(182 days)
- Pressure ulcers, stage II, III & IV wounds
- Venous ulcers
- 1st & 2nd degree bums
Gentell hydrogel is an amorphous gel formed with a high molecular weight hydrophilic polymer, water and aloc vera. This primary wound dressing is intended to provide a moist healing environment. Gel may be removed by gentle irrigation, reducing the potential of tissue damage. Gentell hydrogel is supplied in a multidose cight ounce trigger spray boule and a four ounce tube. This product is not terminally sterilized and bioburden reduction/stasis is achieved through preservation.
This document is a 510(k) summary for the Gentell Hydrogel Wound Dressing, a moist wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria. As such, most of the requested information for acceptance criteria and a study proving those criteria are not available in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices (Carrington Dermal Wound Gel K894541 and Eutra Gel for Wound Dressing K932291) in terms of "design, composition and function." The testing mentioned is primarily for biological safety and product stability.
| Acceptance Criteria (Not explicitly stated as such, but inferred areas of testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Cytotoxicity, Irritation, Sensitization | Testing conducted consistent with Tripartite Biocompatibility Guidance; implies acceptable results (otherwise substantial equivalence would not be granted). |
| Preservative Effectiveness | Testing conducted; implies acceptable results for bioburden reduction/stasis. |
| Functional Equivalence (inferred for providing a moist healing environment) | "Similar in design, composition and function to Carrington Dermal Wound Gel (K894541) and Eutra Gel for Wound Dressing (K932291)." |
| Intended Use | Indicated for Stage II, III & IV pressure ulcers, venous ulcers, 1st & 2nd degree burns. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of clinical performance or diagnostic accuracy. The testing mentioned appears to be laboratory-based biocompatibility and stability testing. Therefore, specific sample sizes for a clinical test set are not provided. The data provenance is also not specified as there are no human subject studies described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study requiring expert-established ground truth for a test set (e.g., diagnostic image interpretation).
4. Adjudication Method for the Test Set
Not applicable. There is no described test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The submission is for a medical device (wound dressing) and not a diagnostic or AI-assisted system that typically undergoes such studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the biocompatibility and preservative effectiveness tests, the "ground truth" would be established by standard laboratory methods and controls for those specific tests as outlined by relevant guidelines (e.g., Tripartite Biocompatibility Guidance). For the claim of "similar in design, composition and function," the ground truth is established by comparison to the chemical composition and documented performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no AI or algorithm involved that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
N/A