Alevicyn SG Antipruritic Gel

K152945 · Oculus Innovative Sciences · FRO · Dec 15, 2015 · SU

Device Facts

• Record ID: K152945
• Device Name: Alevicyn SG Antipruritic Gel
• Applicant: Oculus Innovative Sciences
• Product Code: FRO · SU
• Decision Date: Dec 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and sebortheic 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.

Device Story

Alevicyn SG Antipruritic Gel is a topical, opaque, low-viscosity spray gel used to manage dermatoses and minor burns. Applied by patients under the supervision of a healthcare professional, the gel acts as a skin barrier emollient and moisturizer. By maintaining a moist wound and skin environment, it helps relieve symptoms including burning, itching, erythema, scaling, and pain. The device is supplied in PET bottles with a finger pump sprayer. It is intended for clinical or home use as directed by a physician to support the healing process.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility evaluation per ISO 10993-1 for a breached/compromised surface device, package integrity, visual inspection, pH, and Free Available Chlorine (FAC) testing.

Technological Characteristics

Opaque, low-viscosity spray gel; pH 5.5-7.0; viscosity 500-5000 cP. Non-sterile, preserved per USP <51>. Materials: PET bottle, PP closure. Mechanism: Skin barrier emollient/moisturizer. Shelf life: 24 months.

Indications for Use

Indicated for patients experiencing burning, itching, erythema, scaling, and pain associated with dermatoses (atopic, radiation, seborrheic dermatitis) or first/second degree burns; aids in relieving dry waxy skin by maintaining a moist environment.

Predicate Devices

• Alevicyn SG Gel (K143590)
• TL Triseb Cream (K121134)
• Dermiseb Cream (K123724)
• Loutrex Topical Cream (K120730)

Submission Summary (Full Text)

{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 a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2015

Oculus Innovative Sciences Incorporated Mr. Brian Martin Director of Regulatory Affairs and Quality Control 1129 North Mcdowell Boulevard Petaluma, California 94954

Re: K152945

Trade/Device Name: Alevicyn SG Antipruritic Gel Regulatory Class: Unclassified Product Code: FRO Dated: October 5, 2015 Received: October 6, 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. Iisting 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K152945

Device Name Alevicyn SG Antipruritic Gel

### Indications for Use (Describe)

Rx Indication: Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and sebortheic 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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/1 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in bold, black letters. Above the word, there are three overlapping golden ellipses. Below the word "OCULUS", the words "Innovative Science" are written in a smaller 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: [phone] Fax: [phone]

Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: October 5, 2015

#### II. DEVICE

Name of Device: Alevicyn SG Antipruritic Gel Common or Usual Name: Antipruritic Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO

#### III. PREDICATE DEVICE

Alevicyn SG Gel (K143590) manufactured by Oculus Innovative Sciences, Inc., TL Triseb Cream (K121134), manufactured by Trigen Laboratories, Inc., Dermiseb Cream (K123724) manufactured by IGI Laboratories, Inc., and Loutrex Topical Cream (K120730) manufactured by Acella Pharmaceuticals, LLC

#### 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) screw-top closure and a finger pump sprayer.

#### INDICATIONS FOR USE V.

Rx Indication: Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic 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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo consists of a stylized golden graphic above the word "OCULUS" in bold, black letters. Below "OCULUS" is the text "Innovative Science" in a smaller, non-bold font.

waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the alphanumeric string "K152945" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits that follow. The text is presented in black against a white background, ensuring high contrast and readability.

Image /page/5/Picture/1 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 underneath. Above the word "OCULUS" is a graphic of three overlapping circles in a gold color. The logo is simple and modern, and the colors are clean and professional.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

| Submitter/<br>Holder | Proposed Device:<br>Alevicyn SG Antipruritic Gel<br>Oculus Innovative Sciences | Predicate Device:<br>K143590<br>Alevicyn SG Gel,<br>Oculus Innovative<br>Sciences | Predicate Device:<br>K121134<br>TL Triseb Cream,<br>Trigen Laboratories,<br>Inc. | Predicate Device:<br>K123724<br>Dermiseb Cream,<br>IGI Laboratories, Inc. | Predicate Device:<br>K120730<br>Loutrex Topical Cream,<br>Acella Pharmaceuticals,<br>LLC |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Rx Indication: Alevicyn SG Gel is<br>indicated to manage and relieve<br>the burning, itching, erythema,<br>scaling, and pain experienced<br>with various types of dermatoses,<br>including atopic dermatitis,<br>radiation dermatitis, and<br>seborrhea and seborrheic<br>dermatitis. Alevicyn SG Gel may<br>be also used to relieve the pain of<br>first and second degree burns.<br>Alevicyn SG Gel helps to relieve<br>dry waxy skin by maintaining a<br>moist wound & skin environment,<br>which is beneficial to the healing<br>process. | Rx Indication: Alevicyn<br>SG Antipruritic Gel is<br>indicated to manage and<br>relieve the burning,<br>itching and pain<br>experienced with various<br>types of dermatoses,<br>including radiation<br>dermatitis and atopic<br>dermatitis. Alevicyn SG<br>Antipruritic Gel may be<br>also used to relieve the<br>pain of first and second<br>degree burns. Alevicyn<br>SG Antipruritic Gel<br>helps<br>to relieve dry waxy skin<br>by maintaining a moist<br>wound & skin<br>environment, which is<br>beneficial to the healing<br>process.<br><br>OTC Indication:<br>Alevicyn SG Antipruritic<br>Gel is intended to relieve<br>the burning and itching<br>associated with many | Rx Indication: Under<br>the supervision of a<br>healthcare professional,<br>TL Triseb Cream is<br>indicated to manage and<br>relieve the signs and<br>symptoms of seborrhea<br>and seborrheic<br>dermatitis such as<br>itching, erythema,<br>scaling and pain. TL<br>Triseb Cream helps<br>relieve dry waxy skin<br>by maintaining a moist<br>wound and skin<br>environment, which is<br>beneficial to the healing<br>process. | Rx Indication: Under the<br>supervision of a<br>healthcare professional,<br>Dermiseb Cream is<br>indicated to manage and<br>relieve the signs and<br>symptoms of seborrhea<br>and seborrheic dermatitis<br>such as itching,<br>erythema, scaling and<br>pain. Dermiseb Cream<br>also aids to relieve dry,<br>waxy skin by<br>maintaining a moist<br>wound and skin<br>environment. A moist<br>wound and skin<br>environment is<br>beneficial to the healing<br>process. | Rx Indication: Loutrex<br>Topical Cream is indicated<br>to manage and relieve the<br>signs and symptoms of<br>seborrhea and seborrheic<br>dermatitis such as itching,<br>erythema, scaling and<br>pain. Loutrex Topical<br>Cream helps relieve dry,<br>waxy skin by maintaining<br>a moist wound and skin<br>environment, which is<br>beneficial to the healing<br>process. |
| Submitter/<br>Holder | Proposed Device:<br>Alevicyn SG Antipruritic Gel<br>Oculus Innovative Sciences | Predicate Device:<br>K143590<br>Alevicyn SG Gel,<br>Oculus Innovative<br>Sciences | Predicate Device:<br>K121134<br>TL Triseb Cream,<br>Trigen Laboratories,<br>Inc. | Predicate Device:<br>K123724<br>Dermiseb Cream,<br>IGI Laboratories, Inc. | Predicate Device:<br>K120730<br>Loutrex Topical Cream,<br>Acella Pharmaceuticals,<br>LLC |
| | | common types of skin<br>irritation, lacerations,<br>abrasions, and minor<br>burns. Alevicyn SG<br>Antipruritic Gel is also<br>indicated<br>for the management of<br>irritation and pain from<br>minor burns, including<br>sunburn. | | | |
| Mechanism of<br>Action | Skin barrier emollient and<br>moisturizer | Same | Water based Emollient | Water based Emollient | Water based Emollient |
| Delivery<br>System | Bottle, Spray Gel | Same | Tube | Tube | Tube |
| Physical<br>Characteristics | Appearance: Opaque Colorless<br>semi viscous gel<br>Odor: Slightly Chlorinated | Same | Appearance: Off White<br>Cream<br>Odor: Fragrance Free | Appearance: Off White<br>Cream<br>Odor: Fragrance Free | Appearance: Off<br>White/Yellow Cream<br>Odor: Fragrance Free |
| Sterility Claim | Non-sterile<br>Preserved/Conforming to USP<br><51> | Same | Non Sterile | Non Sterile | Non Sterile |
| Shelf Life | 24 months | Same | >1 year | >1 year | >1 year |
| Source | Sponsor/Manufacturer | Sponsor/Manufacturer | Labeling | Labeling | Labeling |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the text "K152945" in a simple, sans-serif font. The text is black against a white background. The characters are evenly spaced and clearly legible.

Image /page/6/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized gold-colored graphic above the company name. The text "OCULUS" is in a bold, sans-serif font, and below it, in a smaller font, is the text "Innovative Sciences."

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized, abstract design of interconnected golden rings above the company name. The text "OCULUS" is in bold, black letters, and below it, in smaller font, are the words "Innovative Science".

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility Testing

The biocompatibility evaluation 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.

## Bench Testing

The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC). 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 Alevicyn SG Gel (K143590), TL Triseb Cream (K121134), Dermiseb Cream (K123724), and Loutrex Topical Cream (K120730). Therefore, the Oculus Alevicyn SG Gel is substantially equivalent to the predicate devices.