THERAFORM STANDARD/SHEET

K090812 · Sewon Cellontech Co., Ltd. · KGN · Jul 30, 2009 · SU

Device Facts

• Record ID: K090812
• Device Name: THERAFORM STANDARD/SHEET
• Applicant: Sewon Cellontech Co., Ltd.
• Product Code: KGN · SU
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

TheraForm™ Standard/Sheet is a sterile, pliable, porous, absorbable wound dressing derived from porcine collagen. Designed for management of various wound types including chronic, surgical, and trauma-related wounds. Applied topically by clinicians to the wound site to provide a scaffold for healing. Device is fully absorbable and biocompatible. Benefits include wound management and support of healing process.

Clinical Evidence

Bench testing only. Biocompatibility testing performed; device passed all requirements.

Technological Characteristics

Sterile, pliable, porous wound dressing. Material: Highly purified porcine-derived collagen. Form factor: Sheet. Absorbable. Biocompatible.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's, post-laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds in patients requiring wound care.

Predicate Devices

• PriMatrix Dermal Repair Scaffold (K061407)

Submission Summary (Full Text)

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K090812
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### 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: [phone] Fax: [phone]

Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail] Phone: [phone] Fax: [phone]

#### 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

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.

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K090812
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## 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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)

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Daniel Krone Ap. MXM

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

510(k) Number KD90812