← Product Code KGN · K141738 # MEDEOR MATRIX WOUND DRESSING (K141738) _Kensey Nash Corporation Dba Dsm Biomedical · KGN · Feb 17, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K141738 ## Device Facts - **Applicant:** Kensey Nash Corporation Dba Dsm Biomedical - **Product Code:** KGN - **Decision Date:** Feb 17, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular 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, skin tears), and draining wounds. Medeor Matrix Wound Dressing is intended for one time use. ## Device Story Medeor Matrix Wound Dressing is a resorbable, acellular porcine dermis-derived extracellular matrix. Supplied hydrated in double-layer packaging; intended for single-use prescription application to topical wounds. Functions as a wound dressing to support management of various wound types. Sterilized via electron beam irradiation. Healthcare providers apply the dressing to the wound site to facilitate management. Benefits include biocompatible scaffold for wound healing. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009, including cytotoxicity, sensitization, irritation, acute/subacute/chronic systemic toxicity, genotoxicity, and hemocompatibility. Additional safety testing included viral inactivation and residual chemical assessment. Bench testing included hydration and suture testing. Results demonstrate the device is equivalent to the predicate and meets requirements for intended use. ## Technological Characteristics Resorbable porcine dermis-derived extracellular matrix. Single-layer wound dressing. Sterilized via electron beam irradiation. Supplied hydrated in double-peel packaging. Biocompatible per ISO 10993-1:2009. Shelf life: 3 years. ## Predicate Devices - Meso Wound Matrix ([K112888](/device/K112888.md)) ## Reference Devices - Medeor Matrix ([K091499](/device/K091499.md)) - Medeor Matrix ([K103787](/device/K103787.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 17, 2015 DSM Biomedical Ms. Brianna Jordan Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341 Re: K141738 Trade/Device Name: Medeor Matrix Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 15, 2015 Received: January 16, 2015 Dear Ms. Jordan: 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 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. for Sincerely yours, # David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141738 Device Name Medeor Matrix Wound Dressing #### Indications for Use (Describe) Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular 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, skin tears), and draining wounds. Medeor Matrix Wound Dressing is intended for one time use. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." 4-1A {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DSM, a company focused on bright science for brighter living. The logo features a colorful, abstract swirl design on the left, composed of overlapping shapes in shades of blue, green, orange, and purple. To the right of the swirl is the company name, "DSM," in bold, blue letters. Below the name is the tagline, "BRIGHT SCIENCE. BRIGHTER LIVING.," also in blue. ## 510(k) SUMMARY | Submitted By: | DSM Biomedical
735 Pennsylvania Drive
Exton, PA 19341 | |----------------------------|------------------------------------------------------------------------------------------------------------| | Contact Person: | Brianna Jordan
Regulatory Specialist
E: Brianna.Jordan@dsm.com
P: 484-713-2608
F: 484-713-2903 | | Date Prepared: | August 12, 2014 | | Device: | | | Trade Name: | Medeor Matrix Wound Dressing | | Common/Usual Name: | Collagen Wound Dressing | | Classification Name: | Dressing, Wound, Collagen | | Classification Regulation: | N/A | | Device Class: | Unclassified | | Device Code: | KGN | | Advisory Panel: | General and Plastic Surgery | | Predicate Device: | K112888: Meso Wound Matrix [Kensey Nash Corporation] | | Reference Device: | K091499, K103787: Medeor Matrix [Kensey Nash Corporation] | # Device Description: Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only. # Indications for Use: Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: {4}------------------------------------------------ partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular 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), and draining wounds. Medeor Matrix Wound Dressing is intended for one time use. # Technological Characteristics: Medeor Matrix Wound Dressing is substantially equivalent in terms of indications for use, material composition, technological characteristics and performance characteristics to the predicate device, Meso Wound Matrix, [Kensey Nash Corporation] K112888. Medeor Matrix Wound Dressing and Meso Wound Matrix are decellularized, porcine derived extracellular matrices. The only difference is that Medeor Matrix Wound Dressing is comprised of porcine dermis and Meso Wound Matrix is comprised of porcine mesothelium. Medeor Matrix Wound Dressing has identical material, technological and performance characteristics as the reference device, Medeor Matrix (hydrated version) [Kensey Nash Corporation] K091499, K103787. | Characteristic | Medeor Matrix Wound
Dressing
(K141738) | Meso Wound Matrix
(K112888)
(Predicate Device) | Medeor Matrix
(K091499, K103787)
(Reference Device) | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for
Use | Medeor Matrix Wound
Dressing is indicated for
the management of
topical wounds
including: partial and
full-thickness wounds,
pressure ulcers, venous
ulcers, diabetic ulcers,
chronic vascular ulcers,
tunneled/undermined | Meso Wound Matrix is
indicated for the
management of topical
wounds including:
partial and full-thickness
wounds, pressure ulcers,
venous ulcers, diabetic
ulcers, chronic vascular
ulcers,
tunneled/undermined | Medeor Matrix is
indicated for use in
general surgical
procedures for the
reinforcement and repair
of soft tissue where
weakness exists
including but not limited
to defects of the thoracic
wall, suture line | | Characteristic | Medeor Matrix Wound
Dressing
(K141738) | Meso Wound Matrix
(K112888)
(Predicate Device) | Medeor Matrix
(K091499, K103787)
(Reference Device) | | | 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), and draining
wounds. The device is
intended for one time
use. | 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), and draining
wounds. The device is
provided sterile and for
one time use. | reinforcement and
muscle flap
reinforcement;
urogynecological
surgical reinforcement
(excluding transvaginal
repair of pelvic organ
prolapse) including but
not limited to, rectal
prolapse (excluding
rectocele) using
abdominal approach,
vaginal prolapse
(excluding transvaginal
repair of pelvic organ
prolapse), reconstruction
of the pelvic floor using
an abdominal approach
(excluding transvaginal
repair of pelvic organ
prolapse), hernia repair;
soft tissue reconstructive
procedures including
plastic and
reconstructive surgical
applications and for
reinforcement of the soft
tissues, which are
repaired by suture or
suture anchors, including
but not limited to, rotator
cuff, patellar, Achilles,
biceps, quadriceps and | | Characteristic | Medeor Matrix Wound
Dressing
(K141738) | Meso Wound Matrix
(K112888)
(Predicate Device) | Medeor Matrix
(K091499, K103787)
(Reference Device) | | | | | device is not intended to
replace normal body
structure to provide the
full mechanical strength
to support tendon repair
of the rotator cuff,
patellar, Achilles, biceps,
quadriceps, or other
tendons. Sutures used to
repair the tear, and
sutures or bone anchors
used to attach the tissue
to the bone provide
biomechanical strength
for the tendon repair.
The device is provided
sterile and for one time
use. | | Origin | Porcine tissue | Porcine tissue | Porcine tissue | | Device
Characteristics | Resorbable single layer
wound dressing | Resorbable single layer
wound dressing | Resorbable single layer
surgical mesh | | Biocompatible | Yes | Yes | Yes | | Reusable | Single Use Device | Single Use Device | Single Use Device | | Shelf Life | 3 years | 2 years | 3 years | | Sterilization
Method | E-Beam | Ethylene Oxide | E-Beam | | Packaging | Double peel packages | Double peel packages | Double peel packages | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## Biocompatibility and Performance Data: Biocompatibility testing, bench testing and characterization testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of Medeor Matrix Wound Dressing. Biocompatibility testing was completed on the finished sterile device in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable. Bench testing included hydration and suture testing. Testing results indicate that the device is equivalent to the predicate device and meets the requirements for its intended use. ## Substantial Equivalence: Pursuant to section 510(k), Medeor Matrix Wound Dressing is substantially equivalent to the predicate device Meso Wound Matrix (K112888) with regard to indication for use, material, technological characteristics, including principles of operation, and performance characteristics. Medeor Matrix Wound Dressing is identical in material, technological and performance characteristics as the reference device, Medeor Matrix (hydrated version) [Kensey Nash Corporation] K091499, K103787. --- **Source:** [https://fda.innolitics.com/device/K141738](https://fda.innolitics.com/device/K141738) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com