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Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

Promisemed Triple Safety Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually. The Promisemed Triple Safety Pen Needle consists of needle tube, trigger shield, posterior trigger/posterior trigger spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Triple Safety Pen Needle is the modification of Dual Safety Pen Needle cleared in K91853. The baseline location of trigger shield (patient end shield) is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. A click of the trigger shield (patient end shield) indicates the needle has fully penetrated the skin. In addition to above protective design, Promisemed Triple Safety Pen Needle retains two safety shields lock as the predicate has: the shield will lock in place (i) after use (patient-end): after the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place and (ii) upon removal of the needle from the pen (pen connector-end): the posterior trigger (a second shield) covers the pen connector needle when it is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used. Promisemed Triple Safety Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

This is a 510(k) summary for a medical device called the "Promisemed Triple Safety Pen Needle." It's a type of hypodermic needle used with pen injector devices for subcutaneous insulin injections.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established ISO standards for hypodermic needles and sharps injury protection, and the "reported device performance" is that the device complied with these standards. Specific numerical performance data or acceptance criteria thresholds for individual tests within these standards are not detailed in this summary.

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

The document does not specify the exact sample sizes used for performance testing (bench testing). It states that testing was performed according to ISO standards, which typically define minimum sample sizes for various tests.

The data provenance is from Promisemed Hangzhou Meditech Co., Ltd. in Zhejiang, China, the manufacturer, based on bench testing performed to demonstrate compliance with international standards. The study is retrospective in the sense that the testing was conducted on manufactured devices to support the 510(k) submission.

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

This type of device clearance (510(k) for a hypodermic needle) primarily relies on bench testing against established engineering and medical device standards (ISO standards), rather than clinical studies requiring expert consensus for ground truth on patient outcomes. Therefore, information about a number of experts establishing ground truth for a test set is not applicable or provided in this document. The "ground truth" here is the adherence to specified mechanical, physical, and safety performance parameters as defined by the ISO standards.

4. Adjudication method for the test set

Not applicable. This document describes bench testing against engineering standards, not a clinical study involving human judgment that would require 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

Not applicable. This is a physical medical device (a pen needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance claims is established by compliance with international standards (ISO 11608-2, ISO 7864, ISO 23908). These standards define the acceptable performance characteristics for sterile hypodermic needles and sharps injury protection. For example, for the "Trigger force" criterion, the ground truth is simply whether the device achieves a trigger force ≤ 0.7N.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device, not a machine learning model.

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