← Product Code FRO · K141637 # SPB SKIN EMULSION (K141637) _Biotd S.A. · FRO · Jun 3, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K141637 ## Device Facts - **Applicant:** Biotd S.A. - **Product Code:** FRO - **Decision Date:** Jun 3, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process. An OTC topical skin care emulsion to relieve the burning and itching associated with many common types of skin irritation. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process. ## Device Story SPB Skin Emulsion is a topical skin care product containing natural extracts; functions as a wound gel to maintain a moist environment for healing; indicated for management of burning and itching associated with dermatoses or skin irritation. Applied topically by patients or clinicians; provides symptomatic relief. No complex processing or electronic components; acts as a physical barrier/moisturizer. Benefits include skin protection and symptom relief. ## Clinical Evidence Double-blind study with limited volunteers with acute contact dermatitis. Compared SPB Skin Emulsion to MimyX™ Cream and a placebo. Daily observations of redness and itching recorded by trained personnel. SPB performed similarly to the predicate with no observable redness or itching; placebo showed no positive effects. ## Technological Characteristics Topical emulsion; ingredients include deionized water, natural African palm oils, copolymer, silver nanoparticles (preservative), and eucalyptus oil (fragrance). Complies with ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (sensitization/irritation). Single-use; non-sterile; 3-year shelf life. ## Predicate Devices - MimyX™ Cream ([K041342](/device/K041342.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures that suggest human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 3, 2015 BioTD, S.A. % Mr. Richard Gillis, Ph.D. Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701 Re: K141637 Trade/Device Name: SPB Skin Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: April 28, 2015 Received: April 30, 2015 Dear Dr. Gillis: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K141637 Device Name SPB Skin Emulsion Indications for Use (Describe) Prescription Use: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allerge contact dermatitis. SPB helps maintain a moist wound & skin environment, which is be healing process. Over-The-Counter Use: An OTC topical skin care emulsion to relieve the burning associated with many common types of skin irritation. SP helps maintain a moist wound & skin environment, which is beneficial to the healing process. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ ## EMERGO GROUP ## 510(k) Summary #### for ### SPB Skin Emulsion #### 1. Submission Sponsor BioTD, S.A. Edificio 26 Condominio Industrial San Jose de Ulloa Heredia Costa Rica Phone: 1 501 868 8300 Fax: N/A Contact: Robin Wiscovitch, Ph.D, Chief Executive Officer #### 2. Submission Correspondent Emergo Group 816 Congress Ave, Suite 1400 Austin, TX 78701 Cell Phone: (406) 579-8124 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Gillis, PhD, Senior Consultant Email: project.management@emergogroup.com #### 3. Date Prepared June 16, 2014 #### 4. Device Identification | Trade/Proprietary Name: | SPB Skin Emulsion | |----------------------------|------------------------------| | Common/Usual Name: | Wound gel | | Classification Name: | Dressing, Wound, Drug | | Classification Regulation: | Not specified | | Product Code: | FRO | | Device Class: | Unclassified (Pre-Amendment) | | Classification Panel: | General & Plastic Surgery | #### 5. Legally Marketed Predicate Device(s) MimyX™ Cream (K041342) {4}------------------------------------------------ ## EMERGO GROUP #### 6. Device Description SPB Skin Emulsion is a topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB Skin Emulsion contains natural extracts to moisturize the skin. #### 7. Rx Indications for Use Statement: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process. #### OTC Indications for Use Statement: An OTC topical skin care emulsion to relieve the burning and itching associated with many common types of skin irritation. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process. #### 8. Substantial Equivalence Discussion The following table compares the SPB Skin Emulsion to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | BioTD, S.A. | Stiefel Laboratories, Inc. | Significant Differences | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Trade Name | SPB Skin Emulsion | MimyX™ Cream | | | 510(k) Number | Not assigned | K041342 | N/A | | Product Code | FRO | MGQ | None | | Regulation Number | Unclassified | Unclassified | None | | Regulation Name | Dressing, Wound, Drug | Dressing, Wound & Burn,
Hydrogel with Drug and/or
Biologic | None | | Indications for Use,
Rx | As a prescription topical
skin care emulsion to
manage and relieve the
burning and itching
experienced with various
types of dermatoses,
including atopic and allergic
contact dermatitis. SPB
helps maintain a moist
wound & skin environment, | Under the supervision of a
healthcare professional,
MimyX Cream is indicated to
manage and relieve the
burning and itching
experienced with various-
types of dermatoses,
including radiation
dermatitis, atopic dermatitis
and allergic contact | None | | | | | Table 5A - Comparison of Characteristics | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer | BioTD, S.A. | Stiefel Laboratories, Inc. | Significant Differences | | | Trade Name | SPB Skin Emulsion | MimyXTM Cream | | | | | which is beneficial to the
healing process. | dermatitis. MirnyX Cream
helps to relieve dry waxy skin
by maintaining a moist
wound & skin environment,
which is beneficial to the
healing process. | | | | Indications for Use,
OTC | An OTC topical skin care
emulsion to relieve the
burning and itching
associated with many
common types of skin
irritation. SPB helps
maintain a moist wound
& skin environment,
which is beneficial to the
healing process. | MirnyX Cream helps to
nourish skin and relieve the
burning and itching
associated with many
common types of skin
irritation. MimyX Cream may
also be used to soothe minor
burns, including sunburn. | None | | | Material | | | | | | Solvent | Deionized water | purified water | None | | | Oils | Natural African palm oils | Olive oil, glycerin, palm
glycerides, vegetable oil,
lecithin, squalene, betaine,
sacrosine, acetamide MEA | Similar; all ingredients are
moisturizers and skin
conditioners. | | | Polymerizing/
Thickening agents | Copolymer | Hydroxyethylcellulose,
sodium carbomer, carbomer,
xanthan gum, Palmitamide
MEA, pentylene glycol (PTG) | Similar; all are common
thickeners, emulsifiers, and
gel and film formers | | | Preservative | Silver nanoparticles | None | Different; The silver
nanoparticles are a
preservative and do not
interact with the skin.
Biocompatibility results
show no effect on safety. | | | Fragrance | Eucalyptus oil | None | Different; Eucalyptus oil is a
natural fragrance added for
marketing purposes only.
Biocompatibility results
show no effect on safety. | | | Sterile | No | No | None | | | Single-Use | Yes | Yes | None | | | Shelf Life | 3 years | 18 months | None | | | Complies with ISO
10993-1 | Yes | Yes | None | | {5}------------------------------------------------ #### bioTD, S.A. Traditional 510(k) Premarket Submission SPB Skin Emulsion ## EMERGO GROUP {6}------------------------------------------------ ## EMERGO GROUP #### 9. Non-Clinical Performance Data The following testing has been performed to support substantial equivalence: - Cytotoxicity Assay (ISO 10993-5:2010). The test product extract showed no cytotoxic potential. - Sensitization Test (ISO 10993-10:2012). The test substance was non-sensitizing. - Irritation Test (ISO 10993-10:2012). SPB Skin Emulsion was determined to be non-irritating. As part of demonstrating safety and effectiveness of SPB Skin Emulsion and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, BioTD, S.A. completed a number of tests. The SPB Skin Emulsion meets all the requirements for overall design and biocompatibility, which confirm that the outputs meets the design inputs and specifications. The SPB Skin Emulsion passed all testing stated above as shown by the acceptable results obtained. #### 10. Clinical Performance Data There are no new innovative aspects that have been introduced with this device. Clinical testing was performed only to establish substantial equivalence to the predicate device. Performance of SPB Skin Emulsion was compared that of the predicate MimyX™ Cream. A double-blind study was designed with a limited number of volunteers with acute contact dermatitis. Daily observations of redness and itching were recorded by trained personnel after exposure to a known allergen during routine work-related activities. SPB Skin Emulsion performed similarly to the predicate with no observable events of either redness or itching, and the placebo showing no positive effects. These types of devices, including the predicate, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. #### 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. lt has been shown in this 510(k) submission that the differences between the SPB Skin Emulsion and the predicate device do not raise any questions regarding its safety and effectiveness. The SPB Skin Emulsion, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device. --- **Source:** [https://fda.innolitics.com/device/K141637](https://fda.innolitics.com/device/K141637) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com