(103 days)
Not Found
No
The summary describes a topical cream and does not mention any computational or analytical capabilities that would involve AI or ML.
Yes
TL Triseb Cream is indicated to manage and relieve symptoms of seborrhea and seborrheic dermatitis, and helps relieve dry skin by maintaining a moist wound and skin environment, which are therapeutic actions.
No
The device is a cream indicated to manage and relieve symptoms of seborrhea and seborrheic dermatitis, acting as a treatment rather than a diagnostic tool.
No
The device description clearly states it is a "non-sterile viscous emulsion/cream formulation," indicating it is a physical product, not software.
Based on the provided information, TL Triseb Cream is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis on the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: It is a cream formulation applied topically to the skin. IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical site is the skin, where the cream is applied directly.
- Performance Studies: The performance studies described are related to skin irritation and sensitization, which are relevant for a topical therapeutic device, not an IVD.
In summary, TL Triseb Cream is a topical therapeutic device intended for direct application to the skin to treat a medical condition, not a device used to perform tests on specimens outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The prescription product requires a physician to diagnose the disease state.
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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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. TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. Non-sterile, white cream Viscosity 205,920 cps Consistency: smooth homogeneous Microscopy: Uniform emulsion
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
healthcare professional
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)
Repeat Insult Patch Testing with 50 human subjects showed TL Triseb Cream to be a nonprimary irritant and non-primary sensitizer to the skin. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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.