(181 days)
No
The summary describes a topical cream and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a topical cream intended to manage and relieve symptoms of seborrhea and seborrheic dermatitis, which indicates a therapeutic purpose.
No
Loutrex Topical Cream is indicated to manage and relieve symptoms of seborrhea and seborrheic dermatitis, and it helps relieve dry, waxy skin. Its function is therapeutic rather than diagnostic.
No
The device description explicitly states it is a "water based emulsion intended for topical application," which is a physical cream, 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 Loutrex Topical Cream is applied topically to the skin to manage and relieve symptoms of seborrhea and seborrheic dermatitis. This is a direct application to the body for therapeutic purposes.
- Device Description: It is described as a topical cream, a water-based emulsion intended for external application.
- Mechanism of Action: The description focuses on maintaining a moist skin environment to aid healing, which is a physical effect on the skin.
- Lack of In Vitro Testing: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. Loutrex Topical Cream does not fit this description. It is a topical therapeutic device.
N/A
Intended Use / Indications for Use
Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms rof ose. Houven reported in the such as itching, erythema, scaling, and pain. Loutrex ol SEBOTHER and Leave dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Product codes
FRO
Device Description
Loutrex Topical Cream is a non-sterile, white to off-white water based emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Loutrex Topical Cream 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) Application
K120730
Page 1 of
Loutrex Topical Cream
Page 1 of 2
510(k) SUMMARY
(in accordance with 21 CFR 807.87(b) and 21 CFR 807.92)
Loutrex Topical Cream
6 2012 SEP
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared 1.
RRI Group 248 Latitude Lane, Suite 104 Lake Wylie, SC 29710
Phone: (803) 831-7657 (803) 831-1494 Fax:
Contact Person: Lara Noah, Sr. Manager Regulatory Affairs lnoah@rrriint.com
Date Prepared: February 17, 2012
Name of Device and Name/Address of Sponsor 2.
Loutrex Topical Cream
Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 3009
Common or Usual Name
Hydrogel wound dressing
Classification Name
Device Review Panel Product Code Unclassified Reason Submission Type
Unclassified General & Plastic Surgery FRO Pre-Amendment 510(k)
- Substantial Equivalent Devices: 3.
Acella Pharmaceuricals, LLC believes that Loutrex Topical Cream is substantially equivalent to the currently marketed devices, Sinclair Skin Emulsion (a.k.a Sincalir Seborrhea Emulsion), cleared under K050158 and also cleared under K111168, distributed by Promius Pharma, LLC as Promiseb® Topical Cream.
1
Image /page/1/Picture/1 description: The image shows the text "K120.730 page 2 of 2 Loutrex Topical Cream". The text appears to be handwritten and then printed. The text is black and the background is white.
-
- Device Description:
Loutrex Topical Cream is a non-sterile, white to off-white water based emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
- Device Description:
-
Intended Use Indications for Use: ડ.
Loutrex Topical Cream
Rx Use: Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms rof ose. Houven reported in the such as itching, erythema, scaling, and pain. Loutrex ol SEBOTHER and Leave 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. -
- Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of Loutrex Topical Cream and the results are satisfactory.
- Conclusions:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 · Silver Spring, MD 20993-0002
Acella Pharmaceuticals, LLC % RRI Group Ms. Lara Noah Senior Manager, Regulatory Affairs 248 Latitude Lane, Suite 104 Lake Wylie, South Carolina 29710
SEP 6 2012
Re: K120730
Trade/Device Name: Loutrex Topical Cream Regulatory Class: Unclassified Product Code: FRO Dated: August 30, 2012 Received: August 30, 2012
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, 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
3
Page 2 – Ms. Lara Noah
device-related adverse events) (21 CFR 803); 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.
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.htm 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/ReportalProblem/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 yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedica and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Loutrex Topical Cream
Indication for Use
510(k) Number (if known): K120730
Device Name: Loutrex Topical Cream
Indications for Use:
Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Prescription Use: X
AND/OR
Over-the-Counter Use: _
(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) | |
|---|---|
| -------------------------------------------------------- | -- |
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number