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.

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for Tropazone CR, a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in this document are based on demonstrating substantial equivalence to predicate devices, focusing on technological characteristics and safety. The performance is assessed through specific tests to show the device is non-irritating and non-sensitizing, and that it meets cytotoxicity standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance for Tropazone CR
Biocompatibility (Skin)	Non-primary irritant and non-primary sensitizer (as assessed by human patch testing).	Met: Repeat Insult Patch Testing with 50 human subjects showed Tropazone CR to be a non-primary irritant and non-primary sensitizer to the skin.
Biocompatibility (Cytotoxicity)	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).	Met: In a L929 Agar Overlay Cytotoxicity study using Tropazone CR, the cells exhibited a mild to moderate reaction, meeting the specified requirements.
Technological Equivalence	Similar ingredients, application frequency, claims, product description, and physical properties to predicate devices.	Met: Table 1 provides a detailed technological comparison showing similarities across these categories with the predicate devices (Biafine, Tropazone Lotion, MimyX cream, and Zenieva).

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

Human Subjects (Biocompatibility - Irritation/Sensitization):
- Sample Size: 50 human subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study.
L929 Agar Overlay Cytotoxicity Study:
- Sample Size: Not applicable in the same way as human subjects. This is an in vitro test using L929 cells.
- Data Provenance: In vitro laboratory study.

The document does not specify geographical origin but indicates these are studies conducted to support the 510(k) submission, implying they were performed for this purpose (prospective relative to the submission).

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

For human patch testing: The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., assessing the skin reactions). Typically, board-certified dermatologists or allergists would conduct and interpret such studies.
For cytotoxicity testing: Similarly, the document does not specify experts. These are standardized laboratory tests, where "ground truth" is established by adherence to ISO and USP protocols and interpretation by qualified laboratory personnel.

4. Adjudication Method

Not applicable. These studies are clinical (human patch test) and lab-based (cytotoxicity) tests that follow established protocols, not typically requiring adjudication in the context of expert review of images or diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an imaging or diagnostic device that would typically involve human readers interpreting data with and without AI assistance. The studies performed are focused on biocompatibility and physicochemical equivalence.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone (algorithm only) performance study was not conducted. This is a medical device (a wound dressing), not an algorithm or AI system.

7. Type of Ground Truth Used

For human patch testing: The ground truth is generally considered to be the observed physiological reaction of the human skin (e.g., erythema, edema) as assessed by a trained professional following a standardized scoring system.
For cytotoxicity testing: The ground truth is the in vitro cellular response to the device extract, measured against established criteria within the ISO 10993-5 and USP 23 standards.

8. Sample Size for the Training Set

Not applicable. This device is a wound dressing, not an algorithm that requires a training set. The studies performed are for safety and performance testing, not for training AI models.

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

Not applicable, as no training set was used.

Summary

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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: (334) 288-8661 Fax: (334) 288-8651 Toll Free: (800) 344-8661

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 healingprocess andisolates thewound fromharmful germsand otherexternalcontamination.	helps relievedry waxy skinby maintaininga moist woundand skinenvironment,which isbeneficial tothe healingprocess.	dermatitis. Ithelps relievedry waxy skinbymaintaining amoist woundand skinenvironment,which isbeneficial tothe healingprocess.	dry waxy skinby maintaininga moist woundand skinenvironment,which isbeneficial tothe healingprocess.
ProductDescription	Water-basedemulsion	Water-basedemulsion	Water-basedemulsion	Water-basedemulsion	Water-basedemulsion
PhysicalProperties	Non-sterilewhite to off-white cream	Non-sterilewhite to off-white lotion	Non-sterilewhite to off-white thickcream	Non-sterilewhite to off-white thickcream	Non-sterilewhite to off-white thickcream

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 (800) 638-2041 or (301) 796-7100 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

Page __ of

510(k) Number K093544

Regulation Number and Section

N/A