(56 days)
The ValuMed decanting devices are devices intended for the aseptic dispensing of solutions from I.V. containers. Each device is used as follows:
Bag Decanter: Used to dispense fluids from flexible bags
Vial Decanter: Used to dispense fluids from glass vials
Transfer Device: Used to dispense fluids from small vials, or to transfer fluids from container to container.
The ValuMed decanting devices are one piece, injection molded hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, single use, disposable devices.
This document, K023539, is a 510(k) premarket notification for a medical device called "Decanting Devices." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than proving novel claims or establishing new safety and effectiveness standards through extensive clinical trials. Therefore, the information typically found in a clinical study report proving acceptance criteria is not present in this document.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
- Not available. This 510(k) submission does not include specific acceptance criteria for performance metrics or reported performance data from a study. The basis of equivalence is listed as "materials, dimensions, performance, packaging, sterilization and intended use" being "substantially identical" to predicate devices. There's no quantitative performance data provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" in the context of a performance study described in this document. The submission relies on establishing substantial equivalence to existing devices.
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)
- Not applicable. No expert review or ground truth establishment relevant to a performance study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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
- Not applicable. This device is a simple mechanical decanting device, not an AI or imaging device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual, non-algorithmic mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of a performance study is not established or discussed. The "truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth for one.
Summary of the document's approach to "proving" safety and effectiveness:
The K023539 submission for ValuMed decanting devices relies entirely on the concept of substantial equivalence to predicate devices. It states:
- "The ValuMed decanting devices are substantially equivalent to several other legally marketed devices in the United States."
- Specifically, it claims they are "substantially identical in materials, dimensions, performance, packaging, sterilization and intended use" to products from Steri-Systems, Corp (K830232) and Medical Specialty Innovations, Inc. (K961699).
Therefore, the "proof" that the device meets "acceptance criteria" (which aren't explicitly stated but implicitly align with the predicate devices' established safety and effectiveness) is the demonstration that it is fundamentally the same as devices already on the market that have been deemed safe and effective by the FDA. This is the standard pathway for 510(k) clearances for devices of this nature, where comprehensive clinical trials are typically not required.
§ 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.