(253 days)
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.
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.
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, |
N/A