BD AUTOSHIELD DUO PEN NEEDLE

K110703 · Becton, Dickinson and Company · FMI · Jul 27, 2011 · General Hospital

Device Facts

• Record ID: K110703
• Device Name: BD AUTOSHIELD DUO PEN NEEDLE
• Applicant: Becton, Dickinson and Company
• Product Code: FMI · General Hospital
• Decision Date: Jul 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD AutoShield™ Duo Pen Needle is intended for use with pen injector devices for the injection of drugs. The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

Device Story

Safety-engineered pen needle for drug injection via pen injectors; features dual safety shields to prevent accidental needle sticks at both patient and non-patient (pen connection) ends. User attaches needle to pen; inserts at 90° angle; patient-end shield retracts during insertion. Upon removal from skin, patient-end shield deploys and locks; red indicator band confirms usage. Upon removal from pen, non-patient-end orange shield deploys to cover needle. Used in clinical or home settings by healthcare providers or patients. Clear patient-end shield improves needle visualization. Sterile, single-use, disposable device.

Clinical Evidence

Bench testing only. Safety Activation Study and Simulated Use Study conducted with professional healthcare users and non-clinical pen users. Results confirmed device safety, efficacy, and validation of Instructions for Use (IFU). Testing verified compliance with ISO 11608-2 (tubing, patency, needle points, length, load, lubrication, connectivity) and ISO 7864 (cannula load).

Technological Characteristics

Double-ended cannula in injection-molded hub; 30G/31G gauges; 5mm/8mm lengths. Materials: injection-molded plastic, lubricated cannula. Mechanism: dual-shield retraction/locking system. Sterilization: gamma irradiation. Connectivity: mechanical interface (threaded) for pen injectors. Standards: ISO 11608-2, ISO 7864.

Indications for Use

Indicated for use with pen injector devices for drug injection in patients requiring subcutaneous medication delivery. No specific age or gender restrictions; intended for both professional healthcare and non-clinical (patient) 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 AutoShield™ Pen Needle (K060007)

Submission Summary (Full Text)

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JUL 27 2011

l Becton Drive Franklin Lakos, Now Jaraey 07417 ારો: 201.847.6800 www.bd.com

Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of a circular emblem on the left and the letters "BD" on the right. The emblem features a stylized sun rising over a pair of hands, symbolizing the company's mission to improve people's health. The letters "BD" are in a bold, sans-serif font.

Helping all people live healthy lives

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date of Summary Preparation: March 11, 2011

# 1. Submitted By:

Cynthia Lacatena Regulatory Affairs Specialist

Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417

201-847-6869 Phone: [phone] Fax:

# Contact Person:

James Haynes Manager, Regulatory Affairs 201-847-4298 Phone: [phone] Fax: Email: [e-mail]

# Device Name: 2.

BD AutoShield™ Duo Pen Needle Trade Name: Insulin Pen Needle Common Names: Needle, Hypodermic, Single Lumen Classification Name: Class II, 21 CFR 880.5570 FMI Classification:

- 3. Predicate Device: BD AutoShield TM Pen Needle- K060007
Manufactured by: Becton, Dickinson and Company

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#### イ. Device Description:

The BD AutoShield™ Duo Pen Needle is a safety pen needle that provides protection from accidental needle sticks, from both the patient end and nonpatient (pen connection) end.

Currently, BD markets the BD AutoShieldTM safety-engineered pen needles which shield the front, or patient end (needle tip) and have been associated with a lower incidence of needle stick injuries. To further reduce the risk of accidental needle stick injuries, BD developed the AutoShieldTM Duo Pen Needle, which, in addition to the added safety shield on the non-patient (pen connection) end, includes a redesign of the safety shield to a clear safety shield that enables the user to better visualize the needle while inserting it into the skin.

Prior to injection, the user will attach the AutoShield™ Duo Pen Needle to the pen. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. Once the pen is removed from the skin the inner shield will deploy and lock in place. A red indicator band will appear confirming the pen needle has been used. Once the pen needle is removed from the pen, the orange shield on the non-patient (pen connection) end will deploy and cover the needle.

The BD AutoShield™ Duo Pen Needles are offered in various gauge sizes (30G and 31G) and lengths (5mm and 8mm).

An injection molded outer cover is assembled over the patient end of the cannula. This needle assembly is sealed with a peel-away label to provide a sterility barrier and tamper evidence.

The assembly consists of a double-ended cannula that is assembled into an injection molded hub. The internal threads allow the safety pen needle to be screwed onto pen injectors. The patient and non-patient (pen connection) end of the cannula are lubricated for ease of injection and septum penetration.

The patient end of the device has a mechanism that allows the needle to be shielded and locked after use. Once shielded, a red indicator band becomes present indicating product has been used. These product features help reduce the occurrence of accidental needle stick injuries.

The non-patient (pen connection) end of the cannula is visible prior to attachment to the pen injector. Following removal of the device from the pen injector, the needle is shielded with a mechanism that is designed to reduce the occurrence of accidental needle stick injuries.

The BD AutoShield™ Duo Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.

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### Statement of Intended Use/Indications for Use: 5.

The BD AutoShield TM Duo Pen Needle is intended for use with pen injector devices for the injection of drugs.

The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

# Description of Safety and Substantial Equivalence: 6.

A Safety Activation Study and Simulated Use Study were performed to confirm the device's safety and efficacy.

The Safety Activation Study was performed to confirm that both safety shields performed as intended, utilizing both Professional Healthcare Users and Non-clinical Pen Users. Based on performance testing results, the BD AutoShield™ Duo Pen Needle is safe and effective when used as intended.

The Simulated Use Study was performed to Validate the "Instructions For Use" (IFU) utilizing both Professional Healthcare Users and Non-clinical Pen Users. As demonstrated in the study, the use of this product does not alter the injection technique or the functionality of the pen injector.

BD AutoShield™ Duo Pen Needles are similar to BD AutoShield™ Pen Needles in that both use the same operating procedures, incorporate the same basic design, are manufactured using similar materials, offer the same gauge and needle lengths, are sterilized using the same mode and have the same SAL of 10°°.

BD's currently markets AutoShield™ Pen Needle has a safety shield on the patient end (only). The BD AutoShield™ Duo Pen Needle has a safety shield on both the patient end and non-patient (pen.connection) end. The 'Indications For Use' have been revised to reflect the additional safety shield. Both safety pen needle products help protect against accidental needle sticks.

Based on the device features, materials, intended use and performance, BD AutoShield™ Duo Pen Needles were shown to be substantially equivalent to the commercially available predicate device BD AutoShield™ Pen Needle.

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| Performance<br>Characteristic/Test<br>Description | Test Performed | Results |
|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Activation of the Sharps Injury<br>Prevention Feature | Bench Test (BD Protocol)<br>by Professional Healthcare<br>Users and Non-clinical<br>Pen Users. | Met the acceptable criteria per the<br>FDA Guidance document "Guidance<br>for Industry and FDA Staff: Medical<br>Devices with Sharps Injury Prevention<br>Features, August 9, 2005" |
| Simulated Use Study<br>Criteria per US FDA<br>Regulations ICH Guidelines,<br>ISO 14155-1:2003(E), and<br>Good Clinical Practices (GCP) | Validation of Instructions<br>for Use (IFU) by<br>Professional Healthcare<br>Users and Non-clinical<br>Pen Users. | Simulated Use Study results<br>confirmed that the BD AutoShield™<br>Duo is safe and effective when used<br>as intended. |
| | Tubing diameters | Per ISO 11608-2, section 4.3.1<br>(tubing dimensions meet OD and ID<br>requirement). |
| | Patency of lumen | Per ISO 11608-2, section 4.4 (stylet,<br>having a diameter equivalent to 80%<br>±2% of lumen ID passes through<br>freely). |
| | Needle points | Per ISO 11608-2, section 4.5<br>(visually sharp at 2.5X<br>magnification, designed to minimize<br>coring and fragmentation). |
| | Non-Type A Needle<br>(length) | Per ISO 11608-2, section 4.3.3<br>(patient end within indicated length<br>± 1.25 mm) |
| | Cannula load test | Per ISO 11608-2, section 4.9 and 9. |
| | (No pre-conditioning) | ISO 7864 (cannula holds force of<br>34N for 5 seconds). |
| | Cannula load test | Per ISO 11608-2, section 4.9 and 9. |
| | (with pre-conditioning) | ISO 7864 (cannula holds force of<br>34N for 5 seconds). |
| | Lubrication | Per ISO 11608-2, section 4.7<br>(droplets of lubricant shall not be<br>visible with unaided eye inside the<br>needle under normal light conditions<br>(72-135 lux). |
| | Compatibility Testing | Per ISO 11608-2, section 4.10<br>(connectivity (torque). |

The following Table summarizes the validation/verification testing that was performed.

. ..

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Becton, Dickinson and Company Ms. Cynthia Lacatena Regulatory Affairs Specialist BD Medical Diabetes Care 1 Becton Drive MC 372 Franklin Lakes, New Jersey 07417

JUL 27 2011

Re: K110703

Trade/Device Name: BD AutoShield™ Duo Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: II Product Code: FMI Dated: July 7, 2011 Received: July 11, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cinthorn O. wats

Anthony D. Watson, B.S., M.S., M.B.A. 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): K110703

Device Name: BD AutoShield™ Duo Pen Needle

Indications For Use:

The BD AutoShield ™ Duo Pen Needle is intended for use with pen injector devices for the injection of drugs.

The product has two safety shields, which lock in place after use (patient-end) and upon renoval I he product has two salety smelds, whiles to provided shields help reduce the occurrence of needle sticks from both ends of the needle.

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

Over-The-Counter Use __ X ============================================================================================================================================================================ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ista for Rex

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

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510(k) Number: K110703

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