(175 days)
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No
The device is a conventional stopcock and Luer lock plug with an antimicrobial additive. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device, a stopcock and Luer lock plug with antimicrobial properties, is used to control fluid flow, but it does not directly treat a disease or condition; its function is to prevent microbial contamination.
No
The device description clearly states it is for controlling/directing fluid flow and permitting fluid access to the patient, and managing open Luer ports. It has antimicrobial properties to prevent microbial contamination, which are functional features rather than diagnostic. The "Summary of Performance Studies" focuses on antimicrobial efficacy, not diagnostic capability.
No
The device description clearly states it is a physical stopcock and Luer lock plug with an antimicrobial additive, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a stopcock and Luer lock plug used for controlling and directing fluid flow and permitting fluid access to the patient. This is a function performed on the patient or with fluids being administered to the patient, not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description focuses on the functional aspects of a stopcock and Luer lock plug with the addition of an antimicrobial property. It doesn't mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described are focused on assessing the antimicrobial efficacy of the device in preventing microbial contamination on the device itself. This is a measure of the device's ability to remain clean and reduce the risk of infection during its use in fluid administration, not a diagnostic test. The study measures bacterial CFU counts recovered from the device, not from a patient specimen for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, providing diagnostic information, or any other typical characteristics of an IVD.
The device is a medical device used in the administration of fluids to a patient, with an added antimicrobial feature to enhance its safety during this process. It does not perform a diagnostic function.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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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. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 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)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: in vitro study; Sample size: 200 units; Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
- 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.