Who is the manufacturer of Microcyn Plus Skin and Wound Hydrogel?

Oculus Innovative Sciences filed the 510(k) submission for Microcyn Plus Skin and Wound Hydrogel (K153648).

What is the FDA product code for Microcyn Plus Skin and Wound Hydrogel?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Microcyn Plus Skin and Wound Hydrogel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Microcyn Plus Skin and Wound Hydrogel?

Microcyn Skin and Wound Gel (K093585); Sockit Dermal Wound Gel (K090092).

Who can help prepare an FDA 510(k) submission like Microcyn Plus Skin and Wound Hydrogel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Microcyn Plus Skin and Wound Hydrogel

K153648 · Oculus Innovative Sciences · FRO · Apr 19, 2016 · SU

Device Facts

Record ID	K153648
Device Name	Microcyn Plus Skin and Wound Hydrogel
Applicant	Oculus Innovative Sciences
Product Code	FRO · SU
Decision Date	Apr 19, 2016
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Rx Indications for Use: Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns. OTC Indications for Use: Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.

Device Story

Microcyn Plus Skin and Wound Hydrogel is a clear, viscous, slightly chlorinated gel supplied in PET tube-bottles. It functions as a wound barrier and moisturizer. Used in clinical or home settings to manage skin post-procedure (laser, microdermabrasion, chemical peels) and to relieve itch/pain from minor burns, abrasions, and irritations. Applied topically by healthcare professionals or patients. No complex processing or software involved.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including Agar Diffusion (no reactivity), Acute Dermal Toxicity (non-toxic), Primary Eye Irritation (mildly irritating), Cumulative Skin Irritation (negligible), Intracutaneous Injection (irritant), and Kligman Maximization (weak allergenic potential). Bench testing confirmed specifications for viscosity, pH, and Free Available Chlorine.

Technological Characteristics

Viscous hydrogel (12,000-20,000 cP); pH 6.2-7.8. Materials: PET tube-bottles with PP screw-top closure. Non-sterile, preserved per USP <51>. Mechanism: physical wound barrier and moisturizer. No software or electronic components.

Indications for Use

Indicated for management of minor skin irritations following non-ablative laser therapy, microdermabrasion, or superficial chemical peels; relief of itch and pain from minor skin irritations, abrasions, and minor burns. Suitable for Rx (under professional supervision) and OTC use.

Predicate Devices

Microcyn Skin and Wound Gel (K093585)
Sockit Dermal Wound Gel (K090092)

Related Devices

K173896 — Microcyn Antimicrobial Hydrogel · Sonoma Pharmaceuticals, Inc. · Apr 2, 2018
K093585 — MICROCYN SKIN AND WOUND HYDROGEL · Oculus Innovative Sciences, Inc. · Mar 8, 2010
K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL · Oculus Innovative Sciences, Inc. · Feb 2, 2011
K090725 — OCULUS MICROCYN WOUND GEL · Oculus Innovative Sciences, Inc. · May 20, 2009
K123193 — IPM WOUND GEL BIO · Glycobiosciences, Inc. · Mar 3, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 19, 2016 Oculus Innovative Sciences Mr. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 N McDowell Blvd Petaluma. California 94954 Re: K153648 Trade/Device Name: Microcyn Plus Skin And Wound Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: March 16, 2016 Received: March 18, 2016 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. {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/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 yours, # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153648 Device Name Microcyn Plus Skin and Wound HydroGel ## Indications for Use (Describe) Rx Indications for Use: Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns. OTC Indications for Use: Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns. | 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) ### 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 features the word "OCULUS" in a bold, sans-serif font. Above the word, there is a graphic of three overlapping golden rings. Below the word "OCULUS" is the text "Innovative Science" in a smaller, italicized font. ### 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 18, 2014 #### II. DEVICE Name of Device: Microcyn Plus Skin and Wound Hydrogel Common or Usual Name: Wound Gel Classification Name: Hydrogel Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO #### III. PREDICATE DEVICE Microcyn Skin and Wound Gel manufactured by Oculus Innovative Sciences (K093585) Sockit Dermal Wound Gel manufactured by McMerlin Dental Products (K090092) #### IV. DEVICE DESCRIPTION The Microcyn Plus Skin and Wound Hydrogel is a clear gel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of 12,000-20,000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure. #### V. INDICATIONS FOR USE ### Rx Indications for Use: Under the supervision of a health care professional Microcyn Plus Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations. lacerations, abrasions and minor burns. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Science" in a smaller font below it. Above the word "OCULUS" is a graphic of several overlapping ellipses, creating a swirling effect. ### OTC Indications for Use: Microcyn Plus Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. {5}------------------------------------------------ Image /page/5/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 font. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Submitter/ Holder | Proposed Device: Microcyn Plus Hydrogel Oculus Innovative Sciences | Predicate Device: K093585 Microcyn Skin and Wound Hydrogel Oculus Innovative Sciences | Predicate Device: K090092 Sockit Dermal Gel McMerlin Dental Products | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Rx Indications for Use: Under the supervision of a health care professional Microcyn Plus Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. | Rx Indications for Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management mechanically or surgically debrided wounds. | Rx Indications for Use: This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include: • All types of dermal wounds, skin sores, injuries and ulcers of the skin • First & Second degree burns • Pressure ulcers, stages I - IV • Stasis ulcers • Diabetic ulcers • Radiation dermatitis • Post-surgical incision • Surgical sites, including soft tissue graft sites • Foot ulcers • Venous stasis ulcers • Cuts & Abrasions • Partial thickness wounds • Irritation of the skin • Itching • Sunburn • Skin condition associated periostomy care • Chemical peel • Tattooing procedures • Irritation and pain following skin Laser resurfacing treatment • Irritation and pain following dermabrasion therapy | | | OTC Indications for Use: Microcyn Plus Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. | OTC Indications for Use: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from, minor sunburn. | OTC Indications for Use: This product provides for the management of | | Submitter/ Holder | Proposed Device: Microcyn Plus Hydrogel Oculus Innovative Sciences | Predicate Device: K093585 Microcyn Skin and Wound Hydrogel Oculus Innovative Sciences | Predicate Device: K090092 Sockit Dermal Gel McMerlin Dental Products and relieves the pain associated with all minor dermal wounds, minor skin sores, minor injuries and minor irritations of the skin. Examples include: • Minor burns • Minor Cuts & Abrasions • Superficial itching • Sunburn • Minor burns from a chemical peel treatment • Minor irritation and pain following tattooing procedures • Minor irritation and pain following skin laser resurfacing treatment • Minor irritation and pain following dermabrasion therapy | | Sterility Claim | Non-sterile Preserved/Conforming to USP <51> | Same | Non-sterile Natural Preservative Gel from food grade components | | Mechanism of Action | Wound Barrier and moisturizer | Same | Same | | Delivery System | Hydrogel | Same | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features the word "OCULUS" in a bold, sans-serif font. Below the word "OCULUS" is the phrase "Innovative Sciences" in a smaller font. Above the word "OCULUS" is a graphic of three overlapping circles. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Science" in a smaller font below it. Above the word "OCULUS" is a graphic of several overlapping golden circles. The logo is simple and modern, and the use of the color gold gives it a sense of luxury and sophistication. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. Biocompatibility Testing The biocompatibility evaluation for the Microcyn Plus Hydrogel 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. | Study Title | Summary | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Agar Diffusion Test -ISO | No biological reactivity (Grade 0) observed in the L929 cells at 48 hours post exposure. | | Acute Dermal Toxicity - OECD | The test substance is considered non-toxic according to the study protocol criteria. | | Primary Eye Irritation | Mildly irritating to the eye. No other signs of gross toxicity, adverse pharmacological effects, or abnormal behavior. | | Cumulative Skin Irritation Test - FHSA | Negligible irritant – no signs of erythema or edema were noted at any observation period. | | Intracutaneous Injection | Irritant when injected under the skin. | | Kligman Maximization Test, Direct Contact - ISO | The test article elicited no reaction, a Grade I reaction as defined by the scoring system of Kligman, classified as having weak allergenic potential. | ### Bench Testing The following tests were performed to support the performance of Microcyn Plus Hydrogel: package integrity, visual inspection, viscosity, pH, Free Available Chlorine (FAC). The Microcyn Plus Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device. #### VIII. CONCLUSION Microcyn Plus Hydrogel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Skin and Wound Hydrogel manufactured by Oculus Innovative Sciences, Inc. (K093585) and Sockit Dermal Wound Gel manufactured by McMerlin Dental Products (K090092). Therefore, the Oculus Microcyn Plus Hydrogel is substantially equivalent to the predicate devices.