TROPAZONE CR

K093544 · Midlothian Laboratories · FRO · Feb 16, 2010 · SU

Device Facts

• Record ID: K093544
• Device Name: TROPAZONE CR
• Applicant: Midlothian Laboratories
• Product Code: FRO · SU
• Decision Date: Feb 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis.

Device Story

Tropazone CR is a non-sterile, semi-viscous, oil-in-water emulsion wound dressing. It is applied topically to the wound site to maintain a moist environment, which facilitates healing and protects the wound from external contamination. The formulation includes mineral oil, petrolatum, lecithin, and a silicon-based organic polymer. It is a prescription-only device intended for use under the direction of a physician. The device is applied to the affected area up to three times per day or as needed. By maintaining moisture, the dressing helps relieve dry skin and supports the natural healing process of various dermatological conditions and wounds.

Clinical Evidence

Clinical evidence consists of a Repeat Insult Patch Test (RIPT) conducted on 50 human subjects, which demonstrated that the device is a non-primary irritant and non-primary sensitizer. Non-clinical evidence includes an L929 Agar Overlay Cytotoxicity study (ISO 10993-5/USP 23) showing mild to moderate reaction, meeting established safety requirements.

Technological Characteristics

Non-sterile, semi-viscous oil-in-water emulsion. Ingredients: water, mineral oil, petrolatum, glyceryl stearate, PEG-100 stearate, lecithin, cetyl alcohol, dimethicone, imidazolidinyl urea, triethanolamine, methylparaben, propylparaben, fragrance. Biocompatibility testing per ISO 10993-5 and USP 23.

Indications for Use

Indicated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns (including sunburns), and radiation dermatitis in patients requiring topical wound care.

Predicate Devices

• Biafine (K964240)
• Tropazone Lotion (K090337)
• MimyX cream (K041342)
• Zenieva (K073246)

Submission Summary (Full Text)

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K093544 Page 1/3

Tropazone C

#### 510(k) Summary

#### Submitter of the Application:

Bryce Harvey Midlothian Laboratories 760 Industrial Park Boulevard, Unit C Montgomery, Alabama 36117

FEB 1 6 2010

Phone: [phone] Fax: [phone] Toll Free: [phone]

Date: 02-04-10

Trade Name: Tropazone CR

Common Name: Hydrogel wound dressing

| Device Classification: | 21 CFR 878.4022 "Dressing, Wound, Hydrogel" |
|------------------------|---------------------------------------------|
| Class: | Unclassified |
| Product Code: | |

Substantial Equivalence/Predicate Device: Tropazone CR is substantially equivalent to the currently marketed device Biafine cleared under application number K964240, Tropazone Lotion cleared under application number K090337, MimyX cream, cleared under application number K041342 and Zenieva, cleared under application number K073246.

Device Description: Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a prescription medication, requiring a physician's diagnosis of disease state prior to use. This product is formulated as an oil-in-water emulsion containing moisturizing ingredients to keep the area moist. The oil composition of Tropazone CR is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.

The intended use is identical to that of Biafine, Tropazone Lotion, MimyX cream, and Zenieva.

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K093544 Page 2/3

Table 1, below, provides a technological comparison of Tropazone CR and the predicate devices.

| Product Name | Tropazone CR | Biafine | Tropazone | MimyX | Zenieva |
|----------------|-------------------|--------------------|------------------|-----------------|------------------|
| 510(k) | | K964240 | K090337 | K041342 | K073246 |
| Ingredients | Water, liquid | Water, liquid | Water, liquid | Water, olive | Water, olive |
| | paraffin | paraffin, | paraffin | oil, glycerin, | oil, glycerin, |
| | (mineral oil), | ethylene glycol | (mineral oil), | pentylene | pentylene |
| | petrolatum, | monosterate, | petrolatum, | glycol, palm | glycol, palm |
| | alcohol, glyceryl | stearic acid, | alcohol, | glycerides, | glycerides, |
| | stearate, PEG- | propylene | glyceryl | vegetable oil, | vegetable oil, |
| | 100 stearate, | glycol, paraffin | stearate, PEG- | hydrogenated | hydrogenated |
| | paraffin, | wax, squalene, | 100 stearate, | lecithin, | lecithin, |
| | lecithin, cetyl | avocado oil, | paraffin, | squalene, | squalene, |
| | alcohol, | trolamine/sodiu | lecithin, | betaine, | betaine, |
| | dimethicone, | m alginate, | polysorbate 60, | palmitamide | palmitamide |
| | imidazolidinyl | triethanolamine, | DEA-cetyl | MEA, | MEA, |
| | urea, | cetyl palmitate, | phosphate, | sarcosine, | sarcosine, |
| | triethanolamine, | methylparaben | dimethicone, | acetamide | acetamide |
| | methylparaben, | (sodium salt) | carbomer, | MEA. | MEA, |
| | propylparaben, | sorbic acid | imidazolidinyl | hydroxyethyl | hydroxyethyl |
| | fragrance | (potassium salt), | urea, | cellulose, | cellulose, |
| | | polyparaben | methylparaben, | sodium | sodium |
| | | (sodium salt), | propylparaben, | carbomer, | carbomer, |
| | | fragrance | fragrance | xanthan gum | xanthan gum |
| # applications | 3 times per day | 3 times per day | 3 times per | 3 times per | 3 times per |
| Per day | or as needed | or as needed | day or as | day or as | day or as |
| | | | needed | needed | needed |
| Claim | Tropazone CR is | Biafine is for the | Tropazone | MimyX is | Zenieva is used |
| | for the dressing | dressing and | Lotion is used | used to | to manage and |
| | and | management of | to manage and | manage and | relieve the |
| | management of | superficial | relieve the | relieve the | burning and |
| | superficial | wounds, minor | burning and | burning and | itching |
| | wounds, minor | abrasions. | itching | itching | experienced |
| | abrasions, | dermal ulcers, | experienced | experienced | with various |
| | dermal ulcers, | donor sites, 1st | with various | with various | types of |
| | donor sites, 1st | and 2nd degree | types of | types of | dermatoses, |
| | and 2nd degree | burns, including | dermatoses, | dermatoses, | including |
| | burns, including | sunburns and | including | including | radiation |
| | sunburns and | radiation | radiation | radiation | dermatitis, |
| | radiation | dermatitis. | dermatitis. | dermatitis, | atopic |
| | dermatitis. | When applied | atopic | atopic | dermatitis. |
| | | properly to a | dermatitis, | dermatitis, | atopic |
| | | wound, Biafine | atopic | atopic | dermatitis, and |
| | | provides an | dermatitis, and | dermatitis, and | allergic contact |
| | | optimum moist | allergic contact | allergic | dermatitis. It |
| | | environment for | dermatitis. It | contact | helps relieve |

Technological Comparison Table 1.

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K093544 Page 3/3

### Midlothian Laboratories 510(k) Application

**Tropazone CR**

| | | the healing<br>process and<br>isolates the<br>wound from<br>harmful germs<br>and other<br>external<br>contamination. | helps relieve<br>dry waxy skin<br>by maintaining<br>a moist wound<br>and skin<br>environment,<br>which is<br>beneficial to<br>the healing<br>process. | dermatitis. It<br>helps relieve<br>dry waxy skin<br>by<br>maintaining a<br>moist wound<br>and skin<br>environment,<br>which is<br>beneficial to<br>the healing<br>process. | dry waxy skin<br>by maintaining<br>a moist wound<br>and skin<br>environment,<br>which is<br>beneficial to<br>the healing<br>process. |
|------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Description | Water-based<br>emulsion | Water-based<br>emulsion | Water-based<br>emulsion | Water-based<br>emulsion | Water-based<br>emulsion |
| Physical<br>Properties | Non-sterile<br>white to off-<br>white cream | Non-sterile<br>white to off-<br>white lotion | Non-sterile<br>white to off-<br>white thick<br>cream | Non-sterile<br>white to off-<br>white thick<br>cream | Non-sterile<br>white to off-<br>white thick<br>cream |

# Clinical Performance Data

Repeat Insult Patch Testing with 50 human subjects showed Tropazone CR to be a non-primary irritant and non-primary sensitizer to the skin.

# Nonclinical Performance Data:

In a L929 Agar Overlay Cytotoxicity study using Tropazone CR, the cells exhibited a mild to moderate 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).

# Conclusion

Tropazone CR is substantially equivalent to Biafine and the additional predicate devices as demonstrated in Table 1 above.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

# FEB 1 6 2010

Midlothian Laboratories % Mr. Bryce Harvey President 780 Industrial Park Boulevard Unit C Montgomery, Alabama 36117

Re: K093544

Trade/Device Name: Tropazone™ CR Regulatory Class: Unclassified Product Code: FRO Dated: January 11, 2010 Received: January 14, 2010

Dear Mr. Harvey:

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 - Mr. Bryce Harvey

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/ucm1158001.jpm fost 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.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 tollofire ne [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark M. Millkern

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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Tropazone CR

# Indications for Use

510(k) Number (if known):

Device Name: Tropazone™ CR Indications for Use:

Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 200 degree burns, including sunburns, and radiation dermatitis.

Prescription Use: X

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)

Dail Krone for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093544