STOPCOCK & LUER LOCK PLUG

K954970 · Medex, Inc. · FMG · Apr 22, 1996 · General Hospital

Device Facts

• Record ID: K954970
• Device Name: STOPCOCK & LUER LOCK PLUG
• Applicant: Medex, Inc.
• Product Code: FMG · General Hospital
• Decision Date: Apr 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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

Device Story

Antimicrobial stopcock (MX531-1LT) and Luer lock plug (MX491T) used in clinical fluid/drug administration. Devices incorporate elemental metallic silver additive into base materials (polycarbonate, HDPE, acrylic) to minimize microbial contamination. Devices function as standard fluid path components; silver additive provides non-soluble antimicrobial surface. Used by clinicians to control fluid flow and seal ports. Benefit is reduced risk of microbial colonization compared to non-antimicrobial counterparts.

Clinical Evidence

Bench testing only. Large masked in vitro study (n=200) compared antimicrobial devices to non-antimicrobial controls. Devices inoculated with 1.2x10^4 CFU cocktail of 8 microorganisms (S. aureus, P. aeruginosa, E. coli, C. albicans, S. pneumoniae, S. epidermidis, K. pneumoniae, B. subtilis). Tested under 4 contamination/sampling protocols over 72 hours. Results showed statistically significant reduction in CFU counts for antimicrobial devices, with 43% to 99% less microbial contamination and 28% to 99% functional reduction compared to inoculum levels.

Technological Characteristics

Materials: Polycarbonate, HDPE, acrylic. Antimicrobial agent: Elemental metallic silver additive (non-soluble, 0.000000024 g/8 h). Biocompatibility: ANSI/AAMI/ISO 10993. Form factor: 3-way stopcock and Luer lock plug. Fluid path: Clear for visualization. No software or energy source.

Indications for Use

Indicated for use in fluid or drug administration to control/direct fluid flow, permit fluid access to the patient, and terminate open Luer ports.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medex, Inc. MX531-1L (pre-amendment)
• Medex, Inc. MX491 (pre-amendment)
• Vitaphore Corporation VitaGuard® Percutaneous Infection Control Kit (K861563)

Submission Summary (Full Text)

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K954970 APR 22 1996
medexInc
510(k) Summary
K954970

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
[phone]

- 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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6250 Shier-Rings Road Dublin, Ohio 43017-1295 [phone] Fax: [phone]

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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 MX531-1LT and the MX491T are identical to the respective pre-amendment MX531-1L and MX491 devices. The MX531-1LT and the MX531-1L are three-way 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 MX531-1LT 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 MX531-1LT and the MX491T is designed not to be soluble (0.000000024 g/8 h or 2 µg/4 weeks).
- The collagen of the VitaGuard is designed to dissolve with use constantly releasing its silver component (14 µg / 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 seventy-two (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 $1.2 \times 10^{4}$ 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. $1.2 \times 10^{4}$), the antimicrobial devices showed from a 28% to 99% functional reduction in the microbial level.