(158 days)
Under the supervision of a healthcare professional, KerraCel® 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.
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.
This document is a 510(k) summary for a medical device called KerraCel® Ag Gelling Fiber Silver Dressing. It does not describe an AI medical device. Therefore, much of the requested information regarding AI-specific studies and ground truth methodologies is not applicable.
However, I can extract information related to the device's performance based on the provided text.
Here's a summary of the acceptance criteria (implied by the comparative testing) and reported device performance for KerraCel® Ag, along with other applicable information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in this document. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing - K080383) and a reference device (Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber - K121275). Therefore, the "acceptance criteria" can be inferred as "comparable to" or "no significant difference from" the predicate and reference devices.
| Acceptance Criteria (Implied) | Reported Device Performance (KerraCel® Ag) |
|---|---|
| Silver Content: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Moisture Content: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Absorbency: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. The absorbent properties are stated as "similar to K080383" and "more comparable to K121275." |
| Antibacterial Effectiveness: Comparable to predicate/reference devices. | Demonstrated 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 (similar to the predicate which also features silver for antibacterial properties). |
| Tensile Strength (wet & dry): Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Gel Assessment: Comparable to predicate/reference devices. | Creates a "soft cohesive gel" that "intimately conforms to the wound surface and maintains a moist wound healing environment," similar to the predicate. |
| Wet out: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Shrinkage: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Lateral Wicking: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Biocompatibility: Safe for intended use as per ISO 10993-1:2009. | Demonstrated to be safe for its intended use. No new safety concerns relative to biocompatibility. Evaluated for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, and Implantation. |
| Porcine Wound Healing Study (Silver Cytotoxicity): Comparable wound healing to predicate. | No treatment-related abnormal clinical findings. Mean time to complete healing was comparable to Aquacel® Ag-treated wounds. Wound areas were similar with no significant differences. Histopathology evaluation showed total healing scores similar to the predicate device. |
| Endotoxin limit: Meets specifications. | KerraCel® Ag meets endotoxin limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Performance Tests: The sample sizes for each specific bench test (Silver Content, Moisture Content, Absorbency, etc.) are not specified in this document.
- Biocompatibility Testing: The number of samples tested for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation) is not specified.
- Porcine Wound Healing Study:
- Sample Size: Six pigs were involved, with eight 2x2 cm full-thickness wounds created per animal (totaling 48 wounds).
- Data Provenance: The study was a "Pre-Clinical Study" conducted on porcine models. The country of origin is not explicitly stated. The study design is prospective as it involves active treatment and follow-up.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given this is a 510(k) for a wound dressing, not an AI device, there were no "experts" establishing ground truth in the context of diagnostic interpretation.
- In the porcine wound healing study, the evaluation included "Histopathology evaluation." This would typically involve veterinary pathologists. Their specific number and qualifications are not stated.
4. Adjudication Method for the Test Set
Not applicable for device performance and animal studies in this context. Adjudication methods are typically relevant for human clinical trials or expert review of diagnostic results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is not an AI medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used
- Bench Performance Tests: The "ground truth" for these tests would be the measured physical and chemical properties themselves, using standardized testing methods.
- Biocompatibility Testing: The "ground truth" is established through adherence to recognized international standards (e.g., ISO 10993-1:2009 for biocompatibility) and the specific endpoint measurements of each test (e.g., cytotoxicity assays, irritation scores).
- Porcine Wound Healing Study:
- Clinical Findings: Direct observation of the wounds by study personnel.
- Planimetric Analysis: Measurement of wound area.
- Histopathology Evaluation: Microscopic examination of tissue samples by trained pathologists, providing a "ground truth" on tissue response and healing at a cellular level.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
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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
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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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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.
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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.
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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
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- -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.
N/A