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 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.

AI/ML Overview

BD AutoShield™ Duo Pen Needle - Acceptance Criteria and Study Details

The BD AutoShield™ Duo Pen Needle is a safety pen needle designed to prevent accidental needle sticks from both the patient and non-patient ends. The following summarizes the acceptance criteria and study proving the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic/Test Description	Acceptance Criteria	Reported Device Performance
Activation of Sharps Injury Prevention Feature	Met the acceptable criteria per the FDA Guidance document "Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9, 2005"	Met the acceptable criteria per the FDA Guidance document "Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9, 2005"
Simulated Use Study Criteria	Validation of Instructions for Use (IFU) in accordance with US FDA Regulations, ICH Guidelines, ISO 14155-1:2003(E), and Good Clinical Practices (GCP) to confirm safety and effectiveness when used as intended.	Confirmed that the BD AutoShield™ Duo is safe and effective when used as intended, and does not alter injection technique or pen injector functionality.
Tubing Diameters	Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement).	Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement).
Patency of Lumen	Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely).	Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely).
Needle Points	Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation).	Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation).
Non-Type A Needle (length)	Per ISO 11608-2, section 4.3.3 (patient end within indicated length ± 1.25 mm).	Per ISO 11608-2, section 4.3.3 (patient end within indicated length ± 1.25 mm).
Cannula Load Test (No pre-conditioning)	Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds).	Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds).
Cannula Load Test (with pre-conditioning)	Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds).	Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds).
Lubrication	Per ISO 11608-2, section 4.7 (droplets of lubricant shall not be visible with unaided eye inside the needle under normal light conditions (72-135 lux).	Per ISO 11608-2, section 4.7 (droplets of lubricant shall not be visible with unaided eye inside the needle under normal light conditions (72-135 lux).
Compatibility Testing	Per ISO 11608-2, section 4.10 (connectivity (torque)).	Per ISO 11608-2, section 4.10 (connectivity (torque)).

2. Sample Size Used for the Test Set and Data Provenance

Activation of Sharps Injury Prevention Feature (Bench Test): The specific sample size for this test is not explicitly stated, but it involved both "Professional Healthcare Users" and "Non-clinical Pen Users." The data provenance (country of origin, retrospective/prospective) is not specified.
Simulated Use Study (Validation of Instructions for Use): The specific sample size for this study is not explicitly stated, but it involved both "Professional Healthcare Users" and "Non-clinical Pen Users." The data provenance (country of origin, retrospective/prospective) is not specified.
Other Bench Tests (Tubing diameters, Patency of lumen, Needle points, Non-Type A Needle (length), Cannula load test, Lubrication, Compatibility Testing): The document does not specify the sample size for these individual bench tests. These are typically performed in a laboratory setting. Data provenance is implied to be from Becton, Dickinson and Company's internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Activation of Sharps Injury Prevention Feature & Simulated Use Study: These studies utilized "Professional Healthcare Users" and "Non-clinical Pen Users." The specific number and exact qualifications (e.g., years of experience, specific medical field) of these users are not detailed in the provided document. They are considered "experts" in the sense of being intended users of the device.
Other Bench Tests: The "ground truth" for these tests are established by adhering to international standards (ISO, FDA Guidance) and Becton, Dickinson and Company's own protocols. The "experts" involved would be qualified laboratory technicians and engineers with expertise in medical device testing and relevant standards. The number of such individual experts is not specified.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For the "Sharps Injury Prevention Feature" and "Simulated Use Study," it appears the performance was assessed directly against the specified criteria by the participating users and observers, or by the testing personnel. For the other bench tests, compliance with established ISO standards and internal protocols served as the basis for acceptance.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being done. The studies described focus on the standalone performance and safety features of the BD AutoShield™ Duo Pen Needle and its substantial equivalence to a predicate device. The document does not provide data on how human readers (users) improve with or without AI (not applicable here) or device assistance beyond the inherent safety features.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

This question is not applicable as the BD AutoShield™ Duo Pen Needle is a physical medical device, not an algorithm or AI-powered system. The performance evaluated relates to its mechanical safety features and user interaction.

7. Type of Ground Truth Used

Activation of Sharps Injury Prevention Feature: The ground truth was based on the device's ability to perform its intended sharps injury prevention function as observed by users and assessed against FDA guidance.
Simulated Use Study: The ground truth was based on the device's ability to be safely and effectively used according to its Instructions For Use (IFU), as validated by user performance and observation.
Other Bench Tests: The ground truth was based on adherence to established international standards (ISO 11608-2, ISO 7864) and internal protocols for physical and functional properties.

8. Sample Size for the Training Set

The document does not mention a distinct "training set" in the context of device development as understood for AI/ML models. For a physical device like this, the "training" equivalent would be the iterative design and testing phases that lead to the final product. The provided information focuses on the final validation/verification testing.

9. How the Ground Truth for the Training Set Was Established

As there's no explicit "training set" in the AI/ML sense, this question isn't directly applicable. However, during the iterative design and development phases of the BD AutoShield™ Duo Pen Needle, the "ground truth" for guiding improvements would have been established through:

Engineering specifications and design requirements.
Bench testing of prototypes against ISO standards and internal performance metrics.
Feedback from early user evaluations and risk assessments.
Experience gained from the predicate device (BD AutoShield™ Pen Needle).

These elements would have informed the iterative design process, leading to the final device which was then formally validated/verified as described in the provided summary.

Summary

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JUL 27 2011

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

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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: 201-848-8830 Fax:

Contact Person:

James Haynes Manager, Regulatory Affairs 201-847-4298 Phone: 201-847-4859 Fax: Email: James_Haynes@BD.com

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:

1. 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.

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 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.

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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PerformanceCharacteristic/TestDescription	Test Performed	Results
Activation of the Sharps InjuryPrevention Feature	Bench Test (BD Protocol)by Professional HealthcareUsers and Non-clinicalPen Users.	Met the acceptable criteria per theFDA Guidance document "Guidancefor Industry and FDA Staff: MedicalDevices with Sharps Injury PreventionFeatures, August 9, 2005"
Simulated Use StudyCriteria per US FDARegulations ICH Guidelines,ISO 14155-1:2003(E), andGood Clinical Practices (GCP)	Validation of Instructionsfor Use (IFU) byProfessional HealthcareUsers and Non-clinicalPen Users.	Simulated Use Study resultsconfirmed that the BD AutoShield™Duo is safe and effective when usedas intended.
	Tubing diameters	Per ISO 11608-2, section 4.3.1(tubing dimensions meet OD and IDrequirement).
	Patency of lumen	Per ISO 11608-2, section 4.4 (stylet,having a diameter equivalent to 80%±2% of lumen ID passes throughfreely).
	Needle points	Per ISO 11608-2, section 4.5(visually sharp at 2.5Xmagnification, designed to minimizecoring and fragmentation).
	Non-Type A Needle(length)	Per ISO 11608-2, section 4.3.3(patient end within indicated length± 1.25 mm)
	Cannula load test	Per ISO 11608-2, section 4.9 and 9.
	(No pre-conditioning)	ISO 7864 (cannula holds force of34N for 5 seconds).
	Cannula load test	Per ISO 11608-2, section 4.9 and 9.
	(with pre-conditioning)	ISO 7864 (cannula holds force of34N for 5 seconds).
	Lubrication	Per ISO 11608-2, section 4.7(droplets of lubricant shall not bevisible with unaided eye inside theneedle under normal light conditions(72-135 lux).
	Compatibility Testing	Per ISO 11608-2, section 4.10(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 (800) 638-2041 or (301) 796-7100 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

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

510(k) Number: K110703

023

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).