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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 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.

The provided document describes the FDA 510(k) clearance for the BD AutoShield Duo™ Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device (K110703) rather than a comprehensive study proving the device meets specific acceptance criteria for a novel functionality.

Therefore, much of the requested information regarding detailed acceptance criteria and a study to prove meeting them, particularly in the context of AI/ML or comparative effectiveness, is not directly applicable or available in this document. This submission is for a medical device that has minor administrative updates to its intended use statement, harmonizing it with other existing pen needles, and confirms its continued safety and effectiveness through non-clinical testing.

Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a specific table of acceptance criteria with corresponding performance metrics as would be typical for a new device claiming specific performance against a novel metric. Instead, it refers to compliance with established international standards and internal BD test requirements. The "performance" is generally stated as "passed" or "met requirements".

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for each specific test conducted (e.g., number of needles tested for each ISO standard). It generally mentions that testing was conducted to validate the design.

• Sample Size: Not specified in the provided text for individual tests.
• Data Provenance: The testing was conducted by BD (Becton, Dickinson and Company) as part of its design control process, implying internal, prospective testing for regulatory submission. The country of origin of the data is not specified beyond being generated by Becton, Dickinson and Company in Franklin Lakes, New Jersey.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of tests described. The "ground truth" for these tests (functional performance, biocompatibility, sterility) is established by adhering to widely accepted international standards (ISO, ASTM, USP) and internal engineering/quality requirements, rather than expert consensus on subjective evaluations.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, measurable parameters against defined standards, not requiring an adjudication method like those used for subjective clinical assessments or AI model evaluations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The BD AutoShield Duo™ Pen Needle is a physical medical device (pen needle), not an AI/ML software device or a diagnostic tool that involves human readers or AI assistance in interpretation. No MRMC study was mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned in point 3, the ground truth for the non-clinical tests is based on the specifications and acceptance criteria defined within established international standards (ISO, USP, ASTM) and the manufacturer's own validated internal requirements for device function, safety, and sterility. For example:

• Functional: Compliance with dimensional tolerances, force measurements, safety mechanism activation as per ISO standards.
• Biocompatibility: Absence of toxicological responses as per ISO 10993 series.
• Sterility: Sterility assurance level (SAL) of 10-6 as per ISO 11137-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that utilizes a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

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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

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.

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