(91 days)
No
The device description and performance studies focus on the physical characteristics and functional performance of a pen needle for drug injection, with no mention of AI or ML technologies.
Yes
The device is a pen needle, which is used for the subcutaneous injection of drugs, indicating its role in administering therapeutic substances.
No.
The device description and intended use clearly state that the BD Pen Needle is for subcutaneous injection of drugs, not for diagnosis.
No
The device description clearly states it is a physical needle, hub, and shield assembly, which are hardware components.
Based on the provided information, the BD Pen Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of drugs" using a pen injector. This is a direct therapeutic intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a needle, hub, and shield assembly designed for injecting substances into the subcutaneous tissue. This aligns with a drug delivery device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The BD Pen Needle's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
BD 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, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.
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 the same technological characteristics as the predicate devices cleared in K051899 and K131358. 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.
The clarification to the intended use of the BD pen needle device, in the Instruction for Use, does not introduce critical differences or new risks to the intended therapeutic use of the device. The proposed clarification reflects current medical practice and aligns with BD's compatibility summary displayed on the device package. BD conducts internal testing as part of its Quality System, to support the compatibility of its pen needle devices with all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy. This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, with the top profile being the largest and the bottom profile being the the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Becton, Dickerson and Company Meriam Youssef Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K162516
Trade/Device Name: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 15, 2016 Received: September 16, 2016
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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.
1
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang-S
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
2
Indications for Use
510(k) Number (if known) K162516
Device Name BD Pen Needle
Indications for Use (Describe)
BD 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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3
510(k) Summary
| Submitted By: | Meriam Youssef
Staff Regulatory Affairs Specialist, BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 6557
Fax: 201 847 5307 | |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 7, 2016 | |
| Device Name: | Trade Name:
Common Name:
Classification:
Product Code: | BD Pen Needle
Insulin Pen Needle
Class II device; 21 CFR 880.5570,
(hypodermic single lumen needle)
FMI (hypodermic single lumen needle) |
Legally marketed predicate devices to which substantial equivalence is being claimed:
K051899 and K131358: BD Pen Needle Reference Device: K110703: BD AutoShield™ Duo Pen Needle
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, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.
Intended Use:
BD Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
Comparison with Predicate Devices:
The subject device has the same device design, materials, fundamental scientific technology and device performance as the predicate devices (K051899 and K131358). The purpose of this submission is to provide clarification to the intended use which is similar amongst the cited predicate devices. The table below provides a side by side comparison of the subject device compared to its predicate.
4
| Feature | Subject: BD Pen Needle | Predicate Device: BD Pen Needle | Reference Device: BD
AutoShield™ Duo Pen
Needle |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Pending | K051899 and K131358 | K110703 |
| 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,
including insulin and
exenatide. | For use with pen injector
devices for the injection of
drugs.
The product has two
safety shields, which lock
in place after use (patient-
end) and upon removal of
the needle from the pen
(pen connection-end).
The locked shields help
reduce the occurrence of
needle sticks from both
ends of the needle. |
| Needle Gauge Size(s) | Unchanged | 29G, 30G, 31G, 32G | 30G and 31G |
| Needle Length Size(s) | Unchanged | 4mm, 5mm,8mm, and
12.7mm | 5mm and 8mm |
| Tip Geometry
(Configuration) | Unchanged | 3 or 5 bevel | 3 bevel |
| Needle insertion method | Unchanged | Manual | Manual |
| Provided Sterile | Unchanged | YES (Gamma Irradiation) | YES (Gamma Irradiation) |
Testing:
The subject device has the same technological characteristics as the predicate devices cleared in K051899 and K131358. BD has validated the design of the subject device as part of its design control process in accordance with the Ouality 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.
The clarification to the intended use of the BD pen needle device, in the Instruction for Use, does not introduce critical differences or new risks to the intended therapeutic use of the device. The proposed clarification reflects current medical practice and aligns with BD's compatibility summary displayed on the device package. BD conducts internal testing as part of its Quality System, to support the compatibility of its pen needle devices with all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy. This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification.
Conclusion:
The subject device is substantially equivalent to its predicate devices.