ColActive® Transfer is indicated for management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.

Device Description

ColActive® Transfer is a modification to the existing ColActive® Collagen Wound Dressing previously cleared under K050177 on 27th April 2005. ColActive® Transfer is composed of the same base matrix material; collagen and sodium alginate and is made from substantially an equivalent manufacturing process as the predicate. The new product, ColActive® Transfer is a pliable, absorbent, perforated, and biocompatible dressing. ColActive® Transfer dressings absorb and transfer moisture such as wound fluid and maintains a moist environment at the wound surface. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds. ColActive® Transfer dressings contain multiple holes that are evenly distributed across the surface area in order to facilitate the movement of excess exudates through the dressing and away from the wound. The new product will be supplied sterile packaged in a single use heat sealed medical grade foil pouch. The single use primaries will be packed, with a product insert, into cartons for distribution.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for a medical wound dressing, ColActive® Transfer. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly provided in this document.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria with specific quantitative targets. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and performance through "bench testing."

Acceptance Criteria (Inferred from substantial equivalence)	Reported Device Performance (Summary) – ColActive® Transfer
Material Composition	Composed of the same base matrix material: collagen and sodium alginate as the predicate.
Manufacturing Process	Made from substantially an equivalent manufacturing process as the predicate.
Physical Characteristics (Pliability, Absorbency)	Pliable, absorbent, perforated. Controls wound moisture levels through fluid absorption and transfer.
Moisture Management	Absorbs and transfers moisture (wound fluid) and maintains a moist environment at the wound surface. Contains multiple holes to facilitate movement of excess exudates through the dressing. Improved fluid handling capability compared to the predicate due to increased absorbing components and perforations.
Biocompatibility	Biocompatible (implied, as safety is not affected by modifications).
Sterility & Packaging	Supplied sterile, packaged in a single-use heat-sealed medical grade foil pouch. Same packaging and sterilization methods as the predicate.
Indications for Use	Same indicated use as the predicate (management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention).
Safety	Modifications do not affect the safety of the device.
Effectiveness	Modifications improve the effectiveness of the device (specifically, increased absorption capacity and facilitation of fluid passage), and the device is confirmed to be safe and effective for its intended use.
Performance Testing (Bench Testing)	Performance testing included heat stability, crosslinking, fluid/water absorption, and visual testing (defect-free surface and even dressing thickness). These tests confirmed substantial equivalence regarding materials, intended use, and technological characteristics.

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

The document mentions "bench testing," including "heat stability, crosslinking, fluid/water absorption, as well as visual testing (Defect Free surface and even dressing thickness)." However, it does not specify sample sizes for these tests or the data provenance. These are laboratory tests typically performed on manufactured batches of devices, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The study relies on bench testing of physical properties and comparison to a predicate device, not on expert interpretations or ground truth establishment in a clinical context.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench testing of physical device properties.

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

An MRMC comparative effectiveness study was not performed. This is a wound dressing, not an AI-powered diagnostic device, so AI assistance is not relevant.

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

This is not applicable. The device is a physical wound dressing; it does not involve any algorithms or AI for standalone performance.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The "truth" for the performance tests (bench tests) would be the measured physical properties of the device (e.g., absorption capacity in ml/cm², stability at certain temperatures). These are objective measurements against predefined specifications or comparison to the predicate, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable as there is no "training set" for this device. It is a physical medical device, not a machine learning model.

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

This is not applicable, as there is no training set or ground truth in that context.

Summary

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covalon

K123756

Covalon Technologies Inc. A Unique Medical Technologies Company

ISO 13485:2003 CERTIFIED

405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L4Z 3E6 telephone 905.568.8400 facsimile 905.568.5200 www.covalon.com

Special 510(k) Summary of Safety and Effectiveness

1. Sponsor information

Covalon Technologies Inc. 405 Britannia Road East. Suite #106 Mississauga, Ontario, Canada L4Z 3E6

AUG 16 2013

Contact person:

Phone number: Fax number Date of Summary Kim Crooks Vice President of Operations 1-905-568-8400 Ext 265 1-905-568-5200 06 Aug 2013

2. Device name and classification

ColActive® Transfer Proprietary name: Collagen Wound Dressing Common Name: Device Classification: Unclassified General and Plastic Surgery Classification Panel: Product Code: KGN

3. Predicate devices

Manufacturer	Device	510(k) number
Covalon Technologies	ColActive® Collagen Wound Dressing	K050177
Molnlycke Health Care,US, LLC	Mepilex ® Transfer Ag	K123892

4. Indications for use

P.S

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Image /page/1/Picture/0 description: The image shows the word "covaton" in bold black letters with a dotted line going vertically through the middle of the word. Below the word is the text "5. Device Description" in bold black letters. The number 5 is included to indicate that this is the fifth item in a list.

6. Technological Characteristics:

ColActive® Transfer is a pliable and absorbent dressing that controls wound moisture levels through fluid absorption and transfer.

The predicate and the proposed devices have the same intended use and basic fundamental scientific technology. The only modifications to the predicate device consist of increased amounts of absorbing components (collagen and alginate) as well as flattening and perforating after lyophilization. These modifications confer additional absorption capacity, while facilitating passage of excess fluid to secondary dressings, if required. The modifications do not affect the safety but improve the effectiveness of the device.

ColActive® Transfer will be manufactured according to the product specifications and under good manufacturing practices to ensure the device is safe and effective for its intended use.

7. Performance Data

ColActive® Transfer performance testing, includes bench testing such as heat stability. crosslinking, fluid/water absorption, as well as visual testing (Defect Free surface and even dressing thickness) which confirmed that ColActive® Transfer is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).

8. Substantial equivalence

ColActive® Transfer has the following similarities to ColActive® Collagen Wound Dressing which previously received 510(k) concurrence under K050177 on 27th April 2005:

. has the same indicated use,
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Special 510(k) Summary of Safety and Effectiveness

use the same operating principle, .
incorporate the same basic dressing design, .
. incorporate the same materials, and
. are packaged and sterilized using the same materials and processes.

In summary, the modified device, ColActive® Transfer has the same fundamental scientific technology and the same intended use as the predicate device ColActive® The changes that were made improve the fluid handling capability of the dressing and do not affect the safety of the device. Therefore, the modified device ColActive® Transfer is substantially equivalent to its predicate ColActive®.

Covalon Technologies Inc. A Unique Medical Technologies Company

ISO 13485:2003 CERTIFIED

405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L4Z 3E6 telephone 905.568.8400 facsimile 905.568.5200 www.covalon.com

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized representation of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Ticalth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Kim Cooks Vice President of Operations Covalon Technologies Incorporated 405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L.4Z 3E6

Re: K123756 Trade/Device Name: ColActive® Transfer Regulatory Class: Unclassified

Product Code: KGN Dated: July 18, 2013 Received: July 25, 2013

Dear Ms. Cooks:

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 docs 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 or any I 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de receited daily 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.

August 16, 2013

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Page 2 - Kim Cooks

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.html 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting 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: K123756

Device Name: ColActive® Transfer

Indications for Use:

ColActive® Transfer, is indicated for management of full and partial thickness wounds including pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung Dang -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123756

Regulation Number and Section

N/A