Ross Ru Wound Dressing Gel

K162017 · Biotd S.A. · FRO · Apr 20, 2017 · SU

Device Facts

• Record ID: K162017
• Device Name: Ross Ru Wound Dressing Gel
• Applicant: Biotd S.A.
• Product Code: FRO · SU
• Decision Date: Apr 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Wound dressing gel; maintains moist wound environment; absorbs or donates moisture/exudates. Supplied in collapsible low-density polyethylene tube with dispensing orifice. Applied topically to wound sites. Benefits patient by facilitating healing environment. Non-sterile, single-use.

Clinical Evidence

Bench testing only. No clinical data. Testing included cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and antimicrobial effectiveness (USP 51) against P. aeruginosa, E. coli, S. aureus, C. albicans, and A. niger. Shelf life and transport testing also performed.

Technological Characteristics

Gel composition: deionized water, silver nanoparticles, Carbopol, sodium hydroxide. Non-sterile, single-use. 3-year shelf life. Complies with ISO 10993-1 (biocompatibility) and USP 51 (antimicrobial effectiveness).

Indications for Use

Indicated for management of 1st and 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Predicate Devices

• ASAP Antibacterial Silver Wound Dressing Gel (K092826)

Reference Devices

• BioTD Ross Ru Skin Discontinuities (K131176)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [phone] 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: [phone] Office Phone: [phone] Fax: [phone] Contact: Richard Gillis, PhD, Senior Consultant Email: [e-mail]

#### 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<br>BioTD, S.A. | American Biotech Labs, LLC<br> | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | Ross Ru Wound Dressing Gel | ASAP Antibacterial Silver<br>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<br>Gel is indicated for use in<br>the management of 1st<br>and 2nd degree burns,<br>wounds such as stasis<br>ulcers, pressure ulcers,<br>diabetic ulcers, laceration,<br>abrasions, skin tears,<br>surgical incision sites,<br>device insertion site<br>wounds, graft sites and<br>donor sites. | ASAP Antibacterial Silver<br>Wound Dressing Gel is<br>indicated for use in the<br>management of 1st and 2nd<br>degree burns, wounds such<br>as stasis ulcers, pressure<br>ulcers, diabetic ulcers,<br>laceration, abrasions, skin<br>tears, surgical incision sites,<br>device insertion site<br>wounds, graft sites and<br>donor sites. | Same |
| Material | Deionized water, silver<br>nanoparticles, Carbopol,<br>sodium hydroxide | Purified water, nano-silver<br>at 0.1 micron, TEA,<br>carbopol, propylene glycol | Similar; the differences<br>between them are the<br>neutralizing agents to<br>facilitate carbopol<br>gelling. Per the<br>manufacturer's<br>instructions, carbopol<br>requires a neutralizing |

Table 5A - Comparison of Characteristics

{5}------------------------------------------------

| Manufacturer | BioTD, S.A. | American Biotech Labs, LLC | SIGNIFICANT<br>DIFFERENCES |
|-------------------------------------------------|-------------------------------|-------------------------------------------------|-----------------------------------------------------|
| Trade Name | Ross Ru Wound Dressing<br>Gel | ASAP Antibacterial Silver<br>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<br>shelf life is not available |
| Complies with ISO<br>10993-1 | Yes | Yes | Same |
| Complies with<br>Antimicrobial Test<br><USP 51> | 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 <USP 51> – 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.