Description Rx Product:
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 dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Description OTC Product:
MimyX 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.

Device Description

MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.

AI/ML Overview

This document, a 510(k) Pre-Market Notification for MimyX™ Cream, describes a topical emulsion for managing and relieving symptoms of various dermatoses. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML-based medical devices.

Instead, this submission focuses on "substantial equivalence" to previously cleared devices (Biafine® Wound Dressing Emulsion and Sinclair Wound and Skin Emulsion), which is a common pathway for medical device clearance. The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of MimyXTM Cream and results are satisfactory," but it does not provide the specifics of these tests or their results.

Therefore, for the information requested in your prompt, I can only provide an assessment based on the available text, with the understanding that many of the specific details you're looking for (e.g., sample sizes, expert qualifications, adjudication methods) are not present in this type of regulatory submission.

Here's an attempt to answer your questions based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety:	"Functional and performance testing has been conducted to assess the safety... and results are satisfactory."
	(Specific safety endpoints, metrics, or thresholds are not provided.)
Efficacy:	"Functional and performance testing has been conducted to assess the... efficacy of MimyX™ Cream and results are satisfactory."
"Manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis."	(Specific efficacy endpoints, metrics, or thresholds are not provided.)
"Helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process."	(Specific efficacy endpoints, metrics, or thresholds are not provided.)
Comparison to Predicate Devices: "Substantially equivalent" to Biafine® Wound Dressing Emulsion (K964240) and Sinclair Wound and Skin Emulsion (K024367) in terms of being non-sterile topical emulsions that relieve symptoms of various dermatoses.	This is the primary "performance" claim: equivalence in mechanism and intended use. No quantitative performance metrics are provided for direct comparison.

2. Sample size used for the test set and the data provenance

Not Available. The document does not describe a clinical trial or a test set in the context of an AI/ML algorithm. It mentions "functional and performance testing" but provides no details on participant numbers, study design, or data origin (e.g., country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable/Not Available. This information relates to the establishment of ground truth for a diagnostic or prognostic device, typically through expert review of data. MimyX™ Cream is a topical therapeutic emulsion, and the regulatory submission pathway (510(k) substantial equivalence) does not typically require this type of ground truth establishment.

4. Adjudication method for the test set

Not Applicable/Not Available. As above, this concept doesn't apply to this type of device and submission.

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

Not Applicable/Not Available. MimyX™ Cream is a product (cream), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Available. This is not an AI/ML algorithm, so standalone performance is not relevant.

7. The type of ground truth used

Not Available. For this type of product, "ground truth" might refer to established clinical endpoints (e.g., reduction in itching scores, improvement in skin barrier function, physician global assessment of dermatitis severity). However, the document does not specify what specific endpoints were measured or how their "truth" was established in the mentioned "functional and performance testing." The primary "truth" for this submission is that it is "substantially equivalent" to predicate devices already on the market for similar indications, implying comparable safety and efficacy profiles.

8. The sample size for the training set

Not Applicable/Not Available. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable/Not Available. As above, no training set for an AI/ML algorithm exists for this product.

Summary

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Stiefel Laboratories, Inc.

Summary of the safety and efficacy

1.	Submitter of the Application:	Stiefel Laboratories, Inc.255 Alhambra Circle, Suite 1000Coral Gables, FL 33134
	Contact Person:	Mary Jane CarrRoute 145Oak Hill, New York 12460
		Phone: (518) 239-6901 extension 8784Fax: (518) 239-8402
2.	Proprietary Name:	MimyX™ Cream
	Common/Usual Name:	Dressing, Wound & Burn, Hydrw/Drug or Biologic
	Classification Name:	Dressing, Wound & Burn, Hydrw/Drug or Biologic

3. Substantially Equivalent Devices:

Stiefel Laboratories, Inc. believes that MimyX Cream is substantially equivalent to the currently marketed devices, Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) cleared under K964240 and Sinclair Wound and Skin Emulsion cleared under K024367.

4. Device Description:

న. Intended Use of the Device:

The prescription product requires a physician to diagnose the disease state and is indicated for the management and relief of the burning and itching associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The OTC product is indicated for general symptoms such as burning and itching associated with many common types of skin irritation. The formulation forms a protective barrier which helps to keep the wound moist, which is beneficial to the healing process.

6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device(s):

All products referenced are non-sterile emulsions that are applied topically to relieve the symptoms of various dermatoses.

7. Conclusions:

Functional and performance testing has been conducted to assess the safety and efficacy of MimyX1M Cream and results are satisfactory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird. The text is arranged in a circular fashion around the symbol.

Public Health Service

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Jane Carr Assistant Director, Regulatory. Affairs . Stiefel Laboratories, Inc. Route 145 Oak Hill, New York 12460

Re: K041342

Trade/Device Name: MimyXTM Cream Regulatory Class: Unclassified Product Code: MGQ Dated: June 3, 2005 Received: June 6, 2005

Dear Ms. Carr:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Mary Jane Carr

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'll ough finding of substantial equivalence of your device to a legally prematics notification: "Thesults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please its you desire specific as not any and (240) 276-0115. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041342

Device Name:

MimyXTM Cream

Indications for Use:

FOR TOPICAL DERMATOLOGICAL USE ONLY

Description Rx Product:

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 dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Directions for Use (Rx and OTC):

Apply MimyX Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover MimyX Cream with a dressing of choice.

Description OTC Product:

MimyX 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.

Over-The-Counter Use __ XX Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eunice Carter

Jision Sign-Off) Division of General, Restorative and Neurological Devices

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Regulation Number and Section

N/A