(121 days)
for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe
The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Coeur, Inc. Disposable Transfer Sets:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Performance) | Reported Device Performance |
|---|---|
| Bond testing (to verify acceptable performance) | Performed acceptably |
| Leak testing (to verify acceptable performance) | Performed acceptably |
| Sterilization (Surgical Aseptic Level (SAL) of 10⁻⁶) | Achieved (product adoption study verified) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the bond testing, leak testing, or sterilization product adoption study.
The studies appear to be retrospective in nature, done by Coeur, Inc. to verify the performance of their device prior to seeking regulatory approval.
The data provenance is Coeur, Inc., within the USA (Washington, NC, and Lebanon, TN are listed company addresses).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts or a ground truth established by experts for these non-clinical tests. The tests appear to be objective measurements of physical performance.
4. Adjudication Method for the Test Set
Not applicable as there is no mention of expert-led adjudication for these non-clinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (transfer set), and the evaluation focuses on its physical and functional performance, not on clinical diagnostic or treatment efficacy that would involve human readers or AI.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done
This is not applicable. The device is a physical medical accessory, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be:
- Engineering specifications/standards for bond and leak testing (implied by "performs acceptably").
- Microbiological standards (Surgical Aseptic Level (SAL) of 10⁻⁶) for sterilization.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set. The "product adoption study" may refer to testing on a set of actual production units, but it's not a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no training set for an AI algorithm.
§ 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.