(270 days)
OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.
BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients: Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.
The provided document is a 510(k) summary for the device BIAFINE Topical Cream. It aims to demonstrate substantial equivalence to predicate devices for expanded indications, particularly for Over-The-Counter (OTC) use. The document doesn't present a traditional acceptance criteria table with reported device performance in a numerical format often seen in AI/ML device studies. Instead, it relies on demonstrating equivalence through comparison of technological characteristics and supported by existing clinical literature.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence by comparing the technological characteristics of the subject device (BIAFINE Topical Cream) with predicate devices and by citing existing literature supporting the expanded indications. The "reported device performance" is essentially a qualitative claim of effectiveness and safety based on prior knowledge and published studies.
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Technological Characteristics Equivalence: | |
| Indications for Use (Rx & OTC) | |
| Sterility Claim | |
| Mechanism of Action | |
| Delivery System | Substantially Equivalent to Predicates: |
| The technological characteristics of BIAFINE Topical Cream are identical or substantially equivalent to the predicate devices (K964240 BIAFINE, K153648 Microcyn Plus Skin & Wound Hydrogel, K090092 Sockit Dermal Gel, and K043063 OxyBand). All are non-sterile, water-based, preserved, semi-viscous formulations with similar indications and mechanisms (maintaining moist wound environment, except OxyBand which supplies oxygen). | |
| Safety and Effectiveness for Expanded OTC Indications: | |
| Management of superficial wounds (cuts, scrapes, irritations, abrasions, blisters) | |
| 1st degree burns (sunburns) | |
| Minor skin irritations (post non-ablative laser therapy, microdermabrasion, superficial chemical peels) | |
| Relief of itch, pain, burning from minor skin irritations, lacerations, abrasions, minor burns | Supported by Existing Literature and Clinical Studies: |
| Multiple independent clinical studies and published literature on BIAFINE and predicate devices demonstrate effectiveness in wound management (post non-ablative laser procedures, chemical peeling, minor wounds, skin irritation, blisters) and relief of symptoms (burning, pain, itch). Specific studies cited showed successful management of side effects (crusting, redness, discomfort) and equivalency to petrolatum ointment in reducing redness and peeling. No serious complications or unexpected adverse effects were reported. | |
| Preservative Effectiveness: | |
| Meet USP criteria | Meets Criteria: |
| Preservative effectiveness testing of BIAFINE Topical Cream was conducted as per USP and met the criteria. | |
| Shelf-life of opened product: | |
| Supported in-use stability | Supported: |
| An in-use study was performed to support the shelf-life of the opened product. | |
| Physico-chemical properties: | |
| pH, Residual testing, Sulfated Ash, Viscosity, Water Content | Meets Criteria: |
| Limit testing for these properties was conducted to support the in-use study data and preservative efficacy as per USP , and the results met the criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a single "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it leverages "multiple independent clinical studies" and "published literature" as evidence. These studies would have their own sample sizes and data provenance, but those details are not provided in this 510(k) summary. The clinical evidence is retrospective, drawing from previously published research and existing data on BIAFINE and similar products. The countries of origin of the data are not explicitly stated, but clinical studies are cited from various journals, and some references indicate locations such as Marseille, France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This information is not applicable in the context presented. The review relies on published clinical studies and expert consensus inherent in the existing medical literature, rather than establishing new ground truth for a discrete test set. The individual studies cited would have involved medical professionals, but their specific roles in "establishing ground truth" for a single test set are not detailed in this summary.
4. Adjudication Method for the Test Set
N/A. This information is not applicable as there is no mention of a defined "test set" with a need for adjudication in the traditional sense for this 510(k) submission. Evidence is drawn from published literature.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
N/A. An MRMC study is not mentioned. The document describes clinical studies that compared BIAFINE to a placebo or another product (like petrolatum ointment) in specific conditions, but not in the format of an MRMC study designed to evaluate human readers' improvement with AI assistance. This device is a topical cream, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
N/A. This question is not applicable. The device is a topical cream, not an algorithm, so "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used
The "ground truth" for the claims made in this submission is derived from:
- Clinical outcomes and observations from numerous published independent clinical studies.
- Expert consensus inherent in the medical literature and clinical practice regarding wound healing and the management of skin conditions.
- Physiological measurements (e.g., reduction in erythema, edema) and patient-reported outcomes (e.g., relief of itch, pain, burning) from the cited studies.
8. The Sample Size for the Training Set
N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.
N/A