(246 days)
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.
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.
This document is a 510(k) premarket notification for BIAFINE Topical Cream, seeking a determination of substantial equivalence to a previously cleared predicate device (K173549). It focuses on asserting equivalence rather than presenting novel acceptance criteria or a study to prove new performance.
Therefore, the requested information elements related to distinct acceptance criteria, an independent study, sample sizes for test and training sets, expert involvement, and ground truth establishment are largely not applicable (N/A) in the context of this specific regulatory submission.
The essence of this submission is that:
- The subject device (K190342) is identical in formulation, intended use, technology, and performance to its predicate device (K173549).
- The only difference explicitly mentioned and requiring additional testing is related to extending the use-life of the product.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this submission asserts substantial equivalence based on identical characteristics to a predicate, there are no new distinct acceptance criteria or performance metrics reported for the subject device (K190342) in comparison to the predicate, except for the use-life extension.
| Characteristic | Acceptance Criteria for Predicate (Implied) | Reported Performance for Subject Device (K190342) |
|---|---|---|
| Intended Use | As per Predicate (K173549) | Identical to Predicate |
| OTC Indications | As per Predicate (K173549) | Identical to Predicate |
| Sterility Claim | Non-sterile, conforming to USP <51> | Identical to Predicate |
| Mechanism of Action | Maintains a moist wound environment | Identical to Predicate |
| Delivery System | Topical Cream | Identical to Predicate |
| Shelf Life | 12 Month Shelf Life | 12 Month Shelf Life |
| Use Life | 30 Day Use Life (for Predicate) | 12 Month Use Life (Extended) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not describe a separate "test set" in the context of a comparative performance study against a ground truth for the subject device (K190342), as it's asserting equivalence.
- Sample size for test set: N/A (not a new performance study vs. ground truth)
- Data provenance: "Previously submitted non-clinical testing, including biocompatibility and (closed tube) shelf life data, continue to support BIAFINE Topical Cream." This refers to data supporting the predicate device (K173549). "Additional stability testing was conducted to extend the use-life and support multi-use labeling." This implies prospective laboratory testing for the use-life extension.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of regulatory submission (510(k) for substantial equivalence of a topical cream) typically does not involve expert adjudication or ground truth establishment in the way it would for diagnostic software or image analysis. The "ground truth" for the predicate device's efficacy would have been established through clinical trials or accepted scientific principles, but that is not detailed here for a new study.
4. Adjudication Method
N/A. Not relevant for this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance in diagnostic tasks. This device is a topical cream.
6. Standalone (Algorithm Only) Performance Study
N/A. This is a topical cream, not an algorithm.
7. Type of Ground Truth Used
For the claims about the topical cream's efficacy (e.g., maintaining a moist wound environment, relief of pain), the "ground truth" is based on accepted scientific principles for wound care and potentially clinical data submitted for the predicate device. For the use-life extension, the ground truth is established by stability testing results which would demonstrate that the product remains stable and effective over the extended 12-month use period after opening. The specific details of these stability testing results are not provided in this summary.
8. Sample Size for the Training Set
N/A. Not relevant for this type of medical device (topical cream). The product's characteristics are determined by its formulation and manufacturing process, not trained on data.
9. How the Ground Truth for the Training Set Was Established
N/A. Not relevant.
{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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
{3}------------------------------------------------
510(K) SUMMARY
| General Information | |
|---|---|
| Submitter | Contact Person |
| Bausch Americas, Inc.1400 North Goodman StreetRochester, NY 14609General Telephone: 585-338-5800 | Marci HaleviDirector, Regulatory AffairsSurgical Equipment & Devices400 Somerset Corporate Boulevard,Bridgewater, New Jersey 08807Tel: 908-541-8695Mobile: 908-952-5174Email: 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 woundenvironment necessary to the healing process. | Identical to PredicateDevice |
| OTCIndications forUse | BIAFINE Topical Cream is indicated formanagement of superficial wounds such asminor cuts, minor scrapes, minor irritations,minor abrasions, minor blisters, 1st degree burnsincluding sunburns, minor skin irritationsfollowing post non-ablative laser therapyprocedures, microdermabrasion therapy orsuperficial chemical peels. BIAFINE TopicalCream may also be used for relief of itch, painand burning from minor skin irritations,lacerations, abrasions and minor burns. | Identical to PredicateDevice |
| Sterility Claim | Non-sterile, conforming to USP <51> | Identical to PredicateDevice |
| Mechanism ofAction | Maintains a moist wound environment | Identical to PredicateDevice |
| Delivery System | Topical Cream | Identical to PredicateDevice |
| Shelf Life &Use Life | 12 Month Shelf Life30 Day Use Life | 12 Month Shelf Life12 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).
N/A