(60 days)
Not Found
No
The provided text describes a topical cream for wound management and does not mention any AI models or related technologies (ML, DNN, etc.).
Yes
The device is indicated for the management of various types of wounds, including diabetic foot ulcers and pressure ulcers, which are conditions that require therapeutic intervention for healing. It aims to maintain a moist wound environment, which is conducive for wound healing, thus performing a therapeutic function.
No
Explanation: The "Intended Use" section states that the product is "indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers." The "Device Description" explains that it's a formulation "to maintain a moist wound environment," which is "conducive for wound healing." These descriptions indicate a therapeutic or management function, not a diagnostic one. There is no mention of the device identifying, detecting, or measuring a condition or disease.
No
The device is a non-sterile, semi-viscous topical formulation (a cream) designed to maintain a moist wound environment. It is a physical product with specific chemical ingredients and not a software application. The descriptions of its physical form, ingredients, and the non-clinical tests (e.g., shelf-life, biocompatibility, pH value, viscosity) all indicate it is a physical medical device. There is no mention of software components, algorithms, or digital processing.
No.
The device is a topical cream for wound management and does not involve in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the direction of a healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 and USP, 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 and the results meet the criteria as per USP.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
FDA 510(k) Clearance Letter - Bonvadis®
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 9, 2025
Oneness Biotech Co., Ltd.
Tanya Rhodes
Official Correspondent
35F, No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist.,
Taipei, 100
Taiwan
Re: K251093
Trade/Device Name: Bonvadis®
Regulatory Class: Unclassified
Product Code: FRO
Dated: April 10, 2025
Received: April 10, 2025
Dear Tanya Rhodes:
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/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.
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" (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).
Page 2
K251093 - Tanya Rhodes Page 2
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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K251093 - Tanya Rhodes Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Mustafa A. Mazher -S
For Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of 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
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251093
Device Name: Bonvadis®
Indications for Use (Describe):
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
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)
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:
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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."
Page 5
510(k) Summary
K251093 Page 1 of 3
1. General Information
FDA Submission Document No: K251093
510(k) Submitter: Oneness Biotech Co., Ltd.
Address: 35F., No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City 100, Taiwan, R.O.C.
Tel: +886 2 27031098
Submission Contact Person: Angel Hsieh
angel.hsieh@onenessbio.com.tw
June 2, 2025
2. Device Information
Device Name: Bonvadis®
Classification Name: Dressing, Wound, Drug
Common Name: Wound Dressing
Product Codes: FRO
Regulation Number: Unclassified
3. Predicate Devices
- Bonvadis Topical Cream cleared under K232655 on May 22, 2024.
- BIAFINE Topical Cream cleared under K173549 on Aug.13, 2018.
4. Product 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.
5. Indications for Use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers,
Page 6
K251093 Page 2 of 3
venous stasis ulcers, and pressure ulcers.
6. 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 K251093 | Predicate Device K232655 | Predicate Device K173549 |
|---|---|---|---|
| Intended Use | A wound dressing which creates a moist wound environment necessary to the healing process | Identical as subject device | Identical as subject device |
| Rx Indications for Use | Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. | 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. | BIAFINE is indicated for the management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns. |
| Sterility Claim | Non-sterile | Identical as subject device | Identical as subject device |
| Mechanism of Action | Provides a moist wound environment that is conducive to healing process | Identical as subject device | Identical as subject device |
| Delivery System | Topical use on the surface of the wound | Identical as subject device | Identical as subject device |
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
Page 7
K251093 Page 3 of 3
with predicate devices. pH value, Microbial limit per USP and USP, 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 and the results meet the criteria as per USP.
8. Conclusion
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.