(128 days)
The Rowe Dual-Check Valve device is intended for use with IV cannula or extension tube sets for simultaneous or alternate administration of IV drugs and fluids. The check valve is used in conjunction with a standard Luer taper syringe.
The Rowe Dual-Check Valve is a disposable, inexpensive device that has been designed to infuse controlled volumes of fluid quickly. The Rowe Dual-Check Valve is a combination of two onc-way flow valves joined by a "T" fitting. The arrangement allows a syringe to be placed on the medial female luer-lock port. The syringe is then used to draw fluid from the source and then infuse the fluid into the body. The Rowe Dual-Check Valve uses one-way valves that are normally open. Therefore, when the system is placed in a normal intravenous system, gravity driven flow can pass through the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pressure Test | The device must withstand specified pressures without failure. | "assure reliable design and performance" |
| Flow Test | The device must allow for specified fluid flow rates. | "assure reliable design and performance" |
| Torque Test | The device must withstand specified torques without failure or disengagement. | "assure reliable design and performance" |
| Biocompatibility | The device must be biocompatible for its intended use (implied, per general medical device standards). | "assure reliable design and performance" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each test. The data provenance is not explicitly stated but is implicitly from in-house testing conducted by COOK INCORPORATED. There is no indication of retrospective or prospective study design, but rather laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The tests performed are engineering and biocompatibility tests, not clinical performance tests requiring expert assessment of ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements.
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 device is a passive medical device (a valve) and does not involve AI or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for these tests would be objective physical measurements and adherence to predefined engineering specifications and biocompatibility standards. For example:
- Pressure Test: The ability of the device to hold specified pressure without leakage or rupture.
- Flow Test: The measured flow rate of fluid through the device under given conditions.
- Torque Test: The measured torque at which connections maintain integrity or fail.
- Biocompatibility: Results from established in vitro and/or in vivo biocompatibility assays (e.g., cytotoxicity, irritation, sensitization).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve machine learning or a "training set."
§ 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.