(128 days)
Not Found
No
The device description and performance studies focus on the material composition and antimicrobial properties of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is a wound care dressing that aids in the formation of granulation tissue and epithelialization, and acts as an effective barrier to bacterial and fungal penetration, which aligns with the definition of a therapeutic device.
No
The device is a wound care dressing intended for the management and healing of wounds, not for diagnosing any medical condition.
No
The device is a physical wound dressing made of collagen and silver, 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 clearly describes the device as a wound dressing for managing various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the dressing in wound healing (maintaining a moist environment, aiding granulation and epithelialization, acting as a barrier). It does not describe any function related to testing or analyzing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described are related to biocompatibility and antimicrobial function, which are relevant to a wound dressing, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is applied directly to a wound for therapeutic management.
N/A
Intended Use / Indications for Use
CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including:
Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, Donor and Graft sites, Abrasions and lacerations, Traumatic wounds healing by secondary intention, Dehisced surgical wounds, First & Second degree burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
CovaClearAg™ Collagen with Silver, Antimicrobial, Gel Sheet Dressing is an advanced wound care dressing composed of collagen and silver lactate provided in a sterile sheet. CovaClearAg™ Collagen with Silver. Antimicrobial Dressings are pliable, hydrated collagen sheets that maintain a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. Because of its significant water content (77.5%), the dressing provides hydration to the wound surface. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds.
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)
- Biocompatibility Testing: CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing has been tested for biocompatibility as outlined in the General Program Memorandum -#G95-1, Office of Device Evaluation entitled "Use of International Standard ISO -10993 – "Biological Evaluations of Medical Devices Part 1: Evaluation and Testing".
- Safety and Efficacy Evaluation: Conducted to demonstrate that CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is biocompatible.
- Viral Inactivation Study (referenced from predicate device 510(k) filing): A review of the manufacturing process of the raw material (Gelatin) as well as the sterilization process was conducted to assess its effect on Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV). This included an extensive literature review to support the inactivation of these two viruses.
- Kirby-Bauer testing: Performed to show that the product functions with respect to its antimicrobial claims.
- Key Results:
- Biocompatibility testing demonstrated the safety of the product.
- Data provided for the predicate device's 510(k) filing demonstrated the inactivation of PPV and SIV, supporting the safety of the raw material.
- Kirby-Bauer testing results showed the product's antimicrobial function.
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.
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
K05269L
FEB 3 2006
pag 1/4
510 (k) Summary
- OWNERS NAME: COVALON TECHNOLOGIES LTD.
- ADDRESS : 405 BRITANNIA ROAD EAST, SUITE 106 MISSISSAUGA, ONTARIO, CANADA L4Z 3E6
- CONTACT PERSON: ROBERT B. MILLER MD. FRCS(C), FACS DIRECTOR OF CLINICAL AND REGULATORY AFFAIRS
- bHONE : (905) 568-8400
- FAX: (905) 568-5200
- DATE OF PREPARATION: SEPTEMBER 25, 2005
- CovaClearAg™ COLLAGEN WITH SILVER, NAME OF DEVICE: ANTIMICROBIAL GEL SHEET DRESSING
- COMMON NAME: WOUND DRESSING
- CLASSIFICATION NAME: WOUND DRESSING (21 CFR 807.87 PRODUCT CODE FRO)
- SUBSTANTIAL ColActiveAg™ Collagen with Silver Antimicrobial EQUIVALENCE: Wound Dressing (K043296)
SilvaSorb® Silver Antimicrobial Dressing (K002599)
1
510 (k) Notification
CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing Covalon Technologies Ltd.
DEVICE DESCRIPTION: CovaClearAg™ Collagen with Silver, Antimicrobial, Gel Sheet Dressing is an advanced wound care dressing composed of collagen and silver lactate provided in a sterile sheet. CovaClearAg™ Collagen with Silver. Antimicrobial Dressings are pliable, hydrated collagen sheets that maintain a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. Because of its significant water content (77.5%), the dressing provides hydration to the wound surface.
The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds.
CovaClear Ag™ Collagen with Silver, Antimicrobial INTENDED USE: Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including:
Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, Donor and Graft sites, Abrasions and lacerations, Traumatic wounds healing by secondary intention, Dehisced surgical wounds, First & Second degree burns.
Precautions:
If sensitivity to the product develops, discontinue use. CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing may be used under compression therapy under the supervision of a health care professional.
Contraindications:
CovaClear Aq™ Collagen with Silver, Antimicrobial Gel Sheet Dressings should not be used on patients with a known allergy or sensitivity to porcine collagen, to silver or on third degree burns.
2
Warning: This device, when used in preclinical animal testing (in vitro testing) has demonstrated a hemolytic activity above the normal levels. This device is intended for topical use only and should not be used in deeper wounds beyond the Indications for Use statement.
Technological Characteristics of Device:
COMPARATIVE TABLE
CovaClearAg ™ Collagen with Silver Antimicrobial Gel Sheet Dressing ColActive Ag™ Collagen with Silver, Antimicrobial Dressing SilvaSorb® Silver Antimicrobial Wound Dressing
| Product Name | CovaClear Ag™
Collagen with
Silver, Antimicrobial
Gel Sheet
Dressing | ColActiveAg™
Collagen With
Silver Antimicrobial
Dressing | SilvaSorb®, Silver
Antimicrobial
Dressing |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Covalon
Technologies Ltd. | Covalon
Technologies Ltd. | AcryMed, Inc |
| Regulatory status | Subject of this
510(k) | K043296 | K002599 |
| Materials of
Construction | Collagen
Silver Lactate
Silver Chloride | Collagen, Alginate
Silver Lactate
Silver Chloride | Polyacrylate, Silver
Chloride |
| Sterility | Sterile | Sterile | Sterile |
| Comparable Sizes | Yes | Yes | Yes |
| Biocompatibility
Testing | Yes | Yes | Yes |
| Intended Use | Pressure, venous,
diabetic, Vascular
ulcers, 1st & 2nd
degree burns,
various surgical &
traumatic wounds | Pressure, venous,
diabetic, vascular
ulcers, 1st & 2nd
degree burns,
various surgical &
traumatic wounds | Pressure, venous,
diabetic, vascular
ulcers, 1st & 2nd
degree burns,
various surgical &
traumatic wounds |
| Antimicrobial Effect | Yes | Yes | Yes |
pg 3/4
3
pag 4/4
Safety & Efficacy Evaluation
Biocompatibility Testing:
CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing has been tested for biocompatibility as outlined in the General Program Memorandum -#G95-1, Office of Device Evaluation entitled "Use of International Standard ISO -10993 – "Biological Evaluations of Medical Devices Part 1: Evaluation and Testing". These were performed on our finished packaged device that has undergone a validated sterilization process.
We believe that this position is consistent with that set down in FDA Document 'Draft Guidance for the Preparation of a Pre-market Notification for a Non-Interactive Wound and Burn Dressing', Second Revision - November 26, 1997. Attachment 1 contains a testing schedule of all biocompatibility tests conducted that demonstrate that CovaClear Ag ™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is biocompatible, along with all test results.
CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is made from the same Gelatin as it's predicate ColActive Ag™. In the 510(k) filing for ColActiveAg™, the FDA was concerned regarding the inactivation of Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV) in the gelatin manufacturing process or through the sterilization process of the final device. For that 510(k) filing, Covalon conducted a review of the manufacturing process of the raw material as well as the sterilization process and how it affects the PPV and SIV, and included an extensive literature review to support the inactivation of the two aforementioned viruses. The data provided demonstrated the inactivation of both viruses and consequently the safety of the raw material. (Attachment XII)
CONCLUSIONS:
It has been shown that CovaClearAg™ is comparable in composition with the predicate devices and shows substantial equivalence. The Biocompatibility testing shows safety of the product. Results of the Kirby-Bauer testing shows the product functions with respect to its antimicrobial claims.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
2006 FER 3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert B. Miller, M.D., FRCS(C), FACS Director of Clinical and Regulatory Affairs Covalon Technologies Ltd. 405 Britannia Road East, Suite 106 Mississauga, Ontario L4Z 3E6 CANADA
Re: K052696
Trade/Device Name: CovaClearAg™ Collagen with Silver Antimicrobial Gel Sheet Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 13, 2006 Received: January 17, 2006
Dear Dr. Miller:
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 for association 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
5
Page 2 - Dr. Miller
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Darban Muchun
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: Kos 2696
CovaClearAq™ Collagen with Silver Antimicrobial Gel Sheet Device Name: Dressing
Indications for Use: CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet
Dressing is indicated for the management of full and partial thickness wounds including:
- pressure ulcers .
- diabetic ulcers .
- ulcers caused by mixed vascular etiologies ●
- venous ulcers .
- donor and graft sites t
- abrasions and lacerations �
- traumatic wounds healing by secondary intention .
- dehisced surgical wounds ●
- . first and second degree burns
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Daubare Ronelius
ral Restorative. and Neurologi .. Devices
510(k) Number K052696