(79 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a pen needle for drug injection. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
No
A therapeutic device is one that treats a disease or condition. This device is a pen needle used for drug delivery, which is a tool for administering treatment rather than a therapeutic device itself.
No
The device is a pen needle used for subcutaneous drug injection, which is a therapeutic delivery method, not a diagnostic one. Its stated purpose involves delivering a "desired dose of drugs," not identifying a medical condition.
No
The device description clearly states it is a physical pen needle consisting of a needle, base, and shield assembly, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of drugs" using a pen injector device. This is a direct therapeutic action, delivering medication into the body.
- Device Description: The description focuses on the physical components (needle, base, shield) and their function in facilitating injection.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these types of tests.
This device is a medical device used for drug delivery, not for in vitro diagnostic testing.
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 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.
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)
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 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.
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.
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.
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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
K213156
510(k) SUMMARY
Becton, Dickinson and Company
BD Nano™ 2nd Gen Pen Needle
| Submitted By: | Mark William
Regulatory Affairs Specialist
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 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:
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.
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.
| General
Information
Feature | Subject Device:
BD Nano™ 2nd Gen Pen
Needle | Predicate Device:
BD Contoured Base Pen Needle | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213156 | K182320 | N/A |
| Device
Classification | 2 | 2 | Same |
| Regulation
Number | 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 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. | Same |
| Single Use Only | YES | YES | Same |
| Non-pyrogenic | YES | YES | Same |
| Sterilization
method | Gamma irradiation | Gamma irradiation | Same |
| SAL 10-6 | YES | YES | Same |
| General
Information
Feature | Subject Device:
BD Nano™ 2nd Gen Pen
Needle | Predicate Device:
BD Contoured Base Pen Needle | Comparison |
| Cannula Gauge
Size(s) | 34G | 32G | Different; The subject
device introduces a
thinner cannula with a
smaller diameter; The
difference has been
validated with bench
performance data. |
| Cannula Length
Size(s) | 4mm | 4mm | Same |
| Cannula Tip
Geometry | 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 Hub
Material | Polypropylene | Polypropylene | Same |
| Needle Shield
Material | Polypropylene | Polypropylene | Same |
| Needle Shield
Color | 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.