(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 <1112> Conforming to USP <61> <62>." This is compared to Alevicyn SG Gel ("Non-sterile, Preserved/Conforming to USP <51>") 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 <1112>, <61>, <62>, <51> 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Oculus Innovative Sciences Mr. Brian Martin Director Of Regulatory Affairs And Quality Control 1129 N. McDowell Boulevard Petaluma. California 94954
Re: K162217
Trade/Device Name: Loyon Regulatory Class: Unclassified Product Code: FRO Dated: February 14, 2017 Received: February 15, 2017
Dear Mr. Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162217
Device Name Loyon
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized golden swirl above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller, lighter font.
1 510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
I. SUBMITTER
Oculus Innovative Sciences, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551 Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: March 17, 2017
Device Manufacturer: G. Pohl Boskamp GmbH & Co. KG Kieler Straße 11 D-25551 Hohenlockstedt Germany
II. DEVICE
Name of Device: LOYON® Common or Usual Name: Antipruritic Solution Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICES
Alevicyn SG Antipruritic Gel manufactured by Oculus Innovative Sciences (K152945) Tropazone manufactured by Akorn Phamaceuticals (K090337)
IV. DEVICE DESCRIPTION
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.
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Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo consists of a stylized gold-colored graphic above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller, serif font. The graphic above the word "OCULUS" appears to be three concentric ellipses.
V. INDICATIONS FOR USE
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICES
| Submitter/Holder | Proposed Device:LOYON® | Predicate Device:K152945 Alevicyn SG Gel, | Predictae Deive: TropazoneK090337, Akorn Phamaceuticals. |
|---|---|---|---|
| Oculus Innovative Sciences | Oculus Innovative Sciences | ||
| IndicationsforUse | Rx Indication: LOYON® isindicated to manage and relievethe burning, itching, erythema,and scaling experienced withvarious types of dermatoses,including atopic dermatitis,radiation dermatitis, and seborrheaand seborrheic dermatitis. | Rx Indication: Alevicyn SG Gel isindicated to manage and relieve theburning, itching, erythema, scaling, andpain experienced with various types ofdermatoses, including atopic dermatitis,radiation dermatitis, and seborrhea andseborrheic dermatitis. The Alevicyn SGGel may also be used to relieve the painof first and second degree burns. AlevicynSG Gel helps to relieve dry waxy skin bymaintaining a moist wound & skinenvironment, which is beneficial to thehealing process. | Tropazone Lotion is used tomanage and relieve the burning anditching experienced with varioustype of dermatoses, includingradiation dermatitis, atopicdermatitis, and allergic contactdermatitis. It helps relieve drywaxy skin by maintaining a moistwound and skin environment,which is beneficial to the healingprocess. |
| Mechanismof Action | Emollient | Same | Same |
| DeliverySystem | Bottle with spray | Bottle with spray | Tube/ Lotion |
| Sterility | Non-sterileWater Activity USP <1112>Conforming to USP <61> <62> | Non-sterilePreserved/Conforming to USP <51> | Non Sterile - Preserved |
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for LOYON® was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. LOYON® was evaluated for cytotoxic, irritating, sensitizing, and leachable effects.
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Image /page/5/Picture/0 description: The image shows the text 'K162217' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The number is likely an identifier or code of some kind.
Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo consists of the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Sciences" in a smaller font below it. Above the word "OCULUS" is a graphic of several overlapping circles.
Bench Testing
The following tests were performed to support the performance of LOYON®: visual inspection, odor (sensory), viscosity, functional checks, leakage test, volume check, and microbiological bioburden. LOYON® meets specification and performance characteristics and is substantially equivalent to the predicate devices.
CONCLUSION VIII.
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). Therefore, LOYON® is substantially equivalent to the predicate devices.
N/A