(127 days)
Not Found
No
The summary describes a collagen wound dressing and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a wound dressing intended for the management of various types of wounds, indicating a therapeutic application.
No
The device description indicates it is a "wound dressing" for "management of wounds," which are therapeutic functions, not diagnostic. It does not mention any diagnostic capabilities such as detecting or identifying a medical condition.
No
The device description clearly states it is a "sterile, pliable porous wound dressing made of highly purified collagen derived from porcine," indicating it is a physical, material-based 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 states that TheraForm™ Standard / Sheet is for the management of wounds. This involves applying the device directly to a wound on a patient's body to aid in healing.
- Device Description: The description details a wound dressing made of collagen, designed to be applied to a wound.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, TheraForm™ Standard / Sheet is a wound dressing intended for direct application to a wound, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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
Product codes
KGN
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.
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
TheraForm™ Standard / Sheet was subjected to a panel of tests to assess biocompatibility and it passed the requirements of all tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
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.
1
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.
2
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.
3
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,
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: 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