Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf9-k090337
Timestamp: 2019-08-23 10:52:28
Document Index: 330548057

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807', 'art 803', 'art 21']

Read K090337.pdf
Read K090337.pdf text version
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 issubstantially equivalent to the currently marketed devices, MimyX cream, cleared under K041342, Zenieva cleared under K073246 and Biafine cleared under K964240. Device Description Tropazone Lotion isa non-sterile, semi-viscous emulsion intended for topical application. It ispresented for prescription (requires a physician diagnosis of disease state) use. The product isformulated as an oil-in-water emulsion containing a polyacrylic acid polymer as the thickening agent. The oil composition of Tropazone lotion iscomposed 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 isbeneficial to the healing process. Intended use isidentical to that of MimyX and Zenieva.
AUG 1320,09
Table 1 - Technological Comparison Tropazone K090000 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 3 times per day perday or as needed 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. Product Water-based Description emulsion Physical Non-sterile white to Properties off-white lotion Product Name 510(k) Ingredients MimyX K041342 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 Zenieva K073246 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 Biafine K964240 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
3 times per day or as needed 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. Water-based emulsion Non-sterile white to off-white thick cream
3 times per day or as needed 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. Water-based emulsion Non-sterile white to off-white thick cream
3 times per day Biafine is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist 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. Water-based emulsion Non-sterile white to off-white thick cream
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.
Conclusion Tropazone is substantially equivalent to the predicate devices listed in the table above.
% 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 5 10(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 FederalRegulations, 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.
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/ucm 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fdla.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,
510(k)Number (ifknowni: ,
'~0S37
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 _x_ (Part 21 CFR 801 Subpart D)
(Division'Sign-Oil) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number
&amp;&amp;/033'7