(117 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description and performance studies focus on material properties and biological compatibility, not algorithmic processing.
Yes
The device is described as a wound dressing for the management of exuding wounds, indicating its use in treating and healing a medical condition.
No
The device is a wound dressing and its intended use is for the management of wounds, not for diagnosing a medical condition.
No
The device description clearly states it is a "hydrophobic microbe binding wound dressing" consisting of a "Sorbact® wound contact layer," indicating it is a physical, material-based medical device, not software. The performance studies also focus on material properties like extraction and biocompatibility.
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 wounds, shallow cavity wounds, and fistulas. This involves direct application to the body for therapeutic purposes.
- Device Description: The device is a wound dressing designed to bind microbes and manage exudate. This is a topical application, not a test performed on a sample taken from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro analysis.
- Testing Performed: The testing described focuses on the device's physical properties, biocompatibility, and performance as a wound dressing, not on its ability to perform a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Sorbact® Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact® Ribbon Gauze is indicated for shallow cavity wounds and fistulas.
Product codes
FRO
Device Description
Sorbact® Ribbon Gauze is a sterile (gamma irradiation), single use only, hydrophobic microbe binding wound dressing. It consists of a Sorbact® wound contact layer, which allows passage of wound exudate into a secondary dressing.
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)
To verify that the device design met its functional performance and safety requirements, representative samples of the device underwent the following testing. The results of nonclinical testing demonstrate that the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.
● Extraction testing
-o Evaluation of extractable colorants
● Biocompatibility testing
The biocompatibility evaluation of the devices was conducted in accordance with the FDA Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Testing was performed on representative samples of the devices and included the following tests:
- o Cytotoxicity
- Intracutaneous reactivity O
- Sensitization O
- Systemic toxicity (acute) O
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2017
ABIGO Medical AB % Deborah Graveski Sr. Project Manager M Squared Associates. Inc. 575 8th Avenue, Suite 1212 New York, New York 10018
Re: K171225
Trade/Device Name: Sorbact Wound Dressing-Ribbon Gauze Regulatory Class: Unclassified Product Code: FRO Dated: May 23, 2017 Received: May 24, 2017
Dear Deborah Grayeski:
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
1
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.
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 (DICE) 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 (DICE) 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) K171225
Device Name Sorbact Ribbon Gauze
Indications for Use (Describe)
Sorbact Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact Ribbon Gauze is indicated for shallow cavity wounds and fistulas.
| 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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Section 6: 510(k) Summary
| Submitter: | ABIGO Medical AB
Ekonomivägen 5
SE-436 33 Askim
Sweden
Phone: +46 31 748 49 50
Fax: +46 31 68 39 51
Registration Number: 8043991 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Deborah Lavoie Grayeski
M Squared Associates, Inc.
575 8th Avenue, Suite 1212
New York, NY 10018 USA
Office: 703-562-9800x250
Mobile: 202-550-7395
Fax: 703-562-9797
Email: dgrayeski@msquaredassociates.com |
| Date Prepared: | April 25, 2017 |
| Trade Name: | Sorbact® Wound Dressing – Ribbon Gauze |
| Common Name: | Wound Dressing |
| Regulatory Class: | Unclassified (Pre-amendment) |
| Review Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Device: | K063059, Sorbact® Wound Dressings – Ribbon Gauze
ABIGO Medical AB |
Device Description:
Sorbact® Ribbon Gauze is a sterile (gamma irradiation), single use only, hydrophobic microbe binding wound dressing. It consists of a Sorbact® wound contact layer, which allows passage of wound exudate into a secondary dressing.
Indication for Use:
Rx: Sorbact® Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact® Ribbon Gauze is indicated for shallow cavity wounds and fistulas.
4
Comparison of Technological Characteristics with the Predicate Device:
The modification addressed by this 510(k) is a change to the color additive in the Sorbact® Ribbon Gauze. As the intended use, device description, wound contact material, instructions for use, mechanism of action, storage conditions, and shelf life of the modified device are the same as that of the predicate device, both devices have the same fundamental scientific technology.
Performance Data:
To verify that the device design met its functional performance and safety requirements, representative samples of the device underwent the following testing. The results of nonclinical testing demonstrate that the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.
● Extraction testing
- o Evaluation of extractable colorants
● Biocompatibility testing
The biocompatibility evaluation of the devices was conducted in accordance with the FDA Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Testing was performed on representative samples of the devices and included the following tests:
- o Cytotoxicity
- Intracutaneous reactivity O
- Sensitization O
- Systemic toxicity (acute) O
Conclusion:
ABIGO Medical AB considers the Sorbact® Ribbon Gauze to be substantially equivalent to the predicate device.