(84 days)
The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.
The Model D-290P is an administration set that incorporates standard, off-the-shelf, h.V. set components (including a check valve), Medical Grade PVC tubing and a non-fluid path pumping cartridge.
The provided text describes a 510(k) summary for a medical device, the "Model D-290P Administration Set with Check Valve." This document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a study with acceptance criteria and device performance results in the context of AI or diagnostic accuracy.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, ground truth, and training data is not applicable to this type of regulatory submission.
Here's an attempt to address the points based on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not define specific performance acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy, as it pertains to an administration set. The "performance" being evaluated is its functional equivalence for fluid delivery. The document states: "The primary function of the Invacare, Block and IVAC check valve sets is to administer fluids initially from a primary container until empty and then from a secondary container to a patient's vascular system." No quantitative performance data for this function is presented.
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. No test set or data a study of that nature is described for the D-290P administration set itself. The submission relies on "Nonclinical Tests and Results" which states directly: "Nonclinical tests were deemed not necessary to support the claim of substantial equivalence to the Block Medical and IVAC administration sets." This indicates that no significant new testing for performance was conducted or deemed necessary with a specific test set.
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. There is no mention of experts or ground truth establishment in the context of performance testing for this device. The evaluation is based on technological characteristics and components.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method 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 is not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the context of diagnostic accuracy is relevant or established for this device. The "truth" being established is its function as an administration set and its equivalence to predicate devices.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm or AI model is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is mentioned.
Summary of the Study/Submission:
The document describes a 510(k) submission for the "Model D-290P Administration Set with Check Valve" by Invacare Infusion Systems. The primary purpose of this submission is to demonstrate substantial equivalence to two legally marketed predicate devices: Block Medical, Inc. Model V021014 and IVAC Model 59093 Administration Sets with Check Valve.
The "Study" (or rationale for equivalence):
The submission argues that the Model D-290P is substantially equivalent because:
- Similar Design and Technology: It incorporates standard, off-the-shelf IV set components, Medical Grade PVC tubing, and a non-fluid path pumping cartridge, similar to the predicate devices.
- Identical Intended Use: It is intended for use with piggyback infusions in conjunction with a commercially available secondary infusion line and the Invacare Model 1200 pump, which aligns with the function of the predicate devices.
- Similar Technological Characteristics: The "general design and incorporate similar technologies, materials, and components" are described as being the same, raising "no new questions of safety and effectiveness."
- Nonclinical Tests: The submission explicitly states, "Nonclinical tests were deemed not necessary to support the claim of substantial equivalence to the Block Medical and IVAC administration sets." This suggests the demonstration of equivalence relies heavily on the similarity of design, materials, and intended use as well as the proven safety record of the predicate devices and their components.
- Component Certification: A "certificate of compliance for USP Biological Tests has been furnished by Medex, the check valve supplier, for their check valve that is being used in the Model D-290P administration set." This provides assurance regarding the safety of a critical component.
In essence, the "study" for this submission is a comparison and justification of technical characteristics and intended use against existing legally marketed devices, rather than a performance study involving diagnostic accuracy metrics, sample sizes, or expert evaluations.
§ 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.