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Over-the-Counter Use: Medline Burn and Wound Dressing is intended to moisten the management of minor cuts, minor abrasions, minor lacerations and minor burns.

Device Description

Medline Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to moisten the wound. The dressing protects the wound and provides a moist wound environment conducive to healing. Medline Burn and Wound Dressing (OTC) contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes. Medline Burn and Wound Dressing (OTC) is provided non-sterile for single patient use. The subject device is comprised of the following ingredients: Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, and Polyhexanide (PHMB). The Medline Burn and Wound Dressing (OTC) contains a concentration of 0.1% w/w of PHMB, which acts as a preservative to inhibit the growth of microorganisms within the product.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "Medline Burn and Wound Dressing (OTC)". This document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in intended use from prescription to over-the-counter.

Because this is a submission for an over-the-counter wound dressing, and not an AI-powered diagnostic device, many of the typical acceptance criteria and study details related to AI performance (like sensitivity, specificity, MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets for AI models) are not applicable to this document. The submission is about safety and effectiveness for a physical medical product, not an AI algorithm.

Here's an analysis based on the information available, addressing the relevant points and noting where information is not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are related to the safety and effectiveness of the wound dressing for its intended OTC use, primarily demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical testing already completed for the primary predicate device.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance/Comparison
Substantial Equivalence	Comparison of Intended Use	Proposed Device: OTC use for minor cuts, abrasions, lacerations, burns.
Primary Predicate: Professional use for ulcers, 1st/2nd degree burns, partial/full thickness wounds, surgical incisions.
Secondary Predicate: OTC use for minor cuts, abrasions, lacerations, minor burns. Conclusion: Different from primary predicate (Rx vs. OTC), but similar to secondary predicate (OTC). The core device is identical to the primary predicate, just the intended use classification (Rx vs. OTC) is changing.
	Comparison of Technological Characteristics (Design Features, Materials, etc.)	Proposed Device & Primary Predicate: Clear to translucent, water soluble, odorless, amorphous wound gel with surfactant and PHMB as preservative. Same materials (Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB). Secondary Predicate: Similar design features but different full formulation (Purified Water, Glycerol, Hydroxyethylcellulose, Undecylenamidopropyl Betaine, PHMB). Conclusion: Identical to primary predicate (K173911) in all technological characteristics.
	Comparison of Product Code	All (Proposed, Primary, Secondary Predicates) are FRO. Conclusion: Same.
	Comparison of Regulatory Class	All are Unclassified. Conclusion: Same.
	Comparison of Configuration	Proposed & Primary Predicate: 1.75 oz tube. Secondary Predicate: 30 ml tube. Conclusion: Same as primary predicate.
Safety Testing	Biocompatibility (ISO 10993-1, breached/compromised surfaces, prolonged contact)	Previously conducted for K173911 (primary predicate) and referenced. No new tests were performed as the device formulation is identical.
	Microbial Limits (USP)	Previously conducted for K173911 and referenced. No new tests were performed as the device is identical.
	Microbiological Examination of Non-sterile Products (USP)	Previously conducted for K173911 and referenced. No new tests were performed as the device is identical.
Effectiveness Testing	Shelf Life	Previously conducted for K173911 and referenced. No new tests were performed as the device is identical.
	Antimicrobial Effectiveness (USP)	Previously conducted for K173911 and referenced. No new tests were performed as the device is identical.
	Wound Healing Study (Animal)	Previously conducted for K173911 and referenced (under GLP - 21 CFR 58). No new tests were performed as the device is identical.
	Sterile vs. Non-Sterile	Proposed & Primary Predicate: Non-sterile. Secondary Predicate: Sterile by aseptic filtration. Conclusion: Same as primary predicate.
	Reusable vs. Single Use	All (Proposed, Primary, Secondary Predicates) are single patient, multiple use. Conclusion: Same.
Labeling	Clarity for Lay Users (OTC claim)	Implicitly addressed by the FDA guidance document "Deciding When to Submit a 510(k) for Change to an Existing Device," which requires directions for use necessary for lay users to use the device safely and effectively for OTC. While specific labeling details aren't provided in depth, the overall submission implies this was evaluated for the OTC change.

2. Sample Size for the Test Set and Data Provenance

Test Set (for performance testing): Not applicable in the context of an "AI test set" here. The testing was non-clinical and performed on materials/animals for the primary predicate device (K173911).
Data Provenance: The study (non-clinical performance testing, e.g., wound healing study) that supports the current device's performance was conducted under GLP (21 CFR 58) for the primary predicate device K173911. The origin of the animal study data (e.g., country) is not specified in this document. It was retrospective to this particular 510(k) but prospective for the original K173911 application.

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

This information is not provided as the evaluation relies on non-clinical (biocompatibility, shelf-life, animal wound healing) studies rather than expert-adjudicated clinical data for an AI algorithm. The "ground truth" for these tests would be the measured scientific outcomes (e.g., tissue reaction, microbial growth, wound closure rates).

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" requiring expert adjudication in the context of an AI device.

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

Not applicable. This device is a wound dressing, not an AI diagnostic or assistance tool, so no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a wound dressing, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's safety and effectiveness is derived from non-clinical testing results:
- Biocompatibility: Measured biological reactions per ISO 10993-1.
- Shelf Life: Product stability and retention of specifications over time.
- Antimicrobial Effectiveness: Measured reduction in microbial load.
- Microbial Limits/Examination: Measured absence or presence of specific microorganisms.
- Wound Healing Study: Measured physiological endpoints of wound repair in an animal model (e.g., wound closure, tissue regeneration).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI model was used.

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