(13 days)
Pressure Rated: The MaxZero nulti fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
Non Pressure Rated: The MaxZero multi fise extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
The CareFusion MaxZero Extension Sets with Needleless Connector are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. All MaxZero Extension Sets with Needleless Connector 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 Extension Sets with Needleless Connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable.
The document describes the CareFusion MaxZero Extension Sets with Needleless Connector and aims to demonstrate its substantial equivalence to previously marketed predicate devices. The "acceptance criteria" here refer to the performance standards and tests that the new device must meet to prove its safety and effectiveness, similar to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All test results met their acceptance criteria and support that the MaxZero Extension Sets with Needleless Connector are appropriately designed for their intended use." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not provided in this summary. The summary only lists the types of tests performed.
| Test Type | Acceptance Criteria (Not explicitly quantified in summary) | Reported Device Performance (Summary statement) |
|---|---|---|
| Microbial ingress and barrier testing | Ensure effective barrier against microbes | Met acceptance criteria |
| Hemolysis testing | Non-hemolytic | Met acceptance criteria |
| Shelf life performance testing | Maintain performance over specified shelf life (7 days, 200 activations) | Met acceptance criteria |
| Harsh Infusates testing | Compatibility with harsh infusates | Met acceptance criteria |
| ISO Testing | Compliance with relevant ISO standards | Met acceptance criteria |
| Priming volume/flow rate testing | Demonstrate specified priming volume and flow rate | Met acceptance criteria |
| Biocompatibility testing | Biocompatible (per ISO 10993) | Met acceptance criteria |
| Sterilization validation testing | Effective sterilization | Met acceptance criteria |
| Functional/Performance Testing | Ensure safe and effective operation for intended use | Met acceptance criteria |
The document states that a "complete list of functional/performance testing protocols and reports are included in Section 18 of this submission," which is not provided here.
2. Sample size used for the test set and the data provenance:
Not applicable for this type of device submission. This is a medical device, not an AI or data-driven software. The "test set" here refers to physical devices undergoing various laboratory and performance tests. The sample sizes for these physical product tests are not specified in this summary. Data provenance is also not relevant in the context of device testing as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI algorithm study or a study requiring expert consensus for ground truth. The "ground truth" for this device would be established by objective physical and chemical testing against predetermined performance standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or adjudication described for the device performance tests.
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:
Not applicable. This is a medical device, not an AI system being evaluated with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by standardized laboratory testing protocols, national/international standards (e.g., ISO), and engineering specifications designed to ensure the device's safety and effectiveness (e.g., microbial barrier effectiveness, material biocompatibility, pressure ratings).
8. The sample size for the training set:
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI algorithm requiring a training set with ground truth.
§ 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.