Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a topical lotion for skin conditions and does not mention any AI or ML components in its description, intended use, or performance studies.

Therapeutic

Yes
The Intended Use/Indications for Use states that Tropazone Lotion is "used to manage and relieve the burning and itching experienced with various types of dermatoses... It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process." This indicates a therapeutic, rather than diagnostic, purpose.

Diagnostic

No
Tropazone Lotion is intended to manage and relieve symptoms of dermatoses and maintain a moist skin environment for healing, which are therapeutic functions. It does not perform diagnostic measurements or analyses.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "non-sterile, semi-viscous emulsion intended for topical application," which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, Tropazone Lotion is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that Tropazone Lotion is for managing and relieving symptoms of dermatoses by topical application to the skin. This is a direct application to the body for therapeutic or palliative purposes.
Device Description: The description details a topical emulsion for application to the skin.
Lack of In Vitro Testing: There is no mention of the device being used to examine specimens in vitro (outside of the body) to provide information about a physiological state, health, or disease. The performance studies mentioned are related to skin irritation and sensitization, which are relevant to a topical product applied to the body.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose, monitor, or screen for diseases or conditions. Tropazone Lotion does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FRO

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.

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

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041342, K073246, K964240

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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

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.

Intended Use of the Device

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.

Intended use is identical to that of MimyX and Zenieva.

AUG 1 3 2009

1

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, glyceryl
stearate, PEG-100
stearate, paraffin,
lecithin,
polysorbate 60,
DEA-Cetyl
Phosphate,
dimethicone,
carbomer,
imidazolidinyl urea,
methylparaben,
propylparaben,
triethanolamine,
fragrance	Purified water,
olive oil, glycerin,
pentylene glycol,
palm glycerides,
vegetable oil,
hydrogenated
lecithin, squalene,
betaine,
palmitamide MEA,
sarcosine,
acetamide MEA,
hydroxyethyl
cellulose, sodium
carbomer, xanthan
gum	Purified water,
olive oil, glycerin,
pentylene glycol,
palm glycerides,
vegetable oil,
hydrogenated
lecithin, squalene,
betaine,
palmitamide MEA,
sarcosine,
acetamide MEA,
hydroxyethyl
cellulose, sodium
carbomer, xanthan
gum	Purified water, liquid
paraffin, ethylene
glycol monostearate,
stearic acid, propylene
glycol, paraffin wax,
squalene, avocado oil,
trolamine/sodium
alginate,
triethanolamine, cetyl
palmitate,
methylparaben
(sodium salt), sorbic
acid (potassium salt),
polyparaben (sodium
salt) and fragrance
# applications
per day	3 times per day
or as needed	3 times per day
or as needed	3 times per day
or as needed	3 times per day
Claim	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.	MimyX 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.	Zenieva 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.	Biafine 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.
When applied properly
to a wound, Biafine
provides an optimum
moist environment for
the healing process and
isolates the wound
from harmful germs
and other external
contamination.
Product
Description	Water-based
emulsion	Water-based
emulsion	Water-based
emulsion	Water-based emulsion
Physical
Properties	Non-sterile white to
off-white lotion	Non-sterile white to
off-white thick
cream	Non-sterile white to
off-white thick
cream	Non-sterile white to
off-white thick cream

:

2

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.

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 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.

4

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

5

K090337

Indications for Use

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

Device Name: Tropazone Lotion_

Indications for Use:

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.

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