The BD 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. It consists of a needle, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.

AI/ML Overview

The provided text is a 510(k) summary for the BD Pen Needle, which is a medical device. This document is a regulatory submission to the FDA, asserting that the device is substantially equivalent to previously cleared devices. It does not describe a study proving the device meets acceptance criteria in the manner of a clinical trial or a performance study with reported metrics and statistical analyses.

Instead, the document states that the device has the "same technological characteristics as the predicate devices" and that BD has "validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation." It also mentions "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles." However, no specific acceptance criteria or performance results are provided in the document.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document refers to ISO 11608-2 but does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the device's performance results were.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a study involving expert ground truth.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as this is a physical medical device.
How the ground truth for the training set was established: Not applicable.

Summary of what is stated in the document regarding testing:

Testing performed: "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles."
Purpose of the testing: To validate the design as part of BD's design control process and to support the compatibility of its pen needle devices with "all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy."
Conclusion of testing: "This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification."

The document focuses on demonstrating substantial equivalence based on similar technological characteristics and adherence to quality systems and relevant standards, rather than providing detailed study results against specific acceptance criteria.

Summary

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

December 9, 2016

Becton, Dickerson and Company Meriam Youssef Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K162516

Trade/Device Name: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 15, 2016 Received: September 16, 2016

Dear Meriam Youssef:

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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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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K162516

Device Name BD Pen Needle

Indications for Use (Describe)

BD Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitted By:	Meriam YoussefStaff Regulatory Affairs Specialist, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6557Fax: 201 847 5307
Date Prepared:	December 7, 2016
Device Name:	Trade Name:Common Name:Classification:Product Code:	BD Pen NeedleInsulin Pen NeedleClass II device; 21 CFR 880.5570,(hypodermic single lumen needle)FMI (hypodermic single lumen needle)

Legally marketed predicate devices to which substantial equivalence is being claimed:

K051899 and K131358: BD Pen Needle Reference Device: K110703: BD AutoShield™ Duo Pen Needle

Device Description:

Intended Use:

BD Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

Comparison with Predicate Devices:

The subject device has the same device design, materials, fundamental scientific technology and device performance as the predicate devices (K051899 and K131358). The purpose of this submission is to provide clarification to the intended use which is similar amongst the cited predicate devices. The table below provides a side by side comparison of the subject device compared to its predicate.

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Feature	Subject: BD Pen Needle	Predicate Device: BD Pen Needle	Reference Device: BDAutoShield™ Duo PenNeedle
510(k) Number	Pending	K051899 and K131358	K110703
Intended Use	Becton Dickinson PenNeedle is intended for usewith pen injector devicesfor the subcutaneousinjection of drugs.	Becton Dickinson PenNeedle is intended for usewith pen injector devicesfor the subcutaneousinjection of drugs,including insulin andexenatide.	For use with pen injectordevices for the injection ofdrugs.The product has twosafety shields, which lockin place after use (patient-end) and upon removal ofthe needle from the pen(pen connection-end).The locked shields helpreduce the occurrence ofneedle sticks from bothends of the needle.
Needle Gauge Size(s)	Unchanged	29G, 30G, 31G, 32G	30G and 31G
Needle Length Size(s)	Unchanged	4mm, 5mm,8mm, and12.7mm	5mm and 8mm
Tip Geometry(Configuration)	Unchanged	3 or 5 bevel	3 bevel
Needle insertion method	Unchanged	Manual	Manual
Provided Sterile	Unchanged	YES (Gamma Irradiation)	YES (Gamma Irradiation)

Testing:

The subject device has the same technological characteristics as the predicate devices cleared in K051899 and K131358. BD has validated the design of the subject device as part of its design control process in accordance with the Ouality System Regulation. This testing included functional performance per ISO 11608-2: Needle-based injection systems for medical use -Requirements and test methods- Part 2: Needles.

The clarification to the intended use of the BD pen needle device, in the Instruction for Use, does not introduce critical differences or new risks to the intended therapeutic use of the device. The proposed clarification reflects current medical practice and aligns with BD's compatibility summary displayed on the device package. BD conducts internal testing as part of its Quality System, to support the compatibility of its pen needle devices with all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy. This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification.

Conclusion:

The subject device is substantially equivalent to its predicate devices.

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).