Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.

Device Description

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

AI/ML Overview

Based on the provided text, the document is an FDA 510(k) clearance letter and summary for a medical device called Bonvadis®. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific, quantitative acceptance criteria through a comparative effectiveness study, especially not for AI/ML-enabled devices.

Therefore, most of the requested information regarding acceptance criteria, study design parameters (sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set details), and statistical proof of meeting those criteria is not applicable to this document. The provided text describes non-clinical testing to support the device's safety and effectiveness for a wound dressing, not a study involving AI/ML performance metrics.

However, I can extract the relevant information regarding the performance data and the conclusion drawn from it within the context of a 510(k) submission for this type of device.

Here's a breakdown based on the provided document, addressing the prompts where information is available or indicating its absence/non-applicability:

The provided document describes the 510(k) clearance for a wound dressing called Bonvadis®. This process primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria via a clinical comparative effectiveness study, especially not for an AI/ML device. The "performance data" mentioned refers to non-clinical tests.

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

The document does not present quantitative acceptance criteria in the typical sense of an AI/ML medical device performance study (e.g., sensitivity, specificity thresholds). Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness comparable to predicate devices. The "reported device performance" is that the device meets the criteria of these tests.

Feature/Test	Acceptance Criteria (Implied: Comparable to Predicate/Standard)	Reported Device Performance
Shelf-life stability	Maintain properties over time within specifications.	Performed; results meet criteria as per USP.
In-use stability	Maintain properties during and after typical use by consumer.	Performed; results meet criteria as per USP.
Transepidermal water loss (TEWL)	Likely demonstrates ability to maintain skin barrier / moist wound environment similar to predicate devices.	Performed.
Water retention capacity	Demonstrates ability to maintain a moist wound environment.	Performed.
Biocompatibility tests	Meets ISO 10993 standards for biological safety (e.g., cytotoxicity, sensitization, irritation).	Performed; "Biocompatibility evaluation" was done.
Toxicological risk assessment	Absence of unacceptable toxicological risk.	Performed.
Usability	Clear instructions, ease of application/use for the intended user (healthcare professional).	Performed.
Transportation tests	Withstands transportation conditions without degradation or damage.	Performed.
pH value	Within an acceptable range, likely neutral, similar to predicates.	Conducted; "results meet the criteria as per USP<51>." (Note: USP<51> is for preservative efficacy, not pH directly, but pH is often a factor)
Microbial limit (per USP<61> and USP<62>)	Below specified microbial contamination levels.	Conducted; "results meet the criteria as per USP<51>." (Again, USP<51> is for preservative efficacy, implying effective preservation against microbial growth).
Weight	Consistent product weight.	Conducted.
Viscosity	Consistent semi-viscous formulation.	Conducted.
Water loss rate	Consistent with maintaining a moist wound environment.	Conducted.
Endotoxin testing	Below specified endotoxin limits (important for topical products that may be applied to compromised skin).	Conducted.
Preservative efficacy (as per USP<51>)	Preservatives effectively inhibit microbial growth within the product.	Conducted; "results meet the criteria as per USP<51>."
Overall Safety and Effectiveness (Conclusion)	The device is as safe, effective, and performs as well as the predicate devices.	"Bonvadis has demonstrated that the device is as safe, effective, and performs as well as the predicate devices."

2. Sample sizes used for the test set and the data provenance

The document refers to "non-clinical tests" and does not specify sample sizes in the context of human data or AI/ML test sets. The tests are laboratory-based (e.g., chemical, physical, microbial, biocompatibility). Data provenance is not described in terms of country of origin or retrospective/prospective as it pertains to product testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for chemical, physical, and microbial tests is established by laboratory standards (e.g., USP monographs, ISO standards), not by human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

Not applicable for non-clinical laboratory tests.

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

Not applicable. This is a wound dressing, not an AI-enabled diagnostic or treatment device.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by established laboratory testing methodologies and specifications, such as those outlined in United States Pharmacopeia (USP) standards (e.g., USP<51>, USP<61>, USP<62>) and potentially ISO standards for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable.

In summary, the provided document is a 510(k) clearance for a conventional medical device (wound dressing) and therefore does not contain the information typically associated with the development and validation of an AI/ML-enabled medical device. The "performance data" refers to standard quality control and safety testing of the physical product, not the statistical performance of an algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with "FDA" in a solid blue square and the rest of the text in a lighter shade of blue.

June 7, 2024

StemCyte Inc. Angel Hsieh Regulatory Affairs Manager 13800 Live Oak Avenue Baldwin Park, California 91706

Re: K232655 Trade/Device Name: Bonvadis® Regulatory Class: Unclassified Product Code: FRO

Dear Angel Hsieh:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 22, 2024. Specifically, FDA is updating this SE Letter as an administrative correction to the clearance letter, as it was not signed by/for the Assistant Director.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, Ph.D., OHT4: Office of Surgical and Infection Control Devices 301-796-6196, yuchieh.chiu@fda.hhs.gov.

Sincerely,

Mustafa A. Mazher -S

for Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 22, 2024

StemCyte Inc. Angel Hsieh Regulatory Affairs Manager 13800 Live Oak Avenue Baldwin Park, California 91706

Re: K232655

Trade/Device Name: Bonvadis® Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2024 Received: April 22, 2024

Dear Angel Hsieh:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpm/pm.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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

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Indications for Use

510(k) Number (if known) K232655

Device Name Bonvadis®

Indications for Use (Describe)

Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.

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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510(k) Summary

1. General Information
FDA Submission Document No: K232655
510(k) Submitter:	StemCyte Inc.
Address:	13800 Live Oak Avenue, Baldwin Park, CA 91706, USA
Tel:	+1 626 6462457
Submission Contact Person:	Angel Hsieh
	angel.hsieh@stemcyte.com.tw

May. 21, 2024

1. Device Information
  Device Name: Bonvadis® Classification Name: Dressing, Wound, Drug Common Name: Wound Dressing Product Codes: FRO Regulation Number: Unclassified
1. Predicate Devices
  Bonvadis Topical Cream cleared under K212554 on Aug. 19, 2022. BIAFINE Topical Cream cleared under K173549 on Aug.13, 2018.

Product Description 4.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

5. Indications for Use

Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.

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1. Summary of Technological Characteristics
  Bonvadis® and BIAFINE products are non-sterile water based, preserved, semi-viscous formulations which have similar indications for use and storage. All three products retain a neutral pH, and are used topically in addition both contain humectant and emollient components which donate moisture to the skin.

Characteristic	Subject Device	Predicate Device	Predicate Device
	K232655	K212554	K173549
Intended Use	A wound dressing whichcreates a moist woundenvironment necessary tothe healing process	Identical as subjectdevice	Identical as subjectdevice
Rx Indications for Use	Under the direction of ahealthcare professional,the Rx product isindicated for themanagement of partialthickness wounds, closedpost-surgical wounds,and 1st and superficial2nd degree burns.	-	BIAFINE is indicated forthe management offull thickness wounds,pressure sores,dermal ulcers includinglower leg ulcers,radiation dermatitis,donor sites and 2nddegree burns.BIAFINE may also beused for relief of itch,pain and burning fromminor skin irritations,lacerations, abrasionsand minor burns.
OTC indications for Use	-	For Over-the-CounterUse: Bonvadis® isindicated for themanagement of minorskin lacerations,abrasions, cuts, andminor burns.	BIAFINE is indicated formanagement ofsuperficial wounds suchas minor cuts, minorscrapes, minor irritations,minor abrasions, minorblisters, 1st degree burnsincluding sunburns,minor skin irritationsfollowing post nonablative laser therapyprocedures,microdermabrasiontherapy or superficialchemical peels.
			BIAFINE may also beused for relief of itch,pain and burning fromminor skin irritations,lacerations, abrasionsand minor burns.
Sterility Claim	Non-sterile	Identical as subjectdevice	Identical as subjectdevice
Mechanism of Action	Provides a moist woundenvironment that isconducive to healingprocess	Identical as subjectdevice	Identical as subjectdevice
Delivery System	Topical use on thesurface of the wound	Identical as subjectdevice	Identical as subjectdevice

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7. Performance Data

Non-clinical tests including Shelf-life stability, In use stability, Transepidermal water loss (TEWL), Water retention capacity test, Biocompatibility tests and toxicological risk assessment, usability and Transportation tests were performed to support the safety and effectiveness to be substantial equivalence with predicate devices. pH value, Microbial limit per USP<61> and USP<62>, Weight, Viscosity, Water loss rate, and Endotoxin testing were conducted to support the Shelf life and In-Use study data and preservative efficacy as per USP<51> and the results meet the criteria as per USP<51>.

Conclusion 8.

In accordance with non-clinical test results, including shelf-life stability, in-use stability, TEWL, water retention capacity, biocompatibility evaluation, toxicological risk assessment, usability, transportation, quality inspections, and preservative effectiveness tests, Bonvadis has demonstrated that the device is as safe, effective, and performs as well as the predicate devices.

Regulation Number and Section

N/A