BD AUTOSHIELD PEN NEEDLE

K060007 · Becton, Dickinson & CO · FMI · Mar 23, 2006 · General Hospital

Device Facts

• Record ID: K060007
• Device Name: BD AUTOSHIELD PEN NEEDLE
• Applicant: Becton, Dickinson & CO
• Product Code: FMI · General Hospital
• Decision Date: Mar 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Device Story

BD AutoShield™ Pen Needle is a sterile, single-use, disposable hypodermic needle for subcutaneous drug delivery via pen injectors. Device features integrated safety shield; shield hides needle prior to use; retracts during 90-degree skin insertion; automatically extends and locks after needle removal to prevent accidental needle sticks. Used by clinicians and patients in various settings. Output is drug delivery; safety mechanism provides passive protection against sharps injuries. Benefits include reduced risk of needle stick injuries and improved user confidence through needle concealment.

Clinical Evidence

Bench testing and simulated clinical testing performed. Simulated clinical environment study evaluated safety feature functionality using both professional healthcare workers and non-clinician pen users. No clinical data on patient outcomes provided; testing focused on device performance and safety mechanism efficacy.

Technological Characteristics

Single lumen hypodermic needle; gauges 29G, 30G, 31G; lengths 5mm, 8mm, 12.7mm. Features integrated, spring-loaded/retractable safety shield mechanism. Sterile (gamma irradiation), non-toxic, non-pyrogenic. Mechanical operation; no energy source or software.

Indications for Use

Indicated for patients requiring subcutaneous injection of drugs, including insulin and exinatide, using pen injector devices. Suitable for use by both professional healthcare workers and non-clinician users.

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 Needle (K051889)

Submission Summary (Full Text)

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K060007

Confidential & Proprietary

# Attachment 4

MAR 2 3 2006

#### 510(k) Summary Of Safety and Effectiveness

- I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

| | • Address: | BD Medical – Pharmaceutical Systems<br>1 Becton Drive<br>Franklin Lakes, NJ 07417-1885 |
|--------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | • Registration Number:<br>• Contact Person: | 2243072<br>James W. Haynes<br>Senior Regulatory Affairs Specialist<br>Telephone No.: 201-847-4298<br>Fax No.: 201-847-7040 |
| | • Date of Summary: | December 28, 2005 |
| Device | • Trade Name: | BD AutoShield™ Pen Needle |
| | • Classification Name:<br>• Classification:<br>• Performance Standards: | Single Lumen Hypodermic Needle<br>Class II<br>None Established under 514 of the Food, Drug<br>and Cosmetic Act |

- II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description

The BD AutoShield™ Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD AutoShield™ Pen Needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). The BD AutoShield™ Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.

Additionally, the BD AutoShield™ Pen Needle is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the AutoShield™ Pen Needle to the pen. The shield of

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Confidential & Proprietary

K060007

AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.

- · Intended Use
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

- · Synopsis of Performance Study Results
Bench testing and simulated clinical testing was performed to confirm the device's safety and efficacy. Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users.

Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended.

### III. Predicate Device Summary Table

· Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the BD AutoShield™ Pen Needle was shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---------------------|------------------|----------|--------------------|
| Becton<br>Dickinson | BD Pen Needle | K051889 | September 13, 2005 |

James W. Haynes

12/30/05

Date

Semor Regulatory Affairs Specialist Becton Dickinson Medical - Pharmaceutical Systems Becton Dickinson and Company

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MAR 2 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James W. Haynes Senior Regulatory Affairs Specialist BD Medical-Pharmaceutical Systems Becton, Dickinson and Company 1 Becton Drive (MC 440) Franklin Lakes, New Jersey 07417

Re: K060007

Trade/Device Name: BD AutoShieldTM Pen Needle Regulation Number: 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: February 8. 2006 Received: February 10, 2006

Dear Mr. Haynes:

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 (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 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.

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

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#### Page 2 - Mr. James W. Haynes

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 (QS) 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 continue 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 your 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,

Sytti Y. Michael M.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

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## INDICATIONS FOR USE

510(K) Number (IF Known):

DEVICE NAME: BD AutoShield™ Pen Needle

INDICATIONS FOR USE:

The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.

PRESCRIPTION USE (Per 21 CFR § 801.109) OR Over-the-Counter Use (OPTIONAL FORMAT 1-2-96)

(Please do not Write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antony D. my

enn logy, General Huspital

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