Partial and full-thickness wounds .
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic 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)
Draining wounds

Device Description

TheraForm™ Standard / Sheet Absorbable Collagen Membrane is a sterile, pliable porous wound dressing made of highly purified collagen derived from porcine. TheraForm™ Standard / Sheet is completely absorbable and highly biocompatible.

AI/ML Overview

This document, K090812, is a 510(k) premarket notification for a wound dressing called TheraForm™ Standard / Sheet.

Here's an analysis of the provided information concerning acceptance criteria and studies:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	"TheraForm™ Standard / Sheet was subjected to a panel of tests to assess biocompatibility and it passed the requirements of all tests."

Study Information

This 510(k) summary document describes a biocompatibility study. It is not a study that directly proves device performance in terms of clinical effectiveness or comparison to a predicate device in a comparative effectiveness study in the way typically seen for diagnostic or AI-driven devices. Instead, it focuses on ensuring the safety of the materials.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the "panel of tests" for biocompatibility. There is no information regarding the provenance of any data used for these tests (e.g., country of origin, retrospective or prospective).
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):
Not applicable. For biocompatibility testing, ground truth is established through standardized laboratory assays and regulatory guidelines rather than expert consensus on clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies when interpreting ambiguous results or establishing a "ground truth" through expert consensus for diagnostic or prognostic devices. This is not relevant for biocompatibility testing.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device (a wound dressing). This device is not an AI-driven or diagnostic device that requires human interpretation. The 510(k) focuses on substantial equivalence to a predicate device based primarily on design, materials, indications, and manufacturing, along with biocompatibility testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done, as this is not an AI-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the biocompatibility tests, the "ground truth" would be established by the compliance of the test results with international standards and regulatory guidelines for biocompatibility (e.g., ISO 10993 series). This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather a determination based on chemical and biological assay results.
The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
How the ground truth for the training set was established:
Not applicable. There is no training set for this device.

Summary

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K090812
Page 1 of 2

510(K) Summary

Submitter

Sewon Cellontech Co., Ltd. Heon Kang Park 5th Fl., Wooyoung Techno Center, 273-15, Seong Su 2ga 3-dong, Seongdong-Gu, Seoul, S. Korea Phone: 82-2-460-3128 Fax: 82-2-499-2865

Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@kodent.co.kr Phone: 562-404-8466 Fax: 562-404-2757

Device Information

Trade Name: TheraForm™ Standard / Sheet

Common Name: Wound Dressing

Classification Name: Dressing, Wound, Collagen

Product Code: KGN

Regulation Number: N / A

Device Class: Class II

General Description

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K090812
Page 2 of 2

Indication for Use

TheraForm™ Standard / Sheet is intended for the management of wounds including:

. Partial and full-thickness wounds
� Pressure ulcers
. Venous ulcers
. Diabetic ulcers
. Chronic ulcers
Tunneled / undermined wounds �
Surgical wounds (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound t dehiscence)
Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
Draining wounds

Predicate Devices

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

PriMatrix Dermal Repair Scaffold (K061407) manufactured by TEI BIO Sciences Inc. .

Comparison to Predicate Devices

Comparisons have established that the subject of TheraForm™ Standard / Sheet is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

Performance Data

TheraForm™ Standard / Sheet was subjected to a panel of tests to assess biocompatibility and it passed the requirements of all tests.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sewon Cellontech, Co., Ltd. % Kodent, Inc. Jung Bae Bang 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K090812

Trade/Device Name: TheraForm™ Standard/Sheet Regulatory Class: Unclassified Product Code: KGN Dated: July 15, 2009 Received: July 15, 2009

Dear Jung Bae Bang:

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.

JUL 30 2009

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 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.

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Page 2 - Jung Bae Bang

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Indication for Use

510(K) Number: K090812

Device Name: TheraForm™ Standard / Sheet

Indication for Use:

TheraForm™ Standard / Sheet is intended for the management of wounds including:

Partial and full-thickness wounds .
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic 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)
Draining wounds

Prescription Use X AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(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 (ODE)

Page 1 of 1

Daniel Krone Ap. MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KD90812

Regulation Number and Section

N/A