(85 days)
BIONECT® Hydrogel Gauze Pads provide a moist wound environment that is supportive to wound healing. They are indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT Hydrogel Gauze Pads may also be used under the care of a health cure professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.
BIONECT® Hydrogel Gauze Pads are sterile cotton gauze pads impregnated with a hydrogel that is prepared from sodium hyaluronate and purfied water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharidc biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Gauze Pads, since they are a hydrogel dressing, provide a soothing, moist environment that is supportive to wound healing.
This document is a 510(k) Premarket Notification for BIONECT® Hydrogel Gauze Pads. It concerns the substantial equivalence of this device to a previously cleared predicate device. The information provided is primarily for regulatory approval and does not contain detailed acceptance criteria and study data in the way one might expect for a diagnostic or AI-driven device.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic devices. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and showing safety and efficacy for its intended use through biocompatibility and clinical experience.
| Acceptance Criterion Type | Details Provided in Document | Reported Device Performance |
|---|---|---|
| Technological Equivalence | The technological characteristics of the device such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate devices cited. | BIONECT® Hydrogel Gauze Pads are described as providing a "soothing, moist environment that is supportive to wound healing," which is consistent with the predicate. The device functions as a hydrogel to provide a moist wound environment. |
| Biocompatibility | In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the bulk solution that impregnates BIONECT® Hydrogel Gauze Pads. The results indicate the materials are non-cytotoxic, non-irritating, and non-sensitizing. This is to ensure "safe use of BIONECT® Hydrogel Gauze Pads as a hydrogel temporary dressing in contact with breached or compromised skin." | The tests found the materials to be non-cytotoxic, non-irritating, and non-sensitizing. This supports the safe use of the device. |
| Clinical Safety & Efficacy | Evidence of safety and effectiveness for intended use. The document states, "Clinical experience with BIONECT® Hydrogel Gauze Pads in approximately 430 patients with various types of ulcers and burns in 16 clinical trials (13 controlled), indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use." | Clinical experience, based on the mentioned studies, indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use. The FDA's conditional approval (K984262) further clarifies limitations (e.g., "may not be labeled for use on third degree burns," "may not be labeled as having any accelerating effect on the rate of wound healing or epithelization"). This implies that within the defined scope, the device performed safely. |
| Intended Use Equivalence | The indication statements for BIONECT® Hydrogel Gauze Pads "are not different from the predicate device identified." | The device is indicated for dressing and management of minor burns; superficial cuts, lacerations, and abrasions; minor irritations of the skin; and under professional care for partial to full thickness dermal ulcers, surgical wounds, and second-degree burns. This is consistent with the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: "approximately 430 patients"
- Data Provenance: The document states "Clinical experience... in 16 clinical trials (13 controlled)." It does not specify the country of origin of the data or whether the studies were retrospective or prospective, though "clinical trials" generally implies prospective data collection.
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)
This is not applicable to the provided document. The "ground truth" for a wound dressing is typically the observed clinical outcome (e.g., wound healing, absence of adverse events), not a judgment requiring experts to establish a "truth" within a test set as would be for an AI diagnostic. The clinical trials themselves, overseen by healthcare professionals, establish the observed safety and efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic studies where multiple readers interpret images or data. For a wound dressing, the clinical outcomes are observed and recorded by the treating clinicians in the clinical trials.
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
This is not applicable to the provided document. The device is a wound dressing, not an AI-driven diagnostic or imaging aid that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the provided document. The device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the performance of BIONECT® Hydrogel Gauze Pads relies on outcomes data from clinical trials, specifically regarding safety and efficacy in wound healing, and biocompatibility testing results. The primary "truth" demonstrated is that the device is "safe for its intended use" and performs similarly to its predicate.
8. The sample size for the training set
This is not applicable to the provided document. As this is not an AI/machine learning device, there is no "training set." The clinical trials served as the basis for demonstrating safety and efficacy for real-world use.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of medical device.
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