(14 days)
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
The Blood Sampling Set consists of non-DEHP PVC tubing, and configured with one or more stopcocks with needleless valves, and a male luer lock for connection with the patients catheter. An optional configuration includes check valves, non-DEHP PVC tubing and transfer spike to allow for withdrawing flush solution from an IV bag into a syringe. All sets can be ordered with a choice of various on/off clamps, depending on the clinician's and hospital protocol. The Blood Sampling Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Blood Sampling Set":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Bond Joint Strength | Met the acceptance criteria as outlined in ISO 8536-4 |
| Fluid Flow Leak Testing | Met the acceptance criteria as outlined in ISO 8536-4 |
| Flow Rate Comparison | Met the acceptance criteria as outlined in ISO 8536-4 (comparison between proposed and predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison). The data provenance is implied to be directly from testing conducted by Acacia, Inc., as these tests were performed to assure substantial equivalence. It's not specified as retrospective or prospective, but as performance testing for a new device, it would inherently be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The described tests are not clinical studies requiring expert ground truth establishment. They are engineering performance tests against a standard (ISO 8536-4).
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against a standard, not requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a medical accessory (Blood Sampling Set / IV Extension Set), not an imaging or diagnostic AI device that would typically require such a study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison) are standalone performance evaluations of the device itself, without human-in-the-loop interaction in an interpretive sense.
7. The Type of Ground Truth Used
The ground truth for the performance tests was established by the ISO 8536-4 standard. This standard defines the requirements and acceptance criteria for infusion equipment, and the device's performance was measured against these objective, pre-defined technical specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory, not an AI or machine learning model that would require a 'training set.'
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it. The "ground truth" for the device's design and manufacturing is adherence to relevant standards and established engineering best practices.
§ 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.