BIAFINE Topical Cream

K190342 · Bausch Health Americas Incorporated · FRO · Oct 18, 2019 · SU

Device Facts

• Record ID: K190342
• Device Name: BIAFINE Topical Cream
• Applicant: Bausch Health Americas Incorporated
• Product Code: FRO · SU
• Decision Date: Oct 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

BIAFINE Topical Cream is a white oil-in-water emulsion wound dressing; supplied in lined aluminum tubes. Device maintains moist wound environment to facilitate healing. Applied topically by patient or caregiver to superficial wounds and minor burns. Acts as physical barrier/moisturizer to provide relief from itch, pain, and burning. No complex electronics or software involved.

Clinical Evidence

No clinical data. Substantial equivalence supported by identical formulation, mechanism of action, and non-clinical performance data (biocompatibility and stability testing).

Technological Characteristics

Oil-in-water topical cream; 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, sorbic acid, propyl paraben, and fragrance. Non-sterile, conforms to USP <51>. Delivery via lined aluminum tubes.

Indications for Use

Indicated for management of superficial wounds (minor cuts, scrapes, irritations, blisters, 1st degree burns/sunburns) and skin irritations following non-ablative laser, microdermabrasion, or chemical peels. Also indicated for relief of itch, pain, and burning associated with minor skin irritations, lacerations, abrasions, and burns.

Predicate Devices

• BIAFINE Topical Cream (K173549)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 510(K) SUMMARY

| General Information | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Contact Person |
| Bausch Americas, Inc.<br>1400 North Goodman Street<br>Rochester, NY 14609<br>General Telephone: [phone] | Marci Halevi<br>Director, Regulatory Affairs<br>Surgical Equipment & Devices<br><br>400 Somerset Corporate Boulevard,<br>Bridgewater, New Jersey 08807<br>Tel: [phone]<br>Mobile: [phone]<br>Email: [e-mail] |

| 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,

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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)<br>BIAFINE Topical Cream | Subject Device (K190342)<br>BIAFINE Topical Cream |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | A wound dressing which creates a moist wound<br>environment necessary to the healing process. | Identical to Predicate<br>Device |
| OTC<br>Indications for<br>Use | BIAFINE Topical Cream is indicated for<br>management of superficial wounds such as<br>minor cuts, minor scrapes, minor irritations,<br>minor abrasions, minor blisters, 1st degree burns<br>including sunburns, minor skin irritations<br>following post non-ablative laser therapy<br>procedures, microdermabrasion therapy or<br>superficial chemical peels. BIAFINE Topical<br>Cream may also be used for relief of itch, pain<br>and burning from minor skin irritations,<br>lacerations, abrasions and minor burns. | Identical to Predicate<br>Device |
| Sterility Claim | Non-sterile, conforming to USP <51> | Identical to Predicate<br>Device |
| Mechanism of<br>Action | Maintains a moist wound environment | Identical to Predicate<br>Device |
| Delivery System | Topical Cream | Identical to Predicate<br>Device |
| Shelf Life &<br>Use Life | 12 Month Shelf Life<br>30 Day Use Life | 12 Month Shelf Life<br>12 Month Use Life |

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### 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).