(270 days)
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a topical cream for wound management, with no mention of AI or ML.
Yes.
The document states that BIAFINE is indicated for the "management" and "relief of itch, pain and burning" for various wounds and skin irritations, which are therapeutic claims. It also references clinical studies showing its effectiveness in wound management and symptom relief.
No
Explanation: The provided information describes BIAFINE as a topical cream used for the management and relief of various skin conditions and wounds. Its purpose is therapeutic (treatment and symptom relief), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a "white oil-in-water cream" and lists chemical ingredients, indicating it is a topical drug or medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of various types of wounds and skin irritations. This involves applying the product topically to the skin for therapeutic purposes.
- Device Description: The device is described as a topical cream with a list of ingredients.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is applied to the body, not used to test samples from the body.
Therefore, BIAFINE Topical Cream falls under the category of a topical wound management product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OTC Indications and Usage:
BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, 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, abrasions and minor burns.
RX Indications and Usage:
BIAFINE is indicated for 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, abrasions and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject of this 510(k) submission is for the BIAFINE Topical Cream which is substantially equivalent to the predicate. BIAFINE Topical Cream is identical to the formulation, intended use, technology and the performance of the existing product currently commercialized.
Ingredients: 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.
BIAFINE is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Non-Clinical Performance Data:
Non-clinical testing was conducted to support the safety and effectiveness of BIAFINE Topical Cream. An in-use study was performed to support the shelf-life of opened product. Preservative effectiveness testing of BIAFINE Topical cream conducted as per USP . The preservative effectiveness of BIAFINE Topical Cream meet USP criteria. pH, Residual testing. Sulfated Ash. Viscosity and Water Content limit testing were conducted to support the In-Use study data and preservative efficacy as per USP and the results meet the criteria as per USP .
Clinical Performance Data:
Clinically, the expanded use of BIAFINE OTC for cosmetic procedures and blister indications and the current general use of the marketed BIAFINE is the same: to aid the natural wound healing process by providing an optimum moist environment. Cosmetic procedures such as post-laser therapy, chemical peeling and dermabrasion treatment stimulate like wound healing processes as each of these procedures enhance skin rejuvenation to fight signs of skin aging as well as treat various dermatologic pathologies. such as acne, melasma, and photodamage. Whether a wound is acute or chronic, caused by pressure or burns, scientists and medical professionals recognize that a moist environment can support the natural process of wound healing in all types of wounds. Therefore, the same data and results from BIAFINE prescription (Rx) product on wound healing as well as published literature on the benefits of BIAFINE in various wound types including minor blisters and minor skin irritations following post non-ablative laser therapy procedures, are considered applicable for support of expanded indications of BIAFINE for OTC (over the counter) use.
Multiple independent clinical studies have been reported in the scientific literature on BIAFINE. BIAFINE has been shown effective in wound management of post non-ablative laser procedures, chemical peeling and minor wounds, skin irritation, and blisters, as well as relief of wound symptoms, such as burning, pain and itch.
The results of the published studies on post laser treatment with BIAFINE showed successful management of the side effects (both signs and symptoms) from phototherapy, including crusting, redness, and temporary discomfort. A blinded pilot study evaluated erythema, edema and scarring with BIAFINE use post-laser treatment. In another study, BIAFINE was used post 3DEEP non-ablative skin tightening treatment followed by a Fractional skin resurfacing treatment. There were no incidences of infections, scarring, hyper/ hypopigmentation, or any other serious complications or any unexpected adverse effects were detected or reported. BIAFINE was tested in a single-center, split-face, double-blind, randomized trial comparing reduction of post treatment redness and peeling versus petrolatum ointment (PBO) after the Microlaser Peel procedure and a treatment with a 2940nm Er:YAG laser. In this study, BIAFINE achieved a reduction in redness and peeling and appears to be equivalent to PBO in resolving redness and peeling produced by MicroLaserPeel procedures.
Published results from a randomized, single-center, double-blind, split-face clinical study evaluated BIAFINE compared to a placebo cream in 20 volunteers after 5-ALA (aminolevulinic acid) and PDT (photodynamic therapy) treatment. This study also evaluated subjective assessments for itching and tenderness. The assessments showed that BIAFINE topical emulsion appeared to be equivalent on itching, tenderness and peeling at Week 1. Relief of pain and itch from BIAFINE was also shown in several radiation dermatitis studies. One study compared BIAFINE versus petrolatum as supportive care for patients with head and neck cancer (HNSCC) undergoing radiation therapy with concurrent chemotherapy. The study was conducted to assess the anticipated skin reactions and subjective symptoms that regularly involve pain and itch (the same symptoms of pain, itch and burn that are associated with superficial wounds, minor abrasions, 1st degree burns, including sunburns) and blisters, one of the signs of radiation dermatitis. The study showed the use of BIAFINE can effectively manage the acute irradiation induced dermal injury and associated symptoms.
The collective safety data and the in-use clinical testing results found in the literature on blisters, relief of pain, itch, burn, and in non-ablative, chemical peel and dermabrasion procedures, demonstrates that the predicate devices (BIAFINE (510(k) K964240), OxyBand (510(k): K043063), Microcyn Plus Skin and Wound Hydrogel (510(k) K153648) and Sockit Dermal Gel (510(k) K090092) and the subject (BIAFINE OTC) device can be used effectively for the added indications.
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.
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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 13, 2018
Valeant Pharmaceuticals Esha Desai Senior Manager Regulatory Affairs 400 Somerset Corporate Boulevard Bridgewater, NJ 08807
Re: K173549 Trade/Device Name: Biafine Regulatory Class: Unclassified Product Code: FRO Dated: July 9, 2018 Received: July 11, 2018
Dear Esha Desai:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
1
manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K173549
Device Name BIAFINE
Indications for Use (Describe)
OTC Indications and Usage:
BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, 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, abrasions and minor burns.
RX Indications and Usage:
BIAFINE is indicated for 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, 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 reqarding 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
1 510(k) SUMMARY
1. General Information
| Submitter: | Contact Person: |
|---|---|
| Valeant Pharmaceuticals | Esha Desai |
| 1400 North Goodman Street | 400 Somerset Corporate Blvd. |
| Rochester, NY 14609 | Bridgewater, NJ 08807 |
| General Telephone: 585-338-5800 | 908-541-3273 |
| Esha.Desai@valeant.com |
Preparation Date: August 13, 2018
-
- Names
| Device Name | BIAFINE Topical Cream |
|---|---|
| Classification Name | Dressing, Wound and Burn, Hydrogel W/Drug And/Or Biologic |
| 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. |
Reference Device OxyBand cleared under K043063 on March 24, 2005
-
- Product Description
The subject of this 510(k) submission is for the BIAFINE Topical Cream which is substantially equivalent to the predicate. BIAFINE Topical Cream is identical to the formulation, intended use, technology and the performance of the existing product currently commercialized.
- Product Description
Ingredients: 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.
4
BIAFINE is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure.
-
- Indications for Use
Rx Indications and Usage:
BIAFINE is indicated for 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:
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.
-
- Summary of Technological Characteristics
The technological characteristics of the BIAFINE Topical Cream are substantially equivalent to those of the predicate devices. All three products are non-sterile water based, preserved, semi-viscous formulations which have similar indications for use and storage. BIAFINE and Microcyn 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
| | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Reference
Device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject
Device
BIAFINE
Topical Cream | K964240
BIAFINE
Topical Cream | K153648
Microcyn Skin
& Wound
Hydrogel | K090092
Sockit
Dermal Gel | Reference
Device
OxyBand
(K043063) |
| Intended Use | A wound
dressing which
creates a moist
wound
environment
necessary to
the healing
process. | Identical as
subject device | Identical as
subject device | Identical as
subject device | Identical as
subject device |
| Rx
Indications for
Use | BIAFINE is
indicated for
the
management
of: | BIAFINE is
intended to be
used as a
wound
dressing for
the following | Under the
supervision of a
health care
professional
Microcyn Plus
Wound Gel is | This product
provides for the
management of
and relieves the
pain associated
with all types of | The
Prescription
OxyBand TM
Wound
Dressings are
intended to |
| • Full
Thickness
Wounds
• Pressure
Sores
• Dermal
Ulcers
including
lower leg
ulcers
• Radiation
Dermatitis
• Donor Sites
2nd Degree
burns
BIAFINE may
also be used
for relief of
itch, pain and
burning from
minor skin
irritations,
lacerations,
abrasions and
minor burns. | indications:
Superficial
wounds
Minor
Abrasions
Leg Ulcers
Donor Sites
1st and 2nd
degree burns,
including
sunburn
Radiation
Dermatitis
Dermal ulcers
Full Thickness
Wounds
Pressure Sores | intended for the
management of
post non
ablative laser
therapy
procedures, post
microdermabras
ion therapy and
following
superficial
chemical peels.
Microcyn Plus
Wound Gel
may also be
used to relieve
itch and pain
from minor skin
irritations,
lacerations,
abrasions and
minor burns. | dermal wounds,
skin sores,
injuries and
ulcers of the
skin.
Examples
include:
• All types of
dermal wounds,
skin sores,
injuries and
ulcers of the
skin
• First &
Second degree
burns
• Pressure
ulcers, stages I - IV
• Stasis ulcers
• Diabetic
ulcers
• Radiation
dermatitis
• Post-surgical
incision
• Surgical sites,
including soft
tissue graft sites
• Foot ulcers
• Venous stasis
ulcers
• Cuts &
Abrasions
• Partial
thickness
wounds
• Irritation of
the skin
• Itching
• Sunburn
• Skin condition
associated
periostomy care
• Chemical peel
• Tattooing
procedures
• Irritation and
pain following
skin Laser
resurfacing
treatment
• Irritation and | provide a
moist
environment to
facilitate the
normal wound
healing
process.
OxyBand ™
Wound
Dressings can
be used to
cover and
protect
wounds and
catheter sites
or used as a
secondary
dressing for
other wound
products such
as gauze,
alginates,
hydrogels,
debridement
facilitators, or
a protective
cover over at
risk skin. The
OxyBand ™
Wound
Dressings are
indicated for:
• Clean
closed
surgical
incisions
• Skin graft
donor
sites
• Stage I or
II pressure
ulcers,
pressure
sores,
Superficial wounds
such
as abrasions,
skin tears, and
blisters,
lacerations
• First and
second | |
| | | | | pain following
dermabrasion
therapy | degree
burns
• Chafed
skin, skin
continuou
sly
exposed to
moisture
• Secondary
dressing
over
gauze,
alginates or
hydrogels |
| OTC
Indications for
Use | BIAFINE is
indicated for
management
of
• Superficial
Wounds such
as minor cuts,
minor scrapes,
minor
irritations,
minor
abrasions and
minor blisters
• 1st Degree
burns,
including
sunburns
• Minor skin
irritations
following post
non ablative
laser therapy
procedures,
microdermabr
asion 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. | Same as Rx
indications in
clearance
letter. | Microcyn Plus
Wound Gel is
intended for the
management of
minor skin
irritations
following post
non ablative
laser therapy
procedures,
microdermabras
ion therapy or
superficial
chemical peels.
Microcyn Plus
Wound Gel
may also be
used to relieve
itch and pain
from minor skin
irritations,
lacerations,
abrasions and
minor burns | This product
provides for the
management of
and relieves the
pain associated
with all minor
dermal wounds,
minor skin
sores, minor
injuries and
minor irritations
of the skin.
Examples
include:
• Minor burns
• Minor Cuts &
Abrasions
• Superficial
itching
• Sunburn
• Minor burns
from a chemical
peel treatment
• Minor
irritation and
pain following
tattooing
procedures
• Minor
irritation and
pain following
skin laser
resurfacing
treatment
• Minor
irritation and
pain following
dermabrasion
therapy | The Over-The-
Counter
OxyBand™ W
ound
Dressings are
intended
to protect
light to
moderate
wounds,
including skin
tears, scrapes,
minor pressure
sores,
abrasions,
blisters,
lacerations,
minor bums, to
protect chafed
or irritated
skin or
skin
continuously
exposed to
moisture, and
to create a
moist
environment
for
wound
healing |
| Sterility Claim | Non-sterile | Identical as
subject device | Identical as
subject device | Non-sterile
Natural
Preservative
Gel from food
grade
components | Identical as
subject device |
| Mechanism of
Action | Maintains a
moist wound
environment' | Identical as
subject device | Identical as
subject device | Identical as
subject
device | Supplies
oxygen to the
wound |
| Delivery
System | Topical Cream | Identical as
subject device | Topical
Hydrogel | Topical
Hydrogel | permeable gas
emitting
reservoir |
Premarket Notification Traditional 510(k)
5
6
Premarket Notification Traditional 510(k)
BIAFINE Topical Cream
7
8
-
- Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that BIAFINE Topical Cream is substantially equivalent to the predicate devices.
- Safety and Effectiveness Information
-
- Performance Data
Non-Clinical Performance Data:
- Performance Data
Non-clinical testing was conducted to support the safety and effectiveness of BIAFINE Topical Cream. An in-use study was performed to support the shelf-life of opened product. Preservative effectiveness testing of BIAFINE Topical cream conducted as per USP . The preservative effectiveness of BIAFINE Topical Cream meet USP criteria. pH, Residual testing. Sulfated Ash. Viscosity and Water Content limit testing were conducted to support the In-Use study data and preservative efficacy as per USP and the results meet the criteria as per USP .
Clinical Performance Data:
Clinically, the expanded use of BIAFINE OTC for cosmetic procedures and blister indications and the current general use of the marketed BIAFINE is the same: to aid the natural wound healing process by providing an optimum moist environment. Cosmetic procedures such as post-laser therapy, chemical peeling and dermabrasion treatment stimulate like wound healing processes as each of these procedures enhance skin rejuvenation to fight signs of skin aging as well as treat various dermatologic pathologies. such as acne, melasma, and photodamage. 12 Whether a wound is acute or chronic, caused by pressure or burns, scientists and medical professionals recognize that a moist environment can support the natural process of wound healing in all types of wounds. 34 Therefore, the same data and results from BIAFINE prescription (Rx) product on wound healing as well as published literature on the benefits of BIAFINE in various wound types including minor blisters and minor skin irritations following post non-ablative laser therapy procedures, are considered applicable for support of expanded indications of BIAFINE for OTC (over the counter) use .
Multiple independent clinical studies have been reported in the scientific literature on BIAFINE. BIAFINE has been shown effective in wound management of post non-ablative laser procedures, 3,5,6,7,8,9,10 chemical peeling | and minor wounds, skin irritation, 177 10,11,12,13,14, and blisters,11,12,14,15 as well as relief of wound symptoms, such as burning, pain and itch.7,11,12,13,14,15
The results of the published studies on post laser treatment with BIAFINE showed successful management of the side effects (both signs and symptoms) from phototherapy, including crusting, redness, and temporary discomfort.7 A blinded pilot study evaluated erythema, edema and scarring with BIAFINE use post-laser treatment. 8 In another study, BIAFINE was used post 3DEEP non-ablative skin tightening treatment followed by a Fractional skin
9
resurfacing treatment. There were no incidences of infections, scarring, hyper/ hypopigmentation, or any other serious complications or any unexpected adverse effects were detected or reported. BIAFINE was tested in a single-center, split-face, double-blind, randomized trial comparing reduction of post treatment redness and peeling versus petrolatum ointment (PBO) after the Microlaser Peel procedure and a treatment with a 2940nm Er:YAG laser. In this study, BIAFINE achieved a reduction in redness and peeling and appears to be equivalent to PBO in resolving redness and peeling produced by MicroLaserPeel procedures.10
Published results from a randomized, single-center, double-blind, split-face clinical study evaluated BIAFINE compared to a placebo cream in 20 volunteers after 5-ALA (aminolevulinic acid) and PDT (photodynamic therapy) treatment. This study also evaluated subjective assessments for itching and tenderness. The assessments showed that BIAFINE topical emulsion appeared to be equivalent on itching, tenderness and peeling at Week 1.13 Relief of pain and itch from BIAFINE was also shown in several radiation dermatitis studies. One study compared BIAFINE versus petrolatum as supportive care for patients with head and neck cancer (HNSCC) undergoing radiation therapy with concurrent chemotherapy. The study was conducted to assess the anticipated skin reactions and subjective symptoms that regularly involve pain and itch (the same symptoms of pain, itch and burn that are associated with superficial wounds, minor abrasions, 1st degree burns, including sunburns) and blisters, one of the signs of radiation dermatitis. The study showed the use of BIAFINE can effectively manage the acute irradiation induced dermal injury and associated symptoms. 14
16
The collective safety data and the in-use clinical testing results found in the literature on blisters, relief of pain, itch, burn, and in non-ablative, chemical peel and dermabrasion procedures, demonstrates that the predicate devices (BIAFINE (510(k) K964240), OxyBand (510(k): K043063), Microcyn Plus Skin and Wound Hydrogel (510(k) K153648) and Sockit Dermal Gel (510(k) K090092) and the subject (BIAFINE OTC) device can be used effectively for the added indications.
References
-
- Monheit. G. Chemical Peels. Skin Therapy Letter.com. Available at http://www.skintherapyletter.com/2004/9.2/2.html. Accessed September 25, 2017.
-
- American Society for Dermatologic Surgery. Treatments and Procedures. Available at https://www.asds.net/Treatments/. Accessed September 25, 2017.
-
- Field FK, Kerstein, MD. Overview of wound healing in a moist environment. Am J Surg. 1994; 167(1A):2S-6S.
10
-
- Atiyeh BS, Ioannovich J, Al-Amm CA, El-Musa KA. Management of acute and chronic open wounds: the importance of moist environment in optimal wound healing. Curr Pharm Biotechnol. 2002; 3(3):179-95.
-
- Brauer JA, Alabdulrazzaq H, Bae YS, Geronemus RG. Evaluation of a low energy, low density, non-ablative fractional 1927 nm wavelength laser for facial skin resurfacing. J Drugs Dermatol. 2015; 14(11):1262-7.
-
- Laubach HJ, Tannous Z, Anderson RR, et al. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006; 38:142-9.
-
- Shamban AT. Combination hand rejuvenation procedures. Aesthet Surg J. 2009; 29(5):409-13.
-
- Polder KD, Bruce S. Treatment of melasma using a novel 1,927-nm fractional thulium fiber laser: a pilot study. Dermatol Surg. 2012; 38(2):199-206.
-
- Elman M, Frank I, Cohen-Froman H, Harth Y. Effective treatment of atrophic and icepick acne scars using deep non-ablative radiofrequency and multisource fractional RF skin resurfacing. J Cosmetics, Dermatol Sci and Appl. 2012; 2; 267-272.
-
- Gold MH. A single-center, split-face, double-blind, randomized trial comparing reduction of post treatment redness achieved with a trolamine-containing topical emulsion versus petrolatum ointment after microlaser peel therapy. Conference paper presented at American Society for Laser Medicine and Surgery. 2007
-
- Spitalier J, Amalric R, Value of Biafine in the Prevention and Treatment of Immediate Skin Reaction Following Radiotherapy. Marseille, France: Centre Regional De Lutte Contre Le Cancer: 1973:11.
-
- Wang R, Wu F, Wang D, Liu K. Clinical Effect of Biafine in Preventing and Treating Radioactive Skin Destruction of Nasopharyngeal Carcinoma Patients Caused by Concurrent Intensity-Modulated Radiotherapy and Chemotherapy. Chin. J. Clin. Oncol. 2008; 5:58-63.
-
- Garcia B. Goldman M. Gold M. Comparison of Pre- and/or Postphotodynamic Therapy and Intense Pulsed Light Treatment Protocols for the Reduction of Postprocedure-Associated Symptoms and Enhancement of Therapeutic Efficacy. J Drugs in Derm. 2007; 6(9):924-928.
-
- Abbas H, Bensadoun R, Trolamine Emulsion for the prevention of radiation dermatitis in patients with squamous cell carcinoma of the head and neck. Support Care Cancer. 2012: 20(1):185-90.
-
- Amalric R, Robert F, Report on Post-Marketing Therapeutic Experience with Biafine in Radiotherapy. Marseille, France: Department of Radiotherapy at Polyclinique Clairval; 1992:7.
-
- Data on file.
-
- Conclusion
11
BIAFINE Topical Cream shares similar indications for use, identical formulation, manufacturing process, design features, and functional features, and thus is substantially equivalent to, the predicate device BIAFINE. Additionally, Preservative Efficacy testing and In-Use study has been conducted to ensure the substantial equivalenceof the product. Thus, the proposed new indications and updated labeling does not adversely affect the performance of BIAFINE.
BIAFINE is substantially equivalent in intended use, technological characteristics and safety and efficacy to the Microcyn Plus Hydrogel (K153648) and Sockit Dermal Gel (K090092), and is therefore substantially equivalent.