(27 days)
The MZ1000 is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. The MZ1000 can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
The MZ1000 is a zero reflux needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids which using a vascular access device. The MZ1000 is a closed, luer activated device that eliminates the risk of needlestick injuries. The MZ1000 does not require a specific clamping sequence or technique in order to be used safely. The flush volume for the MZ1000 is five milliliters (5ml). The MZ1000 can be used for seven (7) days and 200 activations.
The MZ1000 is a zero reflux needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood, and fluids using a vascular access device. The MZ1000 is a closed, luer-activated device that eliminates needlestick injuries and does not require a specific clamping sequence or technique for safe use.
1. Acceptance Criteria and Reported Device Performance
| Performance Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Zero reflux | The device must demonstrate zero reflux during use. | Met acceptance criteria |
| Low flush volume (5ml) | The device must have a flush volume of 5ml. | Met acceptance criteria (flush volume is 5ml) |
| 7 days & 200 activations | The device must be able to be used for 7 days and withstand 200 activations. | Met acceptance criteria |
| Needleless connector | The device must function as a needleless connector. | Met acceptance criteria |
| No interstitial or dead space internal to the connector | The device must not have any internal interstitial or dead space. | Met acceptance criteria |
| Non-hemolytic | The device must be non-hemolytic. | Met acceptance criteria |
| Flow rate of >6L/hour | The device must achieve a flow rate greater than 6 Liters per hour. | Met acceptance criteria |
| 325 psi & maximum flow rate of 10ml/seconds | The device must withstand 325 psi and a maximum flow rate of 10ml/second. | Met acceptance criteria |
| Disinfect with 70% IPA | The device must be able to be disinfected with 70% Isopropyl Alcohol (IPA). | Met acceptance criteria |
| Cleanse with 2% chlorhexidine gluconate or iodine | The device must be able to be cleansed with 2% chlorhexidine gluconate or iodine. | Met acceptance criteria |
| Functional, microbial ingress, sterility, biocompatibility, and other performance criteria | All functional, microbial ingress, sterility, biocompatibility, and other performance criteria outlined in the testing protocol must be met. | Met all acceptance criteria |
2. Sample Size and Data Provenance
- Sample size for the test set: Not explicitly stated. The document mentions "non-clinical data (bench testing)" that included functional, microbial ingress, sterility, and other performance criteria.
- Data provenance: Bench testing. The country of origin of the data is not specified but is implicitly from the manufacturer, CareFusion, based in San Diego, CA, USA. The data is prospective, as it was generated through specific testing for the submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission does not involve expert-based ground truth for image or clinical data. The assessment is based on objective performance specifications and laboratory testing of the medical device.
4. Adjudication Method for the Test Set
Not applicable. As the testing involves objective performance criteria for a medical device (e.g., flow rate, pressure, microbial ingress), there is no adjudication method in the context of human expert review. The results are determined by the outcome of bench tests against predefined specifications.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The MZ1000 is a medical device (needleless connector), not an AI algorithm for diagnostic interpretation. Therefore, a multi-reader, multi-case comparative effectiveness study of human readers with and without AI assistance is not relevant to this submission.
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done for the MZ1000. The "Performance Data" section explicitly states: "The MZ1000 (subject device) met all of the acceptance criteria for all functional, microbial Ingress, sterility, biocompatibility and other performance criteria which verify it to be substantially equivalent to the predicate devices." This refers to the device performing according to its specifications in bench tests, without human intervention or interpretation of results beyond verification of test outcomes.
7. Type of Ground Truth Used
The ground truth used is based on objective scientific, engineering, and microbiological testing standards and specifications. This includes:
- Functional performance criteria: e.g., flow rate, pressure resistance, flush volume, number of activations.
- Microbial ingress testing: to assess the barrier integrity against microorganisms.
- Sterility testing: to confirm the absence of viable microorganisms.
- Biocompatibility testing: to ensure the device is safe for contact with biological systems.
These are established benchmarks for medical device performance.
8. Sample Size for the Training Set
Not applicable. The MZ1000 is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned, the MZ1000 is a physical medical device and does not utilize a training set in the context of AI or machine learning.
§ 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.