Tropazone Lotion is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Device Description

Tropazone Lotion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a polyacrylic acid polymer as the thickening agent. The oil composition of Tropazone lotion is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.

AI/ML Overview

This device, Tropazone Lotion, is a hydrogel wound dressing. The provided text outlines its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a dedicated study.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a Class I unclassified device (hydrogel wound dressing), the "acceptance criteria" are primarily established by demonstrating equivalency to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics to these predicates.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (Tropazone Lotion)	Comments
Intended Use equivalent to predicates	Used to manage and relieve burning and itching with various dermatoses (radiation, atopic, allergic contact dermatitis); maintains moist wound/skin environment for healing.	Intended use explicitly stated as "identical to that of MimyX and Zenieva."
Technological Characteristics (e.g., composition, application frequency, product description, physical properties) similar to predicates	Ingredients: Purified water, liquid paraffin (mineral oil), petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, lecithin, polysorbate 60, DEA-Cetyl Phosphate, dimethicone, carbomer, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine, fragrance.# applications per day: 3 times per day or as needed.Product Description: Water-based emulsion.Physical Properties: Non-sterile white to off-white lotion.	Compared against MimyX, Zenieva, and Biafine. While ingredients differ, the overall product descriptions and physical properties are presented as similar (e.g., water-based emulsion, non-sterile white/off-white). The 3x/day application is common.
Biocompatibility/Safety (Non-Primary Irritant, Non-Primary Sensitizer)	Considered a non-primary irritant and a non-primary sensitizer to skin under occlusion testing.	This directly addresses safety for skin contact.
Cytotoxicity (low/acceptable biological reactivity)	L929 Agar overlay cytotoxicity study showed mild/moderate reaction.	This indicates a generally acceptable level of cellular interaction.

2. Sample Size Used for the Test Set and Data Provenance

The submission does not describe a test set or clinical study in the traditional sense for evaluating the novel performance of Tropazone Lotion. Instead, it relies on:

Human Safety Test: "Tropazone when tested under occlusion may be considered a non-primary irritant and a non-primary sensitizer to skin." The sample size for this test is not specified. The data provenance is also not specified, but given it's for a US regulatory submission, it's presumably from a study conducted to relevant safety standards. It does not specify if it was retrospective or prospective.
In-vitro Test: "In a L929 Agar overlay cytotoxicity study using Tropazone, the cells exhibited a mild/moderate reaction." The sample size for this in-vitro test is not specified. Data provenance is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no specific "ground truth" derived from expert consensus for a test set in the context of device performance evaluation. The safety and biocompatibility assessments would typically rely on established dermatological and toxicological endpoints, interpreted by qualified personnel, but the number and qualifications of such experts are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical or performance test set requiring adjudication is described.

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

Not applicable. This device is a topical lotion, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was done

Not applicable. This device is a topical lotion, not an algorithm.

7. The Type of Ground Truth Used

For the safety data:

The biocompatibility/irritation/sensitization ground truth would be based on established dermatological endpoints in human or animal models (e.g., skin reactions scored according to a toxicity scale).
The cytotoxicity ground truth would be based on cellular viability and morphology in an in-vitro assay, compared to controls.

For the substantial equivalence claim:

The "ground truth" is the established performance and safety profile of the predicate devices (K041342, K073246, and K964240), based on their prior clearances.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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510(k) Summary

Submitter of the Application

Midlothian Laboratories

760 Industrial Park Blvd., Unit C

Montgomery, AL 36117

Phone: (334) 288-8661

Fax: (334) 288-8651

Toll Free: (800) 344-8661

Trade Name

Tropazone Lotion

Common Name

Hydrogel wound dressing

Device Classification

Hydrogel wound dressing with preservatives

Unclassified, FRO

Substantial Equivalence/ Predicate Device

Tropazone Lotion is substantially equivalent to the currently marketed devices, MimyX cream, cleared under K041342, Zenieva cleared under K073246 and Biafine cleared under K964240.

Device Description

Intended Use of the Device

Intended use is identical to that of MimyX and Zenieva.

AUG 1 3 2009

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K090337
pg 2 of 3

Table 1 - Technological Comparison

. .

Product Name	Tropazone	MimyX	Zenieva	Biafine
510(k)	K090000	K041342	K073246	K964240
Ingredients	Purified water,liquid paraffin(mineral oil),petrolatum,alcohol, glycerylstearate, PEG-100stearate, paraffin,lecithin,polysorbate 60,DEA-CetylPhosphate,dimethicone,carbomer,imidazolidinyl urea,methylparaben,propylparaben,triethanolamine,fragrance	Purified water,olive oil, glycerin,pentylene glycol,palm glycerides,vegetable oil,hydrogenatedlecithin, squalene,betaine,palmitamide MEA,sarcosine,acetamide MEA,hydroxyethylcellulose, sodiumcarbomer, xanthangum	Purified water,olive oil, glycerin,pentylene glycol,palm glycerides,vegetable oil,hydrogenatedlecithin, squalene,betaine,palmitamide MEA,sarcosine,acetamide MEA,hydroxyethylcellulose, sodiumcarbomer, xanthangum	Purified water, liquidparaffin, ethyleneglycol monostearate,stearic acid, propyleneglycol, paraffin wax,squalene, avocado oil,trolamine/sodiumalginate,triethanolamine, cetylpalmitate,methylparaben(sodium salt), sorbicacid (potassium salt),polyparaben (sodiumsalt) and fragrance
# applicationsper day	3 times per dayor as needed	3 times per dayor as needed	3 times per dayor as needed	3 times per day
Claim	Tropazone Lotion isused to manageand relieve theburning and itchingexperienced withvarious types ofdermatoses,including radiationdermatitis, atopicdermatitis, andallergic contactdermatitis. It helpsrelieve dry waxyskin by maintaininga moist wound andskin environment,which is beneficialto the healingprocess.	MimyX isused to manageand relieve theburning and itchingexperienced withvarious types ofdermatoses,including radiationdermatitis, atopicdermatitis, andallergic contactdermatitis. It helpsrelieve dry waxyskin by maintaininga moist wound andskin environment,which is beneficialto the healingprocess.	Zenieva isused to manageand relieve theburning and itchingexperienced withvarious types ofdermatoses,including radiationdermatitis, atopicdermatitis, andallergic contactdermatitis. It helpsrelieve dry waxyskin by maintaininga moist wound andskin environment,which is beneficialto the healingprocess.	Biafine is for thedressing andmanagement ofsuperficial wounds,minor abrasions,dermal ulcers, donorsites, 1st and 2nd degreeburns, includingsunburns, andradiation dermatitis.When applied properlyto a wound, Biafineprovides an optimummoist environment forthe healing process andisolates the woundfrom harmful germsand other externalcontamination.
ProductDescription	Water-basedemulsion	Water-basedemulsion	Water-basedemulsion	Water-based emulsion
PhysicalProperties	Non-sterile white tooff-white lotion	Non-sterile white tooff-white thickcream	Non-sterile white tooff-white thickcream	Non-sterile white tooff-white thick cream

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K090337
pg 3 of 3

Clinical Performance Data

Tropazone when tested under occlusion may be considered a non-primary irritant and a non-primary sensitizer to skin. .

Non-Clinical Performance Data

In a L929 Agar overlay cytotoxicity study using Tropazone, the cells exhibited a mild/moderate reaction.

Carlos Concession

Conclusion

Tropazone is substantially equivalent to the predicate devices listed in the table above.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 1 8 2009

Midlothian Laboratories % Mr. Bryce Harvey President 760 Industrial Park Boulevard, Unit C Montgomery, Alabama 36117

Re: K090337

Trade/Device Name: Tropazone Lotion Regulatory Class: Unclassified Product Code: FRO Dated: June 23, 2009 Received: June 24, 2009

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.

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 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 - Mr. Bryce Harvey

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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millbern

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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K090337

Indications for Use

510(k) Number (if known): Ko 90337

Device Name: Tropazone Lotion_

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil RPOden for nxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090337

Regulation Number and Section

N/A