Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), draining wounds.

Device Description

Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

This submission is for a Collagen Wound Dressing and does not involve an AI/ML device. The "acceptance criteria" and "reported device performance" are framed in terms of biocompatibility and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

Acceptance Criteria	Reported Device Performance
Material Composition and Design: Pliable porous and dense scaffold agent made of highly purified porcine-derived collagen.	Substantially Equivalent: Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked to resist enzymatic degradation, completely absorbable, and highly biocompatible. It is composed of a porous sponge layer and a dense film layer. This composition is considered substantially equivalent to the predicate device, which is also a sterile, pliable porous wound dressing made of highly purified porcine-derived collagen.
Intended Use: Management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds.	Same as Predicate Device: The intended use is stated as "Same as predicate device" and explicitly lists: pressure ulcers, venous ulcers, diabetic ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.
Biocompatibility: Meet requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing.	Passed: Collagen Wound Dressing was subjected to a panel of tests to assess biocompatibility in accordance with ISO 10993-1 and passed the requirements of all tests.
Purity and Identity: Confirmation of purity and identity of Type I collagen.	Confirmed: The purity and identity of Type I collagen have been confirmed by SDS-PAGE analysis.
Viral Inactivation and Removal: Confirmation of viral inactivation and removal.	Confirmed: Viral inactivation and removal have been confirmed.
Safety and Effectiveness: Demonstrate substantial equivalence to a legally marketed predicate device.	Substantially Equivalent: The Collagen Wound Dressing is found to be substantially equivalent to the predicate device (TheraForm™ Standard / Sheet, K090812) in design, material, and its intended use, and meets the requirements for premarket notification, thus deemed as safe and effective.

Note: This device is a medical wound dressing and not an AI/ML diagnostic or assistive device. Therefore, several of the requested categories related to AI/ML studies are not applicable to this submission.

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

No clinical testing was performed for this submission. The evaluation was based on non-clinical testing for biocompatibility and comparison to a predicate device. Therefore, there is no "test set" in the context of an AI/ML algorithm evaluation.

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

Not applicable, as no test set requiring expert ground truth for an AI/ML algorithm was used.

4. Adjudication Method for the Test Set:

Not applicable, as no test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted. This device is a wound dressing, not an AI assistance tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this is a physical medical device and not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" was established by adherence to recognized international standards and analytical methods:

Biocompatibility: Adherence to ISO 10993-1 requirements.
Purity and Identity: Confirmed by SDS-PAGE analysis.
Viral Inactivation and Removal: Confirmed by specific testing for these properties.

For substantial equivalence, the "ground truth" was the characteristics and performance of the legally marketed predicate device, TheraForm™ Standard / Sheet (K090812).

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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JUN - 1 2012

510(K) Summary

Submitter: Jong Sup, Chung Dalim Tissen Co., Ltd 3-5th Fl. Yonnam Bldg., 383-93 Yonnam-dong, Mapo-gu, Seoul, South Korea

Official correspondent: April Lee Kodent Inc. 325 N. Puente st. Unit B Brea, CA 92821 Phone : 714-525-0114 Fax : 714-525-0116

Device Information

Collagen Wound Dressing Trade Name: Common Name: Wound Dressing Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulation Number: N / A Device Class: Class II

Date Prepared: 5/21/2012

General Description

Indication for Use

Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears), draining wounds.

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Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

TheraForm™ Standard / Sheet manufactured by Sewon Cellontech (K090812) .

	Subject Device	Predicate Device
Company	Dalim Tissen Co., Ltd	Sewon Cellontech Co., Ltd.
Device Name	Collagen Wound Dressing	TheraForm™ Standard / Sheet
510(k) Number	N/A	K090812
DeviceClassificationName	Wound Dressing	Wound Dressing
Product Code	KGN	KGN
RegulationNumber	Unclassified	Unclassified
Intended Use	Same as predicate device	Partial and full-thickness wounds-Pressure ulcers-Venous ulcers-Diabetic ulcers-Chronic ulcers-Tunneled / undermined wounds-Surgical wounds (donor sites / grafts,postmoh's surgery, post-laser surgery,podiatric, wound dehiscence)-Trauma wounds (abrasions,lacerations, second-degree bums, and skin tears)-Draining wounds
Description	Collagen Wound Dressing(Absorbable Collagen Membrane) isa sterile, pliable wound dressingmade of highly purified collagenderived from porcine skin. CollagenWound Dressing is completelyabsorbable and highly biocompatible.Collagen Wound Dressing iscomposed of porous sponge layer forthe wound surface and dense filmlayer for protecting wound fromoutside.	TheraForm™ Standard / SheetAbsorbable Collagen Membrane is asterile, pliable porous wound dressingmade of highly purified collagenderived from porcine skin.TheraForm™ Standard / Sheet iscompletely absorbable and highlybiocompatible.
Material	Pliable porous and dense scaffoldagent made of highly purified porcinederived collagen	Pliable porous scaffold agent made ofhighly purified porcine derivedcollagen
Product sizes	Diameter 1 cm circle to 10 x 10cmsquare	40 x 30mm to 100 x 100mm square

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Comparison to Predicate Devices

There are no significant differences between the Collagen Wound Dressing and TheraForm™ Standard / Sheet currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the cleared device in design, material, and its intended use.

Non-Clinical Testing

Collagen Wound Dressing was subjected to a panel of tests to assess biocompatibility in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing and it passed the requirements of all tests. The purity and identity of Type I collagen have been confirmed by SDS-PAGE analysis and the viral inactivation and removal have been confirmed.

Clinical Testing

No clinical testing was performed for this submission.

Conclusion

The Collagen Wound Dressing is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR 21, Part 807. The subject device is as safe and effective as predicate medical devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

JUN - 1 2012

Dalim Tissen Co., Ltd % Kodent Inc. Ms. April Lee Consultant/US Agent 325 North Puente Street Brea, California

Re: K112580

Trade/Device Name: Collagen Wound Dressing Regulation Class: Unclassified Product Code: KGN Dated: May 24, 2012 Received: May 24, 2012

Dear Ms. April Lee:

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

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Page 2 - Ms. Lee

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 (reporting of medical

device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
EL Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112550

Indication for Use

510(K) Number: N/A

Device Name: Collagen Wound Dressing

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter

(Per 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

Page 1 of 1

Evaluation (ODE)
Daniel Kravefor MM
(Division Slun-Offy)

Division of Surgical, Orthopedic, Restorative Devices

510(k) Number K112580

Regulation Number and Section

N/A