TETRIX CREAM

K071483 · Coria Laboratories, Ltd. · FRO · Apr 4, 2008 · SU

Device Facts

• Record ID: K071483
• Device Name: TETRIX CREAM
• Applicant: Coria Laboratories, Ltd.
• Product Code: FRO · SU
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Tetrix™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. TetrixTM Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Device Story

Tetrix Cream is a non-sterile topical cream formulation; intended for prescription use. Device functions as a physical barrier to prevent contact between skin and irritants like nickel salts, neomycin, and fragrance mixtures. Applied topically to manage symptoms of dermatoses; maintains moist wound and skin environment to support healing. Clinical evidence demonstrates barrier efficacy against specific contact allergens.

Clinical Evidence

Clinical studies provided evidence that Tetrix Cream prevents nickel salts, neomycin, and a mixture of fragrances from making contact with the skin. Functional and performance testing conducted; results satisfactory.

Technological Characteristics

Non-sterile emulsion/gel cream formulation. Topical application. Barrier-based mechanism of action. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients experiencing burning and itching associated with dermatoses, including atopic dermatitis, allergic contact dermatitis, and irritant contact dermatitis. Helps relieve dry, waxy skin by maintaining a moist environment.

Predicate Devices

• AtopiClair™ and Skin Emulsion Nonsteroidal Cream (K024367)
• Mimyx™ Cream (K041342)

Submission Summary (Full Text)

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page 1/2

CONFIDENTIA Updated 510(k) Summary

## Section 2 - 510(k) Summary

APR - 4 2008

#### 2.1 Submission Applicant & Correspondent

Applicant: Coria Laboratories, Ltd. 3909 Hulen St. . Fort Worth, TX 76107

Contact: Amy Campbell Phone: [phone]

#### 2.2 Name of Device

Proprietary Namc: Tetrix TM Cream Common Name: Dressing, wound and burn, hydrogen w/drug and/or biologic Classification Name: Dressing, wound and burn, hydrogen w/drug and/or biologic

#### Devices to Which New Device is Substantially Equivalent 2.3

| Sinclair Wound | K024367 marketed as AtopiClair™ and Skin<br>Emulsion Nonsteroidal Cream |
|----------------|-------------------------------------------------------------------------|
| Mimyx™ Cream | K041342 |

#### 2.4 Device Description

Tctrix™ Cream is a non-sterile cream formulation intended for prescription use only,

Clinical studies provided evidence that Tetrix™ Cream prevents nickel salts, neomycin and a mixture of fragrances from making contact with the skin. Please see clinical studies section.

#### 2.5 Intended Use of the Device

Tetrix™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. TetrixTM Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin cnvironment, which is beneficial to the healing process.

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K071483 page 2/2

Coria Laboratories, Ltd. 510(k) K071483: Tetrix™ Crcam

CONFIDENTIAL Updated 510(k) Summary

### Summary of Technological Characteristics of the Device Compared to the Predicate 2.6 Devices

All products referenced are non sterile cmulsion/gel types that are applied topically to manage the symptoms of various types of dermatoses.

#### 2.7 Tests and Conclusions

Functional and performance testing has been conducted to assess the safety and effectiveness of Tetrix™ Crcam and the results are satisfactory.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2008

Coria Laboratories, Ltd. % Healthpoint, Ltd. Ms. Amy Campbell 3909 Hulen Street Fort Worth, Texas 76107

Re: K071483

Trade/Device Name: Tetrix Cream Regulatory Class: Unclassified Product Code: FRO Dated: April 3, 2008 Received: April 3, 2008

Dear Ms. Campbell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Amy Campbell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Complion,s at . [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K071483

Device Name: Tetrix™ Cream

Indications For Use:

Tetrix™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix™ Cream helps to relieve dry, waxy skun by mains and moist wound and skin environment, which is beneficial to the healing process.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off)

Far me

Division of General, Restorative,
and Neurological Devices

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510(k) Number K071483