(273 days)
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.
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.
This document is a 510(k) summary for a medical device (Ross Ru Wound Dressing Gel), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for new AI/ML-based diagnostic devices.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment) are not applicable to this type of regulatory submission because the device is a wound dressing gel, not an AI/ML diagnostic.
The submission focuses on:
- Intended Use Equivalence: Showing the indications for use are the same as the predicate device.
- Technological Characteristics Comparison: Demonstrating similar materials and properties, with minor differences justified.
- Non-Clinical Performance Data: Biocompatibility, irritation, sensitization, and antimicrobial effectiveness tests to show safety.
Here's how to address the prompt based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Criteria
As this is a 510(k) submission for a wound dressing gel, the "acceptance criteria" are not framed as statistical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC) but rather as successful completion of non-clinical safety tests to demonstrate substantial equivalence to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity Assay (ISO 10993-5:2009) | No cytotoxic potential | "The test product extract showed no cytotoxic potential." |
| Sensitization Test (ISO 10993-1:2009, -10:2010, -12:2012) | Non-sensitizing | "The test substance was non-sensitizing." | |
| Irritation Test (ISO 10993-10:2010) | Non-irritating | "Ross Ru Wound Dressing Gel was determined to be non-irritating." | |
| Product Functionality | Antimicrobial Effectiveness Test <USP 51> | Demonstrate preservative activity and inhibition of specified microorganisms | "Ross Ru Wound Dressing Gel was evaluated for preservative activity... Exposure to Ross Ru Skin Discontinuities caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger." |
| Material Properties | Adherence to ISO 10993-1 standards | Compliance with biocompatibility standards | "Complies with ISO 10993-1: Yes" and "Biocompatibility testing per ISO 10993-1" |
| Sterility | (Implied by comparison to predicate) | Non-sterile | "Non-sterile: Same (as predicate)" |
| Shelf Life | Stability for specified period | 3 years | "A maximum shelf life of 3 years has been assigned..." |
| Packaging Integrity | Storage and Transport Testing | No evidence of damage to packaging after transport | "all packaging layers remained in a satisfactory condition following testing with no evidence of damage being observed." |
| Intended Use | Match predicate device | Indications are equivalent to predicate device | "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." (Matches predicate) |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many gel samples were tested for cytotoxicity, how many animals for irritation). These are standard laboratory tests, and specific sample sizes would be detailed in the full test reports, which are not part of this summary document.
- Data Provenance: The tests are standard biological and chemical tests. The provenance is implied to be from certified labs conducting tests for BioTD, S.A. (Manufacturer: Costa Rica) to support the 510(k) submission to the FDA (USA). No country of origin for data (e.g., patient data) is relevant as this is not a clinical study involving patients. The tests are prospective laboratory experiments.
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. This is a physical wound dressing product, not a diagnostic device requiring human expert interpretation to establish "ground truth" for a test set. The "ground truth" for the non-clinical tests is established by the accepted scientific methodologies and results of the respective assays (e.g., if cells died or not in a cytotoxicity assay).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There is no a human-interpreted test set requiring adjudication in this submission.
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 is a medical device (wound dressing gel), not an AI-assisted diagnostic tool. No human reader studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the results of standardized laboratory assays and tests according to recognized international and national standards (e.g., ISO 10993 series, USP 51). For example, for cytotoxicity, the ground truth is the biological response of cells; for antimicrobial effectiveness, it's the observed inhibition of microbial growth.
8. The sample size for the training set
- Not Applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of device.
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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.
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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
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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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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)
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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 | |||
|---|---|---|---|
| ManufacturerBioTD, S.A. | American Biotech Labs, LLC | SIGNIFICANTDIFFERENCES | |
| Trade Name | Ross Ru Wound Dressing Gel | ASAP Antibacterial SilverWound 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 DressingGel is indicated for use inthe management of 1stand 2nd degree burns,wounds such as stasisulcers, pressure ulcers,diabetic ulcers, laceration,abrasions, skin tears,surgical incision sites,device insertion sitewounds, graft sites anddonor sites. | ASAP Antibacterial SilverWound Dressing Gel isindicated for use in themanagement of 1st and 2nddegree burns, wounds suchas stasis ulcers, pressureulcers, diabetic ulcers,laceration, abrasions, skintears, surgical incision sites,device insertion sitewounds, graft sites anddonor sites. | Same |
| Material | Deionized water, silvernanoparticles, Carbopol,sodium hydroxide | Purified water, nano-silverat 0.1 micron, TEA,carbopol, propylene glycol | Similar; the differencesbetween them are theneutralizing agents tofacilitate carbopolgelling. Per themanufacturer'sinstructions, carbopolrequires a neutralizing |
Table 5A - Comparison of Characteristics
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| Manufacturer | BioTD, S.A. | American Biotech Labs, LLC | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | Ross Ru Wound DressingGel | ASAP Antibacterial SilverWound 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 deviceshelf life is not available |
| Complies with ISO10993-1 | Yes | Yes | Same |
| Complies withAntimicrobial Test<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.
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- 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.
N/A