(296 days)
Hydrofera Blue PU Antibacterial Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.
Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g]. The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam: 1. Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria 2. Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria
The Hydrofera Blue PU Antibacterial Dressing is an absorbent wound dressing intended for the local management of various external wounds.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Hydrofera Blue PU) |
|---|---|---|
| Antimicrobial Activity | Equivalence to predicate devices (K013462 and K060832) for broad-spectrum antimicrobial protection as provided by Methylene Blue and Gentian Violet. | Demonstrates in-vitro antimicrobial activity against a broad spectrum of bacteria and fungi, including common wound pathogens like Bacillus subtilis, E-Coli, MRSA, VRE, Serratia marcescens, Staph aureus, Staph epidermidis, Pseudomonas aeruginosa, Pseudomonas florescens, Enterococcus faecalis, Streptococcus pyogenes, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter aerogenes, Yersinia enterocolitica, Candida albicans, Candida krusei, and Candida glabrata. |
| Biocompatibility (per ISO 10993) | No skin irritation, no sensitization reactions, meets requirements for cytotoxicity (no cell death), no acute systemic toxicity, considered non-irritant. | - Extracts did not cause skin irritation. |
- Did not cause sensitization reactions.
- Meets requirements for cytotoxicity (no cell death).
- Did not cause acute systemic toxicity.
- Considered non-irritant. |
| Sterility | Sterilized by Gamma irradiation or electron beam radiation. | Sterilized by Gamma irradiation or electron beam radiation. |
| Physical Performance | Functional similarity to predicate devices in areas like dressing flexibility, wound environment suitability (dry to wet), and non-adhesive nature. | Flexible, suitable for dry to wet wound environments, non-adhesive. |
| Indications for Use | Same intended use as predicate devices for local management of various wound types. | Intended for local management of pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes in-vitro testing and does not mention human subject studies or a "test set" in the context of clinical performance evaluation. The "data provenance" for the in-vitro antimicrobial and biocompatibility testing is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being performed for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The study primarily involves in-vitro antimicrobial activity and biocompatibility testing, not clinical studies with expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. This was not a clinical study involving human readers or assessment of clinical outcomes requiring adjudication.
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 device is a wound dressing, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Hydrofera Blue PU Antibacterial Dressing was established through:
- Laboratory-based In-vitro Testing: For antimicrobial activity, the ground truth was determined by observing the growth inhibition or killing of specific microbial strains under controlled laboratory conditions.
- Standard Biocompatibility Testing (ISO 10993): The ground truth for biocompatibility was established against predefined criteria and endpoints specified in ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity).
8. The Sample Size for the Training Set
Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is detailed under the "In Vitro Antimicrobial Testing" and "Biocompatibility per ISO 10993" sections of the 510(k) submission.
- In Vitro Antimicrobial Testing: This testing compared the Hydrofera Blue PU dressing's antimicrobial spectrum to its predicate devices (Hydrofera K# 013462 and Retro Tech K#060832). The results demonstrated that the Hydrofera Blue PU dressing exhibits activity against a broad range of microorganisms, including many listed for the predicate devices and additional strains. This established its performance equivalence in antimicrobial function.
- Biocompatibility Testing (per ISO 10993): This included specific tests for sensitization, irritation, systemic toxicity, and cytotoxicity. The conclusions drawn from these tests directly state that:
- The dressing extracts did not cause skin irritation or sensitization reactions.
- The dressing meets the requirements for cytotoxicity (no cell death).
- The dressing did not cause acute systemic toxicity.
- The dressing is considered non-irritant.
The submission concludes that "The above testing demonstrates that the Hydrofera Blue PU Antibacterial Wound Dressing is safe and effective and performs as well as the predicate devices," thereby meeting the acceptance criteria for substantial equivalence. The FDA, in its letter, concurred that the device is "substantially equivalent" based on this information.
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