(122 days)
Not Found
No
The description focuses on the emollient formulation and its physical properties, with no mention of AI or ML.
Yes
The device is described as a topical skin care preparation intended to relieve and manage symptoms associated with various dermatoses by maintaining a moist wound and skin environment, which are therapeutic effects.
No
Explanation: The device is described as a topical skin care preparation intended to relieve symptoms and manage skin conditions by maintaining a moist environment, not to diagnose any disease. Its use requires a physician to diagnose the disease and prescribe the product, indicating it's a treatment, not a diagnostic tool.
No
The device description clearly states it is a "topical formulation delivers as a cream or a foam" and is "dispensed via a tube and rubbed into the skin," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Ceramax is a "topical skin care preparation" used to relieve symptoms associated with various dermatoses and dry skin conditions. It works by maintaining a moist skin environment. This is a direct application to the body surface for therapeutic or symptomatic relief.
- Device Description: The description reinforces that it's a "topical formulation" applied to the skin.
- Lack of In Vitro Activity: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health. Ceramax does not perform any such tests on biological samples. It is applied to the body.
Therefore, Ceramax falls under the category of a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Product codes
FRO
Device Description
Ceramax emollient formulation is a non-sterile, off-white, low odor, fragrance free, topical formulation delivers as a cream or a foam. The cream is dispensed via a tube and rubbed into the skin. When the Ceramax formulation is applied to diseased skin protective barrier that helps to maintain a moist wound and skin environment is formed. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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
health care 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were reviewed to support the performance of Ceramax: visual inspection, pH, Viscosity, Bioburden, and Preservative Effectiveness. The Ceramax cream meets specification and performance characteristics and is Oculus Innovative Sciences, Inc. substantially equivalent to the predicate devices.
Biocompatibility Testing related to Ceramax confirmed that the device meets the applicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices and is biocompatible.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2015
Oculus Innovative Sciences, Inc. Mr. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 North McDowell Boulevard Petaluma, California 94954
Re: K152055
Trade/Device Name: Ceramax Skin Barrier Cream Regulatory Class: Unclassified Product Code: FRO Dated: November 2, 2015 Received: November 3, 2015
Dear Mr. Martin:
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
Radiological Health
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
Enclosure
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Indications for Use
510(k) Number (if known) K152055
Device Name Cermax Skin Barrier Cream
Indications for Use (Describe) INDICATION FOR USE
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
Ceramax may be used to relieve dry waxy skin by maintaining 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1 510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92. 510(k) Owner Official Contact Oculus Innovative Sciences, Inc. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551 Device Information Trade or Proprietary Ceramax Skin Barrier Cream Name: Common Name: Wound Dressing Classification Name: Regulation: 21 CFR Unclassified, Pre-amendment status Product Code(s) FRO Device Panel TBD Legally marketed Epiceram K052643, and TL-Cermide K110757 device(s) to which equivalence is claimed: Reason for 510(k) New Device submission Device Description Ceramax emollient formulation is a non-sterile, off-white, low odor, fragrance free, topical formulation delivers as a cream or a foam. The cream is dispensed via a tube and rubbed into the skin. When the Ceramax formulation is applied to diseased skin protective barrier that helps to maintain a moist wound and skin environment is formed. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product. Intended Use Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Performance Testing The following tests were reviewed to support the performance of Ceramax: visual inspection, pH, Viscosity, Bioburden, and Preservative Effectiveness. The Ceramax cream meets specification and performance characteristics and is Oculus Innovative Sciences, Inc.
Cermax Skin Barrier Cream 510(k) K152055
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Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo consists of the word "OCULUS" in large, bold, black letters, with the words "Innovative Sciences" in smaller, black letters underneath. Above the word "OCULUS" is a graphic of several gold-colored, curved lines that resemble an eye.
| substantially equivalent to the predicate devices. | |
|---|---|
| Biocompatibility Testing | Biocompatibility Testing related to Ceramax confirmed that the device meets the |
| applicable requirements of the Blue Book Memorandum G95-1 entitled Use of | |
| International Standards ISO-10993 Biological Evaluation of Medical Devices and | |
| is biocompatible. | |
| Safety and Effectiveness | Ceramax does not raise any new safety and efficacy concerns when compared to a |
similar device already legally marketed. Substantial Equivalence (SE) Rationale
| Substantial Equivalence (SE) Rationale | |||
|---|---|---|---|
| Ceramax | Epiceram | TL-Cermide | |
| Regulatory | |||
| Status | Present application | Predicate | Predicate |
| 510(k) | |||
| Number | K152055 | K052643 | K110757 |
| Product Code | FRO | FRO | FRO |
| Indications for | |||
| Use | Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. | ||
| Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. | Epiceram is intended to be used as a topical skin care preparation to relieve and to manage the burning, itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. | ||
| Epiceram may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. | TL-Cermide Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatitis, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. | ||
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Delivery | |||
| System | Tube | Tube or Can | Tube |
Ceramax is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Epiceram (K052643) distributed by Puracap Pharmaceuticals. Therefore, the Oculus Ceramax is substantially equivalent to the predicate devices.
Submitted by:
Brian W. Martin
Director of Regulatory Affairs and Quality Control
Biwhut
Date Submitted:
October 30, 2015