(12 days)
The MaxGuard Advanced Luer Activated Device with Antimicrobial Technology is a sterile single use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxGuard Connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
The MaxGuard with Antimicrobial Technology may inhibit the growth of microorganisms on the surfaces of the MaxGuard device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.
The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms:
Staphylococcus aureus, ATCC 6558 Staphylococcus epidermidis. ATCC 12228 Escherichia coli, ATCC 8739 Enterococcus faecalis, ATCC 51299 Pseudomonas aeruginosa, ATCC 9027 Klebsiella pneumonia. ATCC 4352 Candida albicans, ATCC 10231
Not Found
This document is a 510(k) premarket notification for a medical device called "MaxGuard Advanced Luer Activated Device with Antimicrobial Technology." It's an FDA clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics in the context of an AI/ML device.
This document describes a medical device designed to reduce microbial contamination in IV lines. The "acceptance criteria" presented are related to its antimicrobial efficacy, specifically its ability to achieve a "4+ log reduction" of certain microorganisms. This is not a study about an AI/ML device, so most of the questions are not applicable.
Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the claimed performance standard for its antimicrobial properties:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Antimicrobial Efficacy Claim) | Reported Device Performance (Antimicrobial Efficacy) |
|---|---|
| Device inhibits the growth of microorganisms on its surfaces. | Device provides a 4+ log reduction of specific organisms. |
Specific organisms for which a 4+ log reduction was demonstrated:
- Staphylococcus aureus, ATCC 6558
- Staphylococcus epidermidis, ATCC 12228
- Escherichia coli, ATCC 8739
- Enterococcus faecalis, ATCC 51299
- Pseudomonas aeruginosa, ATCC 9027
- Klebsiella pneumonia, ATCC 4352
- Candida albicans, ATCC 10231
The following information cannot be found in the provided document, as it pertains to an AI/ML device study, which is not the subject of this 510(k) clearance:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.