(126 days)
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Examples of wounds types which indicated are:
- Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and . sores (partial & full thickness);
- surgical wounds left to heal by secondary intent; .
- . traumatic wounds;
- wounds that are prone to minor bleeding, such as wounds that have been . mechanically or surgically debrided.
DURAFIBER Ag is a non woven dressing made of cellulose and cellulose ethyl sulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The device provides effective antimicrobial properties intended to reduce or inhibit microbial colonization of the device.
The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.
The provided text describes a 510(k) summary for the DURAFIBER Ag dressing, focusing on its substantial equivalence to predicate devices rather than a direct study proving device performance against acceptance criteria. The document highlights biocompatibility testing and an animal model study, but does not present specific acceptance criteria in a quantifiable manner or a study that directly verifies those criteria with reported performance metrics.
Therefore, the following information is extracted or inferred based on the provided text. Many requested fields cannot be directly answered as the nature of this submission (substantial equivalence for a medical dressing) differs significantly from a device that would require clinical performance metrics like sensitivity, specificity, or AI assistance effect sizes.
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a wound dressing, the "acceptance criteria" are primarily related to safety, biocompatibility, and substantial equivalence to legally marketed predicate devices. The document does not specify quantitative performance metrics (like sensitivity, specificity, or error rates) that would typically be found for diagnostic or AI-driven devices.
Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence Basis):
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Based on K103793) |
|---|---|
| Similar Design: Material composition, structure. | "similar design, materials and manufacturing methods" to Aquacel Ag (K080383). Made of cellulose, cellulose ethyl sulphonate with silver. |
| Similar Physical Characteristics: Absorbency, gelling properties. | "similar physical and antimicrobial characteristics" to Aquacel Ag (K080383). "absorbent fibrous dressing that gels on contact with wound fluid." |
| Similar Antimicrobial Characteristics: Silver content, mechanism of action. | "effective antimicrobial properties intended to reduce or inhibit microbial colonization of the device." Silver content similar to ACTICOAT Flex 7 (K083113) and produces silver ions upon contact with wound fluid. |
| Similar Functions: Moist wound environment, microbial reduction. | "provides similar functions to Aquacel Ag (K080383)." Provides a moist wound environment and "effective antimicrobial properties." |
| Similar Intended Use: Management of partial/full thickness wounds, burns, various wound types. | "Intended use, indications and instructions for use for the subject and predicate devices are similar." (Listed wound types in Section 9). |
| Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, safe. | "DURAFIBER Ag dressings are safe for their intended use" based on ISO 10993-1:2003 (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). |
| No Deleterious Clinical Effects on Wound Healing (Animal Model): | "device had no deleterious clinical effects compared with standard treatment" in an animal model. |
| No New Issues of Safety and Effectiveness: | "The subject device does not raise any new issues of safety and effectiveness." |
Study Details
The provided text describes the basis for substantial equivalence for a wound dressing, and the "studies" mentioned are primarily pre-clinical in nature for biocompatibility and an animal model. It does not describe a clinical study in humans designed to meet specific performance criteria often seen in device clearance involving diagnosis or intricate analytical tasks.
1. Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The text states these were conducted "using product that has been packaged and sterilised." It does not specify a "sample size" in terms of number of samples, but rather mentions the types of tests (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). The provenance of these tests is not explicitly stated (e.g., country of origin, specific lab data).
- Animal Model Study: "an animal model" was used. The specific number of animals (sample size) is not provided. The provenance (e.g., specific animal species, location of study) is also undefined.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided as the studies described are pre-clinical (biocompatibility, animal model) and do not involve human interpretation or expert ground truth establishment in the diagnostic sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the types of studies performed (biocompatibility, animal model).
4. 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:
- No, an MRMC study was not done. This device is a medical dressing, not an AI-assisted diagnostic or interpretation device that would involve "human readers" or "AI assistance."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Biocompatibility: Ground truth is established by standardized, validated assays and material science principles as per ISO 10993-1:2003, with results indicating "safe for their intended use."
- Animal Model: Ground truth was based on physiological observations and comparisons of "deleterious clinical effects" against "standard treatment." This would likely involve clinical assessment of wound healing parameters in animals.
7. The sample size for the training set:
- This information is not applicable/provided. The submission describes a medical device, not an AI/ML product requiring a training set.
8. How the ground truth for the training set was established:
- This information is not applicable/provided as there is no training set for this type of device.
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