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.

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.

AI/ML Overview

The provided 510(k) summary does not contain a typical acceptance criteria table with numerical performance goals for CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet Dressing. This submission is for a wound dressing, and the evaluation focuses on demonstrating substantial equivalence to predicate devices through material composition, intended use, and biocompatibility, rather than a clinical performance study with specific quantitative acceptance criteria for a diagnostic or interventional device.

However, based on the document, we can infer the "acceptance criteria" were primarily demonstrating:

Substantial Equivalence in composition and intended use to identified predicate devices: ColActiveAg™ Collagen with Silver Antimicrobial Dressing (K043296) and SilvaSorb® Silver Antimicrobial Dressing (K002599).
Biocompatibility: The device is safe for its intended topical use.
Antimicrobial Effect: The device functions as claimed with respect to its antimicrobial properties.
Viral Inactivation: For the raw material (gelatin), demonstration of inactivation of Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV).

Here's a breakdown of the requested information based on the provided text, acknowledging the nature of this particular 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Conclusion
Substantial Equivalence	Device must be comparable in composition, materials, sterility, comparable sizes, biocompatibility testing (performed), antimicrobial effect (reported), and intended use to predicate devices (ColActiveAg™ and SilvaSorb®).	"It has been shown that CovaClearAg™ is comparable in composition with the predicate devices and shows substantial equivalence." The comparative table (pg 3/4) explicitly lists "Yes" for comparable sizes, biocompatibility testing (performed), and antimicrobial effect, and shows identical intended uses for CovaClearAg™ and its predicates. Materials are also compared.
Biocompatibility	Device must be biocompatible as outlined in G95-1 ("Biological Evaluations of Medical Devices Part 1: Evaluation and Testing") and consistent with the 'Draft Guidance for the Preparation of a Pre-market Notification for a Non-Interactive Wound and Burn Dressing'. Testing performed on the finished packaged device after validated sterilization.	"CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing has been tested for biocompatibility as outlined in the General Program Memorandum -#G95-1... Attachment 1 contains a testing schedule of all biocompatibility tests conducted that demonstrate that CovaClear Ag ™... is biocompatible, along with all test results." "The Biocompatibility testing shows safety of the product."
Antimicrobial Function	Device must demonstrate antimicrobial effect.	"Results of the Kirby-Bauer testing shows the product functions with respect to its antimicrobial claims." The comparative table also indicates "Yes" for "Antimicrobial Effect."
Viral Inactivation	For the gelatin raw material (same as predicate ColActiveAg™), demonstration of inactivation of Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV) during manufacturing or sterilization processes, supported by literature review. (This was a concern noted in the predicate's 510(k) filing and addressed for that device, which then applied to this one as it uses the same gelatin).	"For that 510(k) filing [ColActiveAg™], 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)"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The submission relies on laboratory (biocompatibility, antimicrobial) and literature data to demonstrate substantial equivalence to legally marketed predicate devices, rather than a prospective clinical trial with a "test set" of patients.
Data Provenance: The biocompatibility and antimicrobial testing were performed by the manufacturer, Covalon Technologies Ltd., or contracted labs. The viral inactivation data was re-used from the predicate device's (ColActiveAg™) submission, involving a review of manufacturing processes and an extensive literature review. The country of origin for these specific tests is not explicitly stated but would likely be Canada (where the company is based) or a recognized contract lab. The review of manufacturing processes and literature is inherently retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as there was no "test set" of clinical cases requiring expert interpretation to establish ground truth. Substantial equivalence relies on technical, material, and performance comparisons to predicate devices, supported by laboratory testing.

4. Adjudication Method for the Test Set

Not applicable as there was no "test set" or clinical data requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wound dressing, not an imaging or diagnostic device involving human readers or AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (wound dressing), not an algorithm or AI.

7. The Type of Ground Truth Used

Substantial Equivalence: The ground truth for this aspect is the established regulatory clearance of the predicate devices based on their safety and effectiveness.
Biocompatibility: The ground truth is laboratory testing results conforming to ISO 10993 standards.
Antimicrobial Effect: The ground truth is laboratory testing results from Kirby-Bauer diffusion tests.
Viral Inactivation: The ground truth is data from validated manufacturing processes and scientific literature demonstrating the inactivation of specific viruses.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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)

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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.

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K052696

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 withSilver, AntimicrobialGel SheetDressing	ColActiveAg™Collagen WithSilver AntimicrobialDressing	SilvaSorb®, SilverAntimicrobialDressing
Manufacturer	CovalonTechnologies Ltd.	CovalonTechnologies Ltd.	AcryMed, Inc
Regulatory status	Subject of this510(k)	K043296	K002599
Materials ofConstruction	CollagenSilver LactateSilver Chloride	Collagen, AlginateSilver LactateSilver Chloride	Polyacrylate, SilverChloride
Sterility	Sterile	Sterile	Sterile
Comparable Sizes	Yes	Yes	Yes
BiocompatibilityTesting	Yes	Yes	Yes
Intended Use	Pressure, venous,diabetic, Vascularulcers, 1st & 2nddegree burns,various surgical &traumatic wounds	Pressure, venous,diabetic, vascularulcers, 1st & 2nddegree burns,various surgical &traumatic wounds	Pressure, venous,diabetic, vascularulcers, 1st & 2nddegree burns,various surgical &traumatic wounds
Antimicrobial Effect	Yes	Yes	Yes

pg 3/4

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K052696

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.

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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.

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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

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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

Regulation Number and Section

N/A