ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.

ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.

Device Description

ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel:

Resists microbial colonization within the dressing during shelf storage.
Provides an amorphous gel covering
Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.

ROCHAL Antimicrobial Wound Gel contains:
Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)

AI/ML Overview

The provided text describes the 510(k) premarket notification for Rochal Antimicrobial Wound Gel, comparing it to a predicate device, Prontosan Wound Gel X (K130857). This submission is for a medical device that is a wound dressing, not an AI/ML medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and effect sizes of human readers with AI assistance is not applicable to this document.

The document discusses performance testing relevant to a wound gel, which includes:

ISO 10993 Biocompatibility Studies: These studies demonstrate that the device is safe for biological contact.
Large-Animal, Full-Thickness Wound Healing Study: This study was conducted to demonstrate the safety of the device in a relevant biological model.
USP <51> Preservative Effectiveness Testing: This confirms the appropriateness of the chosen preservative (Polyaminopropyl Biguanide - PHMB) in the product formulation.
Real-time Aging Study: This study assesses the stability and performance of the product over its proposed shelf life of six months.

The conclusion drawn is that the Rochal Antimicrobial Wound Gel is substantially equivalent to the predicate device based on similar intended uses, product form, and function, and demonstrated safety and effectiveness through the battery of tests mentioned above.

Summary

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February 7, 2020

Rochal Industries, LLC William Coulston Ouality & Regulatory Manager 12000 Network Blvd. Ste B200 San Antonio, Texas 78249

Re: K192527

Trade/Device Name: Rochal Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 3, 2020 Received: January 6, 2020

Dear William Coulston:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kimberlv M. Ferlin. Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192527

Device Name Rochal Antimicrobial Wound Gel

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known)

K192527

Device Name Rochal Antimicrobial Wound Gel

Indications for Use (Describe)

ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.

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

_ 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!

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."

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510(k) Summary

1. Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd. Ste B200 San Antonio, Texas, 78249
1. Submitter's Contact Person William J. Coulston Quality & Regulatory Manager (210) 375-9349 ext 125 wcoulston@rochalindustries.com
1. Date of 510(k) Summary Preparation: 7 February 2020
Device Name (Proprietary) 4. Rochal Antimicrobial Wound Gel
ട്. Common Name Wound Dressing
Classification Name 6. Dressing, Wound, Drug
1. Device Class Unclassified
1. Device Code FRO

9. Description of Device

Resists microbial colonization within the dressing during shelf storage.
. Provides an amorphous gel covering

Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.

ROCHAL Antimicrobial Wound Gel contains:

Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)

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10. Intended Use of Device

Rochal Antimicrobial Wound Gel is intended for over-the-counter (OTC) and professional (Rx) use as follows:

For Over-the-Counter Use: ROCHAL Antimicrobial Wound Gel is intended for . the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
. Professional Use: ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.

These indications are similar to the predicate device.

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11. Legally Marketed Device for substantial equivalence comparison:

Feature BeingCompared	SUBJECT DEVICERochal Antimicrobial Wound Gel	PREDICATE DEVICEProntosan Wound Gel X (K130857)	DISCUSSION
Indications forUse (Rx)	Rochal Antimicrobial Wound Gelis intended for the management ofulcers (including diabetic foot andleg ulcers and pressure ulcers),first and second-degree burns,partial and full thickness wounds,large surface area wounds, andsurgical incisions.	K130857: Rx: Prontosan® WoundGel X is indicated for themanagement of ulcers (includingdiabetic foot and leg ulcers andpressure ulcers), 1st and 2nd degreeburns, partial and full thicknesswounds, large surface area woundsand surgical incisions.	The same.
Indications forUse (OTC)	ROCHAL Antimicrobial WoundGel is intended for themanagement of minor skinscrapes, minor cuts, minorlacerations, minor burns (1stdegree burns), minor irritations.	K130857: OTC: Prontosan WoundGel X is indicated for themanagement minor cuts, minorlacerations, minor burns (1st degreeburns), and abrasions.	Similar – slight rewording butwithin the same type anddegree of injury
Technology	Clear, colorless gel	Clear, colorless gel	Similar - different formulationbut does not raise differentquestions related to safety oreffectiveness.
Performance	USP<51> preservativeeffectiveness testing	USP <51>, modified StrikeThrough Barrier testing	Similar – both use PHMB as apreservative.
Biocompatibility	Biocompatibility Testing: ISO10993-1, surface device withprolonged contact (>24hours to 30days) on breached or compromised	Biocompatibility Testing	The subject device hasdemonstrated to be safe for useas a surface device withprolonged contact (>24hours to
	surfaces	30 days) on breached or
		compromised surfaces

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12. Performance Testing

Rochal Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe and as effective as its predicate device. Additionally, a large-animal, full-thickness wound healing study was conducted to demonstrate safety. USP<51> preservative effectiveness testing demonstrates the chosen preservative is appropriate for a product formulation. The results of real-time aging study indicate the product is stable and maintains performance for the proposed shelf life of six months.

13. Substantial Equivalence Conclusion

Rochal Antimicrobial Wound Gel has very similar indications for use, and similar product form and function as the predicate device, Prontosan Wound Gel X (K130857).

On the basis of the information presented in this 510(k) submission, Rochal Industries LLC, concludes (a) that Rochal Antimicrobial Wound Gel is substantially equivalent to the predicate device, as it has the same intended uses as the predicate device; and (b) demonstrates the device is as safe and effective as the legally marketed predicate device.

Regulation Number and Section

N/A