen needle ## 3.0 Predicate Device: B-D 30g x 5/16” pen needle ## 4.0 Device Description: The double-pointed Type 304 stainless steel needle is epoxy bonded to a plastic hub (polypropylene) and covered with a plastic needle shield (polyethylene). This needle/hub/shield assembly is placed in a plastic outer container (polyethylene), the open end of which is sealed closed with a laminate seal for subsequent protection. Gamma irradiation sterilization will be employed and the product will meet $10^{-6}$ sterility assurance levels. During use, the laminate seal is peeled away and the exposed needle hub is screwed onto the Pen injector device. This exposed needle hub will penetrate the rubber septum of an insulin containing cartridge (supplied by others). After the needle shield is removed, it is ready for a subcutaneous insulin injection. The needle assembly is a single-use disposable device. ## 5. Intended Use: The intended use for the modified device remains the same as the predicate device; for use with a pen injector device for the subcutaneous injection of insulin. 021897.PZ1 19 {1} 6. Technological Characteristics: The B-D 31g x 5/16” pen needle and the predicate device (the B-D 30g x 5/16” pen needle) have the same technological characteristics. SEE ITEM 4 ABOVE FOR A DESCRIPTION. N.B. The only change to the predicate device is the gauge size of the needle. 7. Performance Summary: The B-D 31g x 5/16” pen needle has been bench tested, which included needle pull-out, penetration and insulin injection forces and has proven to function in an equivalent manner as the predicate device. Based on the results of bench testing the B-D 31g x 5/16” pen needle is considered safe and effective when used as intended. 011195.pz1 20 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970737](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970737) **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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