Search Results

Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including: Pressure ulcers, Leg ulcers, Diabetic foot ulcers, Graft wounds and donor sites, Skin tears, First and second degree burns, Surgical wounds, Lacerations and abrasions.

The Retro-Tech Dressing is a dry medium, wound dressing. Retro-Tech Dressing is an absorbent foam. It is ideal for highly exudating wounds. It provides both antibacterial and antifungal protection. It is extremely hydrophilic.

This 510(k) summary describes a wound dressing product, the Retro-Tech Dressing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, and ground truth methodologies are not explicitly provided in the document.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document states that the Retro-Tech Dressing and predicate devices were compared in various areas and "found to have similar technological characteristics and to be equivalent," implying that the device meets the characteristics of the predicate, but no specific performance metrics or acceptance criteria are listed.

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

Not applicable. There is no mention of a clinical or analytical test set with associated sample sizes or data provenance for proving performance against set criteria. The submission relies on technological characteristic comparison.

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

Not applicable. As no specific test set requiring expert ground truth is described, this information is not present.

4. Adjudication Method for the Test Set:

Not applicable.

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

No. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a wound dressing, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. This is a physical wound dressing, not an algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of typical device performance studies involving diagnostic or prognostic outputs. The "ground truth" for this submission is effectively the established characteristics and equivalency of the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

Summary of Device Equivalence and Performance Information Available:

The submission focuses on establishing substantial equivalence to predicate devices (K013462, K022416, K032742) based on the following technological characteristics:

• Indications For Use: Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds and donor sites, skin tears, first and second degree burns, surgical wounds, lacerations and abrasions. These are the same as the predicate devices.
• Design: Similar to predicate devices.
• Materials: Similar to predicate devices. The device is described as a "dry medium, wound dressing," an "absorbent foam," "antibacterial and antifungal," and "extremely hydrophilic."
• Performance: Stated as similar to predicate devices. No specific quantitative performance data is provided beyond this general statement of equivalence. "In-Vitro Antibacterial Activity" is listed as a 'Testing Done' characteristic, implying it was evaluated, but no results or specific acceptance criteria for this are given in the summary.
• Sterility: Similar to predicate devices.
• Testing Done: Includes "In-Vitro Antibacterial Activity."
• Where Used: Similar to predicate devices.
• Anatomical Sites: Similar to predicate devices.

The FDA's decision to grant 510(k) clearance (K060832) is based on this assertion of substantial equivalence, meaning the device is deemed as safe and effective as the legally marketed predicate devices without requiring new clinical efficacy data.

Ask a specific question about this device