(90 days)
3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist enviroment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facilitate autolytic debridement. Common applications include: IV catheters, other intravascular catheters and percutaneous devices, clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, superficial wounds such as abrasions, skin tears, and blister, first and second degree burns, chafed skin or skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels, protective eye covering during surgery or for patients with corneal abrasions.
3M Tegaderm™ Transparent Dressing consists of a thin, polyurethane film backing with a hypoallergenic, acrylate, pressure sensitive adhesive. The dressing is transparent and possess good oxygen and moisture vapor permeability and yet is impermeable to liquids and bacteria
This 510(k) submission (K973036) for the 3M Tegaderm™ Transparent Dressing is focused on deleting a warning/contraindication regarding its use over arterial catheter sites, rather than introducing a new device or significantly altering the device's fundamental function. Therefore, the traditional format of acceptance criteria and device performance based on a new study is not applicable here.
The submission primarily relies on extant information and regulatory guidance to support the change in labeling.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the context of a new performance study for the device itself. Instead, the "acceptance criteria" for this 510(k) effectively revolve around the justification for removing the warning.
| Acceptance Criteria (for warning deletion) | Reported Device Performance/Justification |
|---|---|
| Lack of supporting literature for warning | "Neither literature, clinical studies, CDC guidelines... nor FDA Device Labeling Guidance re the use of Precautions, Warnings or Contraindications support such a warning." |
| No conclusive clinical studies supporting warning | "Neither... clinical studies... support such a warning." |
| CDC Guidelines for Prevention of Intravascular Device-Related Infections (no mention of arterial catheter warning) | "CDC guidelines for the Prevention of Intravascular Device-Related Infections... support such a warning." (Implicitly, the CDC guidelines do not support the warning, hence its proposed deletion). |
| FDA Device Labeling Guidance (no mention of arterial catheter warning) | "FDA Device Labeling Guidance re the use of Precautions, Warnings or Contraindications support such a warning." (Implicitly, the FDA guidance do not support the warning). |
| Substantial equivalence to other standard transparent dressings without such warning | "3M Tegaderm Transparent Dressings are substantially equivalent to other standard transparent dressings on the market, none of which contraindicate or warn against use over arterial catheter sites at this time, as evidenced by labeling presented in this submission." |
2. Sample Size Used for the Test Set and Data Provenance:
No new "test set" and corresponding sample size are mentioned for this particular 510(k) submission. The submission relies on existing knowledge and the absence of data supporting the warning. The data provenance would be a combination of:
- Retrospective analysis of existing literature and clinical studies.
- Prospective review of CDC guidelines and FDA guidance documents.
- Review of labeling from other commercially available transparent dressings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable to this submission. The "ground truth" here is the lack of evidence to support a warning, which is established through a review of existing scientific and regulatory documentation, rather than a new expert consensus on a test set.
4. Adjudication Method for the Test Set:
Not applicable, as no new test set or expert adjudication process is described.
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/imaging device submission, nor does it involve human reader performance.
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.
7. The Type of Ground Truth Used:
The "ground truth" used to justify the deletion of the warning is a combination of:
- Absence of supporting scientific literature/clinical studies.
- Compliance with established medical guidelines (CDC).
- Consistency with regulatory guidance (FDA).
- Market precedent (labeling of equivalent devices).
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning or AI algorithm development described.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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