← Product Code FRO · K143590 # Alevicyn SG Antipruritic Gel (K143590) _Oculus Innovative Sciences · FRO · Jun 4, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K143590 ## Device Facts - **Applicant:** Oculus Innovative Sciences - **Product Code:** FRO - **Decision Date:** Jun 4, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process. OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn. ## Device Story Alevicyn SG Antipruritic Gel is an opaque, low-viscosity hydrogel spray used to manage dermatoses and minor burns. It functions as a skin barrier emollient and moisturizer to maintain a moist wound/skin environment. The device is applied topically by patients (OTC) or under the supervision of a healthcare professional (Rx) to relieve burning, itching, and pain. It is supplied in PET bottles with a finger pump sprayer. The gel provides symptomatic relief and supports the healing process by preventing skin dryness. ## Clinical Evidence Bench testing only. Biocompatibility testing conducted per ISO 10993 standards, including cytotoxicity, systemic injection, ocular irritation, 7-day cumulative skin irritation on wounded/intact skin, and Buehler sensitization. Bench testing confirmed package integrity, pH, Free Available Chlorine (FAC), and antimicrobial preservative effectiveness. ## Technological Characteristics Hydrogel wound dressing; pH 5.5-7.0; Free Available Chlorine (FAC) 140-150 ppm; non-sterile; supplied in PET bottles with PP screwtop and finger pump sprayer. Mechanism: skin barrier emollient and moisturizer. Biocompatibility per ISO 10993. ## Predicate Devices - Epicyn Hydrogel ([K102945](/device/K102945.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, connected by flowing lines that resemble ribbons or banners. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 4, 2015 Oculus Innovative Sciences Incorporated Mr. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 North McDowell Boulevard Petaluma, California 94954 Re: K143590 Trade/Device Name: Alevicyn SG Antipruritic Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2015 Received: May 1, 2015 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 (reporting of medical device-related 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. {1}------------------------------------------------ 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours. # Jennifer R. Stevenson -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143590 Device Name Alevicyn SG Antipruritic Gel ### Indications for Use (Describe) Rx: Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process. OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn. | 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)
| | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo consists of a stylized golden ellipse made of three curved lines, positioned above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller, lighter font. #### 9 510(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: December 17, 2014 #### II. DEVICE Name of Device: Alevicyn SG Antipruritic Gel Common or Usual Name: Hydrogel Wound Dressing Classification Name: Wound, Dressing, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO #### III. PREDICATE DEVICE Epicyn Hydrogel manufactured by Oculus Innovative Sciences (K102945) #### IV. DEVICE DESCRIPTION The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screwtop closure and a finger pump sprayer. #### INDICATIONS FOR USE V. Rx Indication: Under the supervision of a health care professional, Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features 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 golden rings. OTC Indication: Alevicyn SG Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, abrasions, and minor burns. Alevicyn SG Gel is also indicated for the management of irritation and pain from minor burns, including sunburn. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE | Submitter/
Holder | Proposed Device:
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences | Predicate Device: K102945
Epicyn Hydrogel
Oculus Innovative Sciences | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for
Use | Rx Indication: Alevicyn SG Gel is indicated to
manage and relieve the burning, itching and
pain experienced with various types of
dermatoses, including radiation dermatitis and
atopic dermatitis. Alevicyn SG Gel may be also
used to relieve the pain of first and second
degree burns. Alevicyn SG Gel helps to
relieve dry waxy skin by maintaining a moist
wound & skin environment, which is
beneficial to the healing process.

OTC Indication: Alevicyn SG Gel is intended to
relieve the burning and itching associated with
many common types of skin irritation,
lacerations, abrasions, and minor burns.
Alevicyn SG Gel is also indicated for the
management of irritation and pain from minor
burns, including sunburn. | Epicyn hydrogel is intended indicated to
manage and relieve the burning, itching and
pain experienced with various types of
dermatoses, including radiation dermatitis and
atopic dermatitis. The Epicyn Gel may also
be used to relieve the pain of first and
second degree burns. Epicyn Gel helps to
relieve dry waxy skin by maintaining a
moist wound & skin environment, which is
beneficial to the healing process. | | Mechanism of
Action | Skin barrier emollient and moisturizer | Same | | Delivery
System | Hydrogel | Same | | Physical
Characteristics | pH: 5.5-7.0
FAC: 140- 150 ppm | Same | | Sterility Claim | Non-sterile | Same | | Shelf Life | 24 months | Same | | Source | Sponsor/Manufacturer | Sponsor/Manufacturer | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a series of overlapping golden ellipses above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller font. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility Testing The biocompatibility data provided for the Alevicyn SG Gel was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO- 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."" May 1, 1995, 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. The solution is considered a breached/compromised surface device with limited contact. Biocompatibility testing completed: Cytotoxicity -Agar Diffusion Test -ISO, Direct Systemic Injection Test -ISO, Primary Ocular Irritation - ISO, Direct Contact 7 Day Cumulative Skin Irritation Study on Wounded and Intact Skin, Direct Buehler Sensitization Test -ISO. # Bench Testing The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC), and antimicrobial preservative effectiveness testing. The Alevicyn SG Gel meets specification and performance characteristics and is substantially equivalent to the predicate device. #### VIII. CONCLUSION Alevicyn SG Gel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Epicyn Atopic Dermatitis Hydrogel manufactured by Oculus Innovative Sciences, Inc. (K102945). Therefore, the Oculus Alevicyn SG Gel is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K143590](https://fda.innolitics.com/device/K143590) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com