(154 days)
Not Found
No
The summary describes a skin emulsion for treating dry skin conditions and dermatoses. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The device description and intended use are consistent with a topical medical device.
Yes.
The device is intended for treating dry skin conditions and managing symptoms of various dermatoses, including aiding in the healing process, which aligns with the definition of a therapeutic device.
No
Explanation: The device, TL-Cermide Skin Emulsion, is described as a treatment for dry skin conditions and associated symptoms, not for diagnosing them. Its intended use is therapeutic, aimed at relief and healing.
No
The device description clearly states it is a "ceramide-dominant formulation," indicating it is a topical emulsion, which is a physical substance applied to the skin, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat dry skin conditions and manage symptoms of dermatoses. This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, or tissue).
- Device Description: The description is of a topical skin emulsion, not a diagnostic test or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly intended for topical application to the skin for therapeutic and symptomatic relief, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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 dermatoses, 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.
Product codes
FRO
Device Description
TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation
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
Not Found
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 TL-Cermide Skin Emulsion and the 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
N/A
0
510(k) SUMMARY
(in accordance with 21 CFR 807.87(b) and 21 CFR 807.92)
TL-Cermide Skin Emulsion AUG 1 9 2011
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared 1.
RRI Group, Inc. 248 Latitude Lane, Suite 104 Lake Wylie, SC 29710
Phone: (803) 831-7657 (803) 831-1494 Fax:
Contact Person: Lara Noah lnoah@rriint.com
Date Prepared: July 20, 2011
Name of Device and Name/Address of Sponsor 2.
TL-Cermide Skin Emulsion
Trigen Laboratories, Inc. 2400 Main Street Ext., Suite 6 Sayreville, NJ 08872
Common or Usual Name
Dressing, Wound & Burn, Hydrogel w/drug biologic
Classification Name
| Device | Unclassified |
|---|---|
| Review Panel | General & Plastic Surgery |
| Product Code | FRO |
| Unclassified Reason | Pre-Amendment |
| Submission Type | 510(k) |
- Substantial Equivalent Devices: 3.
ﺑ . -. Trigen Laboratories Inc. believes that TL-Cermide Skin Emulsion is substantially equivalent to the currently marketed device, EPICERAM® Skin Barrier Emulsion (Radiodermatitis Emulsion) cleared under K052643.
1
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Device Description: 4.
TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation -
Intended Use Indications for Use: ம்
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 dermatoses, 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 -
Summary of the Technological Characteristics of the Device Compared to the Predicate Device(s): 6.
All products referenced are non-sterile emulsions that are applied topically to relieve the symptoms of various dermatoses, including, but not limited to atopic dermatitis, irritant contact dermatitis and radiation dermatitis. -
- Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of TL-Cermide Skin Emulsion and the results are satisfactory.
- Conclusions:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RRI Group, Inc. % Ms. Lara Noah Senior Manager, Regulatory Affairs 248 Latitude Lane, Suite 104 Lake Wylie, South Carolina 29710-1457
AUG 1 9 2011
Re: K110757
Trade/Device Name: TL-Cermide Skin Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: July 20, 2011 Received: July 21, 2011
Dear Ms. Noah:
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. Iisting 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
3
Page 2 - Ms. Lara Noah
forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 101
Indications for Use
510(k) Number (if known): K110757
Device Name: TL-Cermide Skin Emulsion
Indications For Use:
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 dermatoses, 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Daniel Keane for MSM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110757