(424 days)
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
The Decanting Device is provided as sterile and is intended for use in a single procedure only. There are four proposed models: GC0652DD, GC 0653DD and GC0654DD and GC0654 DT. Model GC0652DD, GC0654DD and GC0654 DT consist of spike and cap for spike. Model GC0653DD consists of Protective Cap, Needle Tip, Cover and stick.
Through the use of a spike/stick, facilitates creation of a sterile fluid path. Decanting device help ensure an aseptic transfer or removal of fluids/medication from flexible and rigid containers.
For models GC0653DD and GC0652DD, insert the decanter spike/stick by piercing the rubber opening of the glass vial. Tilt the decanting device body until desired flow is reached, ensuring the spike/stick air ventilation holes remain inside the glass vial.
The provided text is a summary of a 510(k) premarket notification for GCMEDICA transfer devices. It primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility testing. The document does not describe a clinical study in the way typically expected for software or AI medical devices (i.e., with acceptance criteria related to accuracy, sensitivity, specificity, etc., or human reader studies).
It confirms that no clinical study was included in this submission (Section 5.9). Therefore, it's not possible to provide information related to AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance.
Here's an analysis based on the information provided, focusing on the device's functional and safety acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the successful passing of various bench and biocompatibility tests. The "reported device performance" is the statement that all tests "were passing."
| Test Category | Specific Test Criteria (Implied) | Reported Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11 Standards | All tests passing |
| In Vitro Cytotoxicity | Meets ISO 10993-5 requirements | Passing |
| Skin Sensitization | Meets ISO 10993-10 requirements (Guinea Pig Maximization Test) | Passing |
| Intracutaneous Reactivity | Meets ISO 10993-10 requirements | Passing |
| Acute Systemic Toxicity | Meets ISO 10993-11 requirements | Passing |
| Pyrogen | Meets ISO 10993-11 requirements | Passing |
| In Vitro Hemocompatibility | Meets ISO 10993-4 requirements | Passing |
| Performance (Bench) | Internal Standards (Appearance, Dimension, Unimpeded, Sealing, Conn. Strength, Penetration Force, Fluid Flow, Leakage) | All tests passing |
| Particulate Matter | Meets USP requirements | Passing |
| Sterilization | Meets ISO 11135-1:2014 requirements | All tests passing |
2. Sample Sizes Used for the Test Set and Data Provenance
This is not applicable as there was no clinical study or test set of patient data in the typical sense for AI/software. The "test set" refers to physical device samples used for bench and biological testing. The document does not specify the exact number of units tested for each benchmark test, only that "The results of all testing were passing." The provenance is "internal standards."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth for these types of physical device tests typically involves standardized measurement instruments and validated laboratory procedures, not expert interpretation of diagnostic data.
4. Adjudication Method
Not applicable, as there was no expert review or human interpretation of diagnostic data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The submission explicitly states, "No Clinical Study is included in this submission."
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical device (transfer device), not a software or AI algorithm.
7. Type of Ground Truth Used
For biocompatibility: Recognized international standards (ISO 10993 series).
For performance bench testing: Internal standards, USP for particulate matter, and ISO 11135-1:2014 for sterilization.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
§ 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.