(187 days)
Abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stages I-IV, stasis ulcers, venous ulcers.
Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to three (3) days. The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix. The silver is intended to prevent microbes from passing through the dressing during use. The dressings are offered in two configurations:
- a paste;
- a paste applied to a non-adherent polyurethane foam layers in various sizes and shapes;
The device is sterilized by gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device (wound dressing) and DOES NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
This document describes a traditional 510(k) for a physical medical device, the "Algidex Ag Silver Alginate Wound Dressing." The submission focuses on demonstrating substantial equivalence to predicate devices (SilverSite and Calgitrol Ag) based on technological characteristics and performance tests related to the physical properties and antimicrobial effectiveness of the wound dressing.
The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are highly relevant to AI/ML medical device submissions, where algorithms are evaluated for their diagnostic or predictive performance against established ground truth.
Therefore, I cannot extract the requested information from this document because it is not an AI/ML device submission.
The document discusses "performance tests" for the wound dressing, which are entirely different from the performance evaluation of an AI algorithm. For instance, it mentions:
- AATCC 100 test method: This is a standard test for antibacterial activity of fabrics.
- Antimicrobial barrier testing: Evaluating the dressing's ability to prevent microbial passage.
- Absorbency test: Measuring fluid absorption.
These are not related to AI model performance metrics like sensitivity, specificity, AUC, human reader improvement, or ground truth established by expert consensus on imaging data.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 4, 2018
DeRoyal Industries, Inc. Sarah Bennett Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K173072
Trade/Device Name: Algidex Ag Silver Alginate Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 5, 2018 Received: March 5, 2018
Dear Sarah Bennett:
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 Aments, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3
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) K173072
Device Name
Algidex Ag Silver Alginate Wound Dressing
Indications for Use (Describe)
Abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stages I-IV, stasis ulcers, venous ulcers.
Type of Use (Select one or both, as applicable)X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the word "DeRoyal" in blue, with a registered trademark symbol next to it. The logo is simple and modern, with a clean design.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
DeRoyal Industries, Inc. Traditional 510(k) – Algidex Ag Silver Alginate Wound Dressing September 28, 2017
510(k) Summary
| Date prepared: | September 28, 2017 |
|---|---|
| 510(k) Owner: | DeRoyal Industries, Inc.200 DeBusk LanePowell, TN 37849Owner/Operator #1044833 |
| 510(k) Contact: | Sarah BennettRegulatory Affairs SpecialistP: 865-362-6112F: 865-362-3741sabennett@deroyal.com |
| Contract Manufacturer: | DeRoyal Industries, Inc.1595 Highway 33 SouthNew Tazewell, TN 37825FDA Establishment # 2320762 |
| Trade Name: | Algidex Ag Silver Alginate WoundDressing |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug (Pre-Amendment) |
| Device Product Code: | FRO |
| Regulatory Class: | Unclassified |
| Classification Panel: | General & Plastic Surgery |
| Predicate Devices: | SilverSite [K041268] (PrimaryPredicate)Calgitrol Ag Silver Alginate WoundDressing [K011618] |
Device Description
Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to three (3) days. The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix.
September 28, 2017
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Image /page/4/Picture/0 description: The image contains the logo for DeRoyal. The logo consists of a blue, stylized swoosh shape that curves over the text "DeRoyal". The "R" in Royal has a registered trademark symbol next to it. The logo is simple and modern, with a clean design.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com The silver is intended to prevent microbes from passing through the dressing during use. The dressings are offered in two configurations:
-
- a paste;
-
- a paste applied to a non-adherent polyurethane foam layers in various sizes and shapes;
The device is sterilized by gamma irradiation.
Intended Use
Algidex Ag® silver alginate wound dressings are intended to manage abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stage I-IV, stasis ulcers, and venous ulcers.
| Characteristic | Algidex Ag | SilverSite | Calgitrol Ag |
|---|---|---|---|
| Silver Alginate | (K041268) | Silver Alginate | |
| Wound Dressing | (Primary | Wound | |
| Predicate) | Dressing | ||
| (K011618) | |||
| Indications for | Abrasions and | Pressure ulcers | Pressure ulcers |
| Use | lacerations, | (stages I-IV), | (stages I-IV), |
| dermal wounds, | dermal lesions (or | dermal lesions | |
| donor sites, first- | secreting skin | (or secreting | |
| and second-degree | injuries), venous | skin injuries), | |
| burns, surgical | ulcers, stasis | venous ulcers, | |
| incisions, vascular | ulcers, intended to | stasis ulcers, 1st | |
| access sites, | protect vascular | and 2nd degree | |
| pressure ulcers | access sites, | burns, donor | |
| stages I-IV, stasis | intramuscular | sites | |
| ulcers, venous | sites, and surgical | ||
| ulcers | incisions, 1st and | ||
| 2nd degree burns, | |||
| donor sites | |||
| Prescription Only | Yes | Yes | Yes |
| Design | Formulation of | Formulation of | Formulation of |
| ionic silver | ionic silver | ionic silver | |
| combined in an | combined in an | combined in an | |
| alginate and | alginate and | alginate and | |
| maltodextrin | maltodextrin | maltodextrin | |
| matrix. Placed on | matrix. Placed on | matrix. Placed | |
| the wound in a | the wound on a | on the wound in | |
| paste or on a | dressing. | a paste or on a | |
| dressing. | dressing. | ||
| Materials | Silver alginate | Silver alginate | Silver alginate |
| paste placed on | paste placed on | paste placed on | |
| the wound on its | the wound on a | the wound on | |
| own or on a | polyurethane | its own or on a | |
| polyurethane | foam | polyurethane | |
| foam | foam | ||
| Microbial Barrier | Effective for 3 | Effective for 3 | Effective for 3 |
| Effectiveness | days | days | days |
Summary of Technological Characteristics
September 28, 2017
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Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
| Log Reduction | 4 log reduction | 4 log reduction | 4 log reduction |
|---|---|---|---|
| Adherence | Non-adherent | Non-adherent | Non-adherent |
| Moisture Content | 2.46 mL | 2.46 mL | 2.46 mL |
| Silver Content | Contains 141 mgsilver/100sq cm | Contains 141 mgsilver/100sq cm | Contains 141mg silver/100sqcm |
| Biocompatibility | ISO 10993-1compliant | ISO 10993-1compliant | ISO 10993-1compliant |
Summary of Performance Tests
To ensure performance, Algidex Ag was tested when it was developed and originally cleared for the market in 2004, under the brand names SilverSite (K041268) and Calgitrol AG (K011618). Algidex Ag contains the exact same silver alginate and maltodextrin matrix as the predicate devices, and therefore, the testing performed and submitted in the Calgitrol AG 510(k)s continues to support the performance of this device.
The following tests have been performed and are contained within this premarket submission: AATCC 100 test method, antimicrobial barrier testing, and absorbency test. The results indicate the inhibition of microorganism growth within the dressing over the seven-day wear-time of the dressing. The antimicrobial barrier was shown for three days. The absorbency information confirms the dressing absorbs fluid. The proposed device, predicate devices, and other silver-containing devices are substantially equivalent.
Conclusion
The results of performance testing demonstrate that Algidex Ag silver alginate wound dressings are substantially equivalent to the predicate. It is the exact same silver alginate and maltodextrin matrix that was cleared for market in K041268 and K011618. Thus. Algidex Ag is substantially equivalent to the predicate devices.
N/A