(242 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
No
The device is a pen needle intended for drug delivery, not for treating a disease or condition itself.
No
The device is described as a pen needle for subcutaneous injection of drugs, indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical medical device consisting of a cannula, hub, shields, and outer cover, with manufacturing processes like injection molding and sterilization. It does not describe software.
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 use with pen injector devices for subcutaneous injection of drugs." This describes a device used for administering medication directly into the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a needle assembly designed for injection, including a cannula, hub, shields, and packaging. This aligns with a device used for drug delivery.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for performing any kind of test or analysis to provide diagnostic information.
- Performance Studies: The performance studies focus on functional performance, material biocompatibility, sterility, and packaging integrity, which are typical for a medical device used for injection, not for an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The BD Pen Needle's function is to facilitate the in vivo (inside the body) delivery of medication.
N/A
Intended Use / Indications for Use
Becton Dickinson Pen Needle is intended for use with pen injector devices for subcutaneous injection of drugs.
Product codes
FMI
Device Description
The BD Pen Needle has the same intended use/indications for use, technological characteristics, and principles of operation as the predicate device cleared under K162516. The pen needle assembly consists of a double-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the cannula to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the cannula are lubricated using silicone-based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the cannula to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide a sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away tear-drop label is pre-printed with information, which includes the lot number and needle gauge / length. The BD Pen Needle is a single-use disposable device and is provided sterile (gamma irradiation sterilization). It 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The subject device has the same technological characteristics as the predicate device cleared under 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 11608-2:2012, ISO 9626:2016, and BD internal test requirements. Material changes were evaluated in accordance with ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.
Functional Performance Testing:
- ISO 11608-2: 2012 Needle-based injection systems for medical use Requirements and test methods – Part 2: Needles
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- BD internal test requirements
Biocompatibility Testing: The device was categorized as surface medical device contacting intact skin involving prolonged contact duration for components involving direct contact with intact skin externally communicating medical device; direct contact with tissue; prolonged contact duration. The following testing was conducted according to ISO 10993-1:2018 - Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process:
- Cytotoxicity
- Sensitization
- Intracutaneous reactivity
- Irritation
- Material Mediated Pyrogenicity
- Genotoxicity
- Implantation and Particulate Analysis
- Chemical Characterization
- Toxicological Risk Assessment
Particulate matter Testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria.
Sterility, Shipping and Shelf-life:
- The BD Pen Needle is sterilized using a validated gamma irradiation sterilization method by Cobalt 60. It has been validated via the method described in ISO 11137-2:2013 -Sterilization of Health Care Product- Radiation Part 2: Establishing the Sterilization Dose. The sterilization parameters were chosen to assure the sterilization dose provides a minimum SAL of 10-6.
- Residuals are not applicable for the gamma irradiation sterilization method.
- Limulus Amebocyte Lysate (LAL) assay was used to measure the endotoxin limit the requirement was met. The product is non-Pyrogenic.
- This device is packaged in an Outer Cover with a tamper evident peel-away tear drop label. The tear drop label is the sterility barrier of the medical device.
- Sterile barrier testing performed on the subject device:
- Tear drop label removal force
- Seal integrity
- Sterile barrier testing performed on the subject device:
- Packaging Integrity Testing under simulated shipping conditions were conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging deemed acceptable for protection of product and sterility maintenance.
- Accelerated stability testing has been conducted to validate the sterility and performance of the BD Pen Needle device to support the shelf-life of 5 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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 ADMINISTRATION' in blue text.
July 11, 2022
Becton, Dickinson and Company Charlton Foo Senior Manager Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K213478
Trade/Device Name: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI
Dear Charlton Foo:
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 issued June 28, 2022. Specifically, FDA is updating this SE Letter as an administrative correction to correct the device name on the Indications for Use form and include the missing date information on the original SE Letter which should have been June 28, 2022.
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Becton, Dickinson and Company Charlton Foo Senior Manager, Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K213478
Trade/Device Name: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 23, 2022 Received: May 25, 2022
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
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,
Image /page/2/Picture/5 description: The image shows a digital signature. The signature is for Courtney Evans -S. The date of the signature is 2022.06.28. The time of the signature is 10:46:16 -04'00'.
For 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
Enclosure
3
Indications for Use
510(k) Number (if known) K213478
Device Name BD Pen Needle
Indications for Use (Describe)
Becton Dickinson Pen Needle is intended for use with pen injector devices for 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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4
K213478.510K Summary
Submitter:
Submission Correspondent:
Charlton Foo Senior Manager Regulatory Affairs Tel: 857 270 1395
Applicant:
Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417
Contact:
Mark O'Donnell Vice President, Regulatory Affairs, Medical Segment Tel: 805 452 3449
- Date Prepared: June 28, 2022
- Device Name: Trade Name: BD Pen Needle Common Name: BD Pen Needle Regulation Name: Hypodermic Single Lumen Needle Regulation: 21 CFR 880.5570 Device Class: Class II Product Code:
Predicate
K162516: BD Pen Needle
Device Description:
The BD Pen Needle has the same intended use/indications for use, technological characteristics, and principles of operation as the predicate device cleared under K162516. The pen needle assembly consists of a double-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the cannula to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP
5
ends of the cannula are lubricated using silicone-based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the cannula to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide a sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away tear-drop label is pre-printed with information, which includes the lot number and needle gauge / length. The BD Pen Needle is a single-use disposable device and is provided sterile (gamma irradiation sterilization). It is non-toxic and non-pyrogenic.
Image /page/5/Figure/1 description: The image shows the different parts of a pen needle. The parts are labeled as the outer shield, inner shield, pen needle, and tear drop label. The image shows the parts separated from each other.
| Gauge (G) | Length (mm) | Bevel | Wall Thickness |
|---|---|---|---|
| 29G | 12.7mm | 3 | Thin Wall |
| 31G | 8mm | 3 | Thin Wall |
| 31G | 8mm | 5 | Thin Wall |
| 31G | 6mm | 3 | Thin Wall |
| 31G | 5mm | 3 | Thin Wall |
| 31G | 5mm | 5 | Thin Wall |
| 31G | 5mm | 3 | Extra Thin Wall |
| 32G | 6mm | 3 | Thin Wall |
| 32G | 4mm | 3 | Thin Wall |
| 32G | 4mm | 5 | Thin Wall |
| 32G | 4mm | 5 | Extra Thin Wall |
The BD Pen Needles are offered in the following sizes:
Indication for Use:
| Characteristics | Predicate Device
Device Name
(K162516) | Subject Device
Device Name
(K213478) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Indication 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. |
| Prescription Only or Over the
Counter | Over the Counter | Over the Counter |
The indications for use statement for the subject device is identical to the predicate device.
6
Technological Characteristics
The subject device has the same fundamental scientific technology as the predicate (K162516), which operates on the principles of a single lumen needle. Compared the predicate, the subject device consists of design, performance, method, material, and labeling changes. The submission provides supporting evidence on the performance and biocompatibility of the subject device to support product changes and provide the substantiation to the most current standards and regulations. The table below provides a sideby-side comparison of the subject device compared to the predicate.
| Subject BD Pen Needles (K213478) | Predicate BD Pen Needles (K162516) | Comparison | ||
|---|---|---|---|---|
| Image | Image: Pen Needle with Outer Shield, Inner Shield, and Tear drop label | Image: Pen Needle with Outer Shield, Inner Shield, and Tear drop | Same | |
| General Information | ||||
| 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. | Same | |
| Device Classification | 2 | 2 | Same | |
| Product Type | Hypodermic single lumen needle | Hypodermic single lumen needle | Same | |
| Product Code | FMI | FMI | Same | |
| Regulation Number | 880.5570 | 880.5570 | Same | |
| Single Use | YES | YES | Same | |
| Sterilization method | Gamma irradiation | Gamma irradiation | Same | |
| SAL 10-6 | YES | YES | Same | |
| Tamper Evident Feature | YES (tear-drop label) | YES (tear-drop label) | Same | |
| Non-pyrogenic and Endotoxin Free | YES | YES | Same | |
| Design | ||||
| Subject BD Pen Needles | Predicate BD Pen Needles (K162516) | Comparison | ||
| Configurations | 29G x 12.7mm Thin Wall 3 bevel | |||
| 31G x 8mm Thin Wall 3 or 5 bevel | ||||
| 31G x 5mm Thin Wall 3 or 5 bevel | ||||
| 31G x 5mm Extra Thin Wall 3 bevel | ||||
| 32G x 6mm Thin Wall 3 bevel (cleared under K182320- BD Contoured Pen Needle) | ||||
| 32G x 4mm Thin Wall 3 bevel | ||||
| 32G x 4mm Extra Thin Wall 5 bevel | ||||
| 31G x 6mm Thin Wall 3 bevel | ||||
| 32G x 4mm Thin Wall 3 bevel | 29G x 12.7mm Thin Wall 3 bevel | |||
| 31G x 8mm Thin Wall 3 or 5 bevel | ||||
| 31G x 5mm Thin Wall 3 or 5 bevel | ||||
| 31G x 5mm Extra Thin Wall 3 bevel | ||||
| 32G x 6mm Thin Wall 3 bevel (cleared under K182320- BD Contoured Pen Needle) | ||||
| 32G x 4mm Thin Wall 3 bevel | ||||
| 32G x 4mm Extra Thin Wall 5 bevel | Different See Comment # 1 | |||
| Needle Gauge Size(s) | 29G, 31G, 32G | 29G, 31G, 32G | Same | |
| Cannula Length(s) | 4mm, 5mm,6mm, 8mm, and 12.7mm | 4mm, 5mm,8mm, and 12.7mm | Different See Comment # 2 | |
| Wall Thickness | Thin Wall or Extra Thin Wall | Thin Wall or Extra Thin Wall | Same | |
| Needle insertion method | Manual | Manual | Same | |
| Angle of Insertion | Straight 90 degrees | Straight 90 degrees | Same | |
| Tip Geometry | 3 or 5 bevel | 3 or 5 bevel | Same | |
| Materials | ||||
| Component | Sub-component | Subject BD Pen Needles | Predicate BD Pen Needles (K162516) | Comparison |
| Hub | Polypropylene | Polypropylene | Same | |
| Cannula/Needle | Stainless Steel 304 | Stainless Steel 304 | Same | |
| Pen Needle | Hub/Cannula Adhesive | UV-cured Adhesive Dymax or Loctite | UV-cured Adhesive Dymax or Loctite | Different See Comment # 3 |
| Lubricant (Patient End) | Medical Grade Silicone | Medical Grade Silicone | Same | |
| Lubricant (Non-Patient End) | Medical Grade Silicone | Medical Grade Silicone | Same | |
| Inner Shield | N/A | Polyethylene with or without Colorant (blue, purple, orange, pink or green) or Polypropylene with Colorant (green) | Polyethylene with or without Colorant (blue, purple, pink or green) or Polypropylene with Colorant (green) | Different See Comment # 4 |
| Outer Cover | N/A | Polyethylene or Polypropylene | Polyethylene or Polypropylene | Same |
| Tear Drop Label and Ink | N/A | Paper with foil layer and ink | Paper with foil layer and ink | Different See Comment # 5 |
Substantial Equivalence Table
7
Comment 1: New configuration 31G x 6mm and 32G x 4mm 5 bevel Thin Wall was introduced to the BD pen needle family. New length was in range of previously cleared sizes under K162516. The differences between the predicate and the subject device do not raise any new questions of safety or effectiveness.
8
Comment 2: New configuration 31G x 6mm was introduced to the BD pen needle family. New length was in range of previously cleared sizes under K162516. The differences between the subject device do not raise any new questions of safety or effectiveness.
Comment 3: Loctite adhesive's curing agent sourced from a new supplier. The differences between the predicate and the subject device do not raise any new questions of safety or effectiveness.
Comment 4: New blue colorant formulation introduced for 8mm pen needle and orange colorant for 31G x 6mm (orange colorant was cleared under K182320- BD Contoured Pen Needle and under K190054 – BD Insulin Syringe Device). The differences between the predicate and the subject device do not raise any new questions of safety or effectiveness.
Comment 5: A new tear-drop label ink formulation has been introduced for the BD Pen Needle. The differences between the predicate and the subject device do not raise any new questions of safety or effectiveness.
Performance Testing
Non-clinical Testing
The subject device has the same technological characteristics as the predicate device cleared under 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 11608-2:2012, ISO 9626:2016, and BD internal test requirements. Material changes were evaluated in accordance with ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.
Functional Performance Testing
- · ISO 11608-2: 2012 Needle-based injection systems for medical use Requirements and test methods – Part 2: Needles
- · ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- BD internal test requirements .
Biocompatibility Testing
The device was categorized as surface medical device contacting intact skin involving prolonged contact duration for components involving direct contact with intact skin externally communicating medical device; direct contact with tissue; prolonged contact duration. The following testing was conducted according to ISO 10993-1:2018 - Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
- . Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
9
- Irritation ●
- Material Mediated Pyrogenicity ●
- Genotoxicity
- Implantation and Particulate Analysis .
- Chemical Characterization .
- o Toxicological Risk Assessment
Particulate matter Testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria.
Sterility, Shipping and Shelf-life
- The BD Pen Needle is sterilized using a validated gamma irradiation sterilization method . by Cobalt 60. It has been validated via the method described in ISO 11137-2:2013 -Sterilization of Health Care Product- Radiation Part 2: Establishing the Sterilization Dose. The sterilization parameters were chosen to assure the sterilization dose provides a minimum SAL of 10-6.
- Residuals are not applicable for the gamma irradiation sterilization method. ●
- Limulus Amebocyte Lysate (LAL) assay was used to measure the endotoxin limit the ● requirement was met. The product is non-Pyrogenic.
- . This device is packaged in an Outer Cover with a tamper evident peel-away tear drop label. The tear drop label is the sterility barrier of the medical device.
- o Sterile barrier testing performed on the subject device:
- .. Tear drop label removal force
- . Seal integrity
- o Sterile barrier testing performed on the subject device:
- Packaging Integrity Testing under simulated shipping conditions were conducted to . satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging deemed acceptable for protection of product and sterility maintenance.
- Accelerated stability testing has been conducted to validate the sterility and . performance of the BD Pen Needle device to support the shelf-life of 5 years.
10
Conclusion:
The modifications of the design, material and labelling to the subject device compared to the predicate device in K162516 met the requirements of the standards. The differences between the predicate (K162516) and the subject device do not raise any new or different questions of safety or effectiveness. The BD Pen Needle is substantially equivalent to the predicate BD Pen Needle (K162516).