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Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

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, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 34-gauge size and 4mm length XTW cannula. The device is non-toxic and non-pyrogenic. It is a single-use disposable device that is provided sterile.

Here's a breakdown of the acceptance criteria and the study information for the BD Nano™ 2nd Gen Pen Needle, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify the exact sample sizes (number of devices tested) for the bench functional performance tests. It states "Testing included functional performance per ISO 11608-2:2012... and testing following BD's Internal Specifications." While standards typically mandate minimum sample sizes, the specific numbers for this device are not provided in this summary.
• Data Provenance: The data is from "Non-Clinical Testing" performed by Becton, Dickinson and Company as part of its design control process. This indicates the testing was conducted internally by the manufacturer. It is prospective testing designed to validate the new device. The country of origin of the data is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable as the study described is a non-clinical, bench performance study of a medical device (a pen needle), not a study involving human diagnosis, interpretation of medical images, or clinical outcomes that would require expert-established ground truth. The "ground truth" here is defined by meeting physical and performance specifications outlined in international standards (ISO) and the manufacturer's internal specifications.

4. Adjudication Method for the Test Set

• This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used to reconcile discrepancies among human readers or evaluators, which is not relevant to bench testing of device performance against pre-defined specifications.

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

• No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids or clinical decision support systems, where the goal is to assess the impact of AI on human reader performance. The BD Nano™ 2nd Gen Pen Needle is a physical medical device (pen needle), not an AI system.

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

• Not applicable. This device is a physical pen needle, not an algorithm or AI system. Its performance is evaluated through bench testing against physical and functional standards, not as a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance testing is based on pre-defined technical specifications, international standards (ISO 11608-2:2012, ISO 9626:2016), and the manufacturer's (BD's) internal specifications. For example, a flow rate measurement would be compared against a specified range or minimum value defined by the standard or the manufacturer, making that standard the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. Training sets are used in machine learning for AI algorithms. This device is a physical medical device, and its performance is evaluated through non-clinical testing, not by training an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the same reasons as #8.

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Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The BD Nano™ 2nd Gen Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs. It consists of a needle, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 32 gauge size and 4mm length. It is a singleuse disposable device that is provided sterile. The BD Nano™ 2nd Gen Pen Needle is nontoxic and non-pyrogenic.

The provided text describes the 510(k) summary for the BD Nano 2nd Gen Pen Needle, primarily focusing on its substantial equivalence to a predicate device (BD Contoured Base Pen Needle, K182320) after a material change.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria are based on ISO 11608-2:2012 for functional performance and ISO 10993-1:2018 for biocompatibility. The reported device performance is that it "passed" these tests. Specific quantitative acceptance criteria or performance values are not detailed in this summary.

Functional Performance Tests (per ISO 11608-2):

• Determination of Flow Rate through Needle
• Bond between Hub and Cannula
• Pen Installation and Removal Torque
• Dose Accuracy

Biocompatibility Tests (per ISO 10993-1):

• Cytotoxicity
• Intracutaneous Reactivity
• Skin Sensitization
• Acute Systemic Toxicity
• Subacute / Subchronic Toxicity
• Genotoxicity Bacterial and Mammalian
• Material-Mediated Pyrogenicity
• Implantation
• Bacterial Endotoxin

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test (e.g., number of needles tested for flow rate or bond strength). It refers to "testing" and "validated the design," implying samples were used as per the standards, but the specific number is not provided.

The data provenance is retrospective as the device's design (excluding material changes) and its predicate are already established, and the testing validates the modified device against established standards. The explicit country of origin for the data is not mentioned, but the submission is to the U.S. FDA by a company based in Franklin Lakes, New Jersey, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies evaluating expert interpretation or clinical diagnosis. The "ground truth" for these tests are the objective measurements defined by the ISO standards and their pass/fail criteria.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies involving human judgment or clinical endpoints that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study was included in this submission." The evaluation focuses on non-clinical performance and biocompatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a "pen needle," a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

• Objective performance criteria derived from ISO 11608-2:2012 for functional characteristics (e.g., specific flow rates, torque values, dose accuracy).
• Biological safety endpoints and criteria derived from ISO 10993-1:2018 for biocompatibility (e.g., demonstrating non-cytotoxicity, no sensitization).

These are engineering/materials performance standards and biological safety standards, not clinical pathology, expert consensus, or outcomes data in the usual sense for diagnostic or prognostic devices.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical medical device (pen needle), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as the device is a physical medical device, not an AI algorithm.

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