(23 days)
The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
The CADD® High-Volume Administration Sets with FlowStop is a modification to the current CADD® High-Volume Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The FlowStop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the "CLIP" must be removed to activate the FlowStop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the FlowStop in the open position. The Add-on Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the FlowStop.
The acceptance criteria and study proving the device meets them are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance: Device occludes the tube if placed incorrectly or detached from the pump ("FlowStop" feature). | In-vitro functional testing indicated the device functions according to specifications. |
| Material Biocompatibility: Materials used in the new FlowStop components are biocompatible. | Biocompatibility testing performed on FlowStop components demonstrated biocompatibility. |
| Safety for Human Use: The device is considered safe for human use. | The combination of functional and biocompatibility testing led to the conclusion that the product is acceptable for human use. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated as a separate "test set" in the context of typical AI/diagnostic device studies. The document refers to "in-vitro testing" for functional performance and "biocompatibility testing" for materials. The sample sizes for these specific tests are not provided.
- Data Provenance: The studies were in-vitro (laboratory-based) and focused on the device's functional mechanics and material properties. There is no mention of human data, patient data, country of origin, or retrospective/prospective nature as would be relevant for clinical performance studies.
3. Number and Qualifications of Experts for Ground Truth (Test Set):
- Number of Experts: Not applicable. The ground truth for this device (a medical administration set) is based on engineering specifications for function and established standards for biocompatibility. It does not involve expert interpretation of medical images or other diagnostic data that would require a panel of medical experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (Test Set):
- Adjudication Method: Not applicable. As the evaluation relies on direct functional and material testing against predefined engineering specifications and standards, there is no need for expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of complex medical data (e.g., radiologists reading images with or without AI assistance). The CADD® High-Volume Administration Set with FlowStop is an administration set, not a diagnostic device involving human readers or interpretation.
- Effect Size of Human Readers: Not applicable.
6. Standalone Performance Study:
- Standalone Study: Yes, a standalone study (algorithm-only performance) was conducted, though framed differently for a physical medical device. The "functional testing" and "biocompatibility testing" represent the standalone performance of the device itself (its physical mechanics and material properties) without human intervention in the primary function being tested (i.e., whether the FlowStop occludes, or whether the materials are biocompatible). The studies assessed how the device performed against its intended specifications.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth was based on:
- Engineering Specifications: For the functional performance of the FlowStop (e.g., its ability to occlude the tube under defined conditions).
- Biocompatibility Standards: Established standards and protocols for assessing the safety of materials in medical devices that come into contact with human tissue or fluids.
8. Sample Size for Training Set:
- Sample Size: Not applicable. This device is a physical medical administration set, not an AI/machine learning algorithm that requires a "training set" of data. The design and manufacturing process would involve internal testing and validation, but not in the context of an AI training set.
9. How Ground Truth for Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable, as 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.