LOUTREX TOPICAL CREAM

K120730 · Acella Pharmaceuticals, LLC · FRO · Sep 6, 2012 · SU

Device Facts

• Record ID: K120730
• Device Name: LOUTREX TOPICAL CREAM
• Applicant: Acella Pharmaceuticals, LLC
• Product Code: FRO · SU
• Decision Date: Sep 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Loutrex Topical Cream is a non-sterile, water-based emulsion used as a topical wound dressing. It is applied three times daily or as needed under the supervision of a healthcare professional. The cream functions by maintaining a moist wound and skin environment, which supports the healing process and relieves symptoms associated with seborrhea and seborrheic dermatitis, such as itching, erythema, scaling, and pain. It is intended for prescription use.

Clinical Evidence

No clinical data provided. Functional and performance testing was conducted to assess safety and efficacy with satisfactory results.

Technological Characteristics

Non-sterile, water-based emulsion. Topical application. No electronic components or software.

Indications for Use

Indicated for patients requiring management of seborrhea and seborrheic dermatitis symptoms including itching, erythema, scaling, and pain; helps relieve dry, waxy skin by maintaining a moist environment.

Predicate Devices

• Sinclair Skin Emulsion (K050158)
• Promiseb Topical Cream (K111168)

Submission Summary (Full Text)

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510(k) Application

K120730
Page 1 of
Loutrex Topical Cream
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## 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: [phone] [phone] Fax:

Contact Person: Lara Noah, Sr. Manager Regulatory Affairs [e-mail]

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.

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- 4. 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.

- 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.

- 7. Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of Loutrex Topical Cream and the results are satisfactory.

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# 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

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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 [phone] or [phone] 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

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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