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The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter.

The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum.

The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

AI/ML Overview

The Arisure® Closed Male Luer with Spike Adapter (YM060) is an extravascular administration set.
The device's performance was evaluated through a series of non-clinical tests.

Acceptance Criteria and Device Performance:

Test Name	Acceptance Criteria	Reported Device Performance
Device Flow Rate	Not explicitly stated, but implies meeting functional flow rates	Passed
Leakage	Not explicitly stated, but implies no leakage	Passed
Separation Force	Not explicitly stated, but implies secure connection	Passed
Detachment Force	Not explicitly stated, but implies appropriate release	Passed
Assembly Strength	Not explicitly stated, but implies secure assembly	Passed
Multiple Activations	Not explicitly stated, but implies proper function over multiple uses	Passed
Extended Activations	Not explicitly stated, but implies proper function over prolonged use	Passed
Dry Disconnection	Not explicitly stated, but implies proper function upon disconnection	Passed
Microbial Ingress	Not explicitly stated, but implies prevention of microbial entry	Passed
Particulates	Not explicitly stated, but implies acceptable particulate levels	Passed
Chemical Compatibility	Compatibility with chemicals	Passed
Shelf-Life Testing	Three (3) years	Achieved three (3) years
Distribution Testing	Not explicitly stated, but implies integrity during distribution	Passed
Package Performance Testing	Not explicitly stated, but implies maintaining sterility and integrity	Passed
Package Stability Testing	Not explicitly stated, but implies maintaining sterility and integrity over time	Passed
Penetration ability of the septum of access port	Not explicitly stated, but implies ease of penetration and integrity	Passed
Impermeability of the septum of access port	Not explicitly stated, but implies no fluid passage through septum	Passed
Adhesion strength of the infusion device	Not explicitly stated, but implies secure adhesion	Passed
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Sub-Acute Toxicity, Hemocompatibility)	Meeting ISO 10993-1 requirements for external communicating devices, blood path, indirect contact, prolonged duration (>24 hours to 30 days)	Passed all specified tests
Sterilization Validation (e-beam irradiation)	Sterility Assurance Level (SAL) of 10^-6	Achieved SAL of 10^-6

Study Details:

Sample Size and Data Provenance for Test Set:
- The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., leakage, flow rate). It generally indicates that "Aged, packaged parts underwent the appropriate testing" for shelf-life, and "The following tests were completed with passing results."
- The data provenance is not specified (e.g., country of origin). The studies appear to be non-clinical performance and laboratory tests conducted by the manufacturer, Yukon Medical, LLC. These are retrospective data in the sense that they were collected and analyzed to support the 510(k) submission.
Number of Experts and Qualifications for Ground Truth:
- This information is not applicable. The device is a medical accessory, and its performance criteria are objective, based on engineering, material, and biological standards (e.g., ISO, ASTM). The "ground truth" for these tests is established by the specifications of these standards, not expert consensus in diagnostic interpretation.
Adjudication Method for Test Set:
- This information is not applicable as the evaluation involves objective performance metrics against established standards, not interpretation by human experts.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human interpretation is involved. The Arisure® Closed Male Luer with Spike Adapter is a medical accessory with objective performance characteristics.
Standalone Performance Study:
- Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against engineering, material, and biological standards. This involved testing various mechanical, chemical, and biological attributes of the device without human-in-the-loop performance measurement related to its primary function as a connector.
Type of Ground Truth Used:
- The ground truth used for performance evaluation was based on established international and national standards for medical devices, infusion equipment, and material biocompatibility. These include, but are not limited to, ISO 8536-4, ISO 80369-7, IEC 62366-1, ISO 22413, ISO 15747, ISO 10993 series, ASTM standards (e.g., D4169, F1980), and EN/SS-EN standards for sterilization. The "ground truth" is defined by the measurable parameters and acceptance limits specified within these standards.
Sample Size for Training Set:
- The document describes performance testing for a medical device accessory and does not involve AI or machine learning algorithms that would typically require a "training set." Therefore, this information is not applicable.
How Ground Truth for Training Set Was Established:
- As there is no AI/machine learning component described for this device, a training set and its associated ground truth establishment are not relevant to this submission.

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