(267 days)
The APEX Transfer Set is intended to be used with the APEX Compounding System. The administration sets are to be used in a sterile compounding environment within a pharmacy to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution.
The Apex Compounding System Transfer Set consists of a valved manifold with micro, macro and flex source lines. The proximal end of the source line consists of a luer lock connector which allows for connection to a transfer spike or connector depending upon the source container being used. The outlet tubing connects each valve, through the manifold body and consists of two sections of pump tubing just before ending at a final container connector, a luer adapter, to connect to a final container bag for eventual patient administration. There are 26 source lines on the manifold which correspond to the device's ability to support 26 source containers. Each individual line is labeled with a unique numeric identifier and barcode for traceability and scanning.
The document provided describes the APEX Compounding System Transfer Set, an intravascular administration set (Class II, Product Code: LHI, NEP). It primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. The information requested aligns with studies typically conducted for AI/machine learning medical devices, which this product is not. However, I can extract the relevant information regarding acceptance criteria and performance testing conducted for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection | Free of cracks, damage, kinked tubes, disconnected components, valves seated within 5% of alignment. |
| Leakage | No bubbles observed at joints with 10 psi air pressure (positive pressure). Vacuum pressure shall not fall in 30s while applying 28 in Hg (negative pressure). |
| Joint Strength (Static Load Tensile Force per ISO 8536-4) | Peak pull force joints shall be > 5 lbf pulled to failure at 14 in/min (7 lbf for macro pump tube joints). |
| Valve Torque | Micro valve torque shall not exceed 14.2 oz in. Macro valve torque shall not exceed 42.5 oz in. |
| Vacuum Test | Vacuum pressure shall not fall in 30s while applying 28 in Hg. |
| Occlusion Test | Bubbles shall be observed from end after applying 0.5 psi air pressure while immersed. |
| Luer Gauging (ISO 594-2) | (Performance not explicitly detailed, but implied meeting standard) |
| Barcode Scan | Scan shall match human readable number. |
| Magnetic Flux Density | Shall be > 40 Gauss at a distance of 0.28". |
| Life Cycle Testing (Spallation and Particulate Contamination per USP 788 after simulated use) | (Performance not explicitly detailed, but implied meeting standard) |
| Biocompatibility (ISO 10993-1, including Cytotoxicity, Delayed-type Hypersensitivity, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Material-Mediated Pyrogenicity) | (Performance not explicitly detailed, but implied meeting standard) |
| Associate Device (APEX Compounding System) - Delivery Accuracy | Dextrose 70% at 20-25°C shall be ± 10% at 0.2 mL, ± 3% above 1 mL. Dextrose 70% at 15-30℃ shall be ± 10% at 0.2 mL, ± 6% above 1 mL. Other solutions at 15-30°C shall be ± 10% at 0.2 mL, ± 3% above 1 mL. |
| Associate Device (APEX Compounding System) - Fit | Set shall be able to be attached and removed with audible and tactile feedback and without damage to components. |
| Associate Device (B. Braun Spikes and Fluid Connector, B. Braun Final Containers) - Leakage (Source lines) | No bubbles observed at connections after applying air pressure while immersed. Vacuum pressure shall not fall in 30s while applying 28 in Hg. |
| Associate Device (B. Braun Spikes and Fluid Connector, B. Braun Final Containers) - Leakage (Final container connector) | No leakage when subjected to water pressure source of 20 psi. |
| Comparative Testing: Specific Gravity Interchange | Mean concentration of unintended ingredient during compounding for the subject device shall be 5 lbf pull force," "± 10% delivery accuracy"). |
- The sample size for the training set: Not applicable as there is no training set for a non-AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.