Search Results

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.

Device Description

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are similar dressings with one provided as a film dressing and the latter provided as a film dressing with a soft cloth border. Performance data supports both product configurations.

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing consists of a polyurethane film coated with a transparent chlorhexidine gluconate (CHG) acrylic adhesive. CHG, a broad spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.

The transparent film is breathable, allowing oxygen and moisture vapor exchange, yet is impermeable to external contaminants. including fluids (waterproof), bacteria, viruses* and yeast. The dressing must remain intact to protect the IV site from external contaminants.

3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices.

In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, specifically the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to set and meet new performance criteria. Therefore, the "acceptance criteria" discussed here are implicitly related to the concept of substantial equivalence, meaning the new device performs similarly and is as safe and effective as the predicate device.

It's important to note that this is a medical dressing, not an AI or imaging device. The questions provided in the prompt (e.g., "Number of experts used to establish the ground truth," "MRMC comparative effectiveness study," "standalone algorithm performance") are highly relevant to AI/ML medical devices, but not applicable to this type of traditional medical device submission.

However, I can extract the relevant "performance data" that serves as the "proof" the device meets the criteria for substantial equivalence, as requested.

Here's an analysis based on the provided document, adapting the prompt's framework where possible:

Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing

Study Proving Substantial Equivalence (Implicit Acceptance Criteria)

The proof focuses on demonstrating that the new devices are substantially equivalent to a legally marketed predicate device (BD ChloraShield™ I.V. Dressing with CHG Antimicrobial). This means they perform similarly, and do not raise new questions of safety or effectiveness. The "acceptance criteria" are therefore aligned with demonstrating this equivalence in terms of biocompatibility, physical properties, antimicrobial activity, and wear performance.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Implied Acceptance Criterion (from predicate comparison & testing)	Reported Device Performance (vs. Predicate)
Biocompatibility: Safe for skin contact (prolonged duration, <30 days, breached/compromised skin).	Met: Evaluated in accordance with ISO 10993 and FDA guidance. Battery of tests included: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute System Toxicity and Subacute/Subchronic Toxicity, Implantation. (Specific results are not detailed in this summary, but the completion of these tests meeting established safety profiles is the criterion.)
Physical Properties:	Met: Bench testing showed comparable performance to the predicate device in:
- Tensile and Elongation	- Performed. (Specific values not provided in summary, but implied to be within acceptable range or comparable to predicate.)
- Moisture Vapor Transmission Rate (MVTR)	- Performed. (Specific values not provided in summary, but implied to be within acceptable range or comparable to predicate.)
- Waterproof	- Performed. (Confirmed as waterproof with film being impermeable to fluids.)
Antimicrobial Activity: Effective against target microbes (due to CHG in adhesive).	Met: In vitro (time kill) testing demonstrated an antimicrobial effect against a variety of gram-positive bacteria, gram-negative bacteria, yeast, and mold in the dressing for both configurations. (Specific log reduction or kill rates not provided in summary, but implied to be effective and comparable to predicate.)
Virus Barrier: Provides a barrier to viruses.	Met: In vitro testing shows the film provides a barrier to viruses ≥27 nm in diameter (while intact). Note: No clinical study on prevention of viral infection was conducted.
Wear Performance/Securement: Ability to remain on skin and secure devices for specified duration (e.g., up to 7 days).	Met: Clinical Study Results: A randomized, controlled, open-label study assessed wear performance at 3 and 7 days. At 72 hours (3 days), all dressings (subject and predicate) remained on the arms. At 168 hours (7 days), the subject device remained on the arms. Three of the predicate devices had been removed due to excess lift before 168 hours. The lift of the subject device was substantially equivalent to the predicate device at both 72 and 168 hours. The study demonstrated the subject device secured catheters for seven days.
Adhesive CHG Release: Maintains CHG release throughout use life.	Met: Amount of CHG within the device through release kinetics was studied and implied to be sufficient over the use life. (Specific release profile not provided in summary, but implied to meet requirements.)

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

Clinical Study (Wear Performance):
- Sample Size: 24 healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be a prospective clinical study given the description of a "randomized, controlled, open-label study."
Bench Testing & In vitro Testing:
- Sample Size: Not specified for individual bench tests or in vitro antimicrobial tests. These typically involve a defined number of samples according to standards (e.g., for tensile strength, MVTR, etc.) or bacterial cultures for time-kill assays.
- Data Provenance: These are laboratory tests, provenance is the testing facility/lab.

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

Not Applicable. This is a physical medical device (dressing) and not an AI/imaging device requiring expert interpretation for ground truth.
For the clinical study, "ground truth" would be the observed wear performance and device integrity on subjects.

4. Adjudication Method for the Test Set

Not Applicable. As above, not an AI/imaging study requiring expert adjudication.
For the clinical study, the "adjudication" was the quantitative measurement of dressing lift/removal.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted device or an imaging study.

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

Not Applicable. This is not an algorithm-based device. "Standalone performance" would refer to the dressing's intrinsic properties and direct interaction with the body/catheter, which are assessed through the biocompatibility, bench, and clinical wear studies.

7. The Type of Ground Truth Used

Biocompatibility: Established toxicological and biological response standards (e.g., ISO 10993).
Bench Testing: Engineering and material science standards (e.g., for tensile properties, moisture vapor transmission, waterproofing, CHG release).
Antimicrobial Activity: Microbiological time-kill assays (comparing to established efficacy standards, or benchmarked against predicate).
Clinical Study (Wear Performance): Direct clinical observation and quantitative measurement of dressing adhesion and removal on human subjects. The "ground truth" here is the objective adhesion/lift measurement, comparing the subject device directly to the predicate.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. (As above)

In summary, the "acceptance criteria" for this device are implicitly tied to demonstrating its substantial equivalence to a predicate device across various safety and performance attributes (biocompatibility, physical integrity, antimicrobial function, and wear performance), as evidenced by standard laboratory and a small clinical study. The framework of AI/ML device evaluation does not directly apply here.

Ask a Question

Ask a specific question about this device

Page 1 of 1