(120 days)
No
The device description and performance studies focus on the physical and chemical properties of a hydrogel, with no mention of AI or ML technologies.
Yes
The device is described as relieving itch and pain from minor skin irritations, abrasions, and minor burns, and is intended for the management of post-procedure skin conditions, which aligns with therapeutic purposes.
No
The device, Microcyn Plus Skin and Wound Gel, is described as a hydrogel intended for the management of skin irritations, abrasions, and burns, and to relieve itch and pain. It's a treatment or therapeutic device, not a diagnostic one, as it doesn't aim to identify or diagnose a condition.
No
The device description clearly states it is a "clear gel" and mentions physical properties like odor, viscosity, and packaging (tube-bottles). The performance studies also include biocompatibility and bench testing related to the physical properties of the gel. This indicates it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the management of skin and wound conditions, such as post-laser therapy, microdermabrasion, chemical peels, minor irritations, abrasions, and burns. This involves applying the gel topically to the skin.
- Device Description: The device is described as a clear gel with specific physical and chemical properties (pH, viscosity, odor).
- Mechanism of Action: While not explicitly stated, the description and intended use suggest a topical application for wound healing and symptom relief, not for analyzing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic results.
- Performance Studies: The performance studies focus on biocompatibility and bench testing of the gel's physical properties, not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are typical for IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional (for Rx use)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
- Study Title: Agar Diffusion Test - ISO; Summary: No biological reactivity (Grade 0) observed in the L929 cells at 48 hours post exposure.
- Study Title: Acute Dermal Toxicity - OECD; Summary: The test substance is considered non-toxic according to the study protocol criteria.
- Study Title: Primary Eye Irritation; Summary: Mildly irritating to the eye. No other signs of gross toxicity, adverse pharmacological effects, or abnormal behavior.
- Study Title: Cumulative Skin Irritation Test - FHSA; Summary: Negligible irritant – no signs of erythema or edema were noted at any observation period.
- Study Title: Intracutaneous Injection; Summary: Irritant when injected under the skin.
- Study Title: Kligman Maximization Test, Direct Contact - ISO; Summary: 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:
Tests performed include: package integrity, visual inspection, viscosity, pH, Free Available Chlorine (FAC). Key results: The Microcyn Plus Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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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" 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)
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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.
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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.
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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 | Same | Non-sterile
Natural Preservative Gel from food grade
components |
| Mechanism of
Action | Wound Barrier and moisturizer | Same | Same |
| Delivery
System | Hydrogel | Same | Same |
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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.
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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.