ColActive Ag™ Collagen with Silver, Antimicrobial 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, First and Second degree burns, Donor and graft sites, Abrasions, Dehisced surgical wounds, Traumatic wounds healing by secondary intention.

Device Description

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. 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 are able to be layered for the management of deep wounds.

AI/ML Overview

The provided document is a 510(k) summary for the ColActive Ag™ Collagen with Silver, Antimicrobial Dressing, which focuses on demonstrating substantial equivalence to previously marketed wound dressings. This type of regulatory submission does not typically include detailed clinical studies or performance data with acceptance criteria in the way envisioned by the prompt for an AI-based device. Instead, it relies on demonstrating similar characteristics and safety to existing devices.

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set size, etc.) are not applicable to this 510(k) submission for a wound dressing.

However, I can extract the information that is relevant to the document provided, focusing on what was included to demonstrate safety and equivalence.

Here's a breakdown based on the provided text, acknowledging the limitations for an AI-centric evaluation:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" for device performance in the same way an AI device might have metrics like sensitivity or specificity thresholds. Instead, it focuses on demonstrating biocompatibility and substantial equivalence to predicate devices. The "performance" is primarily shown through the successful completion of standard biocompatibility tests.

Acceptance Criteria (Implied for Biocompatibility)	Reported Device Performance
Device is safe for wound contact.	Demonstrated to be safe wound dressings according to ISO 10993-1.
	All test results taken as a whole confirm safety.
Device is non-toxic, non-irritating, non-sensitizing.	(Implied by adherence to ISO 10993-1, specific test results not detailed in this summary).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the 510(k) summary. Biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) typically involve in vitro and in vivo animal studies (using specific numbers of cells/animals per test), but these details are not provided here.
Data Provenance: Not specified, but generally, ISO 10993 tests are conducted in certified laboratories. The country of origin of the data is not mentioned.
Retrospective or Prospective: Not applicable in the context of biocompatibility testing for this wound dressing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus on medical imaging or diagnoses.
Qualifications of Experts: Not applicable in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Biocompatibility testing has objective endpoints measured in a lab, not subjective interpretations 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

MRMC Study: No, this type of study is not relevant for a wound dressing. This is a medical device, not an AI diagnostic or assistive tool for human readers.

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

Standalone Performance: Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For biocompatibility, the "ground truth" is established by the results of standardized biological tests performed according to ISO 10993-1. These tests assess endpoints like cytotoxicity, irritation, and sensitization. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical wound dressing, not a machine learning model.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable.

Summary

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JUN 6 - 2005 510 (k) Notification ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.

K043296

510 (k) Summary

November 15, 2004 1. Date Prepared:
ﻛﺮﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Covalon Technologies Inc. 2. Submitter 586 Spadina Avenue Toronto M5S 2H2 Ontario, CANADA Tel: (416) 944.3496 Fax: (416) 944.8520

SubmissionCorrespondent:	Paul L. GuilbaudVice President and Director Wound & TissueRepairCovalon Technologies Inc.14510 Kandi CourtLargo, Florida 33774Tel: (727) 595.8184Fax: (727) 517.7005Email: pquilbaud@covalon.com
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Proprietary Name: ColActive Ag™ Collagen with Silver, Antimicrobial 4. Dressing
Common Name: Wound Dressing
1. Requiatory Class: MPG

6. Statement of Substantial Equivalence:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are substantially equivalent in materials of construction and intended use and identical in function to FIBRACOL PLUS Collagen Wound Dressing with Alginate manufactured by Johnson & Johnson Medical, Vitaphore Silver Foam Wound Dressing manufactured by Vitaphore Corporation and Acticoat Silver Coated Dressing manufactured by Westaim Biomedical, Inc.

7. Indications For Use:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including:

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510 (k) Notification 910 (K) Notinoddon'
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.

Pressure ulcers ●
Diabetic ulcers ●
Ulcers caused by mixed vascular etiologies ●
Venous ulcers ●
First and Second degree burns .
Donor and graft sites .
Abrasions .
Dehisced surgical wounds .
Traumatic wounds healing by secondary intention .

Description: 8.

Biocompatibility: 9.

ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe wound dressings. To support the biocompatibility of these products, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices.

When all test results from tests conducted on ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are taken into consideration as a whole, ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe topical wound dressings in accordance with ISO 10993-1.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN € - 2005

Mr. Paul L. Guilbaud Vice President and Director of Wound and Tissue Repair Covalon Technologies Incorporated 14510 Kandi Court Largo, Florida 33774

Re: K043296

Trade/Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 20, 2005 Received: May 23, 2005

Dear Mr. Guilbaud:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becaller by (a) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to trgans) in the Medical Device Amendments, or to conninered phorts to May 20, 1978, as eccordance with the provisions of the Federal Food, DNA A de rices mat nave been require approval of a premarket approval application (PMA). and Costiete Her (110. (110.) that be novice, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provider ing 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 n may be subject to stan as Execural 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 I lease be devilsed that i Drivisantes vour device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I edetar station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic form in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Paul L. Guilbaud

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter water notification. The FDA finding of substantial equivalence of your device to a legally premative nedicate 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 If you desire specific arrivaliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510 (k) Number:

KO43796 Covalon Technologies, Inc.

Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing

Indications for Use:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness including:

Pressure ulcers .
Diabetic ulcers .
Ulcers caused by mixed vascular etiologies ◆
Venous ulcers ●
First and Second degree burns ●
Donor and graft sites .
Abrasions & lacerations ●
Dehisced surgical wounds .
. Traumatic wounds healing by secondary intention

Prescription Use
(Per 21 CFR 801.109) √

OR Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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of Gener 1, Restorative
Neurological Devices
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	K043296

Regulation Number and Section

N/A