MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE

K031200 · Becton, Dickinson & CO · FMI · Jun 24, 2003 · General Hospital

Device Facts

• Record ID: K031200
• Device Name: MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
• Applicant: Becton, Dickinson & CO
• Product Code: FMI · General Hospital
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Device Story

BD Ultra-Fine Pen Needles are sterile, single-use, disposable needles designed for subcutaneous insulin delivery via pen injectors. The assembly includes a needle, hub, and protective shields. Operation involves attaching the needle to a pen injector for manual administration by patients or clinicians. The device features an outer needle shield made of polypropylene to enhance puncture resistance compared to previous polyethylene versions. The fluid path is sterilized via gamma irradiation. The device facilitates insulin therapy by providing a reliable interface between the pen injector and the patient's subcutaneous tissue.

Clinical Evidence

Bench testing only. Penetration force tests were conducted to compare the puncture resistance of the new polypropylene outer needle shield against the predicate polyethylene shield, demonstrating superior performance for the new material.

Technological Characteristics

Single lumen hypodermic needle; components include needle, hub, and shields. Outer needle shield material: polypropylene. Sterilization: gamma irradiation. Non-toxic, non-pyrogenic fluid path. Disposable, single-use.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection via 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

• BD Ultra-Fine™ Pen Needle
• BD Ultra-Fine™ III Pen Needle

Submission Summary (Full Text)

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# JUN 2 4 2003

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. Submitted By:

Cynthia Lacatena Product Registration Coordinator

Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883

Phone: [phone] Fax:

#### 2. Device Name:

| Trade Name: | BD Ultra-Fine™ Original Pen Needle<br>BD Ultra-Fine™ III Short Pen Needle<br>BD Ultra-Fine™ III Pen Needle |
|----------------------|------------------------------------------------------------------------------------------------------------|
| 3. Common Names: | Insulin Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle |

#### 4. Predicate Device:

BD Ultra-Fine™ Pen Needle BD Ultra-Fine™ III Pen Needle

Manufactured by: Becton Dickinson Consumer Healthcare

#### ડ. Device Description:

The Becton Dickinson Ultra-Fine™ Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, needle shield and outer needle shield assembly. The Ultra-Fine Pen Needles are offered in various needles sizes and lengths. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD Pen Needles are disposable, single use devices.

#### స్ Intended Use:

Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

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# 510K Summary of Safety and Effectiveness (Continued)

#### 6. Technological Characteristics:

The BD Ultra-Fine™ Original Pen Needle, BD Ultra-Fine™ III Short Pen Needle and BD Ultra-Fine™ III Pen Needle have the identical technological characteristics and perform equivalently as the predicate device.

The only difference from the predicate device is the outer needle shield material was changed from polyethylene to polypropylene enhancing the puncture resistance properties of the outer needle shield.

#### 7. Performance:

Bench tests relating to the performance of the outer needle shield were conducted. The penetration force tests demonstrated that the polypropylene material had a greater penetration resistance capability then the polyethylene material.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Ms. Cynthia Lacatena Product Registration Coordinator Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, New Jersey 07417-1883

Re: K031200

Trade/Device Name: Becton Dickinson Pen Needles Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 15, 2003 Received: May 28, 2003

Dear Ms. Lacatena:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lacatena

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Puarer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Becton Dickinson Pen Needle

Indications For Usc:

Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Paloma Guccente

(Division Sign-Off) (Division of Anesthesiology, General Hospit Infection Control, Dental Devices

510(k) Number: 403/200

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