(273 days)
No
The device description and performance studies focus on the physical and biological properties of a wound dressing gel, with no mention of AI or ML capabilities.
Yes
The device is a wound dressing gel indicated for the management of various wounds and burns, which are therapeutic applications.
No
The device description and intended use indicate it is a wound dressing gel for healing, not for diagnosing 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a topical application for treating the wound itself, not for testing a sample taken from the body to diagnose a condition or monitor a physiological state.
- Device Description: The device is a wound dressing gel. This is a physical product applied to the wound surface.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) or provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, antimicrobial effectiveness, and physical properties of the gel, which are relevant to a wound dressing, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wound dressing gel does not fit that description.
N/A
Intended Use / Indications for Use
Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
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. Ross Ru Wound Dressing Gel 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)
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 non-● sensitizing.
- Irritation Test (ISO 10993-10:2010). Ross Ru Wound Dressing Gel was determined to be non-irritating.
- . Antimicrobial Effectiveness Test – Ross Ru Wound Dressing Gel was evaluated for preservative activity in compliance with USP 51 Antimicrobial Effectiveness Test, designed to test efficacy of preservatives. Exposure to Ross Ru Skin Discontinuities caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger.
As part of demonstrating safety and effectiveness of Ross Ru Wound Dressing Gel 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 Wound Dressing Gel meets all the requirements for overall design and biocompatibility, which confirm that the outputs meet the design inputs and specifications. The Ross Ru Wound Dressing Gel passed all testing stated above as shown by the acceptable results obtained.
The Ross Ru Wound Dressing Gel complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
- Biocompatibility testing per ISO 10993-1
- Shelf Life Testing – A maximum shelf life of 3 years has been assigned to the Ross Ru Wound Dressing Gel, when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
- Storage and Transport Testing – Multiple packages of Ross Ru Wound Dressing Gel were subjected to transportation followed by inspection. The results demonstrated that all packaging layers remained in a satisfactory condition following testing with no evidence of damage being observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
BioTD, S.A. % Richard Gillis Senior Regulatory Consultant Emergo Group 816 Congress Ave Suite 1400 Austin, Texas 78701
Re: K162017
Trade/Device Name: Ross Ru Wound Dressing Gel Regulatory Class: Unclassified Product Code: FRO Dated: March 13, 2017 Received: March 15, 2017
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 devicerelated 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.
1
If 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" (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.fda.gov/MedicalDevices/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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162017
Device Name Ross Ru Wound Dressing Gel
Indications for Use (Describe)
Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
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)
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3
510(k) Summary
for
Ross Ru Wound Dressing Gel
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: Lawrence Pratt, Chief Executive Officer
2. Submission Correspondent
Emergo Group 2500 Bee Cave Rd, Building 1, Suite 300 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
April 14, 2017
4. Device Identification
| Trade/Proprietary Name: | Ross Ru Wound Dressing Gel |
|---|---|
| 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
ASAP Antibacterial Silver Wound Dressing Gel (K092826)
6. Legally Marketed Reference Device
BioTD Ross Ru Skin Discontinuities (K131176)
4
7. 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. Ross Ru Wound Dressing Gel 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.
8. Indication for Use Statement
Ross Ru Wound Dressing Gel is indicated for use in the management of 1* and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, laceration, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
9. Substantial Equivalence Discussion
The following table compares the Ross Ru Wound Dressing Gel 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.
| Table 5A – Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | |||
| BioTD, S.A. | American Biotech Labs, LLC |
| SIGNIFICANT
DIFFERENCES |
| Trade Name | Ross Ru Wound Dressing Gel | ASAP Antibacterial Silver
Wound Dressing Gel | |
| 510(k) Number | K162017 | K092826 | 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 | Ross Ru Wound Dressing
Gel is indicated for use in
the management of 1st
and 2nd degree burns,
wounds such as stasis
ulcers, pressure ulcers,
diabetic ulcers, laceration,
abrasions, skin tears,
surgical incision sites,
device insertion site
wounds, graft sites and
donor sites. | ASAP Antibacterial Silver
Wound Dressing Gel is
indicated for use in the
management of 1st and 2nd
degree burns, wounds such
as stasis ulcers, pressure
ulcers, diabetic ulcers,
laceration, abrasions, skin
tears, surgical incision sites,
device insertion site
wounds, graft sites and
donor sites. | 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 |
Table 5A - Comparison of Characteristics
5
| Manufacturer | BioTD, S.A. | American Biotech Labs, LLC | SIGNIFICANT
DIFFERENCES |
|-------------------------------------------------|-------------------------------|-------------------------------------------------|-----------------------------------------------------|
| Trade Name | Ross Ru Wound Dressing
Gel | ASAP Antibacterial Silver
Wound Dressing Gel | |
| | | | 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 |
10. 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 non-● sensitizing.
- Irritation Test (ISO 10993-10:2010). Ross Ru Wound Dressing Gel was determined to be non-irritating.
- . Antimicrobial Effectiveness Test – Ross Ru Wound Dressing Gel was evaluated for preservative activity in compliance with USP 51 Antimicrobial Effectiveness Test, designed to test efficacy of preservatives. Exposure to Ross Ru Skin Discontinuities caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger.
As part of demonstrating safety and effectiveness of Ross Ru Wound Dressing Gel 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 Wound Dressing Gel meets all the requirements for overall design and biocompatibility, which confirm that the outputs meet the design inputs and specifications. The Ross Ru Wound Dressing Gel passed all testing stated above as shown by the acceptable results obtained.
The Ross Ru Wound Dressing Gel complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
- Biocompatibility testing per ISO 10993-1
- Shelf Life Testing – A maximum shelf life of 3 years has been assigned to the Ross Ru Wound Dressing Gel, when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
6
- Storage and Transport Testing – Multiple packages of Ross Ru Wound Dressing Gel were subjected to transportation followed by inspection. The results demonstrated that all packaging layers remained in a satisfactory condition following testing with no evidence of damage being observed.
11. 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 device, 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.
12. 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.
The Ross Ru Wound Dressing Gel, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.