(120 days)
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.
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.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for most of the requested parameters. The document is a 510(k) summary for a medical device (Microcyn Plus Skin and Wound Hydrogel), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with acceptance criteria.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for clinical performance. Instead, it reports biocompatibility and bench testing results. The acceptance is implicitly that the device performs safely and effectively, and is substantially equivalent to predicates.
| Study Title | Reported Device Performance | Interpretation of "Acceptance" (Implicit) |
|---|---|---|
| Agar Diffusion Test - ISO | No biological reactivity (Grade 0) observed in the L929 cells at 48 hours post exposure. | No cytotoxicity observed, indicating biocompatibility. |
| Acute Dermal Toxicity - OECD | The test substance is considered non-toxic according to the study protocol criteria. | Non-toxic when applied dermally. |
| Primary Eye Irritation | Mildly irritating to the eye. No other signs of gross toxicity, adverse pharmacological effects, or abnormal behavior. | Tolerable eye irritation (though it's noteworthy that it is irritating) but no systemic toxicity. |
| Cumulative Skin Irritation Test - FHSA | Negligible irritant – no signs of erythema or edema were noted at any observation period. | Non-irritating to skin with repeated exposure. |
| Intracutaneous Injection | Irritant when injected under the skin. | Irritant when injected, indicating it's not suitable for subcutaneous injection (relevant for its intended topical use). |
| 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. | Low allergenic potential. |
| Bench Testing (overall) | The Microcyn Plus Hydrogel meets specification and performance characteristics (package integrity, visual inspection, viscosity, pH, Free Available Chlorine). | Device meets manufacturing and quality specifications for physical and chemical properties. |
Missing Information:
- 2. Sample sized used for the test set and the data provenance: Not mentioned. These are biocompatibility and bench tests, not clinical trials with human subjects as "test sets" in the typical sense for AI.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility and bench tests are laboratory-based, not expert-adjudicated clinical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hydrogel, not an AI diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For biocompatibility, the "ground truth" is defined by standardized test methods and their established biological endpoints (e.g., cell viability, toxicological response). For bench testing, it's defined by product specifications and analytical methods.
- 8. The sample size for the training set: Not applicable. The device is a wound hydrogel, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
This document describes a medical device seeking 510(k) clearance, which means it relies heavily on demonstrating substantial equivalence to legally marketed predicate devices, primarily through technological characteristics and non-clinical performance data (like biocompatibility and bench testing) rather than extensive new clinical studies. The questions you've asked are more typically relevant for AI/ML-enabled diagnostic devices or devices that require new clinical efficacy data for approval or clearance.
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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.
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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
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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 HydrogelOculus Innovative Sciences | Predicate Device: K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences | Predicate Device: K090092Sockit Dermal GelMcMerlin Dental Products |
|---|---|---|---|
| Indications forUse | Rx Indications for Use:Under the supervision of a health careprofessional Microcyn Plus Wound Gel isintended for the management of post non ablativelaser therapy procedures, post microdermabrasiontherapy and following superficial chemicalpeels. Microcyn Plus Wound Gel may also beused to relieve itch and pain from minor skinirritations, lacerations, abrasions and minor burns. | Rx Indications for Use:Under the supervision of a healthcareprofessional, Microcyn Skin and WoundHydroGel is intended for management ofwounds including itch and pain relief associatedwith dermal irritation, sores, injuries and ulcersof dermal tissue. Microcyn Skin and WoundHydroGel is intended for use on first and seconddegree burns, exuding wounds such as legulcers, pressure ulcers, diabetic ulcers, and forthe management mechanically or surgicallydebrided wounds. | Rx Indications for Use:This product provides for the management ofand relieves the pain associated with all types ofdermal wounds, skin sores, injuries and ulcers ofthe 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 Laserresurfacing treatment• Irritation and pain following dermabrasiontherapy |
| OTC Indications for Use:Microcyn Plus Wound Gel is intended for themanagement of minor skin irritations followingpost non ablative laser therapy procedures,microdermabrasion therapy or superficialchemical peels. Microcyn Plus Wound Gel mayalso be used to relieve itch and pain from minorskin irritations, lacerations, abrasions and minorburns. | OTC Indications for Use:Microcyn Skin and Wound HydroGel isintended for use to relieve itch and pain fromminor skin irritations, lacerations, abrasions andminor burns. Microcyn is also indicated for themanagement of irritation and pain from, minorsunburn. | OTC Indications for Use:This product provides for the management of | |
| Submitter/Holder | Proposed Device:Microcyn Plus HydrogelOculus Innovative Sciences | Predicate Device: K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences | Predicate Device: K090092Sockit Dermal GelMcMerlin Dental Productsand relieves the pain associated with all minordermal wounds, minor skin sores, minor injuriesand minor irritations of the skin. Examplesinclude:• Minor burns• Minor Cuts & Abrasions• Superficial itching• Sunburn• Minor burns from a chemical peel treatment• Minor irritation and pain following tattooingprocedures• Minor irritation and pain following skin laserresurfacing treatment• Minor irritation and pain followingdermabrasion therapy |
| Sterility Claim | Non-sterilePreserved/Conforming to USP <51> | Same | Non-sterileNatural Preservative Gel from food gradecomponents |
| Mechanism ofAction | Wound Barrier and moisturizer | Same | Same |
| DeliverySystem | 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 |
|---|---|
| AgarDiffusion Test -ISO | No biological reactivity (Grade 0) observed in the L929cells at 48 hours post exposure. |
| Acute Dermal Toxicity -OECD | The test substance is considered non-toxic according to thestudy protocol criteria. |
| Primary EyeIrritation | Mildly irritating to the eye. No other signs of gross toxicity,adverse pharmacological effects, or abnormal behavior. |
| Cumulative SkinIrritation Test - FHSA | Negligible irritant – no signs of erythema or edema werenoted at any observation period. |
| Intracutaneous Injection | Irritant when injected under the skin. |
| Kligman MaximizationTest, Direct Contact -ISO | The test article elicited no reaction, a Grade I reaction asdefined by the scoring system of Kligman, classified ashaving 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.
N/A