(248 days)
The B. Braun Antibacterial Ultrasite Valve (Ultrasite Ag) is intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors.
The Antibacterial Ultrasite Valve contains a silver based compound which may help to reduce bacterial growth on the surface and within the fluid path of the device.
Testing with Ultrasite Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours.
The Antibacterial Ultrasite Valve is not intended for use in the treatment of existing infections.
B. Braun's Antibacterial Ultrasite® Valve is an individually packaged, sterile, non-pyrogenic, single use, disposable device. The valve is used as an injection site and requires swabbing to disinfect prior to use. The Antibacterial Ultrasite Valve is a needle free reflux valve or needleless access device intended for IV therapy. The valve is accessed by attaching a male luer fitting.
The Antibacterial Ultrasite Valve contains a silver based compound that is impregnated into the polymeric resin of the device components. The antimicrobial compound is intended to reduce bacterial growth.
The provided document for K073396 describes the Antibacterial Ultrasite® Valve, Ultrasite Ag. This device is a needle-free reflux valve intended for IV therapy, incorporating a silver-based compound to reduce bacterial growth.
Here's an analysis of the acceptance criteria and the study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | Tests conducted (details not provided in excerpt) |
| Toxicology | Tests conducted (details not provided in excerpt) |
| Functional Performance | Tests conducted (details not provided in excerpt) |
| Package Integrity | None mentioned beyond "tests conducted" |
| Shipping | Tests conducted (details not provided in excerpt) |
| Microbial Ingress Challenge | Tests conducted (details not provided in excerpt) |
| Antimicrobial Effectiveness | Demonstrated effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours. |
| Neutralization | Tests conducted (details not provided in excerpt) |
| Elution | Tests conducted (details not provided in excerpt) |
Important Note: The provided document is a 510(k) summary, which often summarizes testing without providing granular details of the acceptance criteria (e.g., specific quantitative thresholds for "functional performance" or "biocompatibility") or detailed results beyond a general statement of "demonstrated effectiveness" for the antimicrobial aspect.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests aformentioned for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states that "The Antibacterial Ultrasite Valve was subjected to a variety of tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. This device is a medical device (intravascular administration set) that undergoes laboratory and performance testing, not human-based interpretive testing that would require expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as it pertains to human interpretation tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not conducted or mentioned. This type of study is more relevant for diagnostic imaging or interpretation devices where human readers' performance with and without AI assistance is evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the "Antimicrobial Effectiveness" testing can be considered analogous to "standalone" performance for this device's specific claim. The device itself (the valve with the silver compound) was directly tested for its ability to reduce bacterial growth. This testing was performed independent of human interaction or interpretation beyond laboratory procedures.
7. The Type of Ground Truth Used
For the antimicrobial effectiveness claim, the ground truth was based on microbiological testing results. This typically involves:
- Inoculating the device (or control) with specific bacteria.
- Incubating for a defined period.
- Measuring bacterial viability/reduction compared to control conditions.
- The reduction in bacterial count serves as the "ground truth" for the device's antibacterial efficacy.
For other tests (biocompatibility, functional performance, etc.), the ground truth would be established by validated laboratory methods and predetermined specifications/standards for those types of tests.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device.
§ 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.