Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple mechanical pen needle and does not mention any AI or ML components or functionalities.

Therapeutic

No
This device is a pen needle used for subcutaneous injection of drugs, which is a delivery mechanism, not a device that treats a condition itself.

Diagnostic

No
The device is described as a pen needle for subcutaneous injection of drugs, not for diagnosis. Its purpose is to deliver medication, not to identify or monitor medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical pen needle consisting of a needle, base, and shield assembly, and the performance studies involve functional performance testing of this physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for the subcutaneous injection of drugs." This describes a device used to deliver medication into the body, not to perform tests on samples taken from the body.
Device Description: The description details a needle, base, and shield assembly designed for injection. It doesn't mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays

The device is clearly intended for drug delivery, which falls under a different category of medical devices than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FMI

Device Description

The BD Contoured Base 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 Contoured Base Pen Needle is offered in a 32 gauge size and 4mm length. It is a single-use disposable device that is provided sterile. The BD Contoured Base Pen Needle is non-toxic and non-pyrogenic.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Test Summary: The subject device has the same technological characteristics as the predicate device cleared in K162516. 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 included 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:

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

The results of the functional performance and biocompatibility testing passed and successfully demonstrated the subject device has met the requirements.

Clinical Test Summary: No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K162516

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 23, 2021

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

Re: K182320

Trade/Device Name: BD Contoured Base Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI

Dear Meriam Youssef:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2018. Specifically, FDA is updating this SE Letter to indication for Use form that the cleared device is an Over-the-Counter and not Prescription only (Rx) as previously indicated.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens by phone at 301-796-6294 or email at alan.stevens@fda.hhs.gov.

Sincerely,

Alan M.
Stevens -S3

CAPT Alan 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

1

Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

December 20, 2018

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

Re: K182320

Trade/Device Name: BD Contoured Base Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 19, 2018 Received: November 20, 2018

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 mav, 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

2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sarah B. Mollo

for 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) K182320

Device Name BD Contoured Base 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)

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510(k) Summary K182320

Manufactures Name:	Becton, Dickinson and Company
Parent Company:	Becton, Dickinson and Company (BD Medical- Diabetes Care)
Corresponding Official:	Meriam Youssef
Senior Manager Regulatory Affairs, BD Medical- Diabetes Care
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 6557
Fax: 201 847 5307
Summary Date:	December 20, 2018
Device Name:	Trade Name:
Common Name:
Classification:
Regulation Name:
Regulation Number:
Product Code:	BD Contoured Base Pen Needle
Insulin Pen Needle
Class II device
hypodermic single lumen needle
21 CFR 880.5570
FMI (hypodermic single lumen needle)

Legally marketed predicate device to which substantial equivalence is being claimed: K162516: BD Nano™ Pen Needle

Device Description:

The BD Contoured Base 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 Contoured Base Pen Needle is offered in a 32 gauge size and 4mm length. It is a single-use disposable device that is provided sterile. The BD Contoured Base Pen Needle is non-toxic and non-pyrogenic.

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 the predicate device.

Comparison with Predicate Devices:

The subject device has the same materials, fundamental scientific technology and device performance as the predicated device (K162516). The purpose of this submission is to market the BD Contoured Base Pen Needle device with the changes described in the table below. This 510(k) provides supporting evidence on the performance characteristics of the

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subject device. The table below provides a side by side comparison of the subject device compared to its predicate.

| Feature | Subject: BD Contoured
Base Pen Needle | Predicate Device: BD
Nano™ Pen Needle | Comments |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182320 | K162516 | N/A |
| Indications for Use | Becton Dickinson Pen
Needle is intended for use
with pen injector devices for
the subcutaneous injection of
drugs. | Becton Dickinson Pen
Needle is intended for use
with pen injector devices for
the subcutaneous injection of
drugs. | N/A |
| Intended Use | Becton Dickinson Pen
Needle is intended for use
with pen injector devices for
the subcutaneous injection of
drugs. | Becton Dickinson Pen
Needle is intended for use
with pen injector devices for
the subcutaneous injection of
drugs. | N/A |
| Pen Needle components | Pen needle hub (non-posted)

Inner needle shield (flat
squared contour top and
grips)

Outer Cover (wider outer
cover with flat top and longer
grips)

Cannula (32G x 4mm extra
thin wall 5 bevel) | Pen needle hub (posted)

Inner needle shield (flat top)

Outer Cover (with grips)

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Testing:

Non- Clinical Test Summary:

The subject device has the same technological characteristics as the predicate device cleared in K162516. 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 included 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:

· Chemical Characterization
· Cytotoxicity
Intracutaneous Reactivity
· Skin Sensitization
· Acute Systemic Toxicity
Subacute/ Subchronic Toxicity
Genotoxicity- Bacterial and Mammalian
· Hemolysis Test
· Material Mediated Pyrogenicity
Bacterial Endotoxin

The results of the functional performance and biocompatibility testing passed and successfully demonstrated the subject device has met the requirements.

Clinical Test Summary:

No clinical study is included in this submission.

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Conclusion:
The non-clinical testing demonstrated the subject device is substantially equivalent to its predicate device.