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The Heparin Lock Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection. The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.

The provided text is a 510(k) summary for a medical device called the "Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.

Therefore, the requested information, which is typically found in studies for AI/diagnostic devices (e.g., acceptance criteria tables, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance), is not available in this document.

Here's what the document does provide and why it doesn't fit the requested format:

• Acceptance Criteria & Reported Performance: The document states that "Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use." However, it does not list specific acceptance criteria (e.g., a certain percentage of flushing success, a specific force required for plunger depression) nor does it provide a table of reported performance against these criteria. The emphasis is on material compliance and stability, not diagnostic or predictive performance.
• Sample Size (Test Set) and Data Provenance: Not applicable. This device is a pre-filled syringe, not a diagnostic or AI device that would have a "test set" in the context of diagnostic accuracy.
• Number of Experts/Qualifications & Adjudication Method: Not applicable. These relate to establishing ground truth for diagnostic accuracy, which is not relevant for a pre-filled syringe.
• MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to a physical medical device like a syringe.
• Standalone Performance: Not applicable. This refers to the algorithm's performance without human intervention, which is not relevant for a physical device.
• Type of Ground Truth: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome used to evaluate the accuracy of a diagnostic tool.
• Sample Size (Training Set) & Ground Truth for Training Set: Not applicable. This device does not use a "training set" in the machine learning sense.

What the document does describe as proof of meeting requirements:

The "study" or evidence presented in this 510(k) is primarily focused on demonstrating that the Heparin Lock Flush Syringe is substantially equivalent to legally marketed predicate devices. This involves:

1. Comparison of Technological Characteristics:

   • Same intended use
   • All pre-filled with heparin lock flush solution, USP
   • Single-use, disposable
   • Sterile and pyrogen-free
   • Manufactured using an aseptic process
   • Available in similar syringe sizes and fill volumes
   • Use polypropylene piston-type syringes
   • Packaged in a wrapper or polybag and sealed
   • Use manual energy

2. Non-Clinical Testing:

   • Physical properties of materials tested by suppliers to meet USP Class VI plastic test requirements or ISO 10993 Part 1 (for fluid path components). This ensures biocompatibility and material safety.
   • Materials in contact with the body found safe and effective (cleared through previous FDA submissions, e.g., EMT-Rx Syringe).
   • Test data generated for stability and container/closure suitability. (Specific results or acceptance criteria for these tests are not detailed in this summary).
   • Performance testing indicates the proposed device meets "all functional requirements" and supports its suitability for use. (Again, specific functional requirements and detailed results are not provided in this summary).

In summary, the "study" described is a non-clinical engineering and materials compliance assessment rather than a clinical or diagnostic performance study. The acceptance criteria are largely based on established material standards (USP Class VI, ISO 10993-1) and general functional suitability, for which specific quantitative data is not provided in this summary.

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