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 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.

AI/ML Overview

This 510(k) application for TL Triseb Cream asserts substantial equivalence to a predicate device (Promiseb® Topical Cream) rather than establishing de novo acceptance criteria for the device's performance. Therefore, the information provided does not contain a typical study outlining acceptance criteria, a test set, ground truth, or details on human reader performance, as would be expected for a diagnostic or AI-driven medical device.

Instead, the submission focuses on demonstrating that the new device shares similar technological characteristics and has comparable safety and performance to the already-cleared predicate device.

However, based on the provided text, we can infer some 'acceptance criteria' in terms of safety and the studies conducted to support them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing)	Reported Device Performance (TL Triseb Cream)
Safety:
Non-primary irritant to human skin	Demonstrated to be a non-primary irritant (Met)
Non-primary sensitizer to human skin	Demonstrated to be a non-primary sensitizer (Met)
Not cytotoxic (in vitro)	Exhibited a slight reaction, meeting ISO 10993-5 and USP 23 requirements (Met)
Technological Characteristics (vs. Predicate):
Similar Ingredients	Substantially similar, with minor differences (e.g., acifructol complex, vitis vinifera, glycyrrhetinic acid, and telmesteine absent in TL Triseb but present in Promiseb)
Similar Application per day	2 to 3 times per day or as needed (Same as predicate)
Similar Indications for Use	Identical to predicate device
Similar Product Description	Identical to predicate device (off-white, steroid-free, fragrance-free, water-based emulsion)
Similar Physical Properties	Non-sterile, white cream; Viscosity 205,920 cps (Predicate: 228,800 cps); Consistency: smooth homogeneous; Microscopy: Uniform emulsion

Regarding the specific questions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Safety Tests:
- Repeat Insult Patch Testing: 50 human subjects. The provenance (country of origin) and whether it was retrospective or prospective are not specified, but this type of testing is generally prospective.
- L929 Agar Overlay Cytotoxicity study: This is an in-vitro study (cell culture), so "human subjects" or "country of origin" are not applicable in the same way. The sample size refers to the cells tested, not specified beyond "cells."
Technological Comparison: This involved a direct comparison of product specifications and characteristics, not a human subject test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the studies cited are for safety (irritation, sensitization, cytotoxicity) and material comparison, not for diagnostic performance requiring expert consensus on a 'ground truth' for a specific disease outcome. The 'truth' for the patch test is the observed skin reaction, and for cytotoxicity, it's the cellular response to the extract.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation of medical data. The safety tests performed (patch test, cytotoxicity) do not involve such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study (MRMC, AI assistance) is not relevant to this device, which is a topical cream for seborrheic dermatitis, not a diagnostic imaging or AI-driven tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. Again, this is for an AI/algorithm-based device, which TL Triseb Cream is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the Repeat Insult Patch Testing, the "ground truth" is the observed dermal reaction (e.g., erythema, edema) on the human subjects, typically assessed by a qualified dermatologist or allergist following a standardized protocol.
For the L929 Agar Overlay Cytotoxicity study, the "ground truth" is the cellular response (viability, morphology) observed under a microscope, measured against control cells, as per ISO 10993-5 and USP 23 guidelines.
For the Technological Characteristics Comparison, the "ground truth" is the verified specifications of both the proposed device and the predicate.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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.

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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-30dipolyhydroxystearate, bisabolol,polyglyceryl-6 polyricinoleate, tocopherylacetate, hydrogenated castor oil, butyleneglycol, magnesium sulfate, piroctoneolamine, allantoin, magnesium stearate,disodium EDTA, ascorbyltetraisopalmitate, and propyl gallate.	Purified water, isohexadecane,butyrospermum parkii, pentylene glycol,ethylhexyl palmitate, cera alba, PEG-30dipolyhydroxystearate, bisabolol,polyglyceryl-6 polyricinoleate, tocopherylacetate, hydrogenated castor oil, acifructolcomplex, butylene glycol, magnesiumsulfate, piroctone olamine, allantoin,magnesium stearate, disodium EDTA, vitisvinifera, ascorbyl tetraisopalmitate,glycyrrhetinic acid, propyl gallate, andtelmesteine.
# ApplicationsPer day	2 to 3 times per day or as needed	2 to 3 times per day or as needed
Indications forUse	Under the supervision of a healthcareprofessional, TL Triseb Cream is indicatedto manage and relieve the signs andsymptoms of seborrhea and seborrheicdermatitis such as itching, erythema,scaling and pain. TL Triseb Cream helps torelieve dry waxy skin by maintaining amoist wound & skin environment, which isbeneficial to the healing process.	Under the supervision of a healthcareprofessional, Promiseb Topical Cream isindicated to manage and relieve the signsand symptoms of seborrhea and seborrheicdermatitis such as itching, erythema, scalingand pain. Promiseb Topical Cream helps torelieve dry waxy skin by maintaining amoist wound & skin environment, which isbeneficial to the healing process.
ProductDescription	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-basedemulsion.
PhysicalProperties	Non-sterile, white creamViscosity 205,920 cpsConsistency: smooth homogeneousMicroscopy: Uniform emulsion	Non-sterile, white creamViscosity 228,800 cpsConsistency: smooth homogeneousMicroscopy: 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).

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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.

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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

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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

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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.

Regulation Number and Section

N/A