(332 days)
OTC Use: Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. Prescription Use: Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites: Traumatic wounds.
Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.
This document describes the Silver Gelling Fiber Dressing's acceptance criteria and how it was proven to meet them.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" for performance metrics in a numerical sense; rather, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests and a comparison of characteristics. The performance is largely demonstrated by meeting established standards and showing comparable properties to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Complied with ISO 10993-5:2009 (Tests For In Vitro Cytotoxicity), ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization), ISO 10993-11:2017 (Tests For Systemic Toxicity), and ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to 30d)). No biologically relevant differences in local tolerance after wound creation were observed in a porcine study compared to the predicate device. |
| Sterility & Packaging Integrity | Sterilized by gamma radiation using conditions validated following ISO 11137-2:2013. Complied with ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials), ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration), and USP (Bacterial Endotoxins Test). |
| Antibacterial Activity | Demonstrated ≥ 4 log-reduction of four gram-positive bacteria (Vancomycin-resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus (MRSA)) and four gram-negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days, as assessed by AATCC 100-2012 (Antibacterial Finishes on Textile Materials: Assessment of). Also matches the predicate device’s stated antibacterial duration of 7 days. |
| Wound Healing Performance (In vivo) | A porcine wound healing study demonstrated no biologically relevant differences between the Silver Gelling Fiber Dressing and the predicate device (AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics. |
| Functional Characteristics (Absorbency, Gel Formation, Moist Environment) | "The dressing absorbs wound fluid and creates a soft, conformable gel, which maintains a moist wound environment to support the healing process." (Matches predicate device's described function). |
| Material Composition | Composed of sodium carboxymethylcellulose and 1.2% ionic silver, matching the predicate device. |
| Intended Use (OTC & Prescription) | The indications for use are substantially equivalent to the predicate device, with some minor wording variations for specific wound types. |
| Principle of Operation | The dressing absorbs wound fluid and creates a soft, conformable gel, maintaining a moist wound environment, with silver ions reducing bacterial colonization within the dressing. (Matches predicate). |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Tests (ISO 10993 series): The document does not specify exact sample sizes for these in vitro and in vivo (systemic toxicity) tests. The standards themselves typically outline sample size requirements. Provenance is not explicitly stated but these are laboratory tests following international standards.
- Sterility & Packaging Integrity Tests (ASTM, USP): No specific sample sizes are mentioned, but these are standard laboratory tests. Provenance not specified.
- Antibacterial Activity (AATCC 100-2012): No specific sample size is mentioned in terms of the number of dressings tested, but it describes testing against "four gram-positive bacteria" and "four gram-negative bacteria." Provenance not specified but these are in vitro laboratory tests.
- Porcine Wound Healing Study: The document refers to "the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing)." It does not specify the number of porcine subjects used. This is an animal study, not human data. The provenance of the animals or the location of the study is not specified. All studies appear to be retrospective in the context of the 510(k) submission, meaning they were completed prior to the submission.
There is no test set of human subjects/patients for clinical performance evaluation mentioned in this submission. The "test set" for performance evaluation is primarily in vitro and animal models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The study is for a medical dressing and focuses on non-clinical performance and substantial equivalence to a predicate device. There is no expert-established ground truth in the context of diagnostic or interpretive accuracy, as would be relevant for an AI/CADe device. The "ground truth" for the non-clinical tests is established by the methods outlined in international and national standards (e.g., cell viability in cytotoxicity tests, bacterial counts in antimicrobial tests).
4. Adjudication Method for the Test Set:
Not applicable, as there is no human-interpreted test set requiring adjudication in this context. The non-clinical tests directly measure physical, chemical, or biological properties against established standards or compare them to a control/predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical dressing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI/algorithm-based device. The "device" is a physical wound dressing. The tests performed are "standalone" in the sense that they assess the intrinsic properties and performance of the dressing itself without human intervention in its function.
7. The Type of Ground Truth Used:
- Biocompatibility: Established by standardized methods measuring cellular response (cytotoxicity, irritation, sensitization) and systemic effects. For the porcine study, the ground truth was the wound healing characteristics observed in the animal model.
- Sterility & Packaging Integrity: Established by adherence to validated sterilization methodologies and standardized tests for seal strength and integrity, and bacterial endotoxins.
- Antibacterial Activity: Established by measuring the log-reduction of specific challenge organisms according to the AATCC 100-2012 standard.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
N/A