(158 days)
No
The device description and performance studies focus on the material properties and wound healing efficacy of a silver-impregnated dressing, with no mention of AI or ML technologies.
Yes.
The device is used for the management of acute and chronic wounds, which implies a direct therapeutic effect on the body's condition.
No
Explanation: The device is described as a nonwoven wound dressing that absorbs fluid, creates a gel, and provides an antibacterial barrier. Its purpose is to manage wounds and maintain a moist healing environment, not to diagnose a condition.
No
The device description clearly states it is a "soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver," indicating it is a physical medical 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 describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing that absorbs fluid and provides an antibacterial barrier. This is a physical and chemical interaction with the wound, not an analysis of biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or sample for diagnostic purposes.
- Clinical Studies: The pre-clinical study focuses on wound healing and cytotoxicity, which are relevant to a therapeutic device, not a diagnostic one.
Therefore, KerraCel® Ag is a wound dressing, which is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, KerraGel Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.
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
Under the supervision of a healthcare professional
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)
Performance tests were conducted on KerraCel® Ag in comparison to the predicate, Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383), and to the reference device, Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber (K121275). Tests included: Silver Content, Moisture Content, Absorbency, Antibacterial Effectiveness, Tensile Strength (wet & dry), Gel Assessment, Wet out, Shrinkage, Lateral Wicking, and Biocompatibility.
Biocompatibility testing per ISO 10993-1:2009 for a surface device contacting breached or compromised skin, for permanent duration, included: Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, and Implantation. KerraCel® Ag raised no new safety concerns and was demonstrated to be safe for its intended use.
Pre-Clinical Studies: A porcine wound healing study evaluated the silver cytotoxicity of KerraCel® Ag. Six pigs were involved, each with eight 2 x 2 cm, full-thickness wounds. Left side wounds were treated with the predicate (Aquacel® Ag (K080383)) as control, and right side wounds with KerraCel® Ag. Treatments were applied via 3 x 3 cm patches and covered with a barrier dressing on study Days 1, 4, 7 and 11 (2 and 4-week cohorts) with additional treatments on Days 14, 18, 21 and 24 for 4-week cohort animals.
Results: No treatment related abnormal clinical findings. The mean time to complete healing for KerraCel Ag-treated wounds was comparable to Aquacel Ag -treated wounds. Planimetric analysis showed similar wound areas for both treatments with no significant differences at any time points. Histopathology evaluation revealed that total healing scores of wounds treated with KerraCel Ag were similar to those treated with the predicate device.
No Clinical Studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383)
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.
Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber (K121275)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Exciton Technologies Inc. Ms. Melanie Ussyk Director Of Quality Assurance & Regulatory Affairs 10230 Jasper Ave., Suite 4147 Edmonton, Alberta T5J 4P6 Canada
Re: K162508
Trade/Device Name: Kerracel Ag Gelling Fiber Silver Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 9, 2017 Received: January 10, 2017
Dear Ms. 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. 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 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 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,
Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K162508
Device Name KerraCel Ag Gelling Fiber Silver Dressing
Indications for Use (Describe)
Under the supervision of a healthcare professional, KerraGel Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.
| 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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3
510(k) Summary for KerraCel® Ag
Date of 510(k) Summary Preparation: December 19, 2016
1. Trade (Proprietary) Name
KerraCel® Ag Gelling Fiber Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
-
Contact: Melanie Ussyk Director, Quality Assurance & Regulatory Affairs
Email: mussyk@excitontech.com Phone: (780) 248-1281 Fax: (780) 248-5878 -
Address: Exciton Technologies Inc. Suite 4147-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
-
Contact: Andrew Jackson Regulatory Medical Device Officer
Email: andrew.jackson@crawfordpharma.com Phone: +44 (0) 1565 654920 Fax: +44 (0) 1565 654117
- Address: Crawford Healthcare Ltd King Edward Court, King Edward Road, Knutsford, Cheshire, WA16 OBE
4. Device Classification & Panel
General & Plastic Surgery Devices Panel; unclassified.
4
There have not been prior submissions for KerraCel® Ag submitted to the FDA.
5. Predicate Device(s)
Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383) - Primary
Reference Device: Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber (K121275)
6. Device Description
KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.
7. Indications for Use
Under the supervision of a healthcare professional, KerraCel® Ag may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.
The Indications for Use statement for KerraCel® Ag is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.
8. Summary of Substantial Equivalence
The intended use and directions for use of KerraCel® Ag are equivalent to those of the predicate device, Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383). Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber (K121275) has been identified as a reference device since the absorbent properties of the KerraCel® Ag, although similar to K080383, are more comparable to K121275.
The design, manufacturing, and performance are similar to those of the predicate device and do not raise any new issues concerning safety or effectiveness.
5
a) Summary of Technological Characteristics
KerraCel® Ag consists of a substrate containing sodium carboxymethycellulose (CMC) needled together with tencel/ cellulose fibers; the substrate is then coated with silver while the predicate, Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing, consists of silver coated CMC fibers needled together with non-silver coated fibers. Importantly, both processes produce oxidized silver ions adherent to the substrate. Differences in the process chemistry do not affect the efficacy or safety of the device as demonstrated by the results of performance and biocompatibility testing.
Both KerraCel® Ag and the predicate are sterilized by gamma irradiation.
b) Summary of Performance Data
The following performance tests were conducted on KerraCel® Ag in comparison to the predicate, Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383), and to the reference device, Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber (K121275):
- Silver Content
- Moisture Content ●
- Absorbency
- Antibacterial Effectiveness ●
- Tensile Strength (wet & dry)
- Gel Assessment
- Wet out
- Shrinkage
- Lateral Wicking
- Biocompatibility
Biocompatibility Testing
KerraCel® Ag raised no new safety concerns relative to biocompatibility. Assessment was carried out on the final device as per ISO 10993-1:2009 for a surface device; contacting breached or compromised skin, for permanent duration. The device has demonstrated to be safe for its intended use.
KerraCel® Ag was evaluated for:
- Cytotoxicity
- Sensitization ।
- Irritation
- -Genotoxicity
6
- -Systemic Toxicity
- Implantation -
Pre-Clinical Studies
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of KerraCel® Ag.
Both KerraCel® Ag and the predicate, Aquacel® Ag (K080383), were evaluated in the study. Six pigs were involved in the study. There were a total of eight 2 x 2 cm, full-thickness wounds created per animal (4 wound sites/side). Left side wound sites were treated with the predicate as a control, and right side wound sites were treated with KerraCel® Ag. Treatments were applied via 3 x 3 cm patches and covered with a barrier dressing on study Days 1, 4, 7 and 11 for all animals (2 and 4-week cohorts) and additional treatments were administered on Days 14, 18, 21 and 24 for 4-week cohort animals.
There were no treatment related abnormal clinical findings during the entire study period. The mean time to complete healing for KerraCel Ag-treated wounds was comparable to Aquacel Ag -treated wounds. Based on the planimetric analysis, the wound areas were similar for wounds of both treatments throughout the study period with no significant differences between treatments at any time points.
Histopathology evaluation revealed that the total healing scores of wounds treated with KerraCel Ag was similar to those treated with the predicate device.
No Clinical Studies were conducted with KerraCel® Ag in comparison to the predicate device.
9. Conclusions
KerraCel® Ag and the predicate Aquacel® Ag are both gelling fiber wound dressings, coated with silver, and intended for the management of wounds. Performance (bench) and Biocompatibility evaluation of KerraCel® Ag; in comparison to that of the predicate device, raises no new concerns regarding safety or effectiveness. The data supports that KerraCel® Ag is substantially equivalent to Aquacel® Ag (K080383) for its intended use.