MICROCYN SCAR MANAGEMENT HYDROGEL

K131672 · Oculus Innovative Sciences · PFP · Nov 15, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131672
• Device Name: MICROCYN SCAR MANAGEMENT HYDROGEL
• Applicant: Oculus Innovative Sciences
• Product Code: PFP · General, Plastic Surgery
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Device Story

Microcyn® Scar Management HydroGel is a translucent, silicone oil-based hydrogel for topical management of hypertrophic and keloid scars. Device contains hypochlorous acid and sodium hypochlorite as preservatives to inhibit microbial growth. Applied topically to intact skin by patients or healthcare professionals. Acts as a physical barrier/occlusive agent to manage scar tissue. Benefits include improved scar appearance through management of old and new scars. No complex processing or electronic components; simple topical application.

Clinical Evidence

Clinical testing indicated the device was well tolerated in the study population. Efficacy results demonstrated substantial equivalence to the predicate device, Kelo-cote® Scar Gel. Biocompatibility testing confirmed compliance with ISO-10993 standards.

Technological Characteristics

Translucent silicone oil-based hydrogel. Preserved with hypochlorous acid and sodium hypochlorite. Non-sterile formulation. Biocompatible per ISO-10993.

Indications for Use

Indicated for management of old and new hypertrophic and keloid scars resulting from burns, surgical procedures, and trauma wounds in patients requiring scar management. Suitable for both prescription and OTC use.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Predicate Devices

• Kelo-Cote Topical™ Gel (K002488)
• Beau Rx Scar Care Gel / Atopiclair® (K083718)

Submission Summary (Full Text)

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## 510(k) SUMMARY

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The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

## 510(k) Owner

Oculus Innovative Sciences, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: [phone] Fax: [phone]

**NOV 15 2013**

## Official Contact

Brian W. Martin Director of Regulatory Affairs and Quality. Control

## Device Information

| Trade or Proprietary Name: | Microcyn® Scar Management HydroGel |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Silicone Scar Gel |
| Classification Name: | Elastomer, Silicone, for Scar Management |
| Regulation: | Class 1 per 21CFR §878.4025 |
| Product Code(s) | PFP |
| Legally marketed device(s)<br>to which equivalence is<br>claimed: | Kelo-Cote Topical™ Gel manufactured by Advanced Bio-<br>Technologies, cleared for distribution via 510(k) K002488 |
| | Beau Rx Scar Care Gel currently marketed as Atopiclair®<br>manufactured by Beau Rx Solutions, LLC, cleared for<br>distribution via 510(k) K083718 |
| Reason for 510(k)<br>submission | New Device |
| Device Description | Microcyn® Scar Management HydroGel is a translucent, silicone<br>oil containing hydrogel which is intended for the management of<br>old and new scars including hypertrophic and keloid scarring, on<br>scars resulting from general surgical procedures, as well as<br>trauma wounds, and burns. The product is intended to be applied<br>to intact skin. The product is preserved with a unique mixture of<br>hypochlorous acid and sodium hypochlorite generated through a<br>proprietary process. The mixture of hypochlorous acid and<br>sodium hypochlorite act as a preservative in the non-sterile<br>product to inhibit microbial growth during storage and repeat use.<br>The preservative is identified by the Center for Drug Evaluation<br>and Research (CDER) as an inactive ingredient based on the |
| Intended Use | Rx INDICATIONS: Under the supervision of a health care<br>professional, Microcyn® Scar Management HydroGel is intended<br>for the management of old and new hypertrophic and keloid<br>scarring on scars resulting from burns, general surgical<br>procedures and trauma wounds.<br><br>OTC INDICATIONS: Microcyn® Scar Management HydroGel<br>is intended for the management of old and new hypertrophic and<br>keloid scarring on scars resulting from burns, general surgical<br>procedures and trauma wounds. |
| Performance Testing | The Microcyn® Scar Management HydroGel meets specification<br>and performance characteristics and is substantially equivalent to<br>the predicate device. |
| Biocompatibility Testing | Biocompatibility Testing of the Microcyn® Scar Management<br>HydroGel confirmed that the device meets the applicable<br>requirements of the Blue Book Memorandum G95-1 entitled Use<br>of International Standards ISO-10993 Biological Evaluation of<br>Medical Devices and is biocompatible. |
| Clinical Testing | The Microcyn® Scar Management HydroGel was well tolerated<br>in the study population and efficacy results indicate substantial<br>equivalence to the predicate device, Kelo-cote® Scar Gel. |
| Safety and Effectiveness | The Microcyn® Scar Management HydroGel does not raise any<br>new safety and efficacy concerns when compared to a similar<br>device already legally marketed. |
| Substantial Equivalence<br>(SE) Rationale | The Microcyn® Scar Management HydroGel is substantially<br>equivalent in intended use, technological characteristics, safety,<br>and effectiveness to the Kelo-Cote Topical™ Gel and Beau Rx<br>Scar Care Gel. Therefore, the Microcyn® Scar Management<br>HydroGel is substantially equivalent to the predicate devices. |
| Submitted by: | Brian W. Martin<br>Director of Regulatory Affairs and Quality Control |

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Date Submitted:

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11/13/2013

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

November 15, 2013

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

Rc: K131672

.

Trade/Device Name: Microcyn™ Scar Management HydroGel Regulation Number: 21 CFR 878.4025 Regulation Name: Elastomer, Silicone, for Scar Management Regulatory Class: Class I Product Code: PFP Dated: September 24. 2013 Received: October 1, 2013

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

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Page 2 - Mr. Brian W. Martin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Mark N. Melkerson

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k} Number (if known) K131672

#### Device Name

Microcyn® Scar Management HydroGel

#### Indications for Use (Describe)

Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . . . . . . · . ..

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)