(331 days)
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard proximally valved catheters. The extension set will connect the IV administration set to the catheter.
The Extension Set is designed for Bard proximally valved catheters and attaches to the end of the catheter hub for use in the administration of fluids. The Extension Set opens the valve to facilitate central venous pressure monitoring and/or blood sampling. Extension Sets are packaged individually for single use for a period no longer than 96 hours.
The provided submission describes non-clinical performance testing for the "Extension Set for Bard® Proximally Valved Catheters." This is a medical device for fluid administration, not an AI/ML powered device, therefore many of the requested categories are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Evaluation | Predetermined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Assembly Leak | No leaks at 43.5 psi minimum (air method used) | Met |
| Gravity Flow | 750 ml/hr minimum | Met |
| Priming Volume | NA, test and report results (results are reported to have been generated though values not specified) | Met |
| Assembly Tensile | Must withstand an axial, static tensile force of 15 N (3.37 lbs) for 15 seconds | Met |
| ISO 594 - 1 & 2 Luer Testing | Must pass acceptance criteria outlined in ISO 594-1 and -2. | Met |
| Aspiration Flow | NA, test and report results (results are reported to have been generated though values not specified) | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific test. The testing is described as "bench performance testing," which implies laboratory-based testing of manufactured devices. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as no human data was involved.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an extension set for catheters, and the testing involved bench performance criteria, not medical image interpretation or clinical outcomes requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described as the testing was non-clinical bench testing against predetermined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device, and no MRMC study or human reader performance evaluation was conducted or is relevant for this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithmic device. The performance evaluation focuses on the physical properties and functionality of the extension set itself.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance criteria are established engineering, mechanical, and safety standards and internal protocols (e.g., ISO standards for infusion equipment, Luer fittings, tensile strength requirements, leak integrity, and flow rates).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned.
§ 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.