(133 days)
No
The 510(k) summary describes a biological wound matrix and does not mention any AI or ML components or functionalities.
Yes
The device, Meso Wound Matrix, is intended for the management of various types of topical wounds, indicating it is used to treat or alleviate a disease or injury.
No
The device is described as a resorbable product for managing topical wounds, made of porcine collagen. Its intended use focuses on wound treatment and management, not on diagnosing conditions or diseases.
No
The device description clearly states it is a physical product composed of porcine collagen from peritoneum tissue, supplied as a sheet. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of topical wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description details a "resorbable porcine mesothelium derived product" composed of collagen, supplied as a sheet. This is a material intended for physical interaction with tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health status.
- Focus on Wound Healing: The entire description and intended use revolve around the physical management and healing of wounds.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely different.
N/A
Intended Use / Indications for Use
Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.
The device is intended for one time use.
Product codes
KGN
Device Description
Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.
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
Meso Wound Matrix has undergone biocompatibility, hydration, animal, and viral inactivation testing. The following biocompatibility tests were conducted on the finished device according to the requirements of ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:Evaluation and testing. : Cytotoxicity, Sensitization, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
FEB 1 0 2012
Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K112888". Below that, the text reads "pgv/3".
Image /page/0/Picture/2 description: The image shows the text "Kensey Nash" inside of a rounded rectangle. The text is written in a simple, sans-serif font. The letters are outlined in black, and the inside of the letters are white. The rounded rectangle is also outlined in black.
510(k) Summary
| Submitted by: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 |
|--------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Lori Burns, MS, RAC
Manager, Regulatory Affairs
Ph: (484) 713-2186
Fax: (484) 713-2903 |
| Date Prepared: | February 8, 2012 |
| 510(K) #: | K112888 |
| Device: | |
| Trade Name: | Meso Wound Matrix |
| Common/Usual Name: | Wound Dressing |
ನ ound Dressing Proposed Classification: KGN, unclassified
Device Description:
Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.
1
Intended Use: Meso Wound Matrix is intended for the management of topical wounds including:
- Partial and full thickness wounds .
- . Pressure ulcers
- . Venous ulcers
- Diabetic ulcers .
- Chronic vascular ulcers .
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound . dehiscence )
- Trauma wounds(abrasions, lacerations, second-degree burns and skin tears) .
- Draining wounds .
- Tunneled/ undermined wounds .
Predicate Device:
| Manufacturer | Device | 510(k) |
|---|---|---|
| Cook Biotech, Inc. | Oasis Wound Matrix | K061711 |
Technological Characteristics:
Meso Wound Matrix is technologically identical to the cleared KN ECM Surgical Patch (K094061). Like KN ECM Surgical Patch, Meso Wound Matrix consists of terminally sterilized processed lyophilized porcine peritoneum provided in various sizes and packaged in a double layer package.
Performance Data:
Meso Wound Matrix has undergone biocompatibility, hydration, animal, and viral inactivation testing. The following biocompatibility tests were conducted on the finished device according to the requirements of ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:Evaluation and testing. : Cytotoxicity, Sensitization, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemocompatibility.
Substantial Equivalence:
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K112888
ps 2/3
Based on the material, biocompatibility, bench, and animal testing, and the proposed device labeling, Meso Wound Matrix is substantially equivalent to the identified predicate device in terms of intended use, technological characteristics and principles of operation pursuant to section 510(k).
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 0 2012
Kensey Nash Corporation % Ms. Lori Burns, MS, RAC Manager, Regulatory Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K112888
Trade/Device Name: Meso Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: January 30, 2012 Received: February 01, 2012
Dear Ms. Burns:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Lori Burns, MS, RAC
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/ReportalToblem/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.
.fda.gov/MedicalDevices/ResourcesforIndustry/ucm.htm
Sincerely yours.
Sincerly, yours,
Mark Milliken
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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K112888
pg 1/1
Indications for Use
510(k) Number (if known): K112888
Device Name: Meso Wound Matrix
Indications for Use:
Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.
The device is intended for one time use.
Prescription Use X (Part 21 CFR 801 Subpart D)
. AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kucera for MXM
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112855