(64 days)
No
The device description and performance studies focus on mechanical safety features and standard testing for medical devices, with no mention of AI or ML.
No
The device is a pen needle intended for subcutaneous injection of drugs, which is an accessory to a therapeutic process but not a therapeutic device itself. Its primary function is drug delivery, not direct treatment or diagnosis.
No
Explanation: The device is a pen needle intended for drug injection, not for diagnosing medical conditions.
No
The device description clearly details a physical pen needle assembly with a cannula, hub, and safety shields, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of drugs." This is a therapeutic purpose, delivering medication into the body.
- Device Description: The description details a pen needle assembly designed to attach to a pen injector and facilitate drug delivery. It focuses on the physical mechanism of injection and safety features related to needle sticks.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is used to administer a substance into the body.
N/A
Intended Use / Indications for Use
The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous 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.
Product codes
FMI
Device Description
The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.
The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device 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 Test Summary: The subject device has the same technological characteristics as the predicate device cleared under K110703. 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, ISO 23908:2011, BD internal test requirements, as well as Biocompatibility testing per ISO 10993-1:2018.
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
- ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- BD internal test requirements
Biocompatibility Testing: Conducted according to ISO 10993-1:2018 – Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process:
- Cytotoxicity
- Intracutaneous Reactivity
- Skin Sensitization
- Acute Systemic Toxicity
- Subacute/Subchronic Toxicity
- Genotoxicity - Bacterial and Mammalian
- Material-Mediated Pyrogenicity
- Implantation
- Bacterial Endotoxin
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life:
- Sterilized using a validated gamma irradiation method by Cobalt-60, validated via ISO 11137-2:2013 -Sterilization of Health Care Product – radiation – Part 2: Establishing the Sterilization Dose, with a minimum SAL of 10-6.
- Residuals are not applicable for gamma irradiation.
- Limulus Amebocyte Lysate (LAL) assay was used to measure the endotoxin limit and the requirement was met. The product is non-pyrogenic.
- Packaged in an Outer Cover with a tamper evident peel-away tear drop label, which is the sterility barrier.
- Sterile barrier testing performed: Tear drop label removal force, Seal integrity.
- Package integrity testing under simulated shipping conditions was conducted to satisfy ASTM D4169-16. All packaging was deemed acceptable for protection of product and sterility maintenance.
- Accelerated stability testing has been conducted to validate the sterility and performance to support a shelf-life of 3 years.
Clinical Test Summary: No clinical study was included in this submission.
Key Results: The results of functional performance and biocompatibility testing passed and successfully demonstrated the subject device met requirements. The non-clinical testing has demonstrated the is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food & 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 28, 2022
Becton, Dickinson and Company Alec Paterno Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K223286
Trade/Device Name: BD AutoShield Duo™ Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 25, 2022 Received: October 25, 2022
Dear Alec Paterno:
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,
Courtney Digitally signed by Date: 2022.12.28 Evans -S 14:45:36 -05'00'
For 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
2
Indications for Use
510(k) Number (if known) K223286
Device Name BD AutoShield Duo™ Pen Needle
Indications for Use (Describe)
The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous 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.
| 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K223286 510(k) Summary
| Submitted By: | Alec Paterno | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Senior Regulatory Affairs Specialist | |||||||||
| Becton Dickinson and Company | |||||||||
| 1 Becton Drive | |||||||||
| Franklin Lakes, NJ 07417 | |||||||||
| Tel: 908 670 3376 | |||||||||
| Date Prepared: | December 21, 2022 | ||||||||
| Device Name: | Trade Name:BD AutoShield Duo™ Pen NeedleCommon Name:Pen NeedleClassification:Class II device; 21 CFR 880.5570, (hypodermic single lumen needle)Product Code:FMI (hypodermic single lumen needle) | Trade Name: | BD AutoShield Duo™ 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) |
| Trade Name: | BD AutoShield Duo™ 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:
K110703: BD AutoShield™ Duo Pen Needle
Purpose of Submission:
The purpose of this submission is to provide a minor administrative update to the BD AutoShield Duo™ Pen Needle intended use statement in order to align the statement with that of other marketed BD Pen Needles (cleared under K213478, K213156, and K212015). The overall intended use is the same as the predicate device (K110703), with the clarification, adding the word "subcutaneous", solely intended to harmonize the statement with the rest of our pen needle portfolio. The proposed clarification has no impact on the use of the device, the user interface, technological characteristics, or overall safety and effectiveness of the subject device compared to its predicate.
Device Description:
The BD AutoShield Duo™ Pen Needle has the same intended use/indications for use, technological characteristics, and principles of operation as the predicate device cleared under K110703.
The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.
The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the
4
occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device is non-toxic and non-pyrogenic.
Intended Use:
The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous 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.
The intended use of the subject device remains the same as the predicate device.
Comparison with Predicate Devices:
The subject device has the same fundamental scientific technology and device performance as the predicate device (K110703). The purpose of this submission is to provide a minor update to the wording of the BD AutoShield Duo™ Pen needle intended use statement to clarify proper use of the device and align the statement with that of other marketed BD Pen Needles. The table below provides a side-by-side comparison of the subject device compared to its predicate.
| Feature | Subject Device:
BD AutoShield Duo™ Pen
Needle | Predicate Device:
BD AutoShield™ Duo Pen
Needle | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 510(k) Number | Pending | K110703 | N/A |
| Product Code | FMI | FMI | Unchanged |
| Regulation Number | 21 CFR 880.5570 | 21 CFR 880.5570 | Unchanged |
| Class | Class II | Class II | Unchanged |
| Intended Use | The BD AutoShield Duo™ Pen
Needle is intended for use with
pen injector devices for the
subcutaneous 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. | The BD AutoShield Duo™ Pen
Needle is intended for use with
pen injector devices for the
subcutaneous 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. | Unchanged, with
addition of word
"subcutaneous" to
clarify proper
injection depth |
| Needle Gauge | 30G | 30G and 31G | Unchanged |
| Needle Length | 5mm and 8mm | 5mm and 8mm | Unchanged |
| | Outer Cover | Outer Cover | Unchanged |
| | Sleeve | Sleeve | Unchanged |
| | Outer Shield | Outer Shield | Unchanged |
| | Inner Shield | Inner Shield | Unchanged |
| Pen Needle
Components | Hub | Hub | Unchanged |
| | Cannula | Cannula | Unchanged |
| | Non-patient end Shield | Non-patient end Shield | Unchanged |
| | Tear Drop Label | Tear Drop Label | Unchanged |
| | Patient end &
Non-patient end Springs | Patient end &
Non-patient end Springs | Unchanged |
| Needle insertion
method | Manual | Manual | Unchanged |
| Provided Sterile | Yes (gamma irradiation) | Yes (gamma irradiation) | Unchanged |
| Component Materials | Outer Cover | Polyethylene | Unchanged |
| | Polyethylene | | Unchanged |
5
| Feature | Subject Device:
BD AutoShield Duo™ Pen
Needle | Predicate Device:
BD AutoShield™ Duo Pen
Needle | Comparison |
|---------------------------------------|-----------------------------------------------------|-------------------------------------------------------|------------------------------------|
| Sleeve | Polycarbonate | Polycarbonate | Introduction of
alternate resin |
| Outer Shield | Polycarbonate | Polycarbonate | Introduction of
alternate resin |
| Inner Shield | Polycarbonate | Polycarbonate | Introduction of
alternate resin |
| Hub | Polypropylene | Polypropylene | Unchanged |
| Cannula | Stainless Steel | Stainless Steel | Unchanged |
| Lubricant | Medical Grade Lubricant | Medical Grade Lubricant | Unchanged |
| Non-patient end Shield | Polycarbonate | Polycarbonate | Introduction of
alternate resin |
| Tear Drop Label | Paper | Paper | Unchanged |
| Patient end & Non-patient end Springs | Stainless Steel | Stainless Steel | Unchanged |
The differences between the predicate and subject device do not raise any new questions of safety or effectiveness.
Performance Testing:
Non-Clinical Test Summary
The subject device has the same technological characteristics as the predicate device cleared under K110703. 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, ISO 23908:2011, BD internal test requirements, as well as Biocompatibility testing per ISO 10993-1:2018.
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
- ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection . features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- . BD internal test requirements
Biocompatibility Testing:
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
- Intracutaneous Reactivity
- Skin Sensitization ●
- Acute Systemic Toxicity
- Subacute/Subchronic Toxicity
- Genotoxicity - Bacterial and Mammalian
- Material-Mediated Pyrogenicity ●
- Implantation ●
6
- . Bacterial Endotoxin
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life:
- The BD AutoShield Duo™ Pen Needle is sterilized using a validated gamma irradiation . 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 and 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:
- . Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for protection of product and sterility maintenance.
- Accelerated stability testing has been conducted to validate the sterility and performance of the BD ● AutoShield Duo™ Pen Needle device to support a shelf-life of 3 years.
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 is substantially equivalent to its predicate device.