Search Results

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.

Ask a specific question about this device