Search Results

The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

The Droplet® Pen Needles are sterile, single use needles designed to be used with commercially available pen-injectors for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and healthcare professionals. The pen needle assembly consists of a double-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 cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer protective container. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier. To use a pen needle, the user needs to remove the seal, remove the outer protective cap and attach it to the pen injector. Then the user removes the inner protective cap to expose the needle and make an injection. Following the injection the user inserts the used pen needle into the outer cap to remove the pen needle from the pen injector and dispose of it immediately. The pen needle is individually packaged and sterilized with Gamma radiation. It is intended for single use only. Droplet® Pen Needles are available in the following lengths and gauges: 4 mm x 32G, 5 mm x 32G, 6 mm x 32G, 8 mm x 32G, 5 mm x 31G, 6 mm x 31G, 8 mm x 31G, 10 mm x 29G, 12 mm x 29G.

Here's a breakdown of the acceptance criteria and study information for the Droplet® Pen Needles, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample sizes used for each specific test in the "Non-Clinical Performance Data" section. It broadly states that "Verification/Validation testing was done according to the requirements of ISO 11608-2:2012 as summarized below. All testing met the applicable requirements." Similarly, for biocompatibility, it states "The selection of biocompatibility tests was made based on the requirements of ISO 10993-1. All the tests have been successfully passed." The sterility testing states "Droplet® Pen Needles have passed all relevant sterility tests successfully."

The data provenance is for a manufacturing company located in Poland (HTL-Strefa S.A.). The data would be considered prospective as it's generated for the purpose of a 510(k) submission, meaning the tests were conducted specifically for this device to demonstrate its performance.

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

This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, adhering to international standards (ISO), rather than relying on human expert assessment for "ground truth" in the way clinical studies or image interpretations might.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The testing described is objective, standards-based, and performed in a laboratory/technical setting, rather than through expert human adjudication.

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

There was no MRMC comparative effectiveness study done. This document describes a medical device (pen needles) that does not involve AI or human readers in an interpretive capacity.

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

There was no standalone (algorithm only) performance study done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance data in this submission is based on established international standards and objective measurement criteria. For example:

• Physical and mechanical properties are compared against the specifications in ISO 11608-2:2012 (e.g., materials per ISO 9626, bond strength per Clause 9, freedom from defects per ISO 7864).
• Biocompatibility is evaluated against the requirements of ISO 10993-1.
• Sterility is validated according to ISO 11137-1.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical medical product, not an AI/machine learning model that requires a training set.

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

This information is not applicable/not provided, as there is no training set for this type of device.

Ask a specific question about this device