Who is the manufacturer of TL TRISEB CREAM?

Trigen Laboratories, Inc. filed the 510(k) submission for TL TRISEB CREAM (K121134).

What is the FDA product code for TL TRISEB CREAM?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for TL TRISEB CREAM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TL TRISEB CREAM?

Promiseb Topical Cream (K050158).

Who can help prepare an FDA 510(k) submission like TL TRISEB CREAM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TL TRISEB CREAM

K121134 · Trigen Laboratories, Inc. · FRO · Jul 25, 2012 · SU

Device Facts

Record ID	K121134
Device Name	TL TRISEB CREAM
Applicant	Trigen Laboratories, Inc.
Product Code	FRO · SU
Decision Date	Jul 25, 2012
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Device Story

TL Triseb Cream is a non-sterile, steroid-free, fragrance-free, water-based hydrogel emulsion; applied topically to skin; used to manage seborrhea and seborrheic dermatitis symptoms (itching, erythema, scaling, pain); maintains moist wound/skin environment to aid healing; applied 2-3 times daily or as needed; intended for use under healthcare professional supervision.

Clinical Evidence

Repeat Insult Patch Testing (RIPT) conducted on 50 human subjects demonstrated the device is a non-primary irritant and non-primary sensitizer to the skin.

Technological Characteristics

Non-sterile, viscous, water-based emulsion. Ingredients include purified water, isohexadecane, butyrospermum parkii, pentylene glycol, ethylhexyl palmitate, cera alba, PEG-30 dipolyhydroxystearate, bisabolol, polyglyceryl-6 polyricinoleate, tocopheryl acetate, hydrogenated castor oil, butylene glycol, magnesium sulfate, piroctone olamine, allantoin, magnesium stearate, disodium EDTA, ascorbyl tetraisopalmitate, and propyl gallate. Viscosity: 205,920 cps. Cytotoxicity testing performed per ISO 10993-5 and USP 23.

Indications for Use

Indicated for patients under healthcare professional supervision suffering from seborrhea and seborrheic dermatitis, including symptoms of itching, erythema, scaling, pain, and dry waxy skin.

Predicate Devices

Promiseb Topical Cream (K050158)

Related Devices

K123724 — DERMISEB CREAM · Igi Laboratories, Inc. · Aug 28, 2013
K120730 — LOUTREX TOPICAL CREAM · Acella Pharmaceuticals, LLC · Sep 6, 2012
K143605 — Nutraseb Facial Cream · Isdin Corp. · Apr 14, 2016
K111168 — PRECISION SKIN EMULSION · Precision Dermatology Incorporated · Dec 13, 2011
K110757 — TL-CERMIDE SKIN BARRIER EMULSION · Trigen Laboratories, Inc. · Aug 19, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ TRIGEN 510(k) Application K121134 page 1 of 3 TL Triseb Cream #### 510(k) Summary JUL 2 5 2012 #### I. Administrative Submitter of the Application: Trigen Laboratories 2400 Main Street Suite 6 Sayreville, NY 08872 Phone: 732-721-0070 Fax: 732-721-3430 Contact Person: Pamela Chiappone Date of Preparation: March 20, 2012 #### II. Device Name: Proprietary Name: Common Name: Product Code: Device: TL Triseb Cream Dressing, Wound and Burn, Hydrogel w/Drug and /or Biologic FRO Unclassified #### III. Substantial Equivalent Device: Trigen Laboratories Inc. believes that TL Triseb Cream is substantially equivalent to the currently marketed device, Promiseb@ Topical Cream cleared under K050158. #### IV. Device Description: TL Triseb cream is a non-sterile viscous emulsion/cream formulation. TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. #### V. Intended Use: The prescription product requires a physician to diagnose the disease state. ## VI. 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 signs and symptoms of seborrhea and seborrheic dermatitis. {1}------------------------------------------------ ﺮ ﻣ Table 1, below, provides a technological comparison of TL Triseb and the predicate device. | Product Name | TL Triseb Cream | Promiseb® Topical Cream | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | | K050158 | | Ingredients | Purified water, isohexadecane, butyrospermum parkii, pentylene glycol, ethylhexyl palmitate, cera alba, PEG-30 dipolyhydroxystearate, bisabolol, polyglyceryl-6 polyricinoleate, tocopheryl acetate, hydrogenated castor oil, butylene glycol, magnesium sulfate, piroctone olamine, allantoin, magnesium stearate, disodium EDTA, ascorbyl tetraisopalmitate, and propyl gallate. | Purified water, isohexadecane, butyrospermum parkii, pentylene glycol, ethylhexyl palmitate, cera alba, PEG-30 dipolyhydroxystearate, bisabolol, polyglyceryl-6 polyricinoleate, tocopheryl acetate, hydrogenated castor oil, acifructol complex, butylene glycol, magnesium sulfate, piroctone olamine, allantoin, magnesium stearate, disodium EDTA, vitis vinifera, ascorbyl tetraisopalmitate, glycyrrhetinic acid, propyl gallate, and telmesteine. | | # Applications Per day | 2 to 3 times per day or as needed | 2 to 3 times per day or as needed | | Indications for Use | Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. | Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Promiseb Topical Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. | | Product Description | TL Triseb Cream is an off-white, steroid- free, fragrance-free, water-based emulsion. | Promiseb Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. | | Physical Properties | Non-sterile, white cream Viscosity 205,920 cps Consistency: smooth homogeneous Microscopy: Uniform emulsion | Non-sterile, white cream Viscosity 228,800 cps Consistency: smooth homogeneous Microscopy: Uniform emulsion | Technological Comparison Table 1. #### Clinical Performance Data Repeat Insult Patch Testing with 50 human subjects showed TL Triseb Cream to be a nonprimary irritant and non-primary sensitizer to the skin. ## Nonclinical Performance Data: In a L929 Agar Overlay Cytotoxicity study using TL Triseb Cream, the cells exhibited a slight reaction, meeting the requirements of the L929 Agar Overlay Cytotoxicity Test as described in ISO 10993-5 and USP 23, Biological Reactive Tests In-Vitro (87). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the text "K 121134 page 3 of 3 TL Triseb Cream". The text appears to be handwritten, with the exception of the last line. The first line contains a series of numbers, and the second line indicates that it is page 3 of 3. The last line is the name of a product. ## VII. Conclusion Functional and performance testing has been conducted to assess the safety and efficacy of TL Triseb Cream and the results are satisfactory. Based on the information provided herein, we conclude that the device is substantially equivalent to the predicate, Promiseb Topical Cream. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUL 25 2012 Trigen Laboratories, Incorporated % Pharmaceutical Project Solutions, Incorporated Ms. Melissa Goodhead 11705 Boyette Road, Suite 171 Riverview, Florida 33569 Re: K121134 Trade/Device Name: TL Triseb Cream Regulatory Class: Unclassified Dressing Product Code: FRO Dated: June 20, 2011 Received: June 22, 2011 ### Dear Ms. Goodhead: 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 {4}------------------------------------------------ Page 2 - Ms. Melissa Goodhead 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/CDRH0ffices/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/ReportaProblem/default.him 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Erine Keith Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use K121134 510(k) Number (if known): · Device Name: TL Triseb Cream Indications for Use: Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborthea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps to relieve dry waxy skin by maintaining a moist wound & 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 807 Subpart C) मुंबु (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daiel Kurefu MM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K121134 Page 1 of 1 Confidential Trigen Laboratories, Inc.