BD PEN NEEDLE

K051899 · Becton, Dickinson & CO · FMI · Sep 13, 2005 · General Hospital

Device Facts

• Record ID: K051899
• Device Name: BD PEN NEEDLE
• Applicant: Becton, Dickinson & CO
• Product Code: FMI · General Hospital
• Decision Date: Sep 13, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 subcutaneous injection of drugs, including insulin and exenatide.

Device Story

BD Pen Needles are sterile, single-use, disposable hypodermic needles designed for subcutaneous drug delivery via pen injectors. The device assembly consists of a needle, hub, and shield. Available in various gauges (29G, 30G, 31G) and lengths (5mm, 8mm, 12.7mm). Used by patients or clinicians to administer medications such as insulin and exenatide. The needle facilitates the delivery of a desired dose from a pen injector into the subcutaneous tissue. Benefits include safe, effective, and convenient drug administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hypodermic single lumen needle; sterile (gamma irradiation); non-pyrogenic; disposable; single-use. Available in 29G, 30G, 31G gauges and 5mm, 8mm, 12.7mm lengths.

Indications for Use

Indicated for subcutaneous injection of drugs, including insulin and exenatide, 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

• BD Pen Needles
• Disetronic PenFine Injection Pen Needles

Submission Summary (Full Text)

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# SEP 1 3 2005

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitted By: 1.

John Schalago Manager, Regulatory Affairs

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

201-847-5663 Phone: [phone] Fax:

### Device Name: 2.

| Trade Name: | BD Pen Needles |
|----------------------|--------------------------------|
| Common Names: | Insulin Pen Needles |
| Classification Name: | Hypodermic Single Lumen Needle |

#### Predicate Device: 3.

BD Pen Needles

Manufactured by: Becton Dickinson Consumer Healthcare

Disetronic PenFine Injection Pen Needles

Manufactured by: Dietronic Medical Systems, Incorporated

#### Device Description: 4.

The BD Pen Needles are designed for use with a pen injector for subcutaneous The DD For Nesired dose of a drug, including insulin and exenatide. The pen meedle consists of a needle, hub, and shield assembly. The Becton Dickinson pen needles are offered various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). BD Pen Needles are sterile (gamma irradiation (2mm), vimn, and non-pyrogenic. The pen needles are disposable, single use devices.

{1}------------------------------------------------

# 510K Summary of Safety and Effectiveness (Continued)

### Intended Use: 5.

Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

## Technological Characteristics: 6.

The BD Pen Needle and the predicate device have the identical technological characteristics and perform equivalently.

The only difference between the devices is that the principal device is indicated for delivery of exenatide.

### Performance: 7.

The perform equivalent to the predicate device and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Schalago Manager, Regulatory Affairs Becton Dickinson Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1880

Re: K051899 Trade/Device: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 8, 2005 Received: July 13, 2005

Dear Mr. Schalago:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be (--) p--------------------------------------------------------------------------------------------------------------------------------------relerenced above and have determined are to tegally marketed predicate devices marketed in indications for use stated in also encreases of the enactment date of the Medical Device interstate colliments, or to triay 20, 1978, 1978, 1978, 1978, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 19 Amendments, on to devices mat nave obct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment Processor, market the device, subject to the general approval application (1 Mr ). I The general controls provisions of the Act include controls provisions of the rea. "The gastration, listing of devices, good manufacturing practice, requirements for animons against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classinod (see aboutional controls. Existing major regulations affecting (PMA), It may be subject to sating and the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Schalago

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT - 1.55tazies of that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an the Fec b requirements and 801); good manufacturing practice and ifsing (21 CFR Part 607), laceming (21 CFR Part 820), and if 1 CFR Part 820), and if requirements as set form in the quality bjocents (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) This letter will anow you to ocgin maineting , but antial equivalence of your device to a premarket nothleation. The PDA miang of bassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de recoler at [phone] Also, please note the regulation in prease contact the Other or Comphanes or exet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on the mational and Consumer Assistance at its toll-free Division of Binar-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known):_K051899 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: _____BD Pen Needles______________________________________________________________________________________________________________________________________________

Indications For Use:

Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 4/13/01

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ KOS1899