(425 days)
Not Found
No
The 510(k) summary describes a topical cream and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
While it manages symptoms and aids healing, its primary function is skin care and relief of discomfort, not treatment of a disease or condition in a therapeutic sense.
No
Explanation: The MimyX Cream is indicated to manage and relieve symptoms associated with various types of dermatoses by maintaining a moist wound and skin environment, which aids in the healing process. It does not provide any diagnostic information or determine the presence or absence of a disease.
No
The device is a cream, which is a physical substance applied topically, 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 for "TOPICAL DERMATOLOGICAL USE ONLY" to manage and relieve symptoms of various dermatoses and skin irritations. This involves applying the product to the skin for therapeutic purposes.
- Device Description: It is described as a "non-sterile, semi-viscous emulsion intended for topical application." This aligns with a topical cream or ointment, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
- Anatomical Site: The anatomical site is "Skin," which is the site of application and treatment, not the source of a diagnostic sample.
In summary, MimyX Cream is a topical therapeutic product, not a diagnostic device.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, MimyXTM 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.
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.
Product codes
MGQ
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.
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
Healthcare professional (for prescription use) and lay user (for OTC use).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and performance testing has been conducted to assess the safety and efficacy of MimyX1M Cream and results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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 1000
Coral Gables, FL 33134 |
|----|-------------------------------|-----------------------------------------------------------------------------------------|
| | Contact Person: | Mary Jane Carr
Route 145
Oak Hill, New York 12460 |
| | | Phone: (518) 239-6901 extension 8784
Fax: (518) 239-8402 |
| 2. | Proprietary Name: | MimyX™ Cream |
| | Common/Usual Name: | Dressing, Wound & Burn, Hydr
w/Drug or Biologic |
| | Classification Name: | Dressing, Wound & Burn, Hydr
w/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:
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.
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.
1
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.
2
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
3
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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