(54 days)
The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.
The purpose of this submission is to offer an alternate 1.2 µ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.
The provided 510(k) summary for the CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve and the CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve does not contain information related to a study proving the device meets acceptance criteria.
This document is a 510(k) summary of safety and effectiveness aiming to demonstrate substantial equivalence to previously marketed devices, not a report of a study specifically designed to prove acceptance criteria for a new, unique device.
However, based on the provided text, we can infer some information about acceptance criteria and the "study" conducted.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission, the "acceptance criteria" are implied by the functional and biocompatibility requirements. The "device performance" is a statement that these criteria were met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Specification | Filter functions according to specification. |
| Biocompatibility | Set meets biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Functional specification testing was performed on the alternate filter when used with the anti-siphon valve" and "Biocompatibility testing was conducted" but does not give sample sizes for these tests.
- Data Provenance: The testing was implicitly performed by SIMS Deltec, Inc. (the manufacturer). No country of origin is specified, but given the company's US address, it's likely US-based. The testing is retrospective in the sense that it's reported after completion as part of the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic or image-analysis AI devices. For an administration set, "ground truth" is determined by objective functional and material testing against established standards or specifications.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical evaluations, particularly for diagnostic accuracy. For functional and biocompatibility testing of a medical device like an administration set, the results are typically objectively measured and do not require expert adjudication in this manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a medical administration set, not an AI or diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study of an algorithm was not done. This device is a physical administration set, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on functional specifications and biocompatibility requirements. These are objective, technical standards and tests, rather than expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical administration set, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" for this type of device.
§ 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.