(57 days)
The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.
The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.
The provided 510(k) summary for the CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve indicates that this is a Class II medical device. For such devices, the primary demonstration of safety and effectiveness often relies on substantial equivalence to a predicate device, supported by functional testing rather than extensive clinical studies.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional specifications for the filter | The filter functions according to specification. |
| Biocompatibility requirements | The set meets the biocompatibility requirements. |
| Performance similar to predicate devices in materials, design, and function | Not explicitly detailed as a separate criterion, but assumed as the basis for not requiring clinical studies. The new device's dimensions (length, I.D., O.D.), filter presence, and anti-siphon valve presence are comparable to predicate devices, particularly the CADD-TPN® Administration Set with 1.2 µ Filter and the CADD® Extension Set with Anti-siphon Valve, addressing the "add-on anti-siphon valve" feature. |
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 and antisiphon valve" and "Biocompatibility testing was conducted." The exact number of units or tests performed is not mentioned.
- Data Provenance: Not specified. It's internal testing conducted by SIMS Deltec, Inc. There is no indication of country of origin for the data or whether it was retrospective or prospective. It is implied to be prospective testing for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth for functional and biocompatibility testing is established by technical specifications and standardized testing protocols, not by expert consensus in the clinical sense.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes. For functional and biocompatibility testing, results are determined by adherence to pre-defined technical thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is an administration set, not an algorithm. Performance is assessed through physical and biological testing, not through algorithmic evaluation.
7. The Type of Ground Truth Used:
- Functional Testing: The ground truth for functional testing is the adherence to the device's technical specifications and intended performance (e.g., filter efficacy, anti-siphon valve operation). These specifications would be derived from engineering requirements and industry standards.
- Biocompatibility Testing: The ground truth for biocompatibility is compliance with established biological safety standards (e.g., ISO 10993 series) for medical devices, demonstrated through a battery of tests (e.g., cytotoxicity, irritation, sensitization).
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and function" similarity to existing devices serves as the basis for demonstrating safety and effectiveness, leveraging the established performance of the predicate devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
Summary of the Study:
The study proving the device meets acceptance criteria primarily consisted of functional testing and biocompatibility testing.
- Functional Testing: This testing assessed whether the "alternate filter and antisiphon valve" performed according to their designed specifications. The conclusion was that "the filter functions according to specification." While specific parameters or pass/fail criteria are not detailed in this summary, it implies that the device achieved its intended functional performance for these key components.
- Biocompatibility Testing: This testing evaluated the materials of the device to ensure they are safe for human contact and use without causing adverse biological reactions. The conclusion was that "the set meets the biocompatibility requirements," suggesting compliance with relevant biological safety standards.
The 510(k) submission relied heavily on substantial equivalence to predicate devices. The justification for not conducting clinical studies explicitly states it was "due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets." This means the historical safety and effectiveness data of the predicate devices implicitly served as a basis for the new device's acceptance, supplemented by the targeted functional and biocompatibility tests on the new features (the specific filter and the added anti-siphon valve).
§ 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.