OTC: 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. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and painrelief 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 of mechanically or surgically debrided wounds.

Device Description

Microcyn™ Skin and Wound HydroGel is a clear viscous, odoriess, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene, tamper resistant caps as described in Section 11.3.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called Microcyn™ Skin and Wound HydroGel. This document is a submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full Premarket Approval (PMA) process.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document describes a medical device (Microcyn™ Skin and Wound HydroGel) seeking 510(k) clearance, which is a process to demonstrate substantial equivalence to a predicate device. It is not a study that establishes acceptance criteria and proves performance in the way clinical trials for new drugs or more complex devices might. Instead, the "acceptance criteria" here are implicitly tied to the safety and functionality demonstrated by the predicate device and the general requirements for such wound dressings.

Here's the breakdown based on the information provided, recognizing the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a wound hydrogel, the "acceptance criteria" are primarily related to safety, biocompatibility, and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity or specificity for an AI-powered diagnostic. The device's performance is demonstrated through in-vitro and in-vivo testing to show it is safe and functions as intended.

Acceptance Criteria (Implied by 510(k) Requirements for Wound Dressings)	Reported Device Performance (from text)
Safety and Biocompatibility
- Non-cytotoxic	"Microcyn™ Skin and Wound HydroGel has been subjected to in-vitro and in-vivo biocompatibility testing (cytotoxicity...)" "All of the testing showed that the gel functions as intended without adverse effects." "Microcyn™ Skin and Wound HydroGel has been evaluated in accordance with the International Standard Organization (ISO), Part 10-993 which includes testing for cytotoxicity and sensitization." "Safety has been established through biocompatibility testing, invitro cytotoxicity testing and sensitization testing in species across two species of animal."
- Non-irritating (dermal)	"(dermal irritation...)"
- Non-sensitizing (dermal)	"(...dermal sensitization)." "Microcyn™ Skin and Wound HydroGel has been evaluated in accordance with the International Standard Organization (ISO), Part 10-993 which includes testing for cytotoxicity and sensitization." "Safety has been established through biocompatibility testing, invitro cytotoxicity testing and sensitization testing in species across two species of animal."
Functional Equivalence / Intended Use
- Maintain moist wound environment	"Oculus wound gel maintains a moist wound environment that supports the wound healing process..."
- Encourage autolytic debridement	"...encouraging autolytic debridement."
- Protect against dehydration, contamination	"Microcyn™ wound gel protects against dehydration, contamination and absorbs wound exudates."
- Absorb wound exudates	"...and absorbs wound exudates."
- Manage pain by protecting wound	"The hydrogel barriers manages pain by protecting the wound from contamination and irritation."
- Antimicrobial Effectiveness (inhibition of contamination within gel)	"USP Antimicrobial Effectiveness Testing <51> was performed to support claims that the FAC inhibits contamination within the hydrogel."
Material Stability / Shelf-Life
- Shelf life of 18 months	"Extrapolated results from ongoing stability studies support a product shelf life of 18 months."

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify a "test set" in the context of a dataset for an AI algorithm. The testing described relates to biological and chemical properties of the hydrogel.

Sample Size: Not specified for biocompatibility or other performance tests (e.g., how many animals were used, how many samples for in-vitro tests). It mentions "two species of animal" for sensitization testing, but not the number of animals per species.
Data Provenance: The tests are in-vitro (lab-based) and in-vivo (animal studies, "two species of animal"). There is mention of "Clinical experience with the solution form of the product indicates the Microcyn™ Skin and Wound HydroGel is safe for its intended use," which suggests some human data exists for a previous version or related product, but no details are provided about this "clinical experience" for the hydrogel specifically. The focus for this 510(k) is heavily on bench and animal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable in this context. This is a medical device (hydrogel), not an AI diagnostic algorithm that requires expert-established ground truth on a test set of images or patient data. The "ground truth" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility, antimicrobial effectiveness, etc.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" of expert opinions for a test set in the context of evaluating a wound hydrogel's physical and biological properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to compare human reader performance with and without AI assistance. This document is for a wound dressing, which has a different evaluation paradigm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

No, this is not an AI algorithm. It's a wound hydrogel.

7. The Type of Ground Truth Used

The "ground truth" is established through:

Standardized Biocompatibility Testing: According to ISO 10993 (cytotoxicity, sensitization).
Standardized Antimicrobial Testing: USP Antimicrobial Effectiveness Testing <51>.
Bench Testing: To confirm properties like moisture absorption, exudate control, and physical characteristics.
Animal Testing: For dermal irritation and sensitization in "two species of animal."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for an AI algorithm.

Summary

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510(k) Premarket Notification, K093585 SN02 Microcyn™ Skin and Wound HydroGel March 3, 2010 !

MAR - 8 2010

5.0 510(K) SUMMARY

5.1 Sponsor Information

Company Information:	Oculus Innovative Sciences, Inc.1129 North McDowell Blvd.Petaluma, CA 94954(707) 283-0550(707) 283-0551
Contact Information:	Antoinette DouglasDirector, Regulatory AffairsPhone: (707) 559-2445Email: adouglas@oculusis.com
Date of Preparation:	November 2009

5.2 Device Information

Device Trade Name:	Microcyn™ Skin and Wound HydroGel
Common Name:	Hydrogel Wound Dressing
Classification Name:	Dressing, wound and burn drug/hydrogel
Device Class:	Unclassified under 21 CFR Parts 862-892
Device Code:	FRO
Advisory Panel:	TBD

5.3 Identification of Legally Marketed Device for Substantial Equivalence Comparison

Microcyn™ Skin and Wound HydroGel Solution is substantially equivalent to the following cleared predicate device:

Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel manufactured o by McMerlin Dental Products, LP, cleared for distribution via 510(k) K090092 on September 9, 2009.
Oculus Microcyn Skin and Wound Gel manufactured by Oculus Innovative o Sciences, cleared for distribution via 510(k) K090725 on May 22, 2009 (Appendix 3)

など

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Oculus Innovative Sciences 1129 N. McDowell Blvd. Petaluma, CA 94954

5.4 Device Description

Microcyn™ Skin and Wound HydroGel has been subjected to in-vitro and in-vivo biocompatibility testing (cytotoxicity, dermal irritation and dermal sensitization). These tests results demonstrate the Microcyn™ Skin and Wound HydroGel is a safe for use as temporary dressing when in contact with abraded, breached or compromised skin. Clinical experience with the solution form of the product indicates the Microcyn™ Skin and Wound HydroGel is safe for its intended use.

Revised Intended Use ર્સ્ડ

Microcyn™ Skin and Wound HydroGel is proposed for the following uses:

Over-the -Counter:

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.

Professional Use:

Under the supervision of a healthcare professional, Microcyn Skin and Wound Hydro-Gel 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 of mechanically or surgically debrided wounds.

These indications are similar to that of the predicate device (SockIt!®/ McMerlin Dermal Wound Gel) cleared on September 09, 2009.

Device Technological Characteristics 5.6

Microcvn™ Wound HydroGel is a clear, aqueous hydrogel that exhibits the capacity to absorb moisture and control wound exudate. Hydrogel characteristics are imparted by an inert viscosity enhancing agent. Oculus wound gel maintains a moist wound environment that supports the wound healing process by encouraging autolytic debridement. Microcyn™ wound gel protects against dehydration,

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contamination and absorbs wound exudates. The hydrogel barriers manages pain by protecting the wound from contamination and irritation.

5.7 Manufacturing:

Microcyn™ Skin and Wound HydroGel will be manufactured under the guidelines of Good Manufacturing Practices (GMPs) and according to the established manufacturing, quality and product specifications as detailed in CFR 820. The manufacturing process will be validated before commercial production begins. Established cGMPs procedures will assure that device manufactured at Oculus Innovative Science meet all the established specifications prior to release and is safe and effective for its intended use.

Performance Testing:

Oculus Microcyn™ Skin and Wound HydroGel has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench testing including bioburden, biocompatibility and animal testing have been performed to support the safety and efficacy of the Microcyn™ Skin and Wound HydroGel. All of the testing showed that the gel functions as intended without adverse effects. Microcyn™ Skin and Wound HydroGel has been evaluated in accordance with the International Standard Organization (ISO), Part 10-993 which includes testing for cytotoxicity and sensitization. USP Antimicrobial Effectiveness Testing <51> was performed to support claims that the FAC inhibits contamination within the hydrogel . Extrapolated results from ongoing stability studies support a product shelf life of 18 months.

Substantial Equivalence Discussion/ Conclusion 5.8

Microcyn™ Skin and Wound HydroGel is similar in function and has the same intended use as the predicate device SockIt!®/McMerlin Dermal Wound Gel (manufactured by McMerlin Dental Products), that is legally marketed under 510(k) K090092 as a wound gel. The safety evaluation meets the requirements as detailed by USP and ISO. Safety has been established through biocompatibility testing, invitro cytotoxicity testing and sensitization testing in species across two species of animal.

On the basis of the information presented in this application, Oculus Innovative Sciences concludes that Microcyn™ Skin and Wound HydroGel is safe and

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Image /page/3/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.

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

MAR - 8 2010

Oculus Innovative Sciences, Inc. % Ms. Antoinette Douglas Director, Regulatory Affairs 1135 North McDowell Boulevard Petaluma, California 94954

Re: K093585

Trade/Device Name: Microcyn Skin and Wound HydroGel Regulatory Class: unclassified Product Code: FRO Dated: March 3, 2010 Received: March 5, 2010

Dear Ms. Douglas

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. Ilsting 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.

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Page 2 - Ms. Antoinette Douglas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours.

Daniel Keane

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Oculus Innovative Sciences 1129 N. McDowell Blvd. Petaluma. CA 94954

Indications for Use

510(k) Number (if known): K093585

Device Name: Microcyn Skin and Wound HydroGel

Indications For Use:

OTC:

Professional Use:

Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and painrelief 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 of mechanically or surgically debrided wounds.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use XX (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K092565

Regulation Number and Section

N/A