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The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.

Device Description

An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.

AI/ML Overview

This 510(k) summary describes a traditional medical device (catheter introducer) and not an AI/ML powered device, therefore, many of the requested fields are not applicable.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Activation force within specified limits.	"The activation force was within specified limits." (Specific limits are not provided in the summary.)
Puncture force with shielded needle meets requirement.	"The puncture force with the shielded needle exceeded that with the unshielded needle in all cases." (Specific requirements for puncture force are not provided, but the statement indicates the shielded needle performed better, implying it met or surpassed safety expectations in preventing accidental punctures.)
Force to override needle shielding exceeds minimum.	"The force to override the needle shielding feature exceeds the minimum requirements." (Specific minimum requirements for the override force are not detailed, but the performance confirms the feature requires adequate force to disengage, thus preventing accidental shielding removal.)
Substantially equivalent in safety and effectiveness.	"Substantially equivalent to the T-Peel introducer with the addition of a needlestick protection feature that is comparable in safety and effectiveness to a similar feature in the Punctur-Guard® Blood Collection Needle." (This is a general statement of equivalence based on the successful performance in the specific tests outlined.) The original T-Peel Introducer (K924562) had already been on the market for several years and had undergone previous testing and qualification, indicating its established safety and effectiveness for catheter introduction features. No design, dimensional, or material changes were made to these features in the Blunt T-Peel Plastic Sheath Introducer.

Study Details

Sample size used for the test set and the data provenance: Not applicable. The tests described are bench tests for mechanical properties, not clinical studies on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical properties is established by engineering specifications and physical measurements, not expert consensus in a medical context.
Adjudication method for the test set: Not applicable. The tests involved quantitative measurements (activation force, puncture force, override force) against predefined limits, not subjective adjudication.
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 not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For the mechanical tests, the ground truth was based on established engineering specifications and measurement standards for forces and performance characteristics of medical devices, particularly those with needlestick protection features.
The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML device, and therefore does not have a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

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