(235 days)
No
The summary describes a resorbable porcine dermis-derived wound dressing and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes.
The device is indicated for the management of various topical wounds, which is a therapeutic function.
No
Explanation: The device is a wound dressing intended for the management of topical wounds, not for diagnosis. Its description and intended use focus on treatment and management, not the identification of diseases or conditions.
No
The device description clearly states it is a "resorbable porcine dermisderived dressing," which is a physical material, not software. The performance studies also focus on biocompatibility and bench testing of a physical product.
Based on the provided information, the Medeor Matrix Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of topical wounds. This involves applying the dressing directly to the wound on the patient's body.
- Device Description: It's described as a resorbable porcine dermis-derived dressing. This is a material applied externally.
- No mention of in vitro testing: The description and performance studies focus on biocompatibility, bench testing (hydration, suture), and safety related to the material and its application to the body. There is no mention of testing samples from the body (like blood, tissue, etc.) to diagnose or monitor a condition.
- No mention of analyzing samples: IVDs are designed to analyze samples taken from the human body. This device is applied to the body.
Therefore, the Medeor Matrix Wound Dressing is a medical device intended for direct application to the body for wound management, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
topical wounds
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112888: Meso Wound Matrix
Reference Device(s)
K091499, K103787: Medeor Matrix
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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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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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:
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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 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 |
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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.