BD Contoured Base Pen Needle

K182320 · Becton, Dickinson and Company · FMI · Dec 20, 2018 · General Hospital

Device Facts

• Record ID: K182320
• Device Name: BD Contoured Base Pen Needle
• Applicant: Becton, Dickinson and Company
• Product Code: FMI · General Hospital
• Decision Date: Dec 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

BD Contoured Base Pen Needle is a single-use, sterile, disposable hypodermic needle designed for subcutaneous drug delivery via pen injectors. It consists of a 32G x 4mm cannula, a non-posted hub, an inner needle shield, and an outer cover. The device is used by patients or clinicians to administer medication; the user attaches the needle to a pen injector, performs a manual 90-degree insertion, and delivers the dose. The contoured base and shield design facilitate handling and attachment. The device is non-toxic and non-pyrogenic. It provides a mechanical interface for drug delivery, benefiting patients by enabling consistent, subcutaneous administration of prescribed medications.

Clinical Evidence

No clinical data. Bench testing only. Functional performance validated per ISO 11608-2 (flow rate, bond strength, torque, dose accuracy). Biocompatibility validated per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, genotoxicity, hemolysis, pyrogenicity).

Technological Characteristics

32G x 4mm extra thin wall 5-bevel stainless steel cannula. Hub and shield: polypropylene. Outer cover: polypropylene. Sterilization: Gamma irradiation. Connectivity: None (mechanical). Standards: ISO 11608-2 (functional), ISO 10993-1 (biocompatibility), USP <85> (pyrogenicity).

Indications for Use

Indicated for patients requiring subcutaneous injection of drugs using pen injector devices.

Regulatory Classification

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.

Predicate Devices

• BD Nano™ Pen Needle (K162516)

Submission Summary (Full Text)

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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 [e-mail].

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

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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

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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 ([e-mail]) or phone [phone] 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<br>Senior Manager Regulatory Affairs, BD Medical- Diabetes Care<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: [phone]<br>Fax: [phone] | | |
| Summary Date: | December 20, 2018 | | |
| Device Name: | Trade Name:<br>Common Name:<br>Classification:<br>Regulation Name:<br>Regulation Number:<br>Product Code: | BD Contoured Base Pen Needle<br>Insulin Pen Needle<br>Class II device<br>hypodermic single lumen needle<br>21 CFR 880.5570<br>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<br>Base Pen Needle | Predicate Device: BD<br>Nano™ Pen Needle | Comments |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182320 | K162516 | N/A |
| Indications for Use | Becton Dickinson Pen<br>Needle is intended for use<br>with pen injector devices for<br>the subcutaneous injection of<br>drugs. | Becton Dickinson Pen<br>Needle is intended for use<br>with pen injector devices for<br>the subcutaneous injection of<br>drugs. | N/A |
| Intended Use | Becton Dickinson Pen<br>Needle is intended for use<br>with pen injector devices for<br>the subcutaneous injection of<br>drugs. | Becton Dickinson Pen<br>Needle is intended for use<br>with pen injector devices for<br>the subcutaneous injection of<br>drugs. | N/A |
| Pen Needle components | Pen needle hub (non-posted)<br><br>Inner needle shield (flat<br>squared contour top and<br>grips)<br><br>Outer Cover (wider outer<br>cover with flat top and longer<br>grips)<br><br>Cannula (32G x 4mm extra<br>thin wall 5 bevel) | Pen needle hub (posted)<br><br>Inner needle shield (flat top)<br><br>Outer Cover (with grips)<br><br>Cannula (32G x 4mm extra<br>thin wall 5 bevel) | The subject device with<br>modifications met the<br>requirements per ISO<br>11608-2. Therefore, the<br>modifications do not<br>raise questions<br>respective of safety or<br>efficacy of the subject<br>device. |
| Needle insertion method | Unchanged | Manual | N/A |
| Product type | Unchanged | Hypodermic single lumen<br>needle | N/A |
| Angle of Insertion | Unchanged | Straight 90 degrees | N/A |
| Tip Geometry | Unchanged | 5 Bevel | N/A |
| Tamper Evident Feature | Unchanged | Yes (peel-away label) | N/A |
| Replacement Frequency | Unchanged | Disposable, single use | N/A |
| Provided Sterile (Method<br>of Sterilization) | Unchanged | YES (Gamma Irradiation) | N/A |
| Non-pyrogenic | Unchanged | Yes, per USP<85> | N/A |
| Needle Gauge Size | Unchanged | 32G | N/A |
| Needle Length size | Unchanged | 4mm | N/A |
| Inner Diameter | Unchanged | Dimensions per ISO 9626<br>Table 1 Section 5 | N/A |
| Outer Diameter | Unchanged | Dimensions per ISO 9626<br>Table 1 Section 5 | N/A |
| Cannula | Unchanged | Stainless Steel | N/A |
| Cannula Lubricant | Unchanged | Medical Grade Lubricant | N/A |
| Cannula Adhesive | Unchanged | UV Cured Adhesive | N/A |
| Needle Hub | Unchanged | Polypropylene | N/A |
| Needle Shield | Unchanged | Polypropylene | N/A |
| Feature | Subject: BD Contoured<br>Base Pen Needle | Predicate Device: BD<br>Nano™ Pen Needle | Comments |
| Outer Shield (Outer | Unchanged | Polyethylene or | Predicate device outer |
| Cover) | Polypropylene | Polypropylene | cover material is either<br>polypropylene or<br>polyethylene; while<br>subject device outer<br>cover is<br>polypropylene. |
| Tear drop Label | Unchanged | Paper | N/A |

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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.