(90 days)
The device is intended for the transfer and injection of drugs contained in a vial.
The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. The MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.
The provided FDA 510(k) summary for the MixJect® Transfer Device (K230464) describes performance testing, but it does not specify explicit acceptance criteria in a quantitative manner or provide specific performance data points in a table as requested. Instead, it states that testing "confirm[s] the MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and verify conformity to the applicable external and internal standards and demonstrate substantial equivalence to the predicate device."
Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific numerical values based on this document. However, I can infer the types of performance metrics and the general conclusion of the study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific quantitative acceptance criteria and reported performance values are not provided in this document. The document primarily lists the types of performance tests conducted and generally states that the device meets requirements and standards.
Inferred Performance Metrics (from "Performance Testing" section):
| Performance Metric | (Inferred) Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | ||
| Fragmentation | Conforms to ISO 8536-2:2010 section 6.2.2 requirements | Met applicable design and performance requirements. |
| Particulate Matter | Conforms to USP requirements | Met applicable design and performance requirements. |
| Internal Diameter Upper Skirt | Conforms to ISO 8362-6:2010 Section 4.2 requirements and in-house method | Met applicable design and performance requirements. |
| Luer Gauging | Conforms to ISO 594-1:1986 and ISO 594-2:1998 requirements | Met applicable design and performance requirements. |
| Luer Stability & Compliance (ISO 80369-7) | Conforms to ISO 80369-7:2021, ISO 80369-20:2015 Annex B, C, D, E, F, G requirements | Met applicable design and performance requirements. |
| Residual Volume | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Leakage | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Total Penetration Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Vial Adapter Detachment Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Product Retention in Blister | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Flow Rate | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Removal Force from Blister | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Tyvek Total Peel Test Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Injection Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Aspiration Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Impact Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Needle Protective Cap Removal Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Torque Test | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Functional Performance | ||
| Functionality according to IFU | Device operates as described in Instructions For Use (IFU) | Met applicable design and performance requirements. |
| Label Legibility | Labels are clear and legible | Met applicable design and performance requirements. |
| Biocompatibility | ||
| Cytotoxicity | Conforms to ISO 10993-5:2009 standards | Battery of tests conducted; results were acceptable. |
| Hemolysis (ASTM & ISO) | Conforms to ISO 10993-4:2017 and ASTM F756 standards | Battery of tests conducted; results were acceptable. |
| Maximization and Sensitization | Conforms to ISO 10993-10:2010 standards | Battery of tests conducted; results were acceptable. |
| Intracutaneous Reactivity | Conforms to ISO 10993-10:2010 standards | Battery of tests conducted; results were acceptable. |
| Acute Systemic Toxicity | Conforms to ISO 10993-11:2017 standards | Battery of tests conducted; results were acceptable. |
| Material Mediated Pyrogenicity | Conforms to ISO 10993-11:2017 standards | Battery of tests conducted; results were acceptable. |
| Sterilization | ||
| Sterility Assurance Level (SAL) | Achieve SAL of 10-6 | Achieved SAL of 10-6. |
| Bacterial Endotoxin | Acceptable levels per limulus amebocyte lysate (LAL) testing | Passed with acceptable levels. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its requirements is a series of non-clinical bench performance tests and biocompatibility tests as detailed in the "Performance Data" section of the 510(k) submission.
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size (number of devices) used for each individual performance test or biocompatibility test.
- Data Provenance: The document does not explicitly state the country of origin of the data for the performance or biocompatibility tests. It indicates the manufacturer, West Pharma. Services IL, Ltd., is located in Ra'anana, Israel. The studies are retrospective in the sense that they are laboratory and bench studies conducted on the device, not ongoing clinical observations.
3. Number of Experts and Qualifications:
- Not Applicable. For non-clinical bench testing and biocompatibility assessments, the ground truth is established by objective measurements against recognized international and internal standards, rather than expert consensus on medical images or diagnoses. These tests are typically performed by qualified laboratory technicians and overseen by engineers or scientists with expertise in material science, mechanical testing, and biocompatibility, who interpret the results against established regulatory requirements and standards.
4. Adjudication Method:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is required for ground truth labeling, often for diagnostic accuracy studies. This document reports on bench and biocompatibility testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical trials were not performed for the MixJect® Transfer Device." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is applicable or reported.
6. Standalone Performance Study:
- Yes, in the context of a medical device. The entire "Performance Data" section describes standalone performance of the device itself through a variety of engineering, material, and biological safety tests (bench tests, biocompatibility tests). These tests establish the device's inherent properties and functionality without a human-in-the-loop performance assessment (which would be a clinical trial).
7. Type of Ground Truth Used:
- The ground truth for the performance tests and biocompatibility tests is based on:
- International Standards: e.g., ISO 8536-2, USP , ISO 80369-7, ISO 10993 series, BS EN ISO 11137 series.
- In-house test methods: Developed and validated by the manufacturer to assess specific device functions.
- Established biological principles and safety thresholds: For biocompatibility and sterility.
8. Sample Size for Training Set:
- Not Applicable. This device is a physical medical device (an intravascular administration set), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, material science knowledge, and previous device iterations.
9. How Ground Truth for Training Set Was Established:
- Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.