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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

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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The BeneHold CHG Transparent Film Dressing 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 BeneHold CHG Transparent Film Dressing is used to cover and protect catheter sites and to secure devices to the skin. The dressing consists of a transparent film with an acrylic adhesive which contains Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination. The dressing absorbs between 8 and 21 ml of fluid depending on the dressing size. In vitro testing (barrier, kill time and log reduction) demonstrates that the BeneHold CHG Transparent Film Dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing. BeneHold CHG Transparent Film Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

The provided 510(k) summary (K113836) for the BeneHold CHG Transparent Film Dressing describes performance testing, but does not provide specific acceptance criteria or detailed study results for all tests. It lists the tests performed but largely states that they demonstrated "conformance to design specifications" or that "testing indicates that the BeneHold CHG Transparent Film Dressing is substantially equivalent."

Therefore, much of the requested information regarding specific acceptance criteria, detailed device performance, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific acceptance criteria and quantitative performance metrics are generally not explicitly stated in this 510(k) summary. The summary broadly states that the device "conforms to design specifications" and demonstrated "antimicrobial effect" and "barrier" properties.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size:
  • Test Set: Not specified in the document. The document refers to "in vitro testing" for antimicrobial effects and barrier properties, but the sample sizes (e.g., number of dressings, number of bacterial cultures) are not provided.
  • Training Set: Not applicable as this is a physical medical device, not an AI/ML diagnostic device with a training set.
• Data Provenance: The studies are described as "in vitro testing." The country of origin of the data is not specified, but the submitter is "Avery Dennison Belgie, BVBA" (Belgium) and the contact person is in the US. The studies are described as performance tests, which are typically conducted in a laboratory setting for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable/Not specified. This is a physical device performance study, not an imaging/diagnostic study requiring expert ground truth establishment in a clinical context. Laboratory testing for physical and chemical properties typically relies on standardized methods and measurements rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need resolution. This document describes laboratory-based performance testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not mentioned or implied by the described performance testing. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human reader performance is being evaluated with and without assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• In this context, the "ground truth" for the device's performance tests would be established through scientific measurements and standardized laboratory protocols. For example:
  • For fluid handling capacity, the ground truth is the measured volume of fluid absorbed.
  • For antimicrobial effectiveness, the ground truth is the measured log reduction of microbial population compared to controls based on established microbiological methods.
  • For biocompatibility, the ground truth is determined by standardized in vitro or in vivo tests for irritation, cytotoxicity, and sensitization.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

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