The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following: For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Sterile, single use non-pyrogenic intravenous fluid administration sets which may include a multiport IV manifold, integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The subject devices for this Premarket Notification are manufactured with tubing and drip chamber materials not made with the plasticizer Diethylhexylphthalate (DEHP).

Acceptance Criteria and Device Performance for Q2 and CheckMate Multiport IV Administration Sets and Extension Sets

This document describes the acceptance criteria and the studies performed to demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets (with non-DEHP tubing and drip chamber) meet these criteria, thereby proving substantial equivalence to predicate devices.

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 specific numerical sample sizes used for each of the test sets (e.g., how many units were subjected to high pressure testing, how many for biocompatibility). However, it indicates that testing was performed on "the proposed IV Administration Sets" and "a fully assembled representative IV Administration Set" and "devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber."

The data provenance is internal to Quest Medical, Inc. The studies appear to be prospective as they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device. The country of origin of the data is implicitly the USA, where Quest Medical, Inc. is located.

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

This document describes performance testing for medical devices (IV administration sets), not diagnostic or interpretative studies requiring expert ground truth establishment for a test set. Therefore, this section is not applicable in the context of this submission. The "ground truth" for these tests is defined by established international standards (e.g., ISO 10993) and engineering specifications.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1, none) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Given that this is a submission for an IV administration set based on functional and biocompatibility bench testing, an adjudication method for a "test set" in this context is not applicable. The results are quantitative measurements against predetermined specifications or qualitative observations of performance according to established test protocols.

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. MRMC studies are typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical cases, and the effectiveness of an AI system, with or without human assistance, is evaluated. This submission pertains to an IV administration set, a non-diagnostic medical device.

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

This question is geared towards AI/algorithmic devices. Given that the device is an IV administration set, there is no algorithm involved, and thus, no standalone (algorithm-only) study was performed. The performance evaluation focuses on the physical and chemical properties of the device components.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established industry standards, regulatory guidelines, and scientific protocols. Specifically:

• Bench Testing: Performance specifications derived from engineering principles and comparison to predicate devices.
• Sterilization: Compliance with ISO 10993-7:2008 for Ethylene Oxide residuals.
• Shelf Life: Internal validation protocols to confirm stability over time.
• Biocompatibility: Adherence to ISO 10993-1:2009 for material biocompatibility. Specific tests like Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Material-mediated Pyrogenicity are part of this standard.
• Pyrogenicity: Compliance with established guidelines for endotoxin levels, measured using the kinetic chromogenic LAL method.

8. The Sample Size for the Training Set

This document does not describe a machine learning algorithm, and therefore, there is no training set in the conventional sense. The "training" or development of the device itself would involve engineering design and prototype testing, but not a dataset for training an algorithm.

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

As there is no training set for an algorithm, this question is not applicable. The development of the device relies on design inputs, engineering specifications, and adherence to quality system regulations, rather than ground truth established from a training dataset.

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