(227 days)
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.
LOYON® is a non-sterile, oily solution, exclusively indicated for topical application. LOYON® is used to manage and relieve burning and itching and scaling experienced with various types of dermatoses. It will be supplied in 15mL or 50mL amber glass bottles with a pump sprayer.
This document is a 510(k) summary for the device LOYON®, a non-sterile, oily solution intended for topical application to manage and relieve symptoms of various dermatoses. It asserts that LOYON® is substantially equivalent to two predicate devices: Alevicyn SG Antipruritic Gel (K152945) and Tropazone (K090337).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: | LOYON® was evaluated for cytotoxic, irritating, sensitizing, and leachable effects in accordance with FDA biocompatibility guidance (June 16, 2016) and ISO 10993-1. While specific results are not detailed, the report concludes these tests were performed to support substantial equivalence. |
| Bench Testing (Quality & Performance Characteristics): | The following tests were performed: visual inspection, odor (sensory), viscosity, functional checks, leakage test, volume check, and microbiological bioburden. The report states that "LOYON® meets specification and performance characteristics and is substantially equivalent to the predicate devices." No specific numerical "acceptance criteria" or "reported performance" values (e.g., specific viscosity range, leakage rate) are provided in this summary, but the conclusion implies all criteria for these tests were met. |
| Mechanism of Action Equivalence: | The mechanism of action for LOYON® is stated as "Emollient." This is presented as being the "Same" as the predicate device Alevicyn SG Gel and Tropazone. This implies that the acceptance criterion was that the device should function as an emollient, which it reportedly does. |
| Delivery System Comparison: | LOYON® uses a "Bottle with spray" delivery system. This is noted as "Same" as Alevicyn SG Gel, while Tropazone uses "Tube/ Lotion." The implicit acceptance criterion here is that the delivery system is either identical or functionally equivalent and does not raise new safety/effectiveness questions. The conclusion of substantial equivalence indicates this criterion was met. |
| Sterility & Microbial Control: | LOYON® is "Non-sterile, Water Activity USP Conforming to USP ." This is compared to Alevicyn SG Gel ("Non-sterile, Preserved/Conforming to USP ") and Tropazone ("Non Sterile - Preserved"). The acceptance criterion is likely to demonstrate appropriate microbial control for a non-sterile topical product, which includes water activity and adherence to USP microbiological tests. The report implies these criteria were successfully met. |
| Indications for Use Equivalence: | LOYON®'s indications are to "manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis." This is highly similar to the predicate devices, with minor differences (e.g., Alevicyn PREDICATE also relieves "pain" and helps with "healing process,"Tropazone also includes "allergic contact dermatitis" and includes "healing process"). The acceptance criterion is that the indications for use are substantially equivalent and do not introduce new questions of safety or effectiveness. The document concludes substantial equivalence despite the minor wording variations. |
| Safety and Effectiveness (overall substantial equivalence determination) | The document explicitly states: "LOYON® is substantially equivalent in intended use, with different technological characteristics, that does not raise different safety and effectiveness questions compared to Alevicyn SG Antipruritic Gel manufactured by Oculus Innovative Sciences, Inc. (K152945) and Tropazone (K090337)." This is the ultimate acceptance criterion for a 510(k) submission, and the studies mentioned above were conducted to support this conclusion. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify sample sizes for any of the tests (biocompatibility or bench testing).
The data provenance is also not explicitly stated. These tests are typically performed in a laboratory setting by the manufacturer or a contract research organization. There is no mention of patient data (retrospective or prospective) for clinical efficacy, as the submission focuses on substantial equivalence based on technological characteristics and safety (biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. For the types of tests described (biocompatibility and bench testing), "ground truth" is established through standardized laboratory procedures and measurements, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as no clinical endpoints requiring expert adjudication are described for this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is typically used for diagnostic devices involving human interpretation of images or data, which is not the case for this topical dermatological product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device (LOYON®) described. This is a medical device (a topical solution), not an algorithm or AI system.
7. The Type of Ground Truth Used
For biocompatibility and bench testing, the "ground truth" is based on:
- Standardized Test Methods and Specifications: For example, compliance with ISO 10993-1 for biocompatibility, and USP , , , for sterility/microbial control.
- Engineering and Production Specifications: For visual inspection, odor, viscosity, functional checks, leakage, and volume, "ground truth" is defined by the product's established specifications derived from design and manufacturing requirements.
There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the non-clinical performance data presented.
8. The Sample Size for the Training Set
This question is not applicable as LOYON® is a physical medical device (topical solution), not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
N/A