(88 days)
Not Found
No
The summary describes a passive wound dressing with antimicrobial properties based on silver. There is no mention of any computational analysis, image processing, or learning algorithms.
Yes
The device, Atrauman Ag antimicrobial wound dressing, is intended for use with various types of wounds (e.g., pressure wounds, leg ulcers), which implies a therapeutic purpose of aiding in wound healing and management.
No
This device is a wound dressing designed to provide a moist wound environment and inhibit bacterial growth. It does not perform any diagnostic functions like detecting, monitoring, or identifying diseases or conditions.
No
The device description clearly states it is a physical wound dressing composed of textile, silver, and a hydrophilic matrix. It is a hardware device, 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 treating wounds by providing an antimicrobial dressing and a moist wound environment. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical wound dressing with antimicrobial properties. It does not describe any components or processes used to analyze samples from the human body to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, antimicrobial effectiveness, sterilization, packaging, and shelf-life. These are all relevant to a therapeutic device, not an IVD. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, skin graft donor sites, surgical graft donor sites, surgical wounds, and abrasions.
Product codes
FRO
Device Description
Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
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
Atrauman Ag was evaluated and found to meet standards and requirements for biocompatibility, antimicrobial effectiveness, sterilization, shelf-life, and packaging.
Biocompatibility testing was conducted on the device according to ISO 10993-1 for prolonged exposure (> 24 hours to 30 days), surface device, breached or compromised surface. Cytotoxicity, sensitization, irritation or intracutaneous reactivity, material mediated pyrogenicity.
Antimicrobial Effectiveness: Atrauman Ag wound dressing samples were tested under simulated use conditions with six clinically relevant microorganisms. Results demonstrated that the wound dressings are effective up to 7 days throughout the labeled shelf-life indicating that the antibacterial agent (silver) may help inhibit the growth of bacteria within the dressing.
Sterilization: Atrauman Ag wound dressings are terminally sterilized via gamma irradiation and the method validated with an SAL of 10-6.
Shelf-life: Atrauman Ag is labeled with a 3 year shelf-life according to real-time testing demonstrating full product performance after 3 years aging. Transport testing was performed according to ASTM D4169 and met acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2024
Hartmann USA, Inc. % Lorry Weaver Principal Consultant, Regulatory Affairs Oserve Group US 350 S. Main Street Doyelstown, Pennsylvania 18901
Re: K242758 Trade/Device Name: Atrauman® Ag Regulatory Class: Unclassified Product Code: FRO Dated: September 12, 2024 Received: September 12, 2024
Dear Lorry Weaver:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Mustafa A. Mazher - S" in a large, clear font. The text is black and stands out against the white background. In the background, there is a faded, light blue watermark of the letters "FDA".
For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242758
Device Name Atrauman® Ag
Indications for Use (Describe)
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.
| 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) |
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."
4
510(k) Summary - [21 CFR 807.92]
807.92(a)(1), (2), (3)
| Date Prepared: | November 22, 2024 |
|---|---|
| Submitter's Name: | Hartmann USA |
| 481 Lakeshore Parkway | |
| Rock Hill, SC 29730 | |
| 803-325-7600 | |
| Official Correspondent: | Lorry Weaver, Principal Consultant |
| Qserve Group US | |
| +1 (916) 220-1137 | |
| lorry.weaver@qservegroup.com | |
| Device Trade Name: | Atrauman® Ag |
| Common Name: | Antimicrobial wound dressing with silver |
| Review Panel: | General & Plastic Surgery (OHT4) |
| Classification Name: | Unclassified |
| Regulation No.: | Unclassified |
| Classification Code: | FRO |
| Predicate Device: | Urgotul Ag: 510(k) Number K100430 |
| Product Code: FRO | |
| Regulation: Unclassified |
Device Description Summary 807.92(a)(4):
Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
Intended Use/Indications for Use 807.92(a)(5):
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, skin graft donor sites, surgical graft donor sites, surgical wounds, and abrasions.
5
Technological Comparison 807.92(a)(6):
Atrauman Ag and the predicate device. UrgoTul Ag/Silver have similar indications for use and technological characteristics. Functionally, both devices have a nonadherent contact (hydrophobic polyamide mesh) layer and; both devices include silver for its antibacterial properties within the dressing and both devices have an impregnated hydrophilic matrix that contributes to maintaining a moist environment and exudate absorption. Finally, both devices are suitable for wounds such as moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcer, venous statis ulcer. The antibacterial activity may inhibit growth of bacteria within the dressing up to 7 days. The contact laver of both devices is non-adhesive, non-occlusive, have a matrix design with hydrophilic material. The hydrophilic material provides a moist environment including the wound edges.
Differences between the devices do not raise new and/or different questions of safety and effectiveness. Differences include the UrgoTul Ag/Silver additionally can be used on graft and donor sites while the Atrauman Ag currently does not have data to support that wound type.
Atrauman Ag fibers of the support fabric are coated with elemental silver whereas UrqoTul Aq/Silver uses silver sulfate in the matrix applied to the polyamide mesh along with other ingredients.
Summary of Non-Clinical Test - Performance and Safety Testing 807.92(b)(1):
Atrauman Aq was evaluated and found to meet standards and requirements for biocompatibility, antimicrobial effectiveness, sterilization, shelf-life, and packaging.
Biocompatibility
Biocompatibility testing was conducted on the device according to ISO 10993-1 for prolonged exposure (> 24 hours to 30 days), surface device, breached or compromised surface. Cytotoxicity, sensitization, irritation or intracutaneous reactivity, material mediated pyrogenicity.
The following standards were used:
| Biological Endpoint | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2021 |
| Irritation or intracutaneous reactivity | ISO 10993-23:2021 |
| Material mediated pyrogenicity | ISO 10993-11:2017 |
| Acute, subacute, subchronic systemic toxicity | ISO 10993-11:2017 |
| Implantation effects | ISO 10993-6: 2016 |
6
Antimicrobial Effectiveness
Atrauman Ag wound dressing samples were tested under simulated use conditions with six clinically relevant microorganisms. Results demonstrated that the wound dressings are effective up to 7 days throughout the labeled shelf-life indicating that the antibacterial agent (silver) may help inhibit the growth of bacteria within the dressing.
Sterilization
Atrauman Ag wound dressings are terminally sterilized via gamma irradiation and the method validated with an SAL of 10-6. The sterilization was performed and is monitored according to the following standards:
| Standard number | Title |
|---|---|
| EN 556- | |
| 1:2001/AC:2006 | Sterilization of medical devices -Requirements for medical devices to be |
| designated "STERILE" -Part 1: Requirements for terminally sterilized medical | |
| devices | |
| EN ISO 11137- | |
| 1:2015 + A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for |
| development, validation and routine control of a sterilization process for | |
| medical devices | |
| EN ISO 11137- | |
| 2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the |
| sterilization dose | |
| EN ISO 11737- | |
| 1:2018 + A1:2021 | Sterilization of health care products - Microbiological methods - Part 1: |
| Determination of a population of microorganisms on products | |
| EN ISO 11737- | |
| 2:2020 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of |
| sterility performed in the definition, validation and maintenance of a | |
| sterilization process | |
| ANSI/AAMI | |
| ST72:2019 | Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alter- |
| natives To Batch Testing |
Packaging and Shelf-life
Atrauman Ag is labeled with a 3 year shelf-life according to real-time testing demonstrating full product performance after 3 years aging. Transport testing was performed according to ASTM D4169 and met acceptance criteria.
Summary of Clinical Tests 807.92(b)(1): Not applicable
Not applicable
Conclusions 807.92(b)(1):
Atrauman® Ag and UrgoTul™ Ag are both product code FRO that is an unclassified regulation. The differences between the devices do not raise new and/or different questions of safety and effectiveness. Atrauman® Ag conforms to applicable safety standards and performance data validates the intended use. The predicate comparison table and performance testing provided in this 510(k) is sufficient to demonstrate that the Atrauman® Ag is substantially equivalent to the legally marketed predicate device, UrgoTul™ Ag cleared under 510(k) K100430.