The BD Nano™ 2nd Gen Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs. It consists of a needle, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 32 gauge size and 4mm length. It is a singleuse disposable device that is provided sterile. The BD Nano™ 2nd Gen Pen Needle is nontoxic and non-pyrogenic.

AI/ML Overview

The provided text describes the 510(k) summary for the BD Nano 2nd Gen Pen Needle, primarily focusing on its substantial equivalence to a predicate device (BD Contoured Base Pen Needle, K182320) after a material change.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria are based on ISO 11608-2:2012 for functional performance and ISO 10993-1:2018 for biocompatibility. The reported device performance is that it "passed" these tests. Specific quantitative acceptance criteria or performance values are not detailed in this summary.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 11608-2:2012 (Functional Performance)	Passed
ISO 10993-1:2018 (Biocompatibility)	Passed

Functional Performance Tests (per ISO 11608-2):

Determination of Flow Rate through Needle
Bond between Hub and Cannula
Pen Installation and Removal Torque
Dose Accuracy

Biocompatibility Tests (per ISO 10993-1):

Cytotoxicity
Intracutaneous Reactivity
Skin Sensitization
Acute Systemic Toxicity
Subacute / Subchronic Toxicity
Genotoxicity Bacterial and Mammalian
Material-Mediated Pyrogenicity
Implantation
Bacterial Endotoxin

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

The document does not explicitly state the sample size used for each specific test (e.g., number of needles tested for flow rate or bond strength). It refers to "testing" and "validated the design," implying samples were used as per the standards, but the specific number is not provided.

The data provenance is retrospective as the device's design (excluding material changes) and its predicate are already established, and the testing validates the modified device against established standards. The explicit country of origin for the data is not mentioned, but the submission is to the U.S. FDA by a company based in Franklin Lakes, New Jersey, USA.

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

This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies evaluating expert interpretation or clinical diagnosis. The "ground truth" for these tests are the objective measurements defined by the ISO standards and their pass/fail criteria.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies involving human judgment or clinical endpoints that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study was included in this submission." The evaluation focuses on non-clinical performance and biocompatibility.

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

This section is not applicable. The device is a "pen needle," a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

Objective performance criteria derived from ISO 11608-2:2012 for functional characteristics (e.g., specific flow rates, torque values, dose accuracy).
Biological safety endpoints and criteria derived from ISO 10993-1:2018 for biocompatibility (e.g., demonstrating non-cytotoxicity, no sensitization).

These are engineering/materials performance standards and biological safety standards, not clinical pathology, expert consensus, or outcomes data in the usual sense for diagnostic or prognostic devices.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical medical device (pen needle), not an AI algorithm that requires a "training set."

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

This section is not applicable as the device is a physical medical device, not an AI algorithm.

Summary

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November 19, 2021

Becton Dickinson and Company Charlton Foo Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K212015

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: October 25, 2021 Received: October 26, 2021

Dear Charlton Foo:

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

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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 mediation-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

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Indications for Use

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

Submission Number (if known)

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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Submitted By:	Charlton FooStaff Regulatory Affairs SpecialistBecton Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6869Fax: 201 847 5307
Date Prepared:	June 23, 2021
Device Name:
	Trade Name: BD Nano™ 2nd Gen Pen Needle
	Common Name: Pen Needle
	Classification: Class II device; 21 CFR 880.5570,(hypodermic single lumen needle)
	Product Code: FMI (hypodermic single lumen needle)

Legally marketed predicate device to which substantial equivalence is being claimed: K182320: BD Contoured Base Pen Needle

Device Description:

Intended Use:

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

The intended use of the subject device remains the same as the predicate device.

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Comparison with Predicate Devices:

The subject device has the same fundamental scientific technology and device performance as the predicated device (K182320). The purpose of this submission is to market the BD Nano™ 2nd Gen Pen Needle device with a proposed alternate resin material. The table below provides a side-by-side comparison of the subject device compared to its predicate.

Feature	Subject Device: BD Nano™2nd Gen Pen Needle	Predicate Device: BDContoured Base Pen Needle(K182320)	Comparison
510(k) Number	Pending	K182320	N/A
Product Code	FMI	FMI	Unchanged
RegulationNumber	21 CFR 880.5570	21 CFR 880.5570	Unchanged
Class	II	II	Unchanged
Intended Use	Becton Dickinson Pen Needle isintended for use with pen injectordevices for the subcutaneousinjection of drugs.	Becton Dickinson Pen Needle isintended for use with pen injectordevices for the subcutaneousinjection of drugs.	Unchanged
Needle Gauge	32G	32G	Unchanged
Needle Length	4mm	4mm	Unchanged
Pen NeedleComponents	Needle HubInner Needle ShieldWide Outer CoverCannula (32G x 4mm 5 bevel)Tear Drop Label	Needle HubInner Needle ShieldWide Outer CoverCannula (32G x 4mm 5 bevel)Tear Drop Label	Unchanged
Needleinsertionmethod	Manual	Manual	Unchanged
ProvidedSterile	YES (Gamma Irradiation)	YES (Gamma Irradiation)	Unchanged
Hub	Polypropylene	Polypropylene	Introduction ofalternate polymerfrom a secondarysupplier
Needle	Stainless Steel	Stainless Steel	Unchanged
Lubricant	Medical Grade Lubricant	Medical Grade Lubricant	Unchanged
Feature	Subject Device: BD Nano™2nd Gen Pen Needle	Predicate Device: BDContoured Base Pen Needle(K182320)	Comparison
Inner NeedleShield	Polypropylene	Polypropylene	Introduction ofalternate polymerfrom a secondarysupplier
Wide OuterCover	Polypropylene	Polypropylene	Introduction ofalternate polymerfrom a secondarysupplier
Tear DropLabel	Paper	Paper	Unchanged

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The modifications to the materials were assessed through performance testing per ISO 11608-2:2012 and ISO 10993-1:2018. The differences between the predicate and subject device do not raise any new questions of safety or effectiveness.

Testing:

Non-Clinical Test Summary

The subject device has the same technological characteristics as the predicate device cleared in K182320. BD has 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 per ISO 11608-2: Needle-based injection systems for medical use – Requirements and test methods- Part 2: Needles and Biocompatibility testing per ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing.

Functional Performance Testing include the following tests per ISO 11608-2:

Determination of Flow Rate through Needle .
Bond between Hub and Cannula .
. Pen Installation and Removal Torque
Dose Accuracy ●

Biocompatibility Testing included the following tests per ISO 10993-1:

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Cytotoxicity .
Intracutaneous Reactivity .
Skin Sensitization .
Acute Systemic Toxicity .
Subacute / Subchronic Toxicity .
Genotoxicity Bacterial and Mammalian .
Material-Mediated Pyrogenicity .
Implantation .
. Bacterial Endotoxin

Clinical Test Summary

No clinical study was included in this submission

Conclusion:

The results of functional performance and biocompatibility testing passed and successfully demonstrated the subject device met requirements. The non-clinical testing has demonstrated the subject device is substantially equivalent to its predicate device.

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).