(92 days)
The ChloraShield IV Dressing with CHG Antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.
The ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
The provided text describes a Special 510(k) submission for the "ChloraShield IV Dressing with CHG antimicrobial" due to a change in packaging material. The study reported focuses on verifying that this packaging change does not negatively impact the device's sterility and functionality.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (Original) | 10⁻⁶ |
| Sterility Assurance Level (Revised Packaging) | 10⁻⁶ (confirmed no impact to sterility) |
| Seal Strength | Verified (no specific numerical criteria or results given) |
| Bubble Leak Test | Performed (no specific numerical criteria or results given) |
Note: The primary acceptance criterion explicitly stated and tested related to a numerical value is the Sterility Assurance Level. For Seal Strength and Bubble Leak Test, the text only states they were "verified" or "performed" without providing specific target values or quantitative results. The overarching acceptance criterion is that the new packaging "did not negatively impact the sterility assurance level" and that "the performance, functionality and manufacturing methods remain unchanged."
Study Information
The document describes a verification/validation activity rather than a traditional clinical study with a test set of patients.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated for any of the tests (Sterility, Seal Strength, Bubble Leak Test).
- Data Provenance: The tests were conducted internally by Avery Dennison Belgie, b.v.b.a. No information on country of origin of data or whether it was retrospective or prospective in a clinical sense. These are laboratory/engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts: Not applicable. Ground truth for sterility or mechanical integrity tests is established by standardized laboratory methods and measurements, not expert consensus in the way a clinical image analysis study might.
- Qualifications: Not applicable for this type of testing.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. These are objective laboratory tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, this type of study was not done. The device is a wound dressing, and the study described focuses on the impact of a packaging change on its physical and microbiological properties, not on reader effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI algorithms does not apply. The tests described are for the device's intrinsic properties.
7. The type of ground truth used:
- Ground Truth:
- Sterility: Established by microbiology testing to confirm the absence of viable microorganisms, adhering to a defined Sterility Assurance Level (SAL) of 10⁻⁶. This is an objective, laboratory-derived ground truth.
- Seal Strength and Bubble Leak Test: Established through mechanical testing methods, likely comparing results against established engineering specifications or the performance of the original device packaging. This is an objective, laboratory-derived ground truth.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As there is no training set.
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