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

Device Facts

• Record ID: K970737
• Device Name: B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: FMI · General Hospital
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

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.

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.

Indications for Use

Indicated for subcutaneous insulin injection using a pen injector device.

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

• B-D 30g x 5/16” pen needle

Submission Summary (Full Text)

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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: [phone]
Fax: [phone]

## 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.

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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.

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