(20 days)
Pressure Rated: The MaxZero™ Extension Set with Needle-Free Connector(s) is for single use only. The MaxZero™ Extension Set with Needle-Free Connector(s) 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.
The MaxZero™ Extension Set with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics (neonates, infants, children, adolescents) and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids, All MaxZero™ Extension Set with Needle-Free Connector(s) include the previously cleared zero reflux MZ1000 needleless Connector 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 needle stick injuries. The MaxZero™ 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.
The provided document is a 510(k) summary for the MaxZero™ Extension Set with Needle-Free Connector(s). It details the device's technical characteristics, its substantial equivalence to a predicate device, and the non-clinical testing performed to support its safety and effectiveness.
Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results met their acceptance criteria and support that the MaxZero™ Extension Set with Needle-Free Connector(s) are appropriately designed for their intended use." However, specific numerical acceptance criteria and the exact reported performance results for each test are not provided in this summary. The summary only lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Standards | Met acceptance criteria per ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010, ISO 8536-8:2004, ISO 8536-9:2004, ISO 8536-10:2004, and FDA Guidance for Intravascular Administration Sets. |
| Biocompatibility | Met acceptance criteria per ISO-10993-1:2009, ISO 10993-2:2006, ISO 10993-4:2002, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-12:2012. |
| Sterilization & Shelf Life | Met acceptance criteria per ISO 11137-1:2006, ISO 11137-2:2006, ISO 11607:2003, ASTM F1980-07:2002, ASTM F1140:2000, ASTM D4169:1998, ASTM-F1929-98(04):1998. |
| Additional Performance Data | Met acceptance criteria for Microbial Ingress and Barrier testing, High-Pressure Testing, Air Water Interface Visibility, Set Internal Excess Pressure Testing, Clamps - Internal Excess Pressure and Tubing Open Fluid Path Testing, Bond Pull Testing, Priming Volume and Flow Rate Testing, and Harsh Infusates Testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the individual non-clinical tests. It refers to "design verification performance testing" and lists various standards and additional tests. The data provenance is not specified, but the submission is from CareFusion, Inc., located in San Diego, CA, USA. The testing would have been conducted by or for a US-based company, likely in the US or in a facility adhering to international standards for medical device testing. The data is prospective, as these are engineering and laboratory tests conducted to qualify the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document is discussing a non-clinical evaluation of a medical device (intravascular administration set) rather than diagnostic or imaging software requiring expert interpretation for ground truth establishment. The "ground truth" here is defined by engineering specifications and recognized performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or evaluations of diagnostic systems where there might be disagreement in expert interpretations.
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
There is no MRMC comparative effectiveness study mentioned. The submission is for a physical medical device (extension set) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device, the "ground truth" is established through:
- Engineering specifications and design requirements: The device must meet specific physical and performance parameters (e.g., pressure resistance, flow rates, bond strength).
- Recognized consensus standards: The device performance is evaluated against international standards such as ISO and ASTM for medical devices, luer connectors, sterilization, packaging, and biocompatibility.
- Biocompatibility guidelines: Specific ISO standards define acceptable biological responses and toxicity.
- Regulatory guidance: Adherence to FDA guidance documents for intravascular administration sets.
8. The sample size for the training set
This section is not applicable as there is no machine learning or AI component requiring a training set. The device is a physical product.
9. How the ground truth for the training set was established
This section is not applicable as there is no machine learning or AI component requiring a training set and its associated ground truth establishment.
§ 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.