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Qitexio Luer Lock Syringes are manual devices used to inject fluids into the body. They are also used for delivery of Lipiodol (Ethiodized Oil) Injection.

Medex, a subsidiary of Guerbet Group, designed and manufactures the Qitexio® Luer Lock Syringe, a disposable, handheld syringe available in 3 different volumes (1, 3 and 20 mL). Oitexio® Syringes are standard syringes which are verified to endure the potentially damaging chemical effects of Lipiodol® (Ethiodized Oil), an oil-based contrast media manufactured by Guerbet.

Qitexio® Luer Lock Syringes are manual devices used to inject fluids into the body. Qitexio® Syringes are also used for delivery of Lipiodol® (Ethiodized Oil) Injection.

They are single-use devices, sterilized by gamma radiation.

Standard five-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting movable plunger, O-Ring, rotative finger flange, and backstop. Fitting offered with male luer lock.

This document describes the premarket notification (510(k)) for the Qitexio Luer Lock Syringes, a medical device. The information provided heavily focuses on proving the substantial equivalence of the new device to a predicate device, the Merit Syringe (K173601).

The acceptance criteria for this type of device (a piston syringe) are primarily defined by conformity to established FDA recognized consensus standards and a battery of performance, biocompatibility, and sterilization tests. The document does not describe an AI/ML-driven device or study. Therefore, some of the requested information regarding AI/ML study design, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable to this submission.

Here's a breakdown of the acceptance criteria and proof, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Qitexio Luer Lock Syringes, acceptance criteria are generally met by demonstrating conformity to recognized consensus standards and by passing specific performance tests. The document repeatedly states that the device "complies with" or "met the established acceptance criteria" for these standards and tests. Specific numerical performance results are not provided in this summary, as is common for 510(k) summaries which focus on demonstrating equivalence rather than presenting raw data.

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

The document does not specify the exact sample sizes (number of syringes) used for each individual test (e.g., performance, biocompatibility). It mentions "samples" or "representative device samples" were used.

• Data Provenance: Not explicitly stated regarding country of origin for the test data. However, the manufacturer is Medex, a subsidiary of Guerbet Group, located in France. The testing was conducted to comply with international standards (ISO, ASTM, USP, European Pharmacopoeia) recognized by the FDA for market clearance in the US.
• Retrospective or Prospective: The testing described is prospective, conducted specifically to gain regulatory clearance for the device.

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

• Not Applicable. This submission is for a physical medical device (Piston Syringe), not an AI/ML diagnostic tool requiring expert interpretation as ground truth for a test set. The "ground truth" for this device's performance is established by objective measurements against engineering and biological standards.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not an AI/ML diagnostic tool requiring human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is typically performed for imaging or diagnostic AI/ML devices where the AI assists human readers. It is not relevant for a Piston Syringe.

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

• Not Applicable. This is not an algorithm or software device. The "performance" is that of the physical syringe itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety is established through:

• Conformity to recognized consensus standards (e.g., ISO 7886-1 for syringe function, ISO 10993 for biocompatibility, ISO 11137 for sterilization).
• Objective bench testing measurements (e.g., particulate counts, endotoxin levels, peel force, functional performance like fluid injection).
• Biological assay results (e.g., cytotoxicity, irritation, pyrogenicity).
• Material characterization to ensure compatibility with intended fluids (e.g. Lipiodol).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set."

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

• Not Applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment. Device design and manufacturing processes are validated through engineering principles and quality system regulations (21 CFR Part 820).

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