A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port. The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.

Device Description

The Medex, Inc. antimicrobial stopcock and Luer lock plug are functionally conventional devices, which incorporate antimicrobial properties through the addition of a elemental, metallic silver additive.

AI/ML Overview

This document describes performance testing for Medex, Inc.'s MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the study design: to demonstrate a statistically significant reduction in microbial contamination compared to non-antimicrobial counterparts. The specific performance metrics are the percentage reduction in microbial contamination.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Microbial Contamination Reduction	Statistically significant reduction in CFU count for antimicrobial devices compared to non-antimicrobial devices.	- Median CFU count at every sampling time in all groups was consistently lower for the antimicrobial devices.
		- Antimicrobial devices showed 43% to 99% less microbial contamination between eight and seventy-two hours of use compared to standard non-antimicrobial devices.
		- Antimicrobial devices showed 28% to 99% reduction in microbial level when compared to the initial inoculum level (1.2 x 10^6 total microorganisms).
Statistical Significance	Extremely statistically significant difference.	- The difference was extremely statistically significant in all cases.

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

Sample Size: 200 units were divided into four groups for the in vitro study. This means 50 units per group. The document doesn't specify if this refers to 200 antimicrobial devices and 200 non-antimicrobial devices, or 200 total devices (100 of each type). Given the comparative nature, it's highly probable it refers to 200 of each type (antimicrobial and non-antimicrobial) or 100 of each type to make up the 200 units. Assuming the "200 units" refers to the entire study, it would be 100 antimicrobial and 100 non-antimicrobial devices for comparison.
Data Provenance: The study was an in vitro study. No country of origin is specified for the data, but it's likely connected to Medex, Inc. in Dublin, Ohio, USA. Since it's an in vitro study, the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical trials; it's a controlled laboratory experiment.

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

Not applicable. This was an in vitro microbiological study, not a study requiring expert interpretation of medical images or patient data. The "ground truth" was the measured microbial contamination (CFU count).

4. Adjudication Method for the Test Set

Not applicable. As an in vitro study measuring quantifiable microbial counts, there was no need for expert adjudication.

5. 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/imaging device, but an antimicrobial medical device designed for fluid administration.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance here refers to the device's ability to reduce microbial contamination on its own in a controlled environment.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was direct measurement of microbial contamination in Colony Forming Units (CFUs).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not a machine learning model.

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

Not applicable. There is no "training set" or corresponding ground truth establishment in the context of this device's performance testing. The "ground truth" related to its antimicrobial efficacy was established through direct empirical measurement of bacterial and fungal growth in a controlled laboratory setting.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Medex Inc. The logo consists of a symbol resembling four people holding hands, followed by the word "medex" in bold, black letters. The letters "inc" are in a smaller, outlined font, and there is a line underneath the text.

510(k) Summary

This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

$ 807.92 (a)(1) Submitter's (and Contact) Names, Address, Telephone No., Summary Date

· John Toomey Senior Project Engineer Medex, Inc. 6250 Shier-Rings Road Dublin, Ohio 43017 (614) 791 5415

· 10.20.95

§ 807.92 (a)(2) Device Name (Including Trade Name), Common Name, Classification Name

MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug
· Stopcock and Luer Lock Plug
· Stopcock, I-V Set

$ 807.92 (a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed

Medex, Inc.'s pre-amendment stopcock and Luer lock plug MX531-1L and MX491, respectively.
Additionally, the modified devices use a substantially equivalent technology as the Vitaphore . Corporation's VitaGuard® Percutaneous Infection Control Kit (K861563).

$ 807.92 (a)(4) Description of the Premarket Notification Device

The Medex, Inc. antimicrobial stopcock and Luer lock plug are functionally conventional devices, which incorporate antimicrobial properties through the addition of a elemental, metallic silver additive.
The materials which comprise the MX531-1LT and MX491T have been aggressively tested . per the ANSI/AAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.

§ 807.92 (a)(5) Intended Use

A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port.

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The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.

& 807.92 (a)(6) Technical Characteristics Summary Similarities:

· The base function of the MX531-ILT and the MX491T are identical to the respective preamendment MX531-1L and MX491 devices. The MX531-1LT and the MX531-1L are threeway stopcocks to be used to control/direct fluid flow and permit fluid access to the patient. The MX491T and the MX491 are Luer lock plugs designed to close open or exposed Luer ports.
· The antimicrobial component of the MX531-1LT and the MX491T is technologically similar to the antimicrobial component of the VitaGuard. Both use elemental silver to enhance the performance of the device by reducing the possibility of it becoming contaminated by microorganisms.
· The base material of the MX531-1LT and the MX531-1L are identical: polycarbonate, HDPE, and acrylic.
· The base material of the MX491 and the MX491T are identical: HDPE.
The fluid path of both the MX531-1LT and the MX531-1L are clear to aid in visualization of . the path during priming and use.

Differences:

· The MX531-1L does not incorporate any kind of antimicrobial component, the MX531-1LT incorporates a elemental, metallic silver antimicrobial.
- · The silver antimicrobial is intended to enhance the performance of the MX531-1LT stopcock by reducing the possibility of becoming contaminated by microorganisms.
· The MX491 does not incorporate any kind of antimicrobial component, the MX491T incorporates a elemental, metallic silver antimicrobial.
- · The silver antimicrobial is intended to enhance the performance of the MX491T Luer lock plug by reducing the possibility of it becoming contaminated by microorganisms.
· The MX531-ILT and the MX491T meet the most current biocompatibility standards: ANSI/AAMI/ISO 10993.
- · The MX531-1L and the MX491 meet USP XXIII requirements.
· The silver antimicrobial component of the MX531-ILT and the MX491T is designed not to be soluble (0.00000024 g/8 h or 2 ug/4 weeks).
- · The collagen of the VitaGuard is designed to dissolve with use constantly releasing its silver component (14 ug /4 weeks).

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§ 807.92 (b)(1), (b)(3) Performance Testing Assessment

To assess the antimicrobial efficacy of the modified devices, a large masked in vitro study was completed. The protocol was designed to closely emulate clinical use for the stopcock with Luer lock plug. The study addressed the difference in the amount of recoverable microbes between the antimicrobial devices and their non-antimicrobial counterparts under the following treatments (200 units divided into four groups):

i. The devices were contaminated every twenty-four (24) hours and sampled every eight (8) hours over a seventy-two (72) hour period.
ii. The devices were contaminated every twenty-four (24) hours and sampled every twenty-four (24) hours over a seventy-two (72) hour period.
iii. The devices were contaminated one time and sampled every eight (8) hours over a seventytwo (72) hour period.
iv. The devices were contaminated one time and sampled every twenty-four (24) hours over a seventy-two (72) hour period.

The device fluid paths were inoculated as indicated with a cocktail containing 1.2 x 10 total microorganisms of the following:

Staphylococcus aureus (ATCC #6538)
Pseudomonas aeruginosa (ATCC #9027)
· Escherichia coli (ATCC #8739)
· Candida albicans (ATCC #10231)
Streptococcus pneumoniae (ATCC # 49136)
· Staphylococcus epidermidis (ATCC #12228)
Klebsiella pneumoniae (ATCC #13882)
· Bacillus subtilis (ATCC #6633)

In all cases, the difference between the number of bacterial CFU's (colony forming units) recovered from the antimicrobial and the non-antimicrobial stopcocks and Luer lock plugs was extremely statistically significant. The median CFU count at every sampling time in all groups was consistently lower for the antimicrobial devices compared to the standard non-antimicrobial devices. The antimicrobial devices showed from 43% to 99% less microbial contamination between eight and seventy-two hours of use. When compared to the inoculum level (i.e. 1.2 x 10°), the antimicrobial devices showed from a 28% to 99% function in the microbial level.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.