(382 days)
Not Found
No
The device is a wound dressing gel and the summary describes its physical properties and performance in non-clinical tests. There is no mention of AI or ML in the description, intended use, or performance studies.
Yes
The device is described as a wound dressing gel intended for the topical management of minor cuts, lacerations, abrasions, burns, and skin irritations, all of which are conditions that require therapeutic intervention for healing. It also helps 'inhibit the growth of microorganisms', which is a therapeutic function.
No
The device is a wound dressing gel that facilitates healing by maintaining a moist wound environment and potentially inhibiting microbial growth; it does not diagnose medical conditions.
No
The device description clearly states it is a wound dressing gel supplied in a tube, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Ross Ru is a "wound dressing gel" for "topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations." It is applied directly to the skin surface to aid in wound healing.
- No Specimen Analysis: The device does not involve the analysis of any specimens taken from the body. Its function is to create a favorable environment for wound healing on the skin.
Therefore, based on the provided information, Ross Ru is a topical wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Product codes
FRO
Device Description
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Data:
- Cytotoxicity Assay (ISO 10993-5:2009). The test product extract showed no cytotoxic potential.
- Sensitization Test (ISO 10993-1:2009, -10:2010, -12:2012). The test substance was nonsensitizing.
- Irritation Test (ISO 10993-10:2010). Ross Ru Skin Discontinuities was determined to be non-irritating.
- Antimicrobial Effectiveness Test -Ross Ru Skin Discontinuities was evaluated for preservative activity in compliance with USP 51 Antimicrobial Effectiveness Test, designed to test efficacy of preservatives. Exposure to Ross Ru Discontinuities caused a significant reduction in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger.
The Ross Ru Skin Discontinuities meets all the requirements for overall design and biocompatibility, which confirm that the outputs meets the design inputs and specifications. The Ross Ru Skin Discontinuities passed all testing stated above as shown by the acceptable results obtained.
The Ross Ru Skin Discontinuities complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
MAY 1 2 2014
for
Ross Ru Skin Discontinuities
1. Submission Sponsor
BioTD, S.A. Edificio 26 Condominio Industrial San Jose de Ulloa Heredia Costa Rica Phone: 1 501 868 8300 Fax: N/A Contact: Robin Wiscovitch, Ph.D, Chief Executive Officer
2. Submission Correspondent
Emergo Group 816 Congress Ave, Suite 1400 Austin, TX 78701 Cell Phone: (406) 579-8124 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Gillis, PhD, Senior Consultant Email: project.management@emergogroup.com
3. Date Prepared
May 8, 2014
4. Device Identification
| Trade/Proprietary Name: | Ross Ru Skin Discontinuities |
|---|---|
| Common/Usual Name: | Wound gel |
| Classification Name: | Dressing, Wound, Drug |
| Classification Regulation: | Not specified |
| Product Code: | FRO |
| Device Class: | Unclassified (Pre-Amendment) |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device(s)
ASAP Wound Gel (K082333)
6. Device Description
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin
1
Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw сар.
7. Indication for Use Statement
An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
8. Substantial Equivalence Discussion
The following table compares the Ross Ru Skin Discontinuities to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | BioTD, S.A. | American Biotech Labs, LLC | SIGNIFICANT |
|---|---|---|---|
| DIFFERENCES | |||
| Trade Name | Ross Ru Skin | ASAP Wound Gel | |
| Discontinuities | |||
| 510(k) Number | Not assigned | K082333 | N/A |
| Product Code | FRO | FRO | Same |
| Regulation Number | Not specified | Not specified | Same |
| Regulation Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Indications for Use | An over-the-counter (OTC) | ||
| product for topical | |||
| management of minor | |||
| cuts, lacerations, | |||
| abrasions, 1st and 2nd | |||
| degree burns, and skin | |||
| irritations. | For the topical | ||
| management of minor cuts, | |||
| lacerations, abrasions, 1st | |||
| and 2nd degree burns, and | |||
| skin irritations | Same | ||
| Material | Deionized water, silver | ||
| nanoparticles, Carbopol, | |||
| sodium hydroxide | Purified water, nano-silver | ||
| at 0.1 micron, TEA, | |||
| carbopol, propylene glycol | Similar; the differences | ||
| between them are the | |||
| neutralizing agents to | |||
| facilitate carbopol | |||
| gelling. Per the | |||
| manufacturer's | |||
| instructions, carbopol | |||
| requires a neutralizing | |||
| agent for gelling. TEA or | |||
| sodium hydroxide can | |||
| be used, among others. | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | N/A | NA; predicate device |
| shelf life is not available | |||
| Complies with ISO | |||
| 10993-1 | Yes | Yes | Same |
| Complies with | |||
| Antimicrobial Test | |||
| Yes | Yes | Same |
Table 5A - Comparison of Characteristics
2
9. Non-Clinical Performance Data
The following testing has been performed to support substantial equivalence:
- Cytotoxicity Assay (ISO 10993-5:2009). The test product extract showed no cytotoxic ● potential.
- . Sensitization Test (ISO 10993-1:2009, -10:2010, -12:2012). The test substance was nonsensitizing.
- Irritation Test (ISO 10993-10:2010). Ross Ru Skin Discontinuities was determined to be . non-irritating.
- . Antimicrobial Effectiveness Test -Ross Ru Skin Discontinuities was evaluated for preservative activity in compliance with USP 51 Antimicrobial Effectiveness Test, designed to test efficacy of preservatives. Exposure to Ross Ru Discontinuities caused a significant reduction in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger.
As part of demonstrating safety and effectiveness of Ross Ru Skin Discontinuities and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, BioTD, S.A. completed a number of tests. The Ross Ru Skin Discontinuities meets all the requirements for overall design and biocompatibility, which confirm that the outputs meets the design inputs and specifications. The Ross Ru Skin Discontinuities passed all testing stated above as shown by the acceptable results obtained.
The Ross Ru Skin Discontinuities complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the Ross Ru Skin Discontinuities and the predicate device do not raise any questions regarding its safety and effectiveness. The Ross Ru Skin Discontinuities, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
3
Image /page/3/Picture/0 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. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2014
BioTD, S.A. % Richard Gillis, Ph.D. Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K131176
Trade/Device Name: Ross Ru Skin Discontinuities Regulatory Class: Unclassified Product Code: FRO Dated: March 28, 2014 Received: March 31, 2014
Dear Dr. Gillis:
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 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 - Richard Gillis, Ph.D.
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510{k} Number (if known) K131176
Device Name Ross Ru Skin Discontinuities
Indications for Use (Describe)
Includins to ose (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Joseph Nielsen -S 2014.05.12 07:06:10 -04 0
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