(90 days)
It is intended for use as a primary layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.
The proposed Kendall Curity Petrolatum Gauze Dressing is a sterile, single-use, non-adherent dressing consisting of absorbent gauze impregnated with white petrolatum. It is packaged in metalized chevron pouches and is available in ½" x 72", 1" x 36", 3" x 9", 3" x 18", 3" x 36", 6" x 36" and 1" x 8" sizes.
The provided document is a 510(k) premarket notification for a medical device, specifically a "Petrolatum Gauze Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling acceptance criteria through clinical studies. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is Not Applicable to this 510(k) submission. A 510(k) largely relies on demonstrating substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria from novel clinical trials. The document focuses on material comparison, function, and intended use as defined by the predicate.
| Acceptance Criteria (Not Applicable) | Reported Device Performance (Not Applicable) |
|---|---|
| N/A | N/A |
2. Sample Size Used for the Test Set and the Data Provenance
This information is Not Applicable. No test set based on patient data is described for performance evaluation in this 510(k) submission. The nonclinical testing mentioned (Biocompatibility) would involve laboratory samples, not a "test set" in the context of clinical performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is Not Applicable. No clinical test set requiring expert ground truth establishment for performance evaluation is described.
4. Adjudication Method for the Test Set
This information is Not Applicable. No test set (clinical or performance-based) requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was Not Done as described in this 510(k) submission. The focus is on demonstrating substantial equivalence to a predicate device based on material, function, and intended use, not on a comparative effectiveness study involving human readers and AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is Not Applicable. The device is a petrolatum gauze dressing, not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
This information is Not Applicable. No clinical "ground truth" (expert consensus, pathology, outcomes data) is discussed in the context of device performance evaluation in this 510(k) submission. The ground for comparison is the "legally marketed device" (predicate device).
8. The Sample Size for the Training Set
This information is Not Applicable. The device is a physical dressing, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable for the same reasons as #8.
N/A