(265 days)
Not Found
No
The device description and performance studies focus on the chemical formulation and physical properties of a topical cream, with no mention of AI or ML.
Yes
The device is indicated for the management of wounds and burns, and its formulation is designed to maintain a moist wound environment conducive to healing, which directly addresses a medical condition to restore health.
No
Explanation: The device is described as a formulation intended to maintain a moist wound environment for healing, not for diagnosing a condition.
No
The device description clearly states it is a "non-sterile water based, preserved, semi-viscous formulation" and lists chemical ingredients, indicating it is a physical product (a cream or ointment) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds and burns, which are conditions treated topically. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a topical formulation (cream/ointment) applied to the skin. IVDs are typically reagents, instruments, or kits used in a laboratory or point-of-care setting to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The product's function is to create a moist wound environment to aid healing.
Therefore, based on the provided text, Bonvadis® is a topical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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"
2
(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.
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/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,
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
4
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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5
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
-
- Device Information
Device Name: Bonvadis® Classification Name: Dressing, Wound, Drug Common Name: Wound Dressing Product Codes: FRO Regulation Number: Unclassified
- Device Information
Product Description 4.
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 thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.
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.
- Summary of Technological Characteristics
| Characteristic | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| K232655 | K212554 | 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, 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. | |||
| OTC indications for Use | - | For Over-the-Counter | |
| Use: Bonvadis® is | |||
| indicated for the | |||
| management of minor | |||
| skin lacerations, | |||
| abrasions, cuts, and | |||
| minor burns. | BIAFINE is indicated for | ||
| management of | |||
| superficial wounds such | |||
| as minor cuts, minor | |||
| scrapes, minor irritations, | |||
| minor abrasions, minor | |||
| blisters, 1st degree burns | |||
| including sunburns, | |||
| minor skin irritations | |||
| following post non | |||
| ablative laser therapy | |||
| procedures, | |||
| microdermabrasion | |||
| therapy or superficial | |||
| chemical peels. | |||
| 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
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 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.
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.