Search Results

OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, 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 include 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.

This document is a 510(k) premarket notification for BIAFINE Topical Cream, seeking a determination of substantial equivalence to a previously cleared predicate device (K173549). It focuses on asserting equivalence rather than presenting novel acceptance criteria or a study to prove new performance.

Therefore, the requested information elements related to distinct acceptance criteria, an independent study, sample sizes for test and training sets, expert involvement, and ground truth establishment are largely not applicable (N/A) in the context of this specific regulatory submission.

The essence of this submission is that:

• The subject device (K190342) is identical in formulation, intended use, technology, and performance to its predicate device (K173549).
• The only difference explicitly mentioned and requiring additional testing is related to extending the use-life of the product.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission asserts substantial equivalence based on identical characteristics to a predicate, there are no new distinct acceptance criteria or performance metrics reported for the subject device (K190342) in comparison to the predicate, except for the use-life extension.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not describe a separate "test set" in the context of a comparative performance study against a ground truth for the subject device (K190342), as it's asserting equivalence.

• Sample size for test set: N/A (not a new performance study vs. ground truth)
• Data provenance: "Previously submitted non-clinical testing, including biocompatibility and (closed tube) shelf life data, continue to support BIAFINE Topical Cream." This refers to data supporting the predicate device (K173549). "Additional stability testing was conducted to extend the use-life and support multi-use labeling." This implies prospective laboratory testing for the use-life extension.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This type of regulatory submission (510(k) for substantial equivalence of a topical cream) typically does not involve expert adjudication or ground truth establishment in the way it would for diagnostic software or image analysis. The "ground truth" for the predicate device's efficacy would have been established through clinical trials or accepted scientific principles, but that is not detailed here for a new study.

4. Adjudication Method

N/A. Not relevant for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance in diagnostic tasks. This device is a topical cream.

6. Standalone (Algorithm Only) Performance Study

N/A. This is a topical cream, not an algorithm.

7. Type of Ground Truth Used

For the claims about the topical cream's efficacy (e.g., maintaining a moist wound environment, relief of pain), the "ground truth" is based on accepted scientific principles for wound care and potentially clinical data submitted for the predicate device. For the use-life extension, the ground truth is established by stability testing results which would demonstrate that the product remains stable and effective over the extended 12-month use period after opening. The specific details of these stability testing results are not provided in this summary.

8. Sample Size for the Training Set

N/A. Not relevant for this type of medical device (topical cream). The product's characteristics are determined by its formulation and manufacturing process, not trained on data.

9. How the Ground Truth for the Training Set Was Established

N/A. Not relevant.

Ask a specific question about this device