(135 days)
The BD AutoShield ™ Duo Pen Needle is intended 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.
The BD AutoShield™ Duo Pen Needle is a safety pen needle that provides protection from accidental needle sticks, from both the patient end and nonpatient (pen connection) end.
Currently, BD markets the BD AutoShieldTM safety-engineered pen needles which shield the front, or patient end (needle tip) and have been associated with a lower incidence of needle stick injuries. To further reduce the risk of accidental needle stick injuries, BD developed the AutoShieldTM Duo Pen Needle, which, in addition to the added safety shield on the non-patient (pen connection) end, includes a redesign of the safety shield to a clear safety shield that enables the user to better visualize the needle while inserting it into the skin.
Prior to injection, the user will attach the AutoShield™ Duo Pen Needle to the pen. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. Once the pen is removed from the skin the inner shield will deploy and lock in place. A red indicator band will appear confirming the pen needle has been used. Once the pen needle is removed from the pen, the orange shield on the non-patient (pen connection) end will deploy and cover the needle.
The BD AutoShield™ Duo Pen Needles are offered in various gauge sizes (30G and 31G) and lengths (5mm and 8mm).
An injection molded outer cover is assembled over the patient end of the cannula. This needle assembly is sealed with a peel-away label to provide a sterility barrier and tamper evidence.
The assembly consists of a double-ended cannula that is assembled into an injection molded hub. The internal threads allow the safety pen needle to be screwed onto pen injectors. The patient and non-patient (pen connection) end of the cannula are lubricated for ease of injection and septum penetration.
The patient end of the device has a mechanism that allows the needle to be shielded and locked after use. Once shielded, a red indicator band becomes present indicating product has been used. These product features help reduce the occurrence of accidental needle stick injuries.
The non-patient (pen connection) end of the cannula is visible prior to attachment to the pen injector. Following removal of the device from the pen injector, the needle is shielded with a mechanism that is designed to reduce the occurrence of accidental needle stick injuries.
The BD AutoShield™ Duo Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.
BD AutoShield™ Duo Pen Needle - Acceptance Criteria and Study Details
The BD AutoShield™ Duo Pen Needle is a safety pen needle designed to prevent accidental needle sticks from both the patient and non-patient ends. The following summarizes the acceptance criteria and study proving the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic/Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Activation of Sharps Injury Prevention Feature | Met the acceptable criteria per the FDA Guidance document "Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9, 2005" | Met the acceptable criteria per the FDA Guidance document "Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9, 2005" |
| Simulated Use Study Criteria | Validation of Instructions for Use (IFU) in accordance with US FDA Regulations, ICH Guidelines, ISO 14155-1:2003(E), and Good Clinical Practices (GCP) to confirm safety and effectiveness when used as intended. | Confirmed that the BD AutoShield™ Duo is safe and effective when used as intended, and does not alter injection technique or pen injector functionality. |
| Tubing Diameters | Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement). | Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement). |
| Patency of Lumen | Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely). | Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely). |
| Needle Points | Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation). | Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation). |
| Non-Type A Needle (length) | Per ISO 11608-2, section 4.3.3 (patient end within indicated length ± 1.25 mm). | Per ISO 11608-2, section 4.3.3 (patient end within indicated length ± 1.25 mm). |
| Cannula Load Test (No pre-conditioning) | Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds). | Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds). |
| Cannula Load Test (with pre-conditioning) | Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds). | Per ISO 11608-2, section 4.9 and 9; ISO 7864 (cannula holds force of 34N for 5 seconds). |
| Lubrication | Per ISO 11608-2, section 4.7 (droplets of lubricant shall not be visible with unaided eye inside the needle under normal light conditions (72-135 lux). | Per ISO 11608-2, section 4.7 (droplets of lubricant shall not be visible with unaided eye inside the needle under normal light conditions (72-135 lux). |
| Compatibility Testing | Per ISO 11608-2, section 4.10 (connectivity (torque)). | Per ISO 11608-2, section 4.10 (connectivity (torque)). |
2. Sample Size Used for the Test Set and Data Provenance
- Activation of Sharps Injury Prevention Feature (Bench Test): The specific sample size for this test is not explicitly stated, but it involved both "Professional Healthcare Users" and "Non-clinical Pen Users." The data provenance (country of origin, retrospective/prospective) is not specified.
- Simulated Use Study (Validation of Instructions for Use): The specific sample size for this study is not explicitly stated, but it involved both "Professional Healthcare Users" and "Non-clinical Pen Users." The data provenance (country of origin, retrospective/prospective) is not specified.
- Other Bench Tests (Tubing diameters, Patency of lumen, Needle points, Non-Type A Needle (length), Cannula load test, Lubrication, Compatibility Testing): The document does not specify the sample size for these individual bench tests. These are typically performed in a laboratory setting. Data provenance is implied to be from Becton, Dickinson and Company's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Activation of Sharps Injury Prevention Feature & Simulated Use Study: These studies utilized "Professional Healthcare Users" and "Non-clinical Pen Users." The specific number and exact qualifications (e.g., years of experience, specific medical field) of these users are not detailed in the provided document. They are considered "experts" in the sense of being intended users of the device.
- Other Bench Tests: The "ground truth" for these tests are established by adhering to international standards (ISO, FDA Guidance) and Becton, Dickinson and Company's own protocols. The "experts" involved would be qualified laboratory technicians and engineers with expertise in medical device testing and relevant standards. The number of such individual experts is not specified.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For the "Sharps Injury Prevention Feature" and "Simulated Use Study," it appears the performance was assessed directly against the specified criteria by the participating users and observers, or by the testing personnel. For the other bench tests, compliance with established ISO standards and internal protocols served as the basis for acceptance.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being done. The studies described focus on the standalone performance and safety features of the BD AutoShield™ Duo Pen Needle and its substantial equivalence to a predicate device. The document does not provide data on how human readers (users) improve with or without AI (not applicable here) or device assistance beyond the inherent safety features.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
This question is not applicable as the BD AutoShield™ Duo Pen Needle is a physical medical device, not an algorithm or AI-powered system. The performance evaluated relates to its mechanical safety features and user interaction.
7. Type of Ground Truth Used
- Activation of Sharps Injury Prevention Feature: The ground truth was based on the device's ability to perform its intended sharps injury prevention function as observed by users and assessed against FDA guidance.
- Simulated Use Study: The ground truth was based on the device's ability to be safely and effectively used according to its Instructions For Use (IFU), as validated by user performance and observation.
- Other Bench Tests: The ground truth was based on adherence to established international standards (ISO 11608-2, ISO 7864) and internal protocols for physical and functional properties.
8. Sample Size for the Training Set
The document does not mention a distinct "training set" in the context of device development as understood for AI/ML models. For a physical device like this, the "training" equivalent would be the iterative design and testing phases that lead to the final product. The provided information focuses on the final validation/verification testing.
9. How the Ground Truth for the Training Set Was Established
As there's no explicit "training set" in the AI/ML sense, this question isn't directly applicable. However, during the iterative design and development phases of the BD AutoShield™ Duo Pen Needle, the "ground truth" for guiding improvements would have been established through:
- Engineering specifications and design requirements.
- Bench testing of prototypes against ISO standards and internal performance metrics.
- Feedback from early user evaluations and risk assessments.
- Experience gained from the predicate device (BD AutoShield™ Pen Needle).
These elements would have informed the iterative design process, leading to the final device which was then formally validated/verified as described in the provided summary.
§ 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).