(210 days)
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
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.
This document describes the MatriDerm device, a collagen-elastin wound matrix, and its substantial equivalence to a predicate device (PriMatrix Dermal Repair Scaffold). The information provided focuses on the device's characteristics and safety testing rather than a comparative effectiveness study with AI assistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with specific numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the MatriDerm device to a legally marketed predicate device (PriMatrix Dermal Repair Scaffold) and referencing successful completion of standard biological and bench tests.
However, based on the Performance Test Data section, we can infer some criteria and reported performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility | MatriDerm was determined to be biocompatible based on ISO 10993-1 and FDA Guidance. Evaluated biological endpoints included 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 performed/evaluated on the final, finished, and sterile subject device. |
| Fluid Absorbency | MatriDerm: 22.8 g/g, 11.77 g/100cm² |
| Time to Full Absorbency | MatriDerm: 21 seconds |
| Sterilization Validation | Successfully validated (terminally sterilized by gamma irradiation). |
| Bacterial Endotoxin | No specific value reported, but "successfully performed/evaluated" implies meeting acceptable limits. |
| Viral Inactivation | Compliant with ISO 22442 and FDA Guidance on Medical Device Containing Materials from Derived Animal Sources (Except for In Vitro Diagnostics). |
| Device Characterization | Successfully completed. |
| Irritation/Immunogenicity (Clinical) | Human Repeat Insult Patch Testing (HRIPT): In 60 subjects, MatriDerm was not irritating or immunogenic for a type 4/delayed type hypersensitivity. Skin Prick Testing (SPT): One out of 22 subjects had a positive wheal response at 15 minutes (product test site wheal was bigger than negative control and about the same size as positive control). At 6 hours and 1-2 day time points, all sites were negative, demonstrating a low immunogenic potential. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility: The text states "recommended tests were successfully performed/evaluated on final, finished and sterile subject device." It does not specify sample sizes for each individual biocompatibility test (e.g., cytotoxicity, implantation), nor the provenance of the data.
- Clinical (HRIPT): 60 subjects.
- Clinical (SPT): 22 subjects.
- Data Provenance: The document does not specify the country of origin for the clinical study data or if it was retrospective or prospective. It is implied to be prospective for HRIPT and SPT as these are typically conducted specifically for regulatory submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The evaluations for MatriDerm are primarily based on laboratory testing (biocompatibility, bench tests) and human clinical tests (HRIPT, SPT) that assess biological responses or physical properties, not expert interpretations of images or clinical cases that require "ground truth" establishment in the context of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the studies described (biocompatibility, bench, and clinical skin tests) do not involve expert adjudication methods typically used in diagnostic assessment studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a wound dressing, not a diagnostic AI system, and therefore does not involve human readers or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as MatriDerm is a medical device (wound matrix) and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically defined for diagnostic device evaluation (e.g., pathology for cancer diagnosis) is not directly applicable here. For MatriDerm, the "truth" is established by:
- Biocompatibility: Adherence to ISO standards and FDA guidance, with confirmation through specific biological tests.
- Bench tests: Measurements against material specifications and validated test methods.
- Clinical (HRIPT/SPT): Direct physiological responses in human subjects (e.g., presence/absence of irritation, wheal formation), observed and documented by qualified personnel (not specified in detail, but standard for such clinical tests).
8. The sample size for the training set
This question is not applicable as MatriDerm is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as MatriDerm is a physical medical device, not a machine learning algorithm.
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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
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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 AGJosef-Suwelack-Strasse 248727 Billerbeck / Germany |
|---|---|
| Contact Person: | Zuzana HülsbuschSenior Regulatory Affairs SpecialistPhone: 0049 2543 21820Fax: 0049 2543 2182-150E-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.
| MatriDermK201577(Subject device) | PriMatrix Dermal RepairScaffoldK153690(Predicate) | |
|---|---|---|
| Product Code | KGN | KGN |
| Indications forUse | Partial and full thicknesswounds | Partial and full thicknesswounds |
| MatriDermK201577(Subject device) | PriMatrix Dermal RepairScaffoldK153690(Predicate) | |
| Chronic wounds (e.g.pressure ulcers, venousulcers, diabetic ulcers,chronic ulcers) | Pressure, diabetic, andvenous ulcers | |
| Partial thickness burns | Second-degree burns | |
| Surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric, wounddehiscence) | Surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric, wound dehiscence) | |
| Trauma wounds(abrasions, lacerations andskin 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 woundhealing environmentProvide a scaffold thatallows for wound healing | Provide a moist woundhealing environmentProvide a scaffold that allowsfor wound healing |
| Intended patientpopulation | Patients with woundsdescribed in the IntendedUse statement | Patients with woundsdescribed in the Intended Usestatement |
| Intended Users | Qualified care professionals | Qualified care professionals |
| Operationalenvironment | Health care environment | Health care environment |
| Procedure steps | Cleanse the woundCut dressing to fitApply dressingApply suitable secondarycoverage | Cleanse the woundCut dressing to fitApply dressingApply suitable secondarycoverage |
| Material | Collagen ( $\geq$ 95,8% (w/w))(collagen type I, III, V)Elastin ( $\geq$ 1.8% (w/w))Not crosslinked | CollagenNot crosslinked |
| Collagen Source | Bovine dermis | Fetal bovine dermis |
| Elastin Source | Bovine ligamentum nuchae | Not added |
| MatriDermK201577(Subject device) | PriMatrix Dermal RepairScaffoldK153690(Predicate) | |
| Color | White | White |
| Sterilization | Terminally sterilized bygamma irradiation | Terminally sterilized byethylene oxide |
| Structure | Collagen pad | Collagen pad |
| Size | 3.7cm x 5.2cm x 0.1cm5.2cm x 7.4cm x 0.1cm10.5cm x 14.8 cm x 0.1cm10.5cm x 14.8 cm x 0.2cm21.0cm x 29.7cm x 0.1cm21.0cm x 29.7cm x 0.2cm | 8cm x 8cm8cm x 8cm Fenestrated8cm x 8cm Meshed8cm x 12cm8cm x 12cm Meshed10cm x 12cm10cm x 25cm10cm x 25cm Meshed20cm x 25cm |
| Adaptable | Yes, can be trimmed in dryor wet state to meet theindividual patient's needs | Yes, can be trimmed in dry orwet state to meet theindividual 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/g11.77 g/100cm² | 3.45 g/g7.82 g/100cm² |
| Time to fullabsorbency | 21 seconds | 16 seconds |
| Virus Inactivation | Compliant with ISO 22442and FDA Guidance onMedical Device ContainingMaterials from DerivedAnimal Sources (Except forIn 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.
N/A