(77 days)
The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.
The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Additive Port Cap" (APC) device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details performance testing for engineering characteristics rather than clinical performance or AI/human reader studies. Therefore, many of the requested points related to AI, human readers, and ground truth for clinical outcomes will not be present in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance testing that was conducted, and states that "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria and the exact reported performance values are not explicitly provided in detail within this summary. Instead, it lists the types of tests performed.
Here's a table based on the information available, indicating where details are missing:
| Test Name | Acceptance Criteria (Not explicitly detailed) | Reported Device Performance (Not explicitly detailed) |
|---|---|---|
| Visual Inspection | No gross damage, adequate coverage of drug port, etc. | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Axial Detachment | Force required to remove the cap from IV container (specific force not given) | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Opening Force | Force required to open a properly installed cap (specific force not given) | Met (Implied by statement: "All pre-determined acceptance criteria were met." Also notes: "cannot be opened manually.") |
| Closing Force | Force required to properly install product (specific force not given) | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Dimensional Verification | Dimensional measurements of cap features (specific ranges not given) | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Leakage | Drug port freedom from leakage | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Packaging & Labeling | Integrity of packaging, legibility of label | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Transportation, Shelf Life | Withstand simulated conditions, maintain function after shelf life | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Product Validation (Human Factors & Usability) | Usability for intended purpose (specific metrics not given) | Met (Implied by statement: "All pre-determined acceptance criteria were met.") |
| Tamper Evidence | If opened, causes visible damage to bag/cap or tears bag. | Confirmed: "pulling on the cap in order to remove from the bag tears the bag" and "If a closed cap is opened (e.g. with a tool), it can cause damage to the bag or the cap making it unusable." |
Information Not Found / Not Applicable Given the Device Type:
The device, an "Additive Port Cap," is a physical medical device (plastic cap) designed for tamper evidence and visual indication. It is not an AI/software device or diagnostic imaging device. Therefore, many of the requested points related to AI/ML study design are not applicable to this submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It merely states that "Performance testing to demonstrate tamper evidence was conducted" and lists various tests.
- Data Provenance: Not applicable in the context of clinical data. The tests are engineering and benchtop tests of a physical product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This is a physical device. "Ground truth" in the sense of expert medical interpretation for a diagnostic AI is not relevant here. The "ground truth" for the performance tests would be the measurement results from the engineering tests themselves (e.g., force required to open, presence of leakage).
4. Adjudication Method for the Test Set
- Not applicable. There's no clinical "test set" requiring adjudication by multiple experts. The tests are physical measurements and observations against engineering specifications.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is typically done for diagnostic imaging devices or AI-assisted solutions to compare human performance with and without AI. It is not relevant for a physical device like an IV port cap.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used
- Engineering Specifications and Physical Measurements: The ground truth for this device's performance would be derived from the mechanical properties, dimensional tolerances, and functional performance (e.g., ability to indicate tamper, withstand certain forces, prevent leakage) as defined by its design and intended use. This is established via physical testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no AI/ML device or training set.
§ 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).