(43 days)
Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.
The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.
This document describes a 510(k) submission for a medical device called an "Additive Cap." The submission is for a modification to an existing device, specifically a label change to expand its indications for use. As such, the "study" conducted is a performance test to ensure the modified device still functions as intended.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly mentions one specific performance test.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use. (Implied acceptance for "force to remove" and "biocompatibility") | Test results met acceptance criteria. (Specific force values or biocompatibility results are not provided but are stated to have met criteria). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "force to remove" test.
- Data Provenance: The study was conducted internally by Baxter Healthcare Corporation. It is a prospective test conducted for this 510(k) submission to evaluate the modified device. The country of origin for the data is implied to be the United States, given Baxter's location and the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to a performance test for a mechanical device like an "Additive Cap," especially when the change is a label modification. The "ground truth" for such a device is its mechanical function and material properties, which are assessed through engineering and biocompatibility testing, not through expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review and consensus, typically in diagnostic imaging studies or clinical trials, not for mechanical performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a non-fluid path, non-sterile Additive Cap whose only change is a label modification.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm or AI was not done. This device is a passive mechanical component, not an algorithm.
7. Type of Ground Truth Used
For the "force to remove" test, the "ground truth" is the measured mechanical force required, compared against predefined engineering specifications or performance benchmarks for the device's functionality. For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-5 in this case) and the pass/fail criteria defined by those standards.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical component, not an AI or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).