(349 days)
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.
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.
The provided text describes the regulatory clearance for "SPB Skin Emulsion" and outlines the studies conducted to demonstrate its substantial equivalence to a predicate device, MimyX™ Cream. However, it does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it report detailed performance values in a table. It also does not involve an AI device.
Therefore, many of the requested fields cannot be extracted or are not applicable.
Here's a breakdown of what can be inferred or explicitly stated based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for reduction in redness or itching) or numerical performance metrics for the device. The "performance" assessment is qualitative, stating that the device "performed similarly to the predicate with no observable events of either redness or itching."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): "a limited number of volunteers"
- Data Provenance: Not explicitly stated, but likely prospective as it involved a "double-blind study" with "daily observations." Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document mentions "daily observations of redness and itching were recorded by trained personnel." It does not specify the number of personnel or their qualifications (e.g., doctors, dermatologists, nurses).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not explicitly stated. It's likely that the "trained personnel" made direct observations, but no formal adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: Not applicable. This is not an AI device or a diagnostic device involving human readers interpreting results. The study was a "double-blind study" comparing a topical emulsion to a predicate.
- Effect size of human readers with/without AI: Not applicable, as no AI is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a topical emulsion, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" was based on clinical observation of "redness and itching" by "trained personnel" after exposure to a known allergen. This falls under outcomes data or clinical endpoints based on expert observation.
8. The sample size for the training set
Not applicable. This is a medical device (topical emulsion) and the studies described are clinical performance and biocompatibility studies, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
Summary of what is available:
- Device Name: SPB Skin Emulsion
- Predicate Device: MimyX™ Cream (K041342)
- Type of Study: Double-blind study with a limited number of volunteers with acute contact dermatitis.
- Performance Claim: "SPB Skin Emulsion performed similarly to the predicate with no observable events of either redness or itching, and the placebo showing no positive effects."
- Ground Truth: Daily observations of redness and itching recorded by trained personnel.
- Non-Clinical Testing:
- Cytotoxicity Assay (ISO 10993-5:2010): "no cytotoxic potential."
- Sensitization Test (ISO 10993-10:2012): "non-sensitizing."
- Irritation Test (ISO 10993-10:2012): "non-irritating."
The document focuses on demonstrating that the device is "substantially equivalent" to an existing predicate device based on intended use, technological characteristics, and safety/effectiveness data primarily derived from non-clinical biocompatibility testing and a small clinical comparison study. It does not provide the kind of detailed quantitative performance metrics typically associated with AI/diagnostic device approvals.
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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
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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)
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)
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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/orBiologic | None |
| Indications for Use,Rx | As a prescription topicalskin care emulsion tomanage and relieve theburning and itchingexperienced with varioustypes of dermatoses,including atopic and allergiccontact dermatitis. SPBhelps maintain a moistwound & skin environment, | Under the supervision of ahealthcare professional,MimyX Cream is indicated tomanage and relieve theburning and itchingexperienced with various-types of dermatoses,including radiationdermatitis, atopic dermatitisand 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 thehealing process. | dermatitis. MirnyX Creamhelps to relieve dry waxy skinby maintaining a moistwound & skin environment,which is beneficial to thehealing process. | |||
| Indications for Use,OTC | An OTC topical skin careemulsion to relieve theburning and itchingassociated with manycommon types of skinirritation. SPB helpsmaintain a moist wound& skin environment,which is beneficial to thehealing process. | MirnyX Cream helps tonourish skin and relieve theburning and itchingassociated with manycommon types of skinirritation. MimyX Cream mayalso be used to soothe minorburns, including sunburn. | None | |
| Material | ||||
| Solvent | Deionized water | purified water | None | |
| Oils | Natural African palm oils | Olive oil, glycerin, palmglycerides, vegetable oil,lecithin, squalene, betaine,sacrosine, acetamide MEA | Similar; all ingredients aremoisturizers and skinconditioners. | |
| Polymerizing/Thickening agents | Copolymer | Hydroxyethylcellulose,sodium carbomer, carbomer,xanthan gum, PalmitamideMEA, pentylene glycol (PTG) | Similar; all are commonthickeners, emulsifiers, andgel and film formers | |
| Preservative | Silver nanoparticles | None | Different; The silvernanoparticles are apreservative and do notinteract with the skin.Biocompatibility resultsshow no effect on safety. | |
| Fragrance | Eucalyptus oil | None | Different; Eucalyptus oil is anatural fragrance added formarketing purposes only.Biocompatibility resultsshow no effect on safety. | |
| Sterile | No | No | None | |
| Single-Use | Yes | Yes | None | |
| Shelf Life | 3 years | 18 months | None | |
| Complies with ISO10993-1 | Yes | Yes | None |
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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.
N/A