(51 days)
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.:
- · Pressure Ulcers
- · Venous Stasis Ulcers
- · Diabetic Ulcers
- · 1* and 2nd Degree Burns
- · Surgical Wounds
- · Trauma Wounds
- · Dermal Lesions (Cuts, abrasions, etc)
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as:
- · Superficial cuts
- · Abrasions
- · Lacerations
- Minor scalds
- Minor bums
- Minor skin irritations
FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing.
FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds.
FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes.
The provided text is a 510(k) premarket notification for the FlexiGel-G Hydrogel Wound Dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics as might be found for novel technologies or higher-risk devices.
Therefore, the document does not contain the direct explicit information requested regarding acceptance criteria and a study proving the device meets them in the format of a typical clinical trial. Instead, it relies on demonstrating similarity to a predicate device and fulfilling regulatory requirements for safety and efficacy based on that comparison.
Here's a breakdown of what can be inferred or explicitly stated from the document, and where the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance (FlexiGel-G) | Predicate Device (Intrasite™ Gel) Performance |
|---|---|---|
| Composition | Guar gum, borax, propylene glycol, water | CMC, propylene glycol, water |
| Colour | Clear | Clear |
| Indications For Use | Partial to full thickness wounds e.g.: arterial, diabetic, pressure and venous ulcers, 1st & 2nd degree burns, trauma wounds and dermal lesions (Prescription); Superficial cuts, abrasions, lacerations, minor scalds, minor burns, minor skin irritations (OTC) | Shallow and deep open wounds e.g.: pressure sores, leg ulcers, surgical and malignant wounds, partial thickness burns, scalds, lacerations and grazes. |
| Fluid Donation | 0.22 g/g | 0.18 g/g |
| Fluid Absorption | -0.4 g/g | 0.31 g/g |
| Packaging | Foil pouch / poly tube | Polyethylene bulb applicator |
| Sterility | Steam sterilised; Sterility Assurance Level (SAL) of 10-6 (overkill method per ANSI / AAMI / ISO11134 - 993) | (Not explicitly stated for predicate; assumed to meet similar standards) |
| Biocompatibility | Successfully completed per ISO/Tripartite guidelines (cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation) | (Not explicitly stated for predicate; assumed to meet similar standards) |
Explanation of "Acceptance Criteria" here: For a 510(k), the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This means it must have the same intended use, the same technological characteristics, or if there are differences, those differences do not raise different questions of safety and effectiveness. The table above highlights the comparative features presented to demonstrate this equivalence. The "performance" is simply the reported characteristics of the device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None stated. The submission relies on laboratory testing (biocompatibility, fluid dynamics) and comparison to a predicate device, not a human-subjects test set in the sense of a clinical trial. The "data" provenance for fluid dynamics and composition would be internal lab testing, likely from the UK.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such test set or adjudication method is described.
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
- No MRMC study was done. This device is a wound dressing, not an AI-based diagnostic tool.
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, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" equivalent in this context is the established safety and efficacy profile of the predicate device (Intrasite™ Gel) and the demonstration through laboratory testing (biocompatibility, physical properties like fluid donation/absorption) that FlexiGel-G performs similarly and meets recognized safety standards. For sterility, the ground truth is meeting a 10^-6 SAL via an overkill method.
8. The sample size for the training set
- Not applicable. This device is a physical wound dressing; there is no "training set" in the machine learning sense. The "development" and "testing" involved product formulation, manufacturing process validation (like sterilization), and biocompatibility testing.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The safety and performance validation methods are described:
- Sterilization: Overkill method to achieve a Sterility Assurance Level (SAL) of 10^-6 per ANSI / AAMI / ISO11134 - 993.
- Biocompatibility: Testing successfully completed per ISO/Tripartite guidelines for cytotoxicity, haemolysis, acute systemic toxicity, skin irritation, and sensitisation.
- Functional Characteristics: Laboratory measurements of fluid donation and absorption, compared to the predicate device.
In summary: The provided document is a 510(k) premarket notification. Its "study" is primarily a comparison to a legally marketed predicate device and demonstration of compliance with relevant safety standards and performance characteristics through laboratory testing, not a clinical trial with human subjects and specific performance metrics in the way a diagnostic AI or novel therapeutic device would require. The "acceptance criteria" revolve around proving substantial equivalence and meeting established international standards for sterility and biocompatibility.
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