(210 days)
Not Found
No
The document describes a collagen membrane for wound management and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the management of various types of wounds, indicating a therapeutic purpose in healing and recovery.
No
The "Intended Use / Indications for Use" section indicates the device is for the "management of wounds," which implies treatment rather than diagnosis. There is no mention of identifying, detecting, or classifying diseases or conditions.
No
The device description clearly states it is a "sterile, pliable surgical porous scaffold agent made of highly purified collagen derived from porcine skin" with a "semi-permeable silicone layer," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a sterile, pliable surgical porous scaffold made of collagen with a silicone layer. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, TheraForm™ Bilayer is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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
Product codes
FRO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
TheraForm™ Bilayer was subjected to a panel of tests to assess biocompatibility and it passed the requirements of all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bilayer Matrix Wound Dressing (K021792)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Sewon Cellontech Co., Ltd.
30823
1/2
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: 82-2-460-3270 Fax: 82-2-499-2865
Official Correspondent Kodent Inc. Eugene 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
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
1
2/2
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.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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
7
510(k) Number K090823