THERAFORM BILAYER

K090823 · Sewon Cellontech Co., Ltd. · KGN · Oct 22, 2009 · SU

Device Facts

• Record ID: K090823
• Device Name: THERAFORM BILAYER
• Applicant: Sewon Cellontech Co., Ltd.
• Product Code: KGN · SU
• Decision Date: Oct 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

TheraForm™ Bilayer is intended for the management of wounds including: Partial and full-thickness wounds . Pressure ulcers . Venous ulcers . Diabetic ulcers . Chronic ulcers . 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™ Bilayer is a sterile, pliable, porous wound dressing. Composed of highly purified porcine-derived collagen scaffold with a semi-permeable silicone layer. Silicone layer maintains moist wound environment, increases tear strength, and provides flexible, adherent covering. Device is completely absorbable (excluding silicone layer). Applied to wound surface by clinician to manage various wound types. Acts as physical barrier and scaffold to support wound healing. Benefits include moisture retention and protection of wound bed.

Clinical Evidence

Bench testing only. Device passed all biocompatibility testing requirements.

Technological Characteristics

Sterile, pliable, porous scaffold. Materials: Highly purified porcine-derived collagen and semi-permeable silicone layer. Form factor: Bilayer membrane. Biocompatible and absorbable (collagen component).

Indications for Use

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

Predicate Devices

• Bilayer Matrix Wound Dressing (K021792)

Submission Summary (Full Text)

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Sewon Cellontech Co., Ltd.

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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. Eugene Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

Product Name: TheraForm™ Bilayer

Common Name: Wound Dressing

Classification Name: Unclassified

Product Code: FRO

Regulation Number: N / A

Device Class: Class II

### General Description

TheraForm™ Bilayer Absorbable Collagen Membrane is a sterile, pliable surgical porous scaffold agent made of highly purified collagen derived from porcine skin. TheraForm™ Bilayer is completely absorbable (with the exclusion of silicone layer) and highly biocompatible. The semi-permeable silicone layer helps maintaining moist environment, increases tear strength and provides a flexible adherent covering for the wound surface.

OCT 2 2 2009

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K090823

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### Indication for Use

TheraForm™ Bilayer is intended for the management of wounds including:

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

### Predicate Devices

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

- Bilayer Matrix Wound Dressing (K021792) manufactured by Integra LifeSciences Corporation. .
## Comparison to Predicate Devices

Comparisons have established that the subject of TheraForm™ Bilayer 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™ Bilayer 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

OCT 2 2 2009

Re: K090823

Trade/Device Name: TheraForm™ Bilayer Regulatory Class: Unclassified Product Code: FRO Dated: October 20, 2009 Received: October 20, 2009

Dear Mr. 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.

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 - Mr. Eugene 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,

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: K090823

Device Name: TheraForm™ Bilayer

#### Indication for Use:

TheraForm™ Bilayer is intended for the management of wounds including:

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

Prescription Use

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 Keane

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

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510(k) Number K090823