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3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.

Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.

Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria. viruses* and yeast, and protects the IV site.

In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.

*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.

Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

The provided text is a 510(k) summary for the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing. This document does not include information about acceptance criteria and a study proving the device meets those criteria in the way specifically requested in your prompt (e.g., performance metrics like sensitivity/specificity for a diagnostic device, or detailed clinical study results with effect sizes for comparative effectiveness).

Instead, this submission is a Special 510(k) for a device modification, which means it focuses on demonstrating that the modified device remains substantially equivalent to its own predicate device.

Here's a breakdown based on the information provided in the document, and what is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device."

It doesn't provide specific numerical acceptance criteria (e.g., "X% viral barrier efficacy") or reported numerical performance for this test. It only states that the performance is "substantially equivalent" to the predicate. The predicate device's performance is described as: "In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage."

Therefore, for the specific viral barrier performance, a table cannot be constructed with numerical values from this document. The "acceptance criterion" seems to be "substantially equivalent viral barrier performance to the predicate," and the "reported device performance" is that it met this criterion.

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

The document does not specify the sample size for the viral barrier performance test. It only mentions "Non-clinical testing." The data provenance is also not specified (e.g., country of origin). It is an in vitro test, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided. The viral barrier test is an in vitro (laboratory) performance test, not a subjective interpretation requiring expert consensus.

4. Adjudication Method:

This is not applicable and not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done or reported. This submission is for a dressing, not a diagnostic imaging device where MRMC studies are common.

6. Standalone (Algorithm Only) Performance:

This is not applicable as the device is a physical medical dressing, not an algorithm.

7. Type of Ground Truth Used:

For the viral barrier test, the "ground truth" would be established by the laboratory testing methodology itself (e.g., direct measurement of viral pass-through). This is not explicitly detailed but is inherent to in vitro performance testing.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical dressing, not an AI/ML algorithm that requires a training set.

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

This is not applicable.

Summary based on information provided for K171908:

The provided document is a 510(k) Pre-Market Notification for a modification to a medical device (3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing). The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (itself, specifically K063458, K080620, K153410).

The main "study" mentioned is non-clinical testing for viral barrier performance at the end of shelf-life. The conclusion is that the modified device's performance is "substantially equivalent" to the predicate device. The predicate device's performance regarding viral barrier is described as providing a barrier from viruses 27 nm or larger. No specific numerical acceptance criteria or performance metrics for this test are provided in this regulatory document.

No clinical studies, expert consensus, or AI/ML-related studies (like MRMC or standalone algorithm performance) are part of this particular submission for this device.

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3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing I.V. catheters, other intravascular catheters and percutaneous devices.

Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.

Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity.

The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria, and yeast, and protects the I.V. site.

In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.

Tegaderm™ CHG I.V. Securement dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing in reducing Catheter-Related Bloodstream Infections (CRBSI). While explicit "acceptance criteria" (i.e., pre-defined thresholds the device must meet to be cleared) are not stated in a tabular format, the study results demonstrate the device's efficacy, which served as the basis for its expanded indication.

Implicit Acceptance Criteria (Based on Study Findings supporting Expanded Indication):

Additional Performance Data Mentioned (In Vitro):

• Antimicrobial Effect: Log reduction and barrier testing demonstrate antimicrobial and antifungal effect against gram-positive and gram-negative bacteria, and yeast.
• Suppression of Regrowth: Demonstrated suppression of regrowth over time.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The randomized controlled clinical trial included 1,879 subjects with 4,163 central venous and arterial catheters.
• Data Provenance: The study was conducted at 11 hospitals (12 ICUs) in France. The data is prospective, as it was a randomized controlled trial.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for diagnosing CRBSI within the study. However, the study authors (Timsit JF et al.) likely followed established clinical protocols and expert consensus for CRBSI diagnosis within a critical care setting.

4. Adjudication Method for the Test Set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). However, the definition of CRBSI used in the Timsit study (and subsequent re-analysis using IDSA guidelines) implies a structured diagnostic process based on clinical criteria and laboratory results. This often involves review by infectious disease specialists or hospital epidemiologists, though the specific adjudication process is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study was a randomized controlled clinical trial comparing a medical device (dressing with CHG) to a control (dressing without CHG) in a real-world clinical setting, not assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The study evaluated the clinical effectiveness of a medical device (a dressing containing CHG) in a human-in-the-loop scenario (patients with catheters). There is no "algorithm" in the context of an antimicrobial dressing.

7. Type of Ground Truth Used

The ground truth used for determining CRBSI in the clinical study was based on clinical definitions of infection and laboratory confirmation. Two definitions were applied:

• Timsit et al. (2012) Definition: A specific combination of positive peripheral blood cultures, positive quantitative catheter-tip culture, and absence of other infectious foci. For coagulase-negative staphylococci, matching pulse-field gel electrophoresis patterns were required.
• Infectious Diseases Society of America (IDSA) 2009 Guidelines: A re-analysis incorporated IDSA's definition, which includes bacteremia/fungemia with an intravascular device, clinical manifestations, absence of other sources, and a combination of positive semiquantitative/quantitative catheter cultures or differential time to positivity.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this is a medical device (dressing) and not an AI/ML algorithm. The study was a clinical trial evaluating the effectiveness of the dressing.

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

As mentioned in point 8, there is no "training set" for this type of medical device. The clinical trial directly assessed the device's impact on CRBSI rates in patients.

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