Under the supervision of a healthcare professional, NUTRASEB Facial Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. NUTRASEB Facial Cream helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Device Description

NUTRASEB Facial Cream is a non-sterile, steroid-free, fragrance-free, water-based emulsion for the management of the signs and symptoms of seborrheic dermatitis which is presented for prescription use. NUTRASEB Facial cream is supplied in a polyethylene tube. Two 50 gram polyethylene tubes will be packaged together within a single carton.

AI/ML Overview

This document describes the regulatory approval for a topical cream, not a medical device that uses AI or goes through extensive clinical trials for performance beyond safety and substantial equivalence to a predicate device. Therefore, many of the requested details about acceptance criteria, study methodologies for AI/imaging devices, expert involvement, and ground truth establishment are not applicable.

However, I can extract the relevant information from the provided document regarding the product's performance and the basis for its approval.

Here's an interpretation based on the provided text:

The document is a 510(k) Premarket Notification from the FDA regarding the "NUTRASEB Facial Cream". This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device's efficacy through extensive clinical performance studies. Performance data in this context is primarily related to safety and confirming the new device's similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a topical cream, the "acceptance criteria" are not related to diagnostic accuracy or AI performance metrics. Instead, they pertain to safety and equivalence to the predicate.

Acceptance Criteria (Implied for 510(k) equivalence)	Reported Device Performance (NUTRASEB Facial Cream)
Safety: Non-toxic, non-irritating, non-sensitizing	Cytotoxicity: Not cytotoxic (Agar diffusion; ISO 10993-5:2009)
	Dermal Irritation: "Slightly irritant" in rabbits
	Sensitization Potential: Mildly sensitizing in guinea pigs
	Toxicological Analysis: Safety corroborated by toxicological analysis of components
	Clinical Safety: Rare reports of skin sensitivity; does not appear to induce phototoxicity or photoallergy reaction
Stability: Chemical and microbiological stability over time	Expiration Date: 36 months (closed container), 6 months (after opening) per USP<61>
Equivalence to Predicate: Similar indications for use, design, and materials	Indications for Use: Matches predicate (Promiseb® Topical Cream) for managing seborrhea/seborrheic dermatitis signs/symptoms, maintaining moist skin for healing.
	Design & Materials: Contains similar emollients, humectants, skin conditioning agents, piroctone olamine, and ascorbyl palmitate; non-sterile, water-based emulsion, topical application.

Note: The FDA's determination of substantial equivalence means they believe it is as safe and effective as the predicate device. The "slightly irritant" and "mildly sensitizing" results were acceptable in the context of it being a topical cream for managing a skin condition and balanced against the toxicological analysis and clinical safety observations.

2. Sample Size and Data Provenance

Non-clinical testing:
- Dermal Irritation: Tested in "rabbits" (specific number not given, but typically a small group for this type of test).
- Sensitization Potential: Tested in "guinea pigs" (specific number not given, but typically a small group).
- Cytotoxicity (in vitro): Not applicable to animal or human sample size.
Clinical Performance: "Several clinical tests were conducted," but no specific sample sizes for these tests are provided. The "rare reports of skin sensitivity" suggest this might be based on post-market surveillance data or cumulative safety data from various tests, rather than a single, large-scale controlled clinical trial with a defined sample size for efficacy.
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The context suggests studies were done to support regulatory filing, likely by or for the manufacturer. It's safe to assume these were prospective safety tests conducted specifically for this submission, rather than retrospective analysis of patient data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is not a diagnostic device where expert readers determine ground truth for imaging. The "ground truth" for this product is its chemical properties, biological interactions (safety endpoints), and its ability to relieve symptoms as observed in clinical (safety) studies, which is subjectively reported or objectively measured (e.g., erythema reduction). The experts involved would be toxicologists, dermatologists, and chemists involved in the product's development and safety assessment.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of a set of cases requiring expert review and adjudication for AI performance. Safety data is collected and analyzed by scientific experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specifically for diagnostic imaging devices, often AI-assisted, to compare human reader performance with and without AI assistance. It is not relevant for a topical cream.

6. Standalone Performance (Algorithm Only)

No. This is a topical cream, not an algorithm or an AI device.

7. Type of Ground Truth Used

The "ground truth" for this product's approval is based on:
- Biocompatibility/Safety assays: In-vitro cytotoxicity tests, in-vivo animal irritation and sensitization studies.
- Chemical and Microbiological Stability Data: Laboratory tests confirming the product's shelf life.
- Toxicological Analysis of components.
- Clinical Safety Observations: Reports of skin sensitivity, phototoxicity, and photoallergy reactions, likely from small human safety studies or post-market data.
- Comparison to Predicate Device: The main "ground truth" for a 510(k) is demonstrating that the new device is substantially equivalent to a device already legally marketed for the same intended use.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2016

ISDIN Corp Ms. Karen Kopicko Regulatory Affairs Consult 100 Overlook Center, 2nd Floor Princeton, NJ 08540

Re: K143605

Trade/Device Name: Nutraseb Facial Cream Regulatory Class: Unclassified Product Code: FRO Dated: March 17, 2016 Received: March 18, 2016

Dear Ms. Kopicko:

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) K143605

Device Name NUTRASEB Facial Cream

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for NUTRASEB Facial Cream is provided below.

Device Common Name:	Dressing, Wound
Device Proprietary Name:	NUTRASEB Facial Cream
510(k) Number:	K143605
Submitter:	ISDIN Corp.100 Overlook Center, 2nd FloorPrinceton, New Jersey 08540
Contact:	Karen L Kopicko, Regulatory AffairsISDIN Corp.100 Overlook Center 2nd FloorPrinceton, NJ 08540Phone: (609) 375 2142Fax (609) 375 2001Email: Regulatory.us@isdin.com
Alternate Contact:	Isabel Hereza, Corporate Regulatory AffairsISDIN S.A.Provencals, 3308019, Barcelona, SpainPhone: +34 932 40 20Mobile: +34 690 02 69Fax: +34 93 600 90 47Email: Isabel.Hereza@isdin.com
Date Prepared:	April 05, 2016
Classification Regulation:	Unclassified
Panel:	General & Plastic Surgery
Product Code:	FRO
Predicate Devices:	Sinclair Skin Emulsion (currently marketed asPromiseb® Topical Cream, K050158)

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Indications for Use

Device Description

Comparison of Indications for Use

NUTRASEB Facial Cream shares indications for use with the predicate device, Promiseb® Topical Cream, as both products are steroid-free, fragrance-free, water-based emulsions for the management of the signs and symptoms of seborrhea and seborrheic dermatitis. Both NUTRASEB Facial Cream and the predicate device help relieve dry, waxy skin by maintaining a moist wound environment benefiting the healing process. The proposed Indication for Use for NUTRASEB Facial Cream matches that of Sinclair Skin Emulsion (currently marketed as Promiseb® Topical Cream).

Comparison of Design and Materials

Like the referenced predicate, NUTRASEB Facial Cream contains emollients, humectants, skin conditioning agents, piroctone olamine and ascorbyl palmitate; ingredients known to be helpful in managing the signs and symptoms of seborrhea and seborrheic dermatitis. Both products are non-sterile water-based emulsions, and are applied topically to the affected skin, that upon application form a barrier that enables the skin to stay moist thus being beneficial to the healing process.

Performance Data

The following performance data are provided in support of the substantial equivalence determination.

Non-clinical Performance

Non-clinical testing was conducted to demonstrate the safety of NUTRASEB Facial Cream. Testing included in-vitro test for cytotoxicity (Agar diffusion; ISO 10993-5:2009), dermal

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irritation test in rabbits and test for sensitization potential in guinea pigs (ISO 10993-5:2009). NUTRASEB Facial Cream was not cytotoxic in agar diffusion test. It was "slightly irritant" in rabbits and was mildly sensitizing in guinea pigs. The safety of NUTRASEB Facial Cream is further corroborated by a toxicological analysis of its components.

For the stability studies, the product has undergone chemical and microbiological testing as per USP<61>. The results indicate that in the closed container the product has a 36 month expiration date. Once the tube has been opened the duration of use (expiration date) is 6 months.

Clinical Performance

Several clinical tests were conducted to demonstrate the safety of NUTRASEB Facial Cream. NUTRASEB Facial Cream has been shown to have rare reports of skin sensitivity, and does not appear to induce phototoxicity or photoallergy reaction after application based on available data.

Conclusions

Identical indicated uses, similar technological characteristics and function indicate that NUTRASEB Facial Cream is substantially equivalent to the currently cleared and marketed Promiseb® Topical Cream (cleared under 510(k) K050158 as Sinclair Skin Emulsion). Biocompatibility, non-clinical evidence, supports the substantially equivalent safety of NUTRASEB Facial Cream.

Regulation Number and Section

N/A