(246 days)
Not Found
No
The device description and intended use clearly describe a topical cream with a list of chemical ingredients. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The product is indicated for the management and relief of various superficial wounds, irritations, and burns, which are therapeutic actions.
No
The device, BIAFINE Topical Cream, is indicated for the management and relief of symptoms from various superficial wounds and skin irritations. It does not perform any diagnostic function to identify or assess a medical condition.
No
The device description clearly states it is a "white oil-in-water cream" and lists chemical ingredients, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BIAFINE Topical Cream is for the management and relief of symptoms associated with superficial wounds and skin irritations. This is a topical application for treating the skin directly.
- Device Description: The description details a cream with various ingredients applied to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition. IVDs are used in vitro (outside the body) for diagnostic purposes.
Therefore, BIAFINE Topical Cream is a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject of this submission is the BIAFINE Topical Cream which is substantially equivalent to the predicate. BIAFINE Topical Cream is identical in formulation, intended use, technology and performance of the existing product currently commercialized.
BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients include Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.
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
Not Found
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)
Previously submitted non-clinical testing, including biocompatibility and (closed tube) shelf life data, continue to support BIAFINE Topical Cream. Additional stability testing was conducted to extend the use-life and support multi-use labeling.
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 shows 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 18, 2019
Bausch Health Americas Incorporated Marci Halevi Director, Regulatory Affairs, Surgical Equipment and Devices 1400 N. Goodman St. 14609 USA Rochester, New York 14609
Re: K190342
Trade/Device Name: BIAFINE Topical Cream Regulatory Class: Unclassified Product Code: FRO Dated: September 19, 2019 Received: September 20, 2019
Dear Marci Halevi:
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
1
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 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,
Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190342
Device Name BIAFINE Topical Cream
Indications for Use (Describe)
OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.
| 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)
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3
510(K) SUMMARY
| General Information | |
|---|---|
| Submitter | Contact Person |
| Bausch Americas, Inc. | |
| 1400 North Goodman Street | |
| Rochester, NY 14609 | |
| General Telephone: 585-338-5800 | Marci Halevi |
| Director, Regulatory Affairs | |
| Surgical Equipment & Devices |
400 Somerset Corporate Boulevard,
Bridgewater, New Jersey 08807
Tel: 908-541-8695
Mobile: 908-952-5174
Email: marci.halevi@bauschhealth.com |
| Preparation Date | October 18, 2019 |
|---|---|
| Device Name | BIAFINE Topical Cream |
| Classification Name | Dressing, Wound, Drug |
| Classification | Unclassified |
| Common Name | Wound Dressing |
| Product Codes | FRO |
Performance Standards
No performance standards for this device have been promulgated under Section 514, Federal Food, Drug and Cosmetics Act.
Predicate Devices
BIAFINE Topical Cream was cleared under K173549 on August 13, 2018
Product Description
The subject of this submission is the BIAFINE Topical Cream which is substantially equivalent to the predicate. BIAFINE Topical Cream is identical in formulation, intended use, technology and performance of the existing product currently commercialized.
BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients include Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil,
4
trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the BIAFINE Topical Cream are substantially equivalent to those of the predicate devices and are summarized in the table below.
| Characteristic | Predicate Device (K173549)
BIAFINE Topical Cream | Subject Device (K190342)
BIAFINE Topical Cream |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | A wound dressing which creates a moist wound
environment necessary to the healing process. | Identical to Predicate
Device |
| OTC
Indications for
Use | BIAFINE Topical Cream 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 Topical
Cream may also be used for relief of itch, pain
and burning from minor skin irritations,
lacerations, abrasions and minor burns. | Identical to Predicate
Device |
| Sterility Claim | Non-sterile, conforming to USP | Identical to Predicate
Device |
| Mechanism of
Action | Maintains a moist wound environment | Identical to Predicate
Device |
| Delivery System | Topical Cream | Identical to Predicate
Device |
| Shelf Life &
Use Life | 12 Month Shelf Life
30 Day Use Life | 12 Month Shelf Life
12 Month Use Life |
5
Performance Data
Previously submitted non-clinical testing, including biocompatibility and (closed tube) shelf life data, continue to support BIAFINE Topical Cream. Additional stability testing was conducted to extend the use-life and support multi-use labeling.
Conclusion
BIAFINE Topical Cream shares the same indications for use, identical formulation, identical manufacturing processes, identical mechanism of action and functional features as the predicate BIAFINE Topical Cream and thus is substantially equivalent to the predicate BIAFINE Topical Cream.
BIAFINE Topical Cream is substantially equivalent in intended use, technological characteristics and safety and effectiveness to the BIAFINE Topical Cream (K173549).