(349 days)
No
The 510(k) summary describes a topical skin care emulsion and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is an emulsion used to manage and relieve symptoms (burning and itching) associated with various dermatoses, indicating a therapeutic effect.
No
The device is a topical skin care emulsion designed to manage and relieve symptoms of dermatoses, not to diagnose them. Its intended use is treatment and symptom relief.
No
The device is a topical skin care emulsion, which is a physical substance applied to the skin, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage and relieve symptoms (burning and itching) associated with skin conditions (dermatoses). This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: The device is a topical skin care emulsion applied to the skin. It does not involve testing samples of bodily fluids or tissues in vitro (outside the body) to diagnose a condition.
- Anatomical Site: The device is applied to the skin, which is an external application, not an in vitro test.
- Performance Studies: The performance studies focus on the device's ability to relieve symptoms and its biocompatibility (cytotoxicity, sensitization, irritation) when applied to the skin. They do not involve evaluating the device's ability to detect or measure specific analytes or markers for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
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.
Product codes
FRO
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.
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
Prescription Use: Under the supervision of a healthcare professional
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
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.
Non-Clinical Performance Data:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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)
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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
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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.