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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Like the predicate devices, BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes and lengths. BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and nonpyrogenic.

The pen needle assembly consists of a doubled-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 cartridge. The Patient end and NP end 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 needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10-6 by gamma irradiation. The above information is the same as the predicate device.

Here's a breakdown of the acceptance criteria and study information for the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, 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 states "Bench tests relating to the performance of the BD 31G and 32G XTW Pen Needle with PentaPoint™ were conducted." However, it does not specify the exact sample sizes used for each individual test.

The data provenance is prospective bench testing, conducted by Becton, Dickinson and Company. There is no information regarding country of origin of data beyond the manufacturer's location in Franklin Lakes, New Jersey, USA.

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

This document describes bench testing, which typically relies on established engineering principles, international standards (like ISO 11608-2 and ISO 7864), and standardized test methods rather than expert consensus on medical images or clinical data. Therefore, the concept of "experts establishing ground truth" in the context of medical image interpretation (e.g., radiologists) is not applicable to this type of device and study. The "ground truth" for these tests is defined by the technical specifications and performance criteria outlined in the ISO standards and internal test methods.

4. Adjudication Method for the Test Set

As this is bench testing against established performance standards, an adjudication method (like 2+1, 3+1, none) typically used for subjective assessments or disagreements in clinical trials is not applicable. The results are objectively measured against predefined thresholds in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the physical and mechanical performance of the pen needle against predicate devices and international standards, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a mechanical pen needle, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance described is the device's inherent physical performance.

7. The Type of Ground Truth Used

The ground truth used for these bench tests is based on:

• International Standards: Primarily ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define specific measurement criteria, tolerances, and test methodologies.
• Manufacturer's Internal Test Methods: BD Test Method TP700279 for Penetration Testing and BD Test Method TP700381 for Thumb Force Testing.
• Predicate Device Performance: The primary goal of the study was to demonstrate equivalent performance to previously cleared predicate devices (K123300, K100005, K051899).

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, and bench testing does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. See point 8.

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