(235 days)
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.
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.
This document describes the Medeor Matrix Wound Dressing, a resorbable porcine dermis-derived dressing for topical wounds. However, it is a 510(k) summary for a medical device that is not an AI/ML device.
The provided document does not contain information about a study proving that an AI device meets acceptance criteria. It is a regulatory submission for a physical wound dressing and primarily focuses on demonstrating substantial equivalence to a predicate device based on its material, technological, and performance characteristics, as well as biocompatibility testing.
Therefore, I cannot fulfill the request to provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the provided content.
The information primarily concerns the biocompatibility and physical performance of the wound dressing, not the performance of an AI/ML algorithm.
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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
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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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
| Submitted By: | DSM Biomedical735 Pennsylvania DriveExton, PA 19341 |
|---|---|
| Contact Person: | Brianna JordanRegulatory SpecialistE: Brianna.Jordan@dsm.comP: 484-713-2608F: 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:
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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 WoundDressing(K141738) | Meso Wound Matrix(K112888)(Predicate Device) | Medeor Matrix(K091499, K103787)(Reference Device) |
|---|---|---|---|
| Indications forUse | Medeor Matrix WoundDressing is indicated forthe management oftopical woundsincluding: partial andfull-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/undermined | Meso Wound Matrix isindicated for themanagement of topicalwounds including:partial and full-thicknesswounds, pressure ulcers,venous ulcers, diabeticulcers, chronic vascularulcers,tunneled/undermined | Medeor Matrix isindicated for use ingeneral surgicalprocedures for thereinforcement and repairof soft tissue whereweakness existsincluding but not limitedto defects of the thoracicwall, suture line |
| Characteristic | Medeor Matrix WoundDressing(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 andskin tears), and drainingwounds. The device isintended for one timeuse. | wounds, surgical wounds(donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns andskin tears), and drainingwounds. The device isprovided sterile and forone time use. | reinforcement andmuscle flapreinforcement;urogynecologicalsurgical reinforcement(excluding transvaginalrepair of pelvic organprolapse) including butnot limited to, rectalprolapse (excludingrectocele) usingabdominal approach,vaginal prolapse(excluding transvaginalrepair of pelvic organprolapse), reconstructionof the pelvic floor usingan abdominal approach(excluding transvaginalrepair of pelvic organprolapse), hernia repair;soft tissue reconstructiveprocedures includingplastic andreconstructive surgicalapplications and forreinforcement of the softtissues, which arerepaired by suture orsuture anchors, includingbut not limited to, rotatorcuff, patellar, Achilles,biceps, quadriceps and | |
| Characteristic | Medeor Matrix WoundDressing(K141738) | Meso Wound Matrix(K112888)(Predicate Device) | Medeor Matrix(K091499, K103787)(Reference Device) |
| device is not intended toreplace normal bodystructure to provide thefull mechanical strengthto support tendon repairof the rotator cuff,patellar, Achilles, biceps,quadriceps, or othertendons. Sutures used torepair the tear, andsutures or bone anchorsused to attach the tissueto the bone providebiomechanical strengthfor the tendon repair.The device is providedsterile and for one timeuse. | |||
| Origin | Porcine tissue | Porcine tissue | Porcine tissue |
| DeviceCharacteristics | Resorbable single layerwound dressing | Resorbable single layerwound dressing | Resorbable single layersurgical mesh |
| Biocompatible | Yes | Yes | Yes |
| Reusable | Single Use Device | Single Use Device | Single Use Device |
| Shelf Life | 3 years | 2 years | 3 years |
| SterilizationMethod | E-Beam | Ethylene Oxide | E-Beam |
| Packaging | Double peel packages | Double peel packages | Double peel packages |
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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.
N/A