BEAU RX SCAR CARE GEL

{0}------------------------------------------------ ### 4. 510(k) Summary #### 4.1.1 Sponsor: Beau Rx Solutions, LLC 1440 South Ocean Blvd #5C Lauderdale by the Sea, Fl 33062 JAN 2 6 2009 ### 4.1.2 Contact: Thomas L McGraw, President Phone: 1-954-817-6155 Fax 1-954-782-0018 E-mail Silospheres@bellsouth net Date of Preparation October 15, 2008 ### 4.1.3 Contract Manufacturer: A I G Technologies, Incorporated 1917 N W 40th Court Pompano Beach, Florida 33064 Reg #3003511617 Label Code 66756 ### 4.1.4 Device Identification: Proprietary Name Beau Rx10 Scar Care Gel Common Name Silicone Scar Gel Classification Name: Elastomer, Silicone, for Scar Management CFR 878 4025 Product Code MDA ### 4.1.5 Substantial Equivalence: Beau Rx Solutions product, Beau Rx104 Scar Care Gel, is substantially equivalent in design, composition and function compared to Kelo-cote® Scar Gel manufactured by Advanced Bio-Technologies, Incorporated 510(k) # K002488 and Silicone Scar Gel manufactured by MedTrade Products, Limited 510(k) # K014036 ### 4.1.6 Device Description: Beau RxTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over-the-counter use It is applied topically to aid in the management of both old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds ### 4.1.7 Packaging: Beau Rx TM Scar Care Gel comes in a 15 gram, 30 gram, and 50 gram labeled airless pump applicator, making it easy to apply to difficult areas It is safe, hygienic and easy to use It can be worn during the day or overnight {1}------------------------------------------------ K083718 page 2/7 ### 4.2.1 Sterilization: The emulsion is supplied non-sterile ### 4.2.2 Intended Use: Beau Rx™ Scar Care Gel is intended for the management of old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds ### 4.2.3 Summary of Technological Characteristics Compared to Predicate Devices: Biocompatibility tesung results are documented in Sections 21-25, Attachments I-V Additional documentation is provided in the FDA Drug Master Files found in Sections 26-28. Attachments VI-VIII Beau Rx Solutions product, Beau RxTM Scar Care Gel, is substantially equivalent in design, composition, and function to Kelo-cote® manufactured by Advanced B10-Technologies, 510(k) # K002488 and Silvcone Scar Gel manufactured by MedTrade Products Ltd 510(k) #K014036 A table of comparative features is provided below for ease of review ### 4.2.4. Comparative Features Table: Image /page/1/Figure/8 description: This image shows a table that compares the features of different scar care gels. The table is divided into two sections: "Characteristics" and "Composition". Under "Characteristics", the table lists the names of the scar care gels, including Beau Rx Solutions, LLC Beau Rx™ Scar Care Gel, Advanced Bio-Technologies, Inc. Kelo-cote® Scar Gel, and MedTrade Products, Ltd. Silicone Scar Gel. Under "Composition", the table states that all of the scar care gels are self-drying, topical emulsions made from medical-grade silicones. {2}------------------------------------------------ K083718 page 3/7 | Indication for Use: | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | | For management of old<br>and new Hypertrophic and<br>Keloid scarring on scars re-<br>sulting from burns, general<br>surgical procedures and trauma<br>wounds | | | For management of old and<br>new hypertrophic and Keloid<br>scarring on scars resulting from<br>burns, general surgical procedures<br>and trauma wounds | | Sterilization Method: | | | | Non Sterile | | | Non Sterile | ### 4.3.1 Testing and Conclusion: All required testing to assess the safety and efficacy of Beau Rx™ Scar Care Gel have been conducted and all results were satisfactory The testing results described in these summanes were performed individually on all specific materials used in Beau RxTM Scar Care Gel These summaries (Sections 21-25, Attachments I-V) are intended to serve as biocompatibility screenings Each summary contains the Summary of Health Data and Toxicology Testing of each ingredient used in Beau RxTM Scar Care Gel Further data is provided in the FDA Drug Master File for review (Sections 26-28, Attachments VI-VIII) for each ingredient indicated {3}------------------------------------------------ K083718 page 4/7 # 9.2.1 Comparative Features Table: | COMPARATIVE FEATURES | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics: | | | Beau Rx Solutions, LLC<br>Beau RxTM Scar Care Gel | Advanced Bio-Technologies, Inc.<br>Kelo-cote® Scar Gel<br><br>MedTrade Products, Ltd.<br>Silicone Scar Gel | | Composition: | | | Self drying topical emulsion<br>made from medical grade silicones | Self drying, topical emulsion<br>made from medical grade silicones | | Appearance: | | | White gel | Clear translucent gel | | Indication for Use: | | | For management of old<br>and new hypertrophic and<br>keloid scarring on scars re-<br>sulting from burns, general<br>surgical procedures and<br>trauma wounds | For management of old and<br>new hypertrophic and keloid<br>scarring on scars resulting from<br>burns, general surgical procedures<br>and trauma wounds | | Sterilization Method: | | | Non Sterile | Non Sterile | {4}------------------------------------------------ K083718 page 5/7 ### 10. Device Description ### 10.1.1 Sponsor: Beau Rx Solutions, LLC 1440 South Ocean Blvd #5C Lauderdale by the Sea, F1 33062 ### 10.1.2 Contact: Thomas L McGraw, President Phone 1-954-817-6155 Fax 1-954-782-0018 E-mail Silospheres@bellsouth net Date of Preparation October 15, 2008 #### 10.1.3 Contract Manufacturer: A I G Technologies 1917 N W 40th Court Pompano Beach, Florida 33064 Reg #3003500617 Label Code 66756 ### 10.1.4 Device Identification: Proprietary Name Beau Rx™M Scar Care Gel Common Name Silicone Scar Gel Classification Name Elastomer, Silicone, for Scar Management CFR 878.4025 Product Code MDA ### 10.1.5 Indications for Use: Beau RxTM Scar Care Gel is intended for the management of old and new scars including Hypertrophic and Keloid scarring on scars resulting from general surgical procedures, trauma wounds, and burns {5}------------------------------------------------ K083718 Page 6/7 | Appearance:<br>White gel | Clear translucent gel | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use:<br>For management of old<br>and new hypertrophic and<br>keloid scarring on scars re-<br>sulting from burns, general<br>surgical procedures and trauma<br>wounds | For management of old and<br>new hypertrophic and keloid<br>scarring on scars resulting from<br>burns, general surgical procedures<br>and trauma wounds | | Sterilization Method:<br>Non Sterile | Non Sterile | ### 10.3.1 Comparative Differences Table: | Characteristics: | Beau Rx™ Scar<br>Care Gel | Kelo-cote® Scar<br>Gel | Silicone Scar Gel | |------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------| | Film former and<br>Adhesion Agents | ST-Dimethiconol<br>40, Dimethicone,<br>and Silky Wax 10 | Fumed Silicone<br>Dioxide, a gelling<br>or thixotropic<br>agent | Fumed Silicone<br>Dioxide, a gelling<br>or thixotropic<br>agent | ### 10.3.2 Summary of Differences: ST-Dimethiconol with Dimethicone provides the composition device with the abılıty to form a hıghly substantıve mat film finish on the skın The Sılky Wax 10 (Stearoxytrimethylsilane and Stearyl alcohol), acts as a hardening lubricant which causes a reduction in the clastic contribution of the gum blend under stress and a reduction in the creep of the film This combination of Silky Wax 10, Dimethicone, and ST-Dimethiconol 40 forms a film on the skin creating adhesion to the skin and substantivity to Beau RxTM Scar Care Gel The predicate devices use Fumed Silicone Dioxide (fumed silica) as a gelling or thixothropic agent to stiffen the gel causing adhesion to the skin and film formation ### 10.3.3 Conclusion: Beau RxTM Scar Care Gel has the same intended use and similar technological characteristics as the predicate devices Moreover, the non-clinical testing and the predicate devise comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness Thus, Beau RxTM Scar Care Gel is substantially equivalent to the predicate devices {6}------------------------------------------------ K083718 page 7/7 # 11.2.1 Comparative Features Table: | <b>COMPARATIVE FEATURES</b> | | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics: | Advanced Bio-Technologies, Inc.<br>Kelo-Cote® Scar Gel<br><br>Beau Rx Solutions, LLC.<br>Beau Rx™ Scar Care Gel<br><br>MedTrade Products, Ltd.<br>Silicone Scar Gel | | Composition: | Self drying, topical gel made from medical grade silicones<br><br>Self drying, topical gel made from medical grade silicones | | Appearance: | | | White, gel | Clear translucent gel | | Indications for Use: | | | | For management of old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures, and trauma wounds<br><br>For management of old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures, and trauma wounds | | Sterilization Method: | | | Non Sterile | Non Sterile | {7}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Beau Rx Solutions, LLC % Mr Thomas L McGraw 1440 S Ocean Boulevard, Suite 5C Lauderdale by the Sea, Florida 33062 Re K083718 Trade/Device Name Beau RX™ Scar Care Gel Regulation Number 21 CFR 878 4025 Regulation Name Silcone sheeting Regulatory Class I Product Code MDA Dated October 15, 2008 Received December 15, 2008 JAN 2 6 2009 Dear Mr McGraw 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 etther class II (Special Controls) or class III (PMA), it may be subject to such 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), 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 {8}------------------------------------------------ Page 2 - Mr Thomas L McGraw This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Drvision of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 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 N Millman Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K083718 Device Name Beau RX™ Scar Care Gel Indications For Use The Beau RX™ Scar Care Gel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds | Prescription Use | X | AND/OR | Over-The-Counter Use | |-----------------------------|---|--------|------------------------| | (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off), Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices | 510(k) Number | 1083718 | |---------------|---------| |---------------|---------|