(71 days)
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No
The document describes a silver-impregnated wound dressing and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is indicated for use in treating various types of wounds, and its silver content inhibits bacterial growth, which are therapeutic actions.
No
Explanation: The device is described as a wound dressing with antimicrobial properties, indicated for use in treating various types of wounds, rather than diagnosing conditions.
No
The device description clearly describes a physical wound dressing with silver technology, not a software application.
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 inhibiting bacterial growth in the dressing and providing a barrier. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing and its ability to release silver to inhibit bacterial growth. It does not describe any components or processes used to diagnose a condition or analyze a sample from the human body.
- Performance Studies: The performance studies listed are related to the physical and antimicrobial properties of the dressing itself (silver content, moisture content, pH, absorbency, anti-bacterial effectiveness). They do not involve testing human samples for diagnostic purposes.
IVD devices are used to examine specimens derived 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 a function.
N/A
Intended Use / Indications for Use
The KerraContact® Ag Perf Advanced Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Exciton Technologies Inc. has developed the exsalt® technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven spunlace polyester laminated with gray Delnet® HDPE mesh layers on both sides. Silver in the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing (KerraContact® Ag Perf) inhibits bacterial growth in the dressing for up to 7 days. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/ cm² (4.5% w/w). The KerraContact® Ag Perf has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
KerraContact® Ag Perf meets pyrogen limit specifications.
Mentions image processing
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Mentions AI, DNN, or ML
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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)
The following performance tests were conducted on the KerraContact® Ag Perf in comparison to the predicate (K113564):
- . Silver Content
- o Total Silver Content
- o Silver Release
- o XRD
- o Qualitative Ag2+/3+
- . Moisture Content
- pH
- . Absorbency
- Anti-bacterial Effectiveness
The predicate device provides a barrier to bacterial penetration whereas the subject device does not. All other performance characteristics of the KerraContact® Ag Perf are equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side.
December 6, 2018
Exciton Technologies, Inc. Melanie Ussyk Director of Quality Assurance & Regulatory Affairs 10230 Jasper Avenue, Suite 4147 Edmonton, Alberta T5J 4P6 Canada
Re: K182680
Trade/Device Name: KerraContact Ag Perf Advanced Perforated Silver Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 7, 2018 Received: November 9, 2018
Dear Melanie Ussyk:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Lixin Liu - 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) K182680
Device Name
KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing
Indications for Use (Describe)
The KerraContact® Ag Perf Advanced Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
| 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 KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing
510(k) Number: K182680
Date of 510(k) Summary Preparation: September 7, 2018
1. Trade (Proprietary) Name
KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
-
Contact: Melanie Ussyk Director of Quality Assurance & Regulatory Affairs
Email: mussyk@excitontech.com Phone: (780) 248-1281 -
Address: Exciton Technologies Inc. Suite 4147-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
4. Device Classification & Panel
Classification: Unclassified
Classification name: Dressing, Wound, Drug
Product Code: FRO
5. Predicate Device(s)
exsalt® T7 Wound Dressing(K113564)(also known as KerraContact® Ag Advanced Silver Wound Dressing)
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6. Device Description
Exciton Technologies Inc. has developed the exsalt® technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven spunlace polyester laminated with gray Delnet® HDPE mesh layers on both sides. Silver in the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing (KerraContact® Ag Perf) inhibits bacterial growth in the dressing for up to 7 days. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/ cm² (4.5% w/w). The KerraContact® Ag Perf has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
KerraContact® Ag Perf meets pyrogen limit specifications.
7. Intended Use
KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
8. Summary of Substantial Equivalence
The labeled indications and directions for use of the KerraContact® Ag Perf are equivalent to those of the predicate device, KerraContact® Ag Advanced Silver Wound Dressing (K113564). The design, materials, and manufacturing methods are similar to those of the predicate device, KerraContact® Ag Advanced Silver Wound Dressing. The perforations are added to the dressing during the conversion process when the dressings are cut to size; both the subject device and the predicate device are released against the same final specifications.
The new configuration does not raise any new issues concerning safety or effectiveness.
a) Summary of Technological Characteristics
The KerraContact® Ag Perf consists of 2 outer layers of HDPE with an inner layer of spun lace polyester which are all silver-coated. The skin-contacting materials in both the KerraContact® Ag Perf and the predicate (K113564) are the same.
The perforations in the KerraContact® Ag Perf allow for fluid to wick into and through the dressing with ease; the difference does not impact the dressing performance as demonstrated by the comparative evaluation.
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The KerraContact® Ag Perf and the predicate are both sterilized by gamma irradiation.
b) Summary of Performance Data
The following performance tests were conducted on the KerraContact® Ag Perf in comparison to the predicate (K113564):
- . Silver Content
- o Total Silver Content
- o Silver Release
- o XRD
- o Qualitative Ag2+/3+
- . Moisture Content
- pH
- . Absorbency
- Anti-bacterial Effectiveness
The predicate device provides a barrier to bacterial penetration whereas the subject device does not. All other performance characteristics of the KerraContact® Ag Perf are equivalent to the predicate.
Biocompatibility
The KerraContact® Ag Perf raised no new safety concerns relating to biocompatibility. Both the subject and predicate devices, in their final finished form, were assessed as surface devices, contacting breached or compromised skin, for a prolonged duration. The device risk assessment identified that the surface characteristics of the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing, having an additional manufacturing step (perforations), would not illicit a biological response different from the predicate. The chemical components have remained unchanged in comparison to the predicate. Therefore, the biocompatibility data of the predicate device were leveraged to support the biocompatibility of the subject device. Testing performed on the predicate, KerraContact® Ag Advanced Silver Wound Dressing (K113564), showed that it was non-toxic, non-irritant, and did not elicit a sensitization response. KerraContact® Ag Advanced Silver Wound Dressing (K113564) has been marketed since 2011; there have been no complaints or adverse events reported from use as indicated.
Pre/Clinical Studies
No additional pre-clinical studies were carried out on KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing.
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9. Conclusions
KerraContact® Ag Perf and the predicate KerraContact® Ag Advanced Silver Wound Dressing are both surface devices composed of identical materials, coated with silver, and intended for the management of wounds. The risk assessment and performance evaluation raised no new concerns regarding safety or effectiveness. The information supports that KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing is substantially equivalent to KerraContact® Ag Advanced Silver Wound Dressing (K113564).