(210 days)
No
The device description and performance studies focus on the material composition and biological properties of the dermal matrix, with no mention of AI/ML capabilities or data processing.
Yes
The device is indicated for the management of various types of wounds, aiming to treat or alleviate a medical condition.
No
MatriDerm is described as a device "indicated for the management of wounds" and "composed of bovine collagen fibers and bovine elastin." Its use is primarily for wound treatment and management, not for diagnosing conditions.
No
The device description clearly states that MatriDerm is a physical, single-use, three-dimensional acellular dermal matrix composed of bovine collagen and elastin. This is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- MatriDerm's Intended Use: The intended use of MatriDerm is for the management of wounds. It is applied directly to the wound to aid in healing.
- MatriDerm's Device Description: MatriDerm is a physical matrix made of bovine collagen and elastin. It is a material applied externally to the body.
MatriDerm is a medical device used for wound management, but it does not perform diagnostic testing on specimens taken from the body.
N/A
Intended Use / Indications for Use
MatriDerm is indicated for the management of wounds including:
- Full thickness and partial thickness wounds
- Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- Partial thickness burns
- Trauma wounds (abrasions, lacerations and skin tears)
- Draining wounds
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
MatriDerm is a single-use three-dimensional acellular dermal matrix composed of bovine collagen fibers and bovine elastin. The device is supplied sterile and is available in different sizes providing flexibility of choice based on the treatment protocol, wound location, size and depth. The device can be cut to fit the wound.
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
Qualified care professionals / Health care environment
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:
MatriDerm was determined to be biocompatible based on ISO 10993-1 and "FDA General Guidance on Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process." Device is classified as a surface device with permanent (>30 days) contact with breached, compromised surfaces. Biological endpoints considered: physical and chemical characterization, cytotoxicity, sensitization or intracutaneous reactivity, acute systemic toxicity, subchronic and subacute toxicity, implantation, chronic toxicity, carcinogenicity, material-mediated pyrogenicity. Recommended tests were successfully performed/evaluated on final, finished and sterile subject device is considered to be biocompatible.
Bench:
- Fluid absorbency
- Sterilization Validation
- Bacterial Endotoxin
- Viral Inactivation
- Device Characterization
Clinical:
Human Repeat Insult Patch Testing (HRIPT) and Skin Prick Testing (SPT) were performed to demonstrate MatriDerm is non irritating and non-immunogenic.
- HRIPT: In 60 subjects, demonstrated MatriDerm was not irritating or immunogenic for a type 4/delayed type hypersensitivity.
- SPT: In 22 subjects, 1 subject had a positive wheal response at the 15 minute time point in the positive control site, negative control site, and the product test site. The product test site wheal was bigger than the negative control and about the same size as the positive control. At the 6 hour and 1-2 day time points, all sites were negative. Demonstrated low immunogenic potential.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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January 7, 2021
MedSkin Solutions Dr. Suwelack AG Zuzana Hülsbusch Senior Regulatory Affairs Specialist Josef-Suwelack-Strasse 2 Billerbeck, NRW 48727 Germany
Re: K201577
Trade/Device Name: MatriDerm Regulatory Class: Unclassified Product Code: KGN Dated: November 30, 2020 Received: December 4, 2020
Dear Zuzana Hülsbusch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Kimberly Ferlin, PhD Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201577
Device Name MatriDerm
Indications for Use (Describe)
MatriDerm is indicated for the management of wounds including:
- Full thickness and partial thickness wounds
- Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- Partial thickness burns
- Trauma wounds (abrasions, lacerations and skin tears)
- Draining wounds
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
l. Applicant Information
| Submitter: | MedSkin Solutions Dr. Suwelack AG
Josef-Suwelack-Strasse 2
48727 Billerbeck / Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zuzana Hülsbusch
Senior Regulatory Affairs Specialist
Phone: 0049 2543 21820
Fax: 0049 2543 2182-150
E-Mail: zuzana.huelsbusch@medskin-suwelack.com |
| Establishment Number: | 3002636527 |
| Date of preparation: | 29 May, 2020 |
II. Device Information
| Trade name: | MatriDerm |
|---|---|
| Common name: | Collagen-elastin wound matrix |
| Classification name: | Dressing, Wound, Collagen |
| Product code: | KGN |
| 510(k) Number: | K201577 |
| Device class: | Unclassified |
lll. Predicate device
| Trade name: | PriMatrix Dermal Repair Scaffold |
|---|---|
| Classification name: | Dressing, Wound, Collagen |
| Product Code: | KGN |
| 510(k) Number: | K153690 |
| Device Class: | Unclassified |
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IV. Reference device
| Trade name: | HYCURE |
|---|---|
| Classification name: | Dressing, Wound, Collagen |
| Product Code: | KGN |
| 510(k) Number: | K955506 |
| Device Class: | Unclassified |
V. Device description
MatriDerm is a single-use three-dimensional acellular dermal matrix composed of bovine collagen fibers and bovine elastin. The device is supplied sterile and is available in different sizes providing flexibility of choice based on the treatment protocol, wound location, size and depth. The device can be cut to fit the wound.
Indications for Use:
MatriDerm is indicated for the management of wounds including full thickness wounds, chronic wounds (e.g. pressure ulcers, diabetic ulcers, chronic ulcers), surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), partial thickness burns, trauma wounds (abrasions and skin tears), draining wounds.
VI. Comparison of Technological Characteristics
MatriDerm is a single-use three-dimensional dermal matrix composed of bovine collagen fibers and bovine elastin. The device is provided in sheet form, supplied sterile and is available in different sizes, indicated for the management of wounds. MatriDerm provides a moist wound healing environment and a scaffold that allows for wound healing. MatriDerm differs from the predicate with respect to the bovine elastin hydrolysate and different source of bovine dermis for collagen.
| | MatriDerm
K201577
(Subject device) | PriMatrix Dermal Repair
Scaffold
K153690
(Predicate) |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KGN | KGN |
| Indications for
Use | Partial and full thickness
wounds | Partial and full thickness
wounds |
| MatriDerm
K201577
(Subject device) | PriMatrix Dermal Repair
Scaffold
K153690
(Predicate) | |
| Chronic wounds (e.g.
pressure ulcers, venous
ulcers, diabetic ulcers,
chronic ulcers) | Pressure, diabetic, and
venous ulcers | |
| Partial thickness burns | Second-degree burns | |
| Surgical wounds (donor
sites/grafts, post-Moh's
surgery, post-laser surgery,
podiatric, wound
dehiscence) | Surgical wounds (donor
sites/grafts, post-Moh's
surgery, post-laser surgery,
podiatric, wound dehiscence) | |
| Trauma wounds
(abrasions, lacerations and
skin tears) | Trauma wounds (abrasions,
lacerations, and skin tears) | |
| Draining wounds | Tunneled/undermined wounds | |
| | Draining wounds | |
| Rx or OTC | Rx | Rx |
| Primary function | Provide a moist wound
healing environment
Provide a scaffold that
allows for wound healing | Provide a moist wound
healing environment
Provide a scaffold that allows
for wound healing |
| Intended patient
population | Patients with wounds
described in the Intended
Use statement | Patients with wounds
described in the Intended Use
statement |
| Intended Users | Qualified care professionals | Qualified care professionals |
| Operational
environment | Health care environment | Health care environment |
| Procedure steps | Cleanse the wound
Cut dressing to fit
Apply dressing
Apply suitable secondary
coverage | Cleanse the wound
Cut dressing to fit
Apply dressing
Apply suitable secondary
coverage |
| Material | Collagen ( $\geq$ 95,8% (w/w))
(collagen type I, III, V)
Elastin ( $\geq$ 1.8% (w/w))
Not crosslinked | Collagen
Not crosslinked |
| Collagen Source | Bovine dermis | Fetal bovine dermis |
| Elastin Source | Bovine ligamentum nuchae | Not added |
| | MatriDerm
K201577
(Subject device) | PriMatrix Dermal Repair
Scaffold
K153690
(Predicate) |
| Color | White | White |
| Sterilization | Terminally sterilized by
gamma irradiation | Terminally sterilized by
ethylene oxide |
| Structure | Collagen pad | Collagen pad |
| Size | 3.7cm x 5.2cm x 0.1cm
5.2cm x 7.4cm x 0.1cm
10.5cm x 14.8 cm x 0.1cm
10.5cm x 14.8 cm x 0.2cm
21.0cm x 29.7cm x 0.1cm
21.0cm x 29.7cm x 0.2cm | 8cm x 8cm
8cm x 8cm Fenestrated
8cm x 8cm Meshed
8cm x 12cm
8cm x 12cm Meshed
10cm x 12cm
10cm x 25cm
10cm x 25cm Meshed
20cm x 25cm |
| Adaptable | Yes, can be trimmed in dry
or wet state to meet the
individual patient's needs | Yes, can be trimmed in dry or
wet state to meet the
individual patient's needs |
| Shelf-life | 60 months | 60 months |
| Biocompatible | Yes, ISO 10993-1 | Yes, ISO 10993-1 |
| Biodegradable | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Absorbency | 22.8 g/g
11.77 g/100cm² | 3.45 g/g
7.82 g/100cm² |
| Time to full
absorbency | 21 seconds | 16 seconds |
| Virus Inactivation | Compliant with ISO 22442
and FDA Guidance on
Medical Device Containing
Materials from Derived
Animal Sources (Except for
In Vitro Diagnostics | performed |
The table below summarizes the similarities and differences:
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Overall, the differences in technological characteristics of the subject and predicate device do not raise any different questions of safety and effectiveness.
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Image /page/7/Picture/0 description: The image shows the logo for Medskin Solutions. The logo features the words "medskin solutions" in a light gray, sans-serif font. Above the words is a graphic of a cluster of small circles arranged in a curved, grid-like pattern. Below the words "medskin solutions" is the text "DR. SUWELACK" in a smaller, light gray font.
VII. Performance Test Data
Biocompatibility
MatriDerm was determined to be biocompatible based on ISO 10993-1 and "FDA General Guidance on Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process." Based on the intended use of MatriDerm, the device is classified according to ISO 10993-1 as a surface device with permanent (>30 days) contact with breached, compromised surfaces. Following biological endpoints were considered for the biological safety of MatriDerm: physical and chemical characterization, cytotoxicity, sensitization or intracutaneous reactivity, acute systemic toxicity, subchronic and subacute toxicity, implantation, chronic toxicity, carcinogenicity, material-mediated pyrogenicity. The recommended tests were successfully performedlevaluated on final, finished and sterile subject device is considered to be biocompatible.
Bench
- Fluid absorbency
- Sterilization Validation
- . Bacterial Endotoxin
- . Viral Inactivation
- . Device Characterization
Clinical
Human Repeat Insult Patch Testing (HRIPT) and Skin Prick Testing (SPT) were performed to demonstrate MatriDerm is non irritating and non-immunogenic. In 60 subjects, the HRIPT demonstrated MatriDerm was not irritating or immunogenic for a type 4/delayed type hypersensitivity. In the Skin Prick Testing, 1 out of the 22 subjects had a positive wheal response at the 15 minute time point in the positive control site, negative control site, and the product test site. The product test site wheal was bigger than the negative control and about the same size as the positive control. At the 6 hour and 1-2 day time points, all sites were negative. The Skin Prick Testing demonstrated MatriDerm has a low immunogenic potential.
VIII. Conclusion on substantial equivalence
The technological characteristics of the proposed device are similar to the predicate. Performance of the device is not impacted by the different source of bovine dermis for collagen and addition of hydrolyzed elastin. The conclusions drawn from the data included in this submission demonstrate that MatriDerm is as safe, as effective and is substantially equivalent to the predicate device in indication for use, mechanism of action, performance, animal derived collagen, and biocompatibility.