(134 days)
colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.
colorVees Intravascular Administration Set will be used to administer fluids from t a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments. This device is manufactured using different colored tubes. Its difference from predicated legally marked devices relies in this multiplicity of colored tubing. These colored tubes assist the practitioner to instantaneously identify and follow the delivery tubing when there is a need to run a plurality of intravascular administration sets to the same patient. The fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source (the IV solution itself) to point of delivery (venipuncture site on patient's body).
This document is a 510(k) summary for the VALNET Medical Corp. colorVees IV Sets. It describes the device, its function, and states that its technological characteristics are similar to predicate devices, with the only difference being the colored tubing.
Based on the provided text, the device is considered substantially equivalent to predicate devices, largely due to its similarity in physical and performance characteristics, with the addition of colored tubing as a differentiating feature.
Here's an analysis of the provided information against your requested criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device must administer fluids from a container to a patient's vascular system through a needle or catheter effectively. | The proposed colorVees Intravascular Administration Set "will be used to administer fluids from a container to a patient's vascular system through a needle or catheter." This aligns directly with the functional requirement. |
| Safety - Biocompatibility | The materials used in the device must be biocompatible. | The colored tubes used in the device "comply with biocompatibility requirements of FDA Blue Book Memorandum #G95-1 ISO 10993-1." This directly addresses the biocompatibility criteria. |
| Performance Characteristics | The device should have no significant physical or performance differences from legally marketed predicate devices, other than the added color. | "There are no significant physical differences or performance characteristics from predicated devices. The only difference from predicated legally marked devices relies in its coloring." This statement confirms the device meets the performance criteria by being equivalent to existing predicate devices. |
| Identification Aid | The colored tubing should assist practitioners in identifying and following multiple IV lines to prevent errors. | The device "will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments." The "fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source... to point of delivery." This describes the intended positive impact of the differentiating feature. |
| Substantial Equivalence | Should be substantially equivalent to legally marketed predicate devices. | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate acceptance criterion for a 510(k) submission and was met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not detail any specific test set or clinical study data for this device. The basis for substantial equivalence is primarily a comparison of the technological characteristics to predicate devices. The biocompatibility compliance is noted as per FDA Blue Book Memorandum #G95-1 ISO 10993-1, which implies material testing, but no specific sample size or provenance is given for this.
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)
This information is not provided in the document. The substantial equivalence determination is based on a comparison to predicate devices and compliance with existing standards, rather than expert evaluation of a test set for this specific device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no described test set or clinical study requiring adjudication.
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
No MRMC or comparative effectiveness study is mentioned in the document. This device is a physical medical device (IV Set) and not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an IV Set, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and safety profiles of the predicate devices and adherence to recognized biocompatibility standards (ISO 10993-1). The device's "sameness" in function and physical characteristics (except color) to these predicates, combined with standard compliance, forms the basis of its acceptance.
8. The sample size for the training set
This information is not provided as there is no training set in the context of this type of device submission.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set. The substantial equivalence is established by direct comparison to predicate devices and adherence to relevant standards.
§ 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.