(10 days)
The MaxZero Intravascular Administration set with needleless connector(s) is a device used to administer fluids from a container to a patient's vascular system. The administration set is for single patient use only. The administration set can be used for direct injection, intermittent infusion or continuous infusion.
The CareFusion MaxZero Administration Sets are intravascular administration sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion of drugs, blood and fluids. All MaxZero Administration Sets include the previously cleared zero reflux MZ1000 Needleless Connector (K132413) bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needlestick injuries. The MaxZero Administration Sets are sterile single patient devices. All extension sets included in this submission are not made from material containing natural rubber latex or DEHP.
This document is a 510(k) premarket notification for a medical device (MaxZero Administration Set) and therefore primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving a comparison of the AI device with human performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All test results met their acceptance criteria" and that the device "met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria." However, it does not provide a specific table detailing individual acceptance criteria values and the device's measured performance against each of those criteria.
Instead, it lists the types of non-clinical testing performed:
| Test Type | Reported Device Performance |
|---|---|
| Microbial ingress and barrier | Met acceptance criteria |
| Design verification | Met acceptance criteria |
| Shelf life performance | Met acceptance criteria |
| Harsh Infusates | Met acceptance criteria |
| Priming volume/flow rate | Met acceptance criteria |
| Biocompatibility | Met acceptance criteria |
| Sterilization | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for each of the non-clinical tests. It also does not mention "test sets" in the context of clinical data or human evaluation, as the testing performed was non-clinical.
Provenance: Not applicable as the testing is non-clinical performance and material testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth for this device's performance is established through established engineering and scientific testing standards, not expert consensus on interpretation of medical data.
4. Adjudication Method for the Test Set:
Not applicable. This device is not an AI/imaging device requiring expert adjudication of results.
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:
No. This document explicitly states: "There is no clinical data included in this submission." Therefore, no MRMC study or AI-human performance comparison was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (administration set), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on established engineering principles, material science, and standards for biocompatibility, sterility, fluid dynamics, and microbial barrier properties. These are measured objectively through laboratory tests rather than subjective human interpretation.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
§ 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.