(70 days)
The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.
The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.
The CADD® Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD® Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump.
The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
The CADD® Administration Sets with Flow Stop is a modification to the current CADD® Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
The Flow Stop 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 blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the Flow Stop in the open position.
The Add-on Integral 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 Flow Stop.
The provided document describes two devices: the CADD® Medication Cassette Reservoir with Flow Stop and the CADD® Administration Set with Flow Stop. Both devices are modifications of existing products and incorporate a "Flow Stop" component designed to occlude the tube if the reservoir/set is accidentally placed onto the pump incorrectly or becomes detached.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | The device must function according to specifications, specifically that the Flow Stop component effectively occludes the tube if the reservoir/set is incorrectly attached or detached from the pump. | "The results of the testing indicated that the CADD® Medication Cassette Reservoirs with Flow Stop function according to specifications." (for both devices) |
| Biocompatibility | The materials used in the new Flow Stop components must be biocompatible for human use. | "Biocompatibility testing was performed on the new Flow Stop components." and "the materials used in the device are biocompatible." Therefore, the product is considered acceptable for human use. |
| Intended Use | The device must be suitable for its intended use with CADD® pumps (except CADD®-Micro and CADD-TPN®) for delivery of medications and fluids. | The functional testing and biocompatibility support its use as intended, as concluded by the statement "Therefore, the product is considered acceptable for human use." |
Study Information
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Sample size used for the test set and the data provenance:
- The document states "In-vitro testing was conducted," but does not specify the sample size for the functional testing.
- The data provenance is in-vitro testing, implying a laboratory setting, not human or animal data. The country of origin is not explicitly stated, but the applicant's address is in St. Paul, Minnesota, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The studies were described as "in-vitro testing," suggesting a focus on engineering and material science rather than expert-based ground truth.
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Adjudication method for the test set:
- This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic studies where human expert consensus is needed. The testing described is functional and biocompatibility testing.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary regarding the CADD® Medication Cassette Reservoirs with Flow Stop due to their similarity in materials, design and function to the current CADD® Medication Cassette Reservoirs." The same statement is made for the Administration Set.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a medical accessory (medication cassette reservoir/administration set), not an algorithm or AI system.
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The type of ground truth used:
- The ground truth for the functional performance was based on specifications established for the device's function (i.e., the Flow Stop effectively occluding the tube).
- For biocompatibility, the ground truth was based on established biocompatibility standards and tests for medical device materials.
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The sample size for the training set:
- This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for physical device performance and material properties.
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How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above.
§ 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.