Miro3D Wound Matrix

• K Number: K221520
• Device Name: Miro3D Wound Matrix
• Manufacturer: Reprise Biomedical, Inc.
• Date Cleared: 2022-08-18 ( 85 days)
• Product Code: KGN
• Regulation Number: N/A

Intended Use

The Miro3D Wound Matrix is intended for the management of wounds including: - Partial and full thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Tunneled, undermined wounds - Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - Draining wounds - Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

Device Description

The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

Predicate Devices

K140510

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the biological and structural properties of the wound matrix, and there are no mentions of AI, ML, image processing, or related concepts.

Therapeutic

Yes
The device is intended for the management and healing of various types of wounds, indicating a therapeutic purpose.

Diagnostic

No

The device description clearly states it is a "wound dressing" and a "porous scaffold" intended for wound management and healing, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use, non-crosslinked acellular wound dressing derived from porcine liver tissue, which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Miro3D Wound Matrix is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves applying a dressing to a wound to aid in healing, which is a therapeutic intervention, not a diagnostic test.
• Device Description: The description details a physical wound dressing derived from porcine liver tissue. It's a scaffold designed to provide a protective environment for wound healing. This is a physical device applied externally.
• Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status or disease. IVDs are used to perform tests on samples to diagnose, monitor, or screen for conditions.

In summary, the Miro3D Wound Matrix is a therapeutic device used for wound management, not a diagnostic device used for testing samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
The Miro3D Wound Matrix is intended for the management of wounds including:
- Partial and full thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Tunneled, undermined wounds
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- Draining wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

# Product codes (comma separated list FDA assigned to the subject device)
KGN

# Device Description
The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

# 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
User: Physician or other clinician trained in wound care
Intended Use Environment: Surgical suite, hospital, ambulatory surgery center or out-patient clinic

# 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)
1. Biocompatibility Testing:
    - Cytotoxicity, ISO 10993-5:2009
    - Sensitization, ISO 10993-10:2010
    - Intracutaneous Reactivity, ISO 10993-10:2010
    - Acute Systemic Toxicity, ISO 10993-11: 2017
    - Material Mediated Pyrogenicity, ISO 10993-11:2017
    - Implantation, ISO 10993-6:2016
    - Subacute Systemic Toxicity, ISO 10993-11:2017
    - Subchronic Systemic Toxicity, ISO 10993-11:2017
    - Genotoxicity (Ames Bacterial Reverse Mutation and Mouse Lymphoma), ISO 10993-3:2014
2. Bench Testing:
    - Package Stability Testing, ASTM F988-09, ASTM F2096, ISO 11607-1:2019, ASTM F2825-18, ASTM D4169-16, and ASTM F2096-11
    - Product Testing:
        - Collagen denaturation temperature, ASTM D3418
        - Mechanical testing Dimensional
        - Rehvdration
        - Residual detergent
        - Residual DNA
        - Bacterial endotoxin testing, ST72:2019
        - Viral inactivation
3. Animal Wound Healing Study: GLP Study to evaluate Miro3D compared to MiroDerm as a control article in a porcine full thickness wound healing model. The study results indicated that Miro3D performed comparably to MiroDerm in all aspects evaluated.

# 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.
[K140510](https://510k.innolitics.com/search/K140510)

# 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.
No reference devices were used in this submission.

# 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

Regulation Number and Section

N/A

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 25, 2022

Reprise Biomedical, Inc. Kathy Herzog Regulatory Consultant 17400 Medina Road Suite 100 Plymouth, Minnesota 55447

Re: K221520

Trade/Device Name: Miro3D Wound Matrix Regulatory Class: Not Classified Product Code: KGN

Dear Kathy Herzog:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction to include the 510k Summary document for K221520, as it was inadvertently excluded from our August 18, 2022 SE Letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-247-6328 or at [e-mail].

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director 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

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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2022

Reprise Biomedical, Inc. Kathy Herzog Regulatory Consultant 17400 Medina Road Suite 100 Plymouth, Minnesota 55447

Re: K221520

Trade/Device Name: Miro3D Wound Matrix Regulatory Class: Not Classified Product Code: KGN Dated: Mav 24, 2022 Received: May 25, 2022

Dear Kathy Herzog:

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

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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 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 mediation-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 [phone] or 301-796-7100).

Sincerely,

Julie Morabito, Ph.D. Assistant Director 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221520

Device Name Miro3D Wound Matrix

Indications for Use (Describe)

The Miro3D Wound Matrix is intended for the management of wounds including:

• · Partial and full thickness wounds
• · Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• · Diabetic ulcers
• Tunneled, undermined wounds
• · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• · Draining wounds
• · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

Type of Use (Select one or both, as applicable) | Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

I. SUBMITTER

Reprise Biomedical, Inc. 17400 Medina Road, Suite 100 Plymouth, MN 55447 763-284-6795

Contact Person: Carrie Powers Date Prepared: August 18, 2022

II. DEVICE

Trade/Proprietary Names:	Miro3D Wound Matrix
Common Name:	Animal-derived, extracellular matrix wound care product
Regulation Number:	Unclassified
Regulation Name:	NA
Device Class:	Unclassified
Product Code:	KGN
Panel:	General & Plastic Surgery

III. PREDICATE DEVICE

MiroDerm Wound Matrix (also known as Miromatrix Wound Matrix), K140510 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

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V. INDICATIONS FOR USE

The Miro3D Wound Matrix is indicated for the following:

The Miro3D Wound Matrix is intended for the management of wounds including:

• Partial and full thickness wounds o
• o Pressure ulcers
• Venous ulcers o
• Chronic vascular ulcers ●
• Diabetic ulcers ●
• Tunneled, undermined wounds ●
• Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• Draining wounds o
• . Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Miro3D Wound Matrix is the dry, uncompressed version of MiroDerm which is supplied as a wet, compressed flat sheet. The subject and predicate devices have the same technological characteristics as the change in configuration does not change the Intended Use or fundamental scientific technology of the collagen matrix for wound management. No new device materials or manufacturing materials are introduced with the Miro3D as compared to MiroDerm. The devices have the same material/chemical composition, principle of operation, clinical use, biocompatibility, and sterilization. The device packaging materials for Miro3D (PETG and Tyvek) are commonly used in the medical device industry with a long history of safe use.

| Feature | Miro3D
Wound Matrix
(Subject Device) | MiroDerm
Wound Matrix
(Predicate Device) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K221520 | K140510 |
| Classification | Unclassified (pre-amendment) | Unclassified (pre-amendment) |
| Product Code | KGN | KGN |
| Class | II | II |
| Intended Use | Wound management | Wound management |
| Indications For
Use | The Miro3D Wound Matrix is
intended for the management of
wounds including: | The Miromatrix Wound Matrix
is intended for the management
of wounds including: |
| Feature | Miro3D
Wound Matrix
(Subject Device) | MiroDerm
Wound Matrix
(Predicate Device) |
| | • Partial and full thickness
wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Tunneled, undermined wounds
• Trauma wounds (abrasions,
lacerations, second-degree
burns, and skin tears)
• Draining wounds
• Surgical wounds (donor
sites/grafts, post-Mohs'
surgery, post-laser surgery,
podiatric, wound dehiscence) | • Partial and full thickness
wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Tunneled, undermined wounds
• Trauma wounds (abrasions,
lacerations, second-degree
burns, and skin tears)
• Draining wounds
• Surgical wounds (donor
sites/grafts, post-Mohs'
surgery, post-laser surgery,
podiatric, wound dehiscence) |
| Type of Use | Wound management | Wound management |
| User | Physician or other clinician
trained in wound care | Physician or other clinician
trained in wound care |
| Intended Use
Environment | Surgical suite, hospital,
ambulatory surgery center or
out-patient clinic | Surgical suite, hospital,
ambulatory surgery center or
out-patient clinic |
| Description | Animal-sourced, non-
crosslinked, acellular collagen
tissue matrix | Animal-sourced, non-
crosslinked, acellular collagen
tissue matrix |
| Principle of
Operation | Provide a protective
environment for wound
healing | Provide a protective
environment for wound
healing |
| Material | Perfusion-decellularized
porcine liver | Perfusion-decellularized
porcine liver |
| Resorbable | Yes | Yes |
| Configuration | Three-dimensional collagen
scaffold provided in four sizes
(W x L), all 2 cm thickness
(Model Number)
• 2 cm x 2 cm (3000)
• 3 cm x 3 cm (3005)
• 5 cm x 5 cm (3010)
• 10 cm x 5 cm (3015) | Flat collagen sheet provided in
nine sizes (W x L), thickness
ranging from 0.3 to 1.5 mm
(Model Number):
• 2 cm x 2 cm (BLM-200-02-
0202)
• 2 cm x 3 cm (BLM-200-02-
0203)
• 3 cm x 3 cm (BLM-200-02-
0303) |
| Feature | Miro3D
Wound Matrix
(Subject Device) | MiroDerm
Wound Matrix
(Predicate Device) |
| | | 4 cm x 4 cm (BLM-200-02-0404) 3 cm x 7 cm (BLM-200-02-0307) 5 cm x 5 cm (BLM-200-02-0505) 8 cm x 8 cm (BLM-200-02-0808) 7 cm x 10 cm (BLM-200-02-0710) 8 cm x 15 cm (BLM-200-02-0815) |
| Wound Matrix
Preparation | Rehydrate a minimum of five
minutes in either sterile saline or
lactated Ringer's solution;
cut/trim the wound matrix to fit
wound | Soak for two minutes in either
sterile saline or lactated Ringer's
solution; cut/trim wound matrix
to fit wound |
| Single Use or
Reusable | Single Use | Single Use |
| Sterilization
Method | Electron beam irradiation | Electron beam irradiation |
| Sterilization
Assurance Level
(SAL) | $10^{-6}$ | $10^{-6}$ |
| Packaging | Device package: Packaged dry in a PETG plastic tray and snap-on lid with Tyvek lid seal Sterile barrier: Aluminum laminate foil pouch Shelf box: Cardboard | Device package: Packaged wet in an aluminum laminate foil pouch Sterile barrier: Aluminum laminate foil pouch Shelf box: Cardboard |
| Shelf Life | 18 months (as of this submission
date; real-time aging will
continue to support 3 year shelf
life) | 3 years |
| Storage
Conditions | No special storage conditions
required | No special storage conditions
required |
| Biocompatibility | Biocompatibility testing or
justification for all applicable | Biocompatibility testing or
justification for all applicable |
| Feature | Miro3D
Wound Matrix
(Subject Device) | MiroDerm
Wound Matrix
(Predicate Device) |
| | biological endpoints per ISO
10993-1:2018 were completed | biological endpoints per ISO
10993-1:2009 were completed |
| Viral
Inactivation | Manufacturing process is
capable of inactivating four
viruses | Manufacturing process is
capable of inactivating four
viruses |
| Bench Testing | The following tests were
conducted:
● Residual DNA
● Collagen analysis
● Endotoxin
● Expiration dating
● Residual detergent
● Dimensions
● Rehydration | The following tests were
conducted:
● Residual DNA
● Collagen analysis
● Endotoxin
● Expiration dating
● Residual detergent |
| Animal Wound
Healing Study | GLP Study to evaluate Miro3D
compared to MiroDerm as a
control article in a porcine full
thickness wound healing model | None completed |

Table 1: Subject vs. Predicate Wound Matrix Comparison

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

1. Biocompatibility Testing

• Cytotoxicity, ISO 10993-5:2009 a.
• b. Sensitization, ISO 10993-10:2010
• c. Intracutaneous Reactivity, ISO 10993-10:2010
• d. Acute Systemic Toxicity, ISO 10993-11: 2017
• e. Material Mediated Pyrogenicity, ISO 10993-11:2017
• f. Implantation, ISO 10993-6:2016
• Subacute Systemic Toxicity, ISO 10993-11:2017 g.
• h. Subchronic Systemic Toxicity, ISO 10993-11:2017
• Genotoxicity (Ames Bacterial Reverse Mutation and Mouse Lymphoma), ISO i. 10993-3:2014

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2. Bench Testing

• Package Stability Testing, ASTM F988-09, ASTM F2096, ISO 11607-1:2019, a. ASTM F2825-18, ASTM D4169-16, and ASTM F2096-11
• b. Product Testing
  • 1. Collagen denaturation temperature, ASTM D3418
  • 2. Mechanical testing Dimensional
  • 3. Rehvdration
  • 4. Residual detergent
  • 5. Residual DNA
  • 6. Bacterial endotoxin testing, ST72:2019
  • 7. Viral inactivation

In addition, Reprise Biomedical sponsored a GLP compliant animal study to evaluate Miro3D compared to MiroDerm on healing of porcine full thickness wounds. The study results indicated that Miro3D performed comparably to MiroDerm in all aspects evaluated.

MR compatibility was not evaluated.

VIII. CONCLUSIONS

The subject Miro3D Wound Matrix has the same Intended Use as the predicate MiroDerm Wound Matrix to provide a protective environment for wound healing. The subject and predicate devices have the same technological characteristics as the change in configuration (dry, uncompressed for Miro3D and wet, compressed for MiroDerm) does not change the Intended Use, chemical composition, or fundamental scientific technology of the collagen matrix for wound management. The Miro3D device packaging materials are common in the industry and do not introduce any new hazards. These modifications in configuration and device packaging materials do not raise different questions of safety and effectiveness compared to the predicate device. Performance testing provides evidence the Miro3D device performs as intended and is as safe and effective as the predicate device. Therefore, the subject Miro3D device is substantially equivalent to the predicate MiroDerm device (K140510).