(42 days)
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
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
The manufacturer, Beau Rx Solutions, LLC, did not conduct a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, they performed biocompatibility testing and sought to demonstrate substantial equivalence to legally marketed predicate devices (Kelo-cote® Scar Gel and Silicone Scar Gel) under a 510(k) premarket notification.
The "acceptance criteria" in this context are not quantitative performance metrics for the device's efficacy in scar management, but rather the criteria for demonstrating substantial equivalence to a predicate device, primarily focusing on design, composition, function, intended use, and safety (biocompatibility).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence rather than a de novo marketing application requiring novel efficacy data, the "acceptance criteria" are tied to alignment with the predicate devices.
| Acceptance Criteria (based on predicate device characteristics) | Reported Device Performance (Beau Rx™ Scar Care Gel) |
|---|---|
| Intended Use: Management of old and new hypertrophic and keloid scarring on scars from burns, general surgical procedures, and trauma wounds. | Meets: Beau Rx™ Scar Care Gel is intended for "management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds." |
| Composition: Self-drying topical emulsion/gel made from medical-grade silicones. | Meets: Beau Rx™ Scar Care Gel is a "non-sterile viscous emulsion/gel formulation" and its composition involves ST-Dimethiconol, Dimethicone, and Silky Wax 10 (Stearoxytrimethylsilane and Stearyl alcohol), which are silicone-based components forming a film. The document explicitly states "Self-drying topical emulsion made from medical grade silicones." |
| Sterilization Method: Non-sterile. | Meets: The emulsion is supplied non-sterile. |
| Appearance: (Predicate Kelo-Cote®: Clear translucent gel; Predicate Silicone Scar Gel: Not explicitly stated, but often clear/translucent) | Differs: Beau Rx™ Scar Care Gel is a "White gel." The submission addresses this difference, stating it does not raise new safety or effectiveness concerns. |
| Gelling/Adhesion Agents: Predicate devices use Fumed Silicone Dioxide. | Differs: Beau Rx™ Scar Care Gel uses ST-Dimethiconol, Dimethicone, and Silky Wax 10 to form a film and provide adhesion. The submission addresses this difference, stating it does not raise new safety or effectiveness concerns. |
| Biocompatibility: Must be satisfactory. | Meets: "All required testing to assess the safety and efficacy of Beau Rx™ Scar Care Gel have been conducted and all results were satisfactory." Biocompatibility testing results are documented in Sections 21-25. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific clinical test set for performance efficacy in scar reduction is described. The "testing" mentioned refers to biocompatibility screenings of individual materials used in the gel, not a clinical study on patient scars. The data provenance is from the specific materials used in the device. The document does not specify country of origin or whether chemical testing data was retrospective or prospective, but it implies standard lab testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for biocompatibility is established by standardized material testing according to recognized protocols (e.g., ISO standards, though not explicitly cited, it's implied for medical device materials). There's no mention of experts establishing ground truth for clinical outcomes as no clinical efficacy study was performed for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
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 scar gel, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the submission is primarily based on the established safety and performance characteristics of the predicate devices and the results of biocompatibility testing for the component materials of Beau Rx™ Scar Care Gel. This is a regulatory "ground truth" (i.e., substantial equivalence has been met), not a clinical efficacy ground truth from patient outcome data.
8. The sample size for the training set
Not applicable. No algorithm or AI system was developed that would require a training set. The "training set" in a broader sense would be the cumulative knowledge and regulatory history surrounding silicone scar gels that underpin the substantial equivalence argument, but this isn't a quantifiable "sample size."
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the regulatory submission (substantial equivalence) was established through comparison to predicate devices, supported by material biocompatibility testing.
{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 oldand new Hypertrophic andKeloid scarring on scars re-sulting from burns, generalsurgical procedures and traumawounds | |
| For management of old andnew hypertrophic and Keloidscarring on scars resulting fromburns, general surgical proceduresand 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, LLCBeau RxTM Scar Care Gel | Advanced Bio-Technologies, Inc.Kelo-cote® Scar GelMedTrade Products, Ltd.Silicone Scar Gel |
| Composition: | |
| Self drying topical emulsionmade from medical grade silicones | Self drying, topical emulsionmade from medical grade silicones |
| Appearance: | |
| White gel | Clear translucent gel |
| Indication for Use: | |
| For management of oldand new hypertrophic andkeloid scarring on scars re-sulting from burns, generalsurgical procedures andtrauma wounds | For management of old andnew hypertrophic and keloidscarring on scars resulting fromburns, general surgical proceduresand 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:White gel | Clear translucent gel |
|---|---|
| Indications for Use:For management of oldand new hypertrophic andkeloid scarring on scars re-sulting from burns, generalsurgical procedures and traumawounds | For management of old andnew hypertrophic and keloidscarring on scars resulting fromburns, general surgical proceduresand trauma wounds |
| Sterilization Method:Non Sterile | Non Sterile |
10.3.1 Comparative Differences Table:
| Characteristics: | Beau Rx™ ScarCare Gel | Kelo-cote® ScarGel | Silicone Scar Gel |
|---|---|---|---|
| Film former andAdhesion Agents | ST-Dimethiconol40, Dimethicone,and Silky Wax 10 | Fumed SiliconeDioxide, a gellingor thixotropicagent | Fumed SiliconeDioxide, a gellingor thixotropicagent |
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:
| COMPARATIVE FEATURES | |
|---|---|
| Characteristics: | Advanced Bio-Technologies, Inc.Kelo-Cote® Scar GelBeau Rx Solutions, LLC.Beau Rx™ Scar Care GelMedTrade Products, Ltd.Silicone Scar Gel |
| Composition: | Self drying, topical gel made from medical grade siliconesSelf 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 woundsFor 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 |
|---|---|
| --------------- | --------- |
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.