(144 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a pen needle, with no mention of AI or ML technologies.
No
Explanation: The device is a pen needle intended for subcutaneous injection of drugs, not for therapeutic treatment itself. It is a delivery mechanism for a drug, which would be the therapeutic agent.
No
Explanation: The device is a pen needle for subcutaneous drug injection, not for diagnosing conditions. Its intended use and description clearly state it's for drug delivery, not diagnostic purposes.
No
The device description clearly states it is a physical pen needle consisting of a needle, base, and shield assembly, indicating it is a hardware device.
Based on the provided information, the Becton Dickinson Pen Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for use with pen injector devices 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.
- Performance Studies: The performance studies focus on functional aspects like flow rate, bond strength, and dose accuracy, as well as biocompatibility. These are typical tests for devices that interact with the body for drug delivery, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Becton Dickinson Pen Needle's function is purely for drug delivery.
N/A
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 (comma separated list FDA assigned to the subject device)
FMI
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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
1
- 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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
| Submitted By: | Charlton Foo
Staff Regulatory Affairs Specialist
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 6869
Fax: 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:
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.
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.
4
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: BD
Contoured Base Pen Needle
(K182320) | Comparison |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number | Pending | K182320 | N/A |
| Product Code | FMI | FMI | Unchanged |
| Regulation
Number | 21 CFR 880.5570 | 21 CFR 880.5570 | Unchanged |
| Class | II | II | Unchanged |
| 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. | Unchanged |
| Needle Gauge | 32G | 32G | Unchanged |
| Needle Length | 4mm | 4mm | Unchanged |
| Pen Needle
Components | Needle Hub
Inner Needle Shield
Wide Outer Cover
Cannula (32G x 4mm 5 bevel)
Tear Drop Label | Needle Hub
Inner Needle Shield
Wide Outer Cover
Cannula (32G x 4mm 5 bevel)
Tear Drop Label | Unchanged |
| Needle
insertion
method | Manual | Manual | Unchanged |
| Provided
Sterile | YES (Gamma Irradiation) | YES (Gamma Irradiation) | Unchanged |
| Hub | Polypropylene | Polypropylene | Introduction of
alternate polymer
from a secondary
supplier |
| 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: BD
Contoured Base Pen Needle
(K182320) | Comparison |
| Inner Needle
Shield | Polypropylene | Polypropylene | Introduction of
alternate polymer
from a secondary
supplier |
| Wide Outer
Cover | Polypropylene | Polypropylene | Introduction of
alternate polymer
from a secondary
supplier |
| Tear Drop
Label | Paper | Paper | Unchanged |
5
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:
6
- 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.