(269 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen wound dressing, with no mention of AI or ML.
Yes
The device is described as a wound dressing for the management of various types of wounds, which is a therapeutic function.
No
Explanation: The device is a wound dressing that facilitates the healing of wounds. Its function is therapeutic and restorative, not diagnostic. It does not identify or characterize a disease or condition.
No
The device description clearly states it is a physical wound dressing made of collagen, 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 a wound dressing for managing various types of wounds. This is a topical application for direct interaction with the wound surface, not for analyzing samples taken from the body.
- Device Description: The description details a sterile, pliable, porous, and dense wound dressing made of collagen. This aligns with the physical characteristics of a wound dressing, not an in vitro diagnostic device which typically involves reagents, instruments, or kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In vitro diagnostic devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly manage and support the healing of wounds on the body's surface.
N/A
Intended Use / Indications for Use
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears), draining wounds.
Product codes
KGN
Device Description
Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.
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
Non-Clinical Testing: Collagen Wound Dressing was subjected to a panel of tests to assess biocompatibility in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing and it passed the requirements of all tests. The purity and identity of Type I collagen have been confirmed by SDS-PAGE analysis and the viral inactivation and removal have been confirmed.
Clinical Testing: No clinical testing was performed for this submission.
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
12112580
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JUN
JUN - 1 2012
510(K) Summary
Submitter: Jong Sup, Chung Dalim Tissen Co., Ltd 3-5th Fl. Yonnam Bldg., 383-93 Yonnam-dong, Mapo-gu, Seoul, South Korea
Official correspondent: April Lee Kodent Inc. 325 N. Puente st. Unit B Brea, CA 92821 Phone : 714-525-0114 Fax : 714-525-0116
Device Information
Collagen Wound Dressing Trade Name: Common Name: Wound Dressing Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulation Number: N / A Device Class: Class II
Date Prepared: 5/21/2012
General Description
Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.
Indication for Use
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears), draining wounds.
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KV12880
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Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- TheraForm™ Standard / Sheet manufactured by Sewon Cellontech (K090812) .
| Subject Device | Predicate Device | |
|---|---|---|
| Company | Dalim Tissen Co., Ltd | Sewon Cellontech Co., Ltd. |
| Device Name | Collagen Wound Dressing | TheraForm™ Standard / Sheet |
| 510(k) Number | N/A | K090812 |
| Device | ||
| Classification | ||
| Name | Wound Dressing | Wound Dressing |
| Product Code | KGN | KGN |
| Regulation | ||
| Number | Unclassified | Unclassified |
| Intended Use | Same as predicate device | Partial and full-thickness wounds |
| -Pressure ulcers | ||
| -Venous ulcers | ||
| -Diabetic ulcers | ||
| -Chronic ulcers | ||
| -Tunneled / undermined wounds | ||
| -Surgical wounds (donor sites / grafts, | ||
| postmoh's surgery, post-laser surgery, | ||
| podiatric, wound dehiscence) | ||
| -Trauma wounds (abrasions, | ||
| lacerations, second | ||
| -degree bums, and skin tears) | ||
| -Draining wounds | ||
| Description | Collagen Wound Dressing | |
| (Absorbable Collagen Membrane) is | ||
| a sterile, pliable wound dressing | ||
| made of highly purified collagen | ||
| derived from porcine skin. Collagen | ||
| Wound Dressing is completely | ||
| absorbable and highly biocompatible. | ||
| Collagen Wound Dressing is | ||
| composed of porous sponge layer for | ||
| the wound surface and dense film | ||
| layer for protecting wound from | ||
| outside. | TheraForm™ Standard / Sheet | |
| Absorbable Collagen Membrane is a | ||
| sterile, pliable porous wound dressing | ||
| made of highly purified collagen | ||
| derived from porcine skin. | ||
| TheraForm™ Standard / Sheet is | ||
| completely absorbable and highly | ||
| biocompatible. | ||
| Material | Pliable porous and dense scaffold | |
| agent made of highly purified porcine | ||
| derived collagen | Pliable porous scaffold agent made of | |
| highly purified porcine derived | ||
| collagen | ||
| Product sizes | Diameter 1 cm circle to 10 x 10cm | |
| square | 40 x 30mm to 100 x 100mm square |
2
Comparison to Predicate Devices
There are no significant differences between the Collagen Wound Dressing and TheraForm™ Standard / Sheet currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the cleared device in design, material, and its intended use.
Non-Clinical Testing
Collagen Wound Dressing was subjected to a panel of tests to assess biocompatibility in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing and it passed the requirements of all tests. The purity and identity of Type I collagen have been confirmed by SDS-PAGE analysis and the viral inactivation and removal have been confirmed.
Clinical Testing
No clinical testing was performed for this submission.
Conclusion
The Collagen Wound Dressing is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR 21, Part 807. The subject device is as safe and effective as predicate medical devices
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 1 2012
Dalim Tissen Co., Ltd % Kodent Inc. Ms. April Lee Consultant/US Agent 325 North Puente Street Brea, California
Re: K112580
Trade/Device Name: Collagen Wound Dressing Regulation Class: Unclassified Product Code: KGN Dated: May 24, 2012 Received: May 24, 2012
Dear Ms. April Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Lee
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
EL Keith
fo
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(K) Number: N/A
Device Name: Collagen Wound Dressing
Indication for Use:
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (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
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter
(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
Page 1 of 1
Evaluation (ODE)
Daniel Kravefor MM
(Division Slun-Offy)
Division of Surgical, Orthopedic, Restorative Devices
510(k) Number K112580