(137 days)
No
The device description and intended use are for a simple wound dressing, and there is no mention of AI or ML in the provided text.
Yes
The device, a Hydrogel Wound Dressing, is indicated for the topical management of minor superficial wounds, lacerations, abrasions, and first-degree burns, which are therapeutic applications.
No
The device is a wound dressing for topical management of minor superficial wounds, not for diagnosing conditions.
No
The device description clearly states it is a physical hydrogel wound dressing made of water, polymer, nylon fibers, and metallic silver. It is a tangible product, 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 the "topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns." This describes a device applied directly to the body surface for wound care, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a hydrogel wound dressing with silver. This is a physical dressing for wound treatment, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic or monitoring information about a patient's health status
Therefore, the SilverSeal Hydrogel Wound Dressing is a medical device for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SilverSeal Hydrogel Wound Dressing made with X-Static is indicated for the topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns.
Product codes
FRO
Device Description
Hydrogel Wound Dressings with X-Static are designed to intimately contact the wound as a primary dressing and permit the passage of fluids.
Hydrogel Wound Dressings with X-Static are made of flexible sterile nonadherent hydrogel consisting of water and polymer with nylon fibers coated with metallic silver suspended in the hydrogel.
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)
Hydrogel Wound Dressing with X-Static is the same product that was cleared in K040019 as the X-Static SilverSeal Hydrogel Wound Dressing. Therefore, the performance data provided in K040019 (section 6.2 pages 12-13 of K040019) is applicable to the 510(k) and no new performance data is provided.
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
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510(k) Summary
Device Common Name:
| Device Proprietary Name: | SilverSeal® |
|---|---|
| Submitter: | Alliqua BioMedical, Inc. |
| 2150 Cabot Blvd. West, Suite B | |
| Langhorne, PA 19047 | |
| Phone: 215-702-8550 | |
| Fax: 215-702-8535 | |
| www.alliqua.com | |
| Contact: | Johanna Reinert |
| Manager of Quality Assurance | |
| and Regulatory Affairs | |
| Phone: 267-326-1806 | |
| Fax: 215-702-8535 | |
| Email: jreinert@alliqua.com | |
| Date Prepared: | March 31, 2017 |
| Classification | |
| Regulation: | Unclassified, pre-amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Device: | K040019 – X-Static® SilverSeal Hydrogel Wound |
| Dressing | |
| K023612- Silverlon Contact Wound Dressing |
Dressing, Wound, Drug
Indication for Use: For Over-the-Counter Use:
SilverSeal Hydrogel Wound Dressing made with X-Static is indicated for the topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns.
2
Device Description:
Hydrogel Wound Dressings with X-Static are designed to intimately contact the wound as a primary dressing and permit the passage of fluids.
Basic Scientific Concepts that form the basis for the device:
The Hydrogel Wound Dressing with X-Static permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in the dressing consist of a thin layer of metallic silver.
Significant physical and performance characteristics of the device:
Hydrogel Wound Dressings with X-Static are made of flexible sterile nonadherent hydrogel consisting of water and polymer with nylon fibers coated with metallic silver suspended in the hydrogel.
Substantial Equivalence:
Hydrogel Wound Dressing with X-Static is substantially equivalent to the device that was cleared in K040019. The purpose of this 510(k) is to seek clearance of modified labeling that clarifies Over-the-Counter uses of the previously cleared indications.
Statement of how the technological characteristics of the device compare to those of the predicate device:
The technological characteristics of the device such as flexible primary dressing. permeability to oxygen and fluids that are substantially equivalent to the predicate devices cited.
Performance Data:
Hydrogel Wound Dressing with X-Static is the same product that was cleared in K040019 as the X-Static SilverSeal Hydrogel Wound Dressing. Therefore, the performance data provided in K040019 (section 6.2 pages 12-13 of K040019) is applicable to the 510(k) and no new performance data is provided.
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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
Alliqua BioMedical, Inc. Johanna Reinert Manager of Ouality Assurance and Regulatory Affairs 2150 Cabot Boulevard West Suite B Langhorne, Pennsylvania 19047
Re: K171041
Trade/Device Name: SilverSeal Regulatory Class: Unclassified Product Code: FRO Dated: July 21, 2017 Received: July 21, 2017
Dear Johanna Reinert:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
4
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,
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