Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second degree burns.

Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin.

Device Description

Hyaluronic Acid Topical Wound Cream 0.2%w/w is a white or light straw colored hydrophilic viscous cream containing hyaluronic acid for topical use on wounds.

AI/ML Overview

This document is a 510(k) summary for the Hyaluronic Acid Topical Wound Cream 0.2%w/w, claiming substantial equivalence to a predicate device, Bionect® Cream (K963004). This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve comprehensive studies with specific acceptance criteria, sample sizes, and ground truth definitions as would be present in a de novo classification or premarket approval (PMA) application for novel, high-risk devices or software as a medical device (SaMD).

Instead, "acceptance criteria" here refers to demonstrating that the new device shares the same fundamental scientific technology, physical and performance characteristics, and indications for use as the predicate device, and that any differences do not raise new questions of safety or effectiveness. The study supporting this is primarily biocompatibility testing and comparative analysis rather than a clinical trial with specific performance metrics like sensitivity/specificity.

Let's break down the information provided in the context of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of specific performance metrics like sensitivity, specificity, or F1-score for the device. Instead, the acceptance criteria are implicitly that the new device (Hyaluronic Acid Topical Wound Cream 0.2%w/w) is as safe and effective as the predicate device (Bionect® Cream) and shares the same technological characteristics and intended use.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (Summary)
Technological Characteristics:	The characteristics of Hyaluronic Acid Topical Wound Cream 0.2% w/w are not different from the predicate device (Bionect® Cream). The proposed device uses the same technology (Hyaluronic acid as a moisture-management component) and is a hydrophilic topical cream containing 0.2% w/w sodium hyaluronate.
Intended Use/Indications:	Prescription Use: Indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second-degree burns. (Page 5)
	Over-the-Counter Use: Indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin. (Page 7) (Both indications are stated to be similar to the predicate device.)
Safety and Effectiveness:	"The performed studies demonstrated that Hyaluronic Acid Topical Wound Cream 0.2%w/w is as safe and effective as the predicate device (Bionect® Cream) for its intended use on breached and compromised skin as a moist wound dressing." (Page 5 and 7) This conclusion is based on biocompatibility testing and comparative studies.
Biocompatibility:	Testing conducted according to ISO 10993 'Biological Evaluation of Medical Devices'. (Page 5 and 7)
Physical/Performance Characteristics:	Described as a white or light straw colored hydrophilic viscous cream intended for moisture management on the wound bed to aid in providing a moist wound environment. It is a repeat use, preservative-protected non-sterile topical product. (Pages 5-7) (These characteristics are implied to be consistent with the predicate.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify a "test set" in the context of clinical images or diagnostic performance. The evaluation performed was primarily biocompatibility testing and comparative studies against the predicate device. The sample size for these studies is not provided, nor is the country of origin of the data explicitly stated (other than the sponsor being in India). The nature of these "comparative studies" is not detailed enough to determine if they were retrospective or prospective, but typical biocompatibility testing would involve in-vitro and/or in-vivo animal models, which are prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to this 510(k) submission. There was no clinical ground truth established by experts for a test set, as this is a topical wound cream and not a diagnostic device involving expert interpretation of medical images or other clinical data for performance evaluation. The "ground truth" for demonstrating safety and effectiveness relied on standard biocompatibility tests and comparison to a known safe and effective predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Since there was no test set involving expert review or interpretation of cases, no adjudication method was used or needed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a topical wound cream, not an AI or diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is a topical wound cream, not an algorithm, so a standalone performance evaluation of an algorithm was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (Bionect® Cream), supported by regulatory standards for medical device safety. The studies performed were biocompatibility tests (according to ISO 10993) and comparative studies to show that the new device performed similarly to the predicate. This relies on the assumption that if the new device has identical technological characteristics, similar indications, and passes standard safety tests (biocompatibility), then its safety and effectiveness are "ground-truthed" by the predicate.

8. The sample size for the training set:

This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The development of the cream would involve formulation and laboratory testing, but not in the sense of a data "training set."

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for this type of medical device submission.

Summary

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April 27, 2018

Virchow Biotech Pvt Ltd Bruce Gibbins Doctor 5903 SE Milwaukie Ave Portland, Oregon 97202

Re: K172747 Trade/Device Name: Hyaluronic Acid Topical Wound Cream Regulatory Class: Unclassified Product Code: FRO Dated: August 28, 2017 Received: September 12, 2017

Dear Bruce Gibbins:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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K172747

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Hyaluronic Acid Topical Wound Cream 0.2%w/w

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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

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"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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Hyaluronic Acid Topical Wound Cream 0.2%w/w

Indications for Use (Describe)

Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin.

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.

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

5.1 510(k) Summary for Prescription (Rx) of Hyaluronic Acid Topical Wound Cream 0.2%w/w:

5.1.1 510(k) Sponsor Information:

VIRCHOW BIOTECH PVT LTD Plot No: 318 & 320, 3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd. Madhapur, Hyderabad Telangana State India-500 081

5.1.2 Contact Person

Bruce Gibbins PhD. 5936 N Via Verdosa, Tucson AZ 85750 Contact No: +1 503-781-7565 Email: blgibbins@gmail.com

Date: 13/03/2018

5.1.3 Device Information:

Trade Name(proprietary name)	Common/Usual Name	Classification Name	Device Class
Hyaluronic Acid Topical WoundCream 0.2% w/w	Hyaluronic acidsodium salt hydrogeldressing	Dressing, Wound andBurn, Hydrogel	Unclassified

5.1.4 Legally marketed device to which substantial equivalence is being claimed:

Hyaluronic Acid Topical Wound Cream 0.2%w/w is substantially equivalent in function and intended use to the following commercially available unclassified, non-interactive wound and burn dressing:

Bionect® Cream (K963004) (FIDIA Pharmaceutical Corp.)

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5.1.5 Description of the Device

Hyaluronic Acid Topical Wound Cream 0.2%w/w is a white or light straw colored hydrophilic viscous cream containing hyaluronic acid for topical use on wounds.

5.1.6 Explanation of how the device functions

The device, Hyaluronic Acid Topical Wound Cream 0.2%w/w is a hydrophilic topical cream that is intended for moisture management wound bed of acute and chronic dermal wounds. Hyaluronic Acid Topical Wound Cream 0.2%w/w functions as a moisture management cream to aid in providing a moist wound environment that is recognized to be conducive to healing.

5.1.7 The scientific concepts that form the basis for the device

Hyaluronic acid (HA) is a natural major component of the extracellular matrix and is important in providing support to the cellular constituents of tissues. HA is a muco-polysaccharide that has a high water binding capacity which enables it to trap and preserve water in the tissue environment. These properties serve to maintain tissues in a hydrated state which is needed for vitality and viability. The hydrophilic nature of HA is preserved when it is removed from the tissue environment. This enables HA to be used as a potent moisture management component of topical products such as Hyaluronic Acid Topical Wound cream 0.2%w/w. When used topically, the HA in Hyaluronic Acid Topical Wound Cream 0.2% w/w maintain moisture on the wound.

5.1.8 Physical and performance characteristics

Hyaluronic Acid Topical Wound Cream 0.2%w/w is topical cream base containing sodium hyaluronate 0.2% w/w. The Hyaluronic Acid Topical Wound Cream 0.2% w/w is a repeat use, preservative protected non-sterile topical product.

5.1.9 Indication of Use

Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second degree burns.

5.1.10 Summary of the technological characteristics and substantial equivalence

The characteristics of Hyaluronic Acid Topical Wound Cream 0.2% w/w are not different from the predicate device (Bionect® Cream). The proposed device uses the same technology and is intended for similar indications.

5.1.11 Assessment of Performance Data and Safety

As per regulatory requirements Biocompatibility testing for Hyaluronic Acid Topical Wound Cream 0.2%w/w was conducted according to ISO 10993 'Biological Evaluation of Medical Devices'. A series of comparative studies along with the predicate device, Bionect® cream, were performed to determine the safety of proposed device.

Conclusion:

The performed studies demonstrated that Hyaluronic Acid Topical Wound Cream 0.2%w/w is as safe and effective as the predicate device (Bionect® Cream) for its intended use on breached and compromised skin as a moist wound dressing.

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510(k) Summary

5.2 510(k) Summary for Over-the-counter (OTC) of Hyaluronic Acid Topical Cream 0.2% w/w:

5.2.1 510(k) Sponsor Information:

VIRCHOW BIOTECH PVT LTD Plot No: 318 & 320, 3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd. Madhapur, Hyderabad Telangana State India-500 081

5.2.2 Contact Person

Bruce Gibbins PhD, 5936 N Via Verdosa Tucson AZ 85750 Contact No: +1 503-781-7565 Email:blgibbins @ gmail.com

Date: 13/03/2018

5.2.3 Device Information:

Trade Name (proprietary name)	Common/Usual Name	Classification Name	Device Class
Hyaluronic Acid Topical Wound Cream 0.2%w/w	Hyaluronic acid sodium salt hydrogel dressing	Dressing, Wound and Burn, Hydrogel	Unclassified

5.2.4 Legally marketed device to which substantial equivalence is being claimed:

Hyaluronic Acid Topical Wound Cream 0.2%w/w is substantially equivalent in function and intended use to the following commercially available unclassified, non-interactive wound and burn dressing:

Bionect® Cream (K963004) (FIDIA Pharmaceutical Corp.)

5.2.5 Description of the Device

Hyaluronic Acid Topical Wound Cream 0.2%w/w is a white or light straw colored hydrophilic viscous cream containing hyaluronic acid for topical use on wounds.

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5.2.6 Explanation of how the device functions

The device, Hyaluronic Acid Topical Wound Cream 0.2%w/w is a hydrophilic topical cream that is intended for moisture management on wound bed of acute and chronic dermal wounds. Hyaluronic Acid Topical Wound Cream 0.2%w/w functions as a moisture management cream to aid in providing a moist wound environment that is recognized to be conducive to healing.

5.2.7 The scientific concepts that form the basis for the device

5.2.8 Physical and performance characteristics

Hyaluronic Acid Topical Wound Cream 0.2%w/w is topical cream base containing sodium hyaluronate 0.2% w/w. The Hyaluronic Acid Topical Wound Cream 0.2% w/w is a repeat use, nonsterile preservative protected topical product.

5.2.9 Indication of Use

Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin.

5.2.10 Summary of the technological characteristics and Substantial equivalence

5.2.11 Assessment of Performance Data and Safety

As per regulatory requirements Biocompatibility testing for Hyaluronic Acid Topical Wound Cream 0.2%w/w was conducted according to ISO 10993 'Biological Evaluation of Medical Devices'. A series of comparative studies along with the predicate device, Bionect® Cream, were performed to determine the safety of proposed device.

Conclusion:

Regulation Number and Section

N/A