(271 days)
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.
This document describes the acceptance criteria and performance of the Hydrofera Blue READY - Border device, a wound dressing, as part of its 510(k) submission (K190268) to the FDA.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter Evaluated | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Antibacterial Efficacy (ASTM E2149-10, modified) | ≥ 4 log reduction over 7 days | - 8 gram-positive Organisms tested: 8 experienced ≥ 6 log reduction |
- 10 gram-negative Organisms tested: 10 experienced ≥ 6 log reduction |
| Zone of Inhibition (AATCC 147-2011) | No zone of inhibition | No evidence of growth surrounding the Dressing |
| Dye Leachable | ) | Non-pyrogenic | Device is considered non-pyrogenic. |
| Biocompatibility (Local effects after implantation per ISO 10993-6) | Considered passing | In the rabbit muscle study, the device was considered passing. |
| Biocompatibility (Acute systemic toxicity per ISO 10993-11) | No signs of acute systemic toxicity | Device showed no signs of acute systemic toxicity. |
| Biocompatibility (Hemolysis/Interaction with blood per ASTM Hemolysis Test) | Passed | Passed |
| Biocompatibility (Toxicology Risk Assessment per ISO 10993-1, 10993-11, 10993-3, 10993-17, 10993-18, 21726, and 14971) | Toxicity not expected from intended use | Toxicity is not expected from the intended use of the device. (Note: product has not been tested or evaluated on pediatric or neonatal patient populations). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test in the acceptance criteria table. However, it indicates:
- Antibacterial Efficacy (ASTM E2149-10 modified): 8 gram-positive organisms and 10 gram-negative organisms were tested. The specific number of replicates or samples per organism is not provided.
- Other In Vitro Tests: Standard laboratory testing was performed (e.g., LAL Endotoxin, Wicking Speed, Fluid Retention, Dye Leacheable). The number of samples for these tests is generally small and typical for in vitro device characterization, but not specifically quantified in this summary.
- Biocompatibility: Testing was conducted according to ISO 10993 standards and included animal studies (rabbit for pyrogenicity, implantation, and acute systemic toxicity), but the specific number of animals or samples per test is not detailed in this summary.
Data Provenance: All data appears to be from non-clinical, in vitro, and animal studies conducted to demonstrate device performance and safety. There is no information regarding country of origin, or whether the data is retrospective or prospective, beyond the tests being performed "in support of the substantial equivalence determination." This is typically laboratory data derived from testing performed by or for the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This submission relies entirely on non-clinical (bench and animal) testing. It does not involve a clinical study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance.
- Therefore, there were no experts used to establish ground truth for a test set in the way one would for an AI-powered diagnostic device (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the objective metrics and outcomes of the established laboratory and animal test methods (e.g., bacterial log reduction, ppm of leachable dye, absence of cytotoxic effects).
4. Adjudication Method for the Test Set:
- Since there is no "test set" requiring expert interpretation or consensus for ground truth (as explained above), there was no adjudication method used. The results are direct measurements or observations from standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission states, "No clinical data was required to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component. Therefore, no standalone performance evaluation in that context was performed.
7. The Type of Ground Truth Used:
The ground truth for the performance and safety evaluations are based on objective, standardized laboratory and animal testing results (bench data and in vivo animal study outcomes), verified against predefined acceptance criteria for each test. This includes:
- Microbiological growth/reduction data.
- Chemical concentration measurements.
- Physical property measurements (wicking speed, fluid retention, peel strength).
- Biological responses in cytotoxicity, sensitization, irritation, pyrogenicity, implantation, acute systemic toxicity, and hemolysis tests.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, no ground truth was established for it.
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