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, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 34-gauge size and 4mm length XTW cannula. The device is non-toxic and non-pyrogenic. It is a single-use disposable device that is provided sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BD Nano™ 2nd Gen Pen Needle, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Standard/Requirements)	Reported Device Performance
Bench Functional Performance
Cannula Straightness	ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications	Met requirements
Cannula Stiffness	ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications	Met requirements
Cannula Breakage Resistance	ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications	Met requirements
Flow Rate Measurement	ISO 11608-2:2012, BD Internal Specifications	Met requirements
Cannula Patency	ISO 11608-2:2012, BD Internal Specifications	Met requirements
Patient End Penetration Force	ISO 11608-2:2012, BD Internal Specifications	Met requirements
Cannula Pull Force	ISO 11608-2:2012, BD Internal Specifications	Met requirements
Dose Accuracy	ISO 11608-2:2012, BD Internal Specifications	Met requirements
Material/Design Characteristics
Biocompatibility	Non-toxic	Device is non-toxic
Pyrogenicity	Non-pyrogenic	Device is non-pyrogenic
Sterility (SAL)	10^-6	Achieved 10^-6 SAL
Sterilization Method	Not explicitly stated as "acceptance criteria," but gamma irradiation is used	Gamma irradiation (same as predicate)
Usability/Functionality	For use with pen injector devices for subcutaneous injection of drugs	Met requirements for intended use
Shelf Life	5 years	Supported by testing (implied by "support the 5-year shelf life")

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

The document does not specify the exact sample sizes (number of devices tested) for the bench functional performance tests. It states "Testing included functional performance per ISO 11608-2:2012... and testing following BD's Internal Specifications." While standards typically mandate minimum sample sizes, the specific numbers for this device are not provided in this summary.
Data Provenance: The data is from "Non-Clinical Testing" performed by Becton, Dickinson and Company as part of its design control process. This indicates the testing was conducted internally by the manufacturer. It is prospective testing designed to validate the new device. The country of origin of the data is not explicitly stated.

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

This information is not applicable as the study described is a non-clinical, bench performance study of a medical device (a pen needle), not a study involving human diagnosis, interpretation of medical images, or clinical outcomes that would require expert-established ground truth. The "ground truth" here is defined by meeting physical and performance specifications outlined in international standards (ISO) and the manufacturer's internal specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used to reconcile discrepancies among human readers or evaluators, which is not relevant to bench testing of device performance against pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids or clinical decision support systems, where the goal is to assess the impact of AI on human reader performance. The BD Nano™ 2nd Gen Pen Needle is a physical medical device (pen needle), not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical pen needle, not an algorithm or AI system. Its performance is evaluated through bench testing against physical and functional standards, not as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on pre-defined technical specifications, international standards (ISO 11608-2:2012, ISO 9626:2016), and the manufacturer's (BD's) internal specifications. For example, a flow rate measurement would be compared against a specified range or minimum value defined by the standard or the manufacturer, making that standard the "ground truth."

8. The Sample Size for the Training Set

Not applicable. Training sets are used in machine learning for AI algorithms. This device is a physical medical device, and its performance is evaluated through non-clinical testing, not by training an algorithm.

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

Not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 8, 2021

Becton, Dickinson and Company Mark William Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K213156

Trade/Device Name: BD Nano 2nd Gen Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 15, 2021 Received: November 16, 2021

Dear Mark William:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K213156

Device Name

BD Nano™ 2nd Gen Pen Needle

Indications for Use (Describe)

Becton Dickinson 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K213156

510(k) SUMMARY

Becton, Dickinson and Company

BD Nano™ 2nd Gen Pen Needle

Submitted By:	Mark WilliamRegulatory Affairs Specialist1 Becton DriveFranklin Lakes, NJ 07417Tel: 732-527-5008
Date Prepared:	September 16, 2021
Device Name:	Trade Name:	BD Nano™ 2nd Gen Pen Needle
	Common Name:	BD Pen Needle
	Classification:	Class II device; 21 CFR 880.5570,(hypodermic single lumen needle)
	Product Code:	FMI (Needle, Hypodermic, Single Lumen)

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

BD Contoured Base Pen Needle (K182320)

Reason for Submission:

The purpose of this submission is to market a new BD Pen Needle size that utilizes all the same components and processes as the currently marketed product, BD Contoured Base Pen Needle, but with a 34G cannula instead of a 32G cannula.

Device Description:

{4}------------------------------------------------

Intended Use / Indications for Use

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

The indications for use of the subject device remains the same as its predicate device.

Comparison with Predicate Devices

The technological characteristics of the subject device are similar to those of the predicate device. A summary of the differences between BD Nano™ 2nd Gen Pen Needle subject device and BD Contoured Base Pen Needle cleared under K182320 are outlined in Table 1 below.

GeneralInformationFeature	Subject Device:BD Nano™ 2nd Gen PenNeedle	Predicate Device:BD Contoured Base Pen Needle	Comparison
510(k) Number	K213156	K182320	N/A
DeviceClassification	2	2	Same
RegulationNumber	880.5570	880.5570	Same
Product Code	FMI (Class 2) - Needle,Hypodermic, Single Lumen	FMI (Class 2) - Needle,Hypodermic, Single Lumen	Same
Indications of Use	Becton Dickinson Pen Needle isintended for use with peninjector devices for thesubcutaneous injection of drugs.	Becton Dickinson Pen Needle isintended for use with peninjector devices for thesubcutaneous injection of drugs.	Same
Single Use Only	YES	YES	Same
Non-pyrogenic	YES	YES	Same
Sterilizationmethod	Gamma irradiation	Gamma irradiation	Same
SAL 10-6	YES	YES	Same
GeneralInformationFeature	Subject Device:BD Nano™ 2nd Gen PenNeedle	Predicate Device:BD Contoured Base Pen Needle	Comparison
Cannula GaugeSize(s)	34G	32G	Different; The subjectdevice introduces athinner cannula with asmaller diameter; Thedifference has beenvalidated with benchperformance data.
Cannula LengthSize(s)	4mm	4mm	Same
Cannula TipGeometry	5 Bevel	5 Bevel	Same
Cannula Material	Stainless Steel	Stainless Steel	Same
Cannula Lubricant	Medical Grade Lubricant	Medical Grade Lubricant	Same
Cannula Adhesive	UV Cured Adhesive	UV Cured Adhesive	Same
Needle HubMaterial	Polypropylene	Polypropylene	Same
Needle ShieldMaterial	Polypropylene	Polypropylene	Same
Needle ShieldColor	Green	Green	Same
Outer Shield(Cover) Material	Polypropylene	Polypropylene	Same
Tear Drop Label	Paper	Paper	Same

Table 1: Comparison of Subject and predicate devices

{5}------------------------------------------------

Non-Clinical Testing:

The subject device has similar technological characteristics as the predicate device cleared under K182320. BD validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance

{6}------------------------------------------------

per ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles and testing following BD's Internal Specifications. The cannula component was also evaluated in accordance with ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.

Bench Functional Performance

Testing was conducted according to 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. The evaluation performed included all testing impacted by the proposed change of introducing a 34G cannula to support the 5-year shelf life and ensure the functionality of the subject device per the intended use. The performance testing consisted of cannula straightness, cannula stiffness, cannula breakage resistance, measurement of flow rate, cannula patency, patient end penetration force, cannula pull force, and dose accuracy.

Results of testing demonstrated that the BD Nano™ 2nd Gen Pen Needle met the requirements for its intended use and is as safe and effective as its predicate device.

Clinical Test Summary

Not Applicable.

Conclusions

The modifications to the subject device met all performance testing requirements. The modifications between the predicate (K182320) and the subject devices do not raise any new or different questions of safety or effectiveness.

The BD Nano™ 2nd Gen Pen Needle is substantially equivalent to the predicate BD Contoured Base Pen Needle (K182320) with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.

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).