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.

AI/ML Overview

The provided FDA 510(k) summary for the Miro3D Wound Matrix does not describe a study that uses AI/ML or involves human readers interpreting diagnostic images. Instead, it describes a medical device, a wound matrix, and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them as related to AI/ML or human interpretation of images. The document exclusively details the bench testing and animal study for a physical wound care device, not a diagnostic or AI-driven system.

However, I can extract the acceptance criteria and study findings related to the Miro3D Wound Matrix's physical and biological performance, as described in the provided text.

Acceptance Criteria and Study for Miro3D Wound Matrix (Non-AI/ML Device)

Based on the provided 510(k) summary for the Miro3D Wound Matrix, the acceptance criteria and supporting studies are focused on demonstrating the device's physical properties, biocompatibility, and performance in wound healing, compared to a predicate device. This is not an AI/ML diagnostic or image interpretation study.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implicit from comparability)	Reported Device Performance and Study Findings
Intended Use	Same as predicate (Wound management: providing a protective environment for wound healing)	The Miro3D Wound Matrix has the same Intended Use as the predicate MiroDerm Wound Matrix.
Material/Chemical Composition	Same as predicate (Perfusion-decellularized porcine liver)	"The devices have the same material/chemical composition..."
Principle of Operation	Same as predicate (Provide a protective environment for wound healing)	"The devices have the same... principle of operation..."
Clinical Use	Same as predicate	"The devices have the same... clinical use..."
Biocompatibility	Meets ISO 10993 standards for relevant biological endpoints (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Implantation, Subacute Systemic Toxicity, Subchronic Systemic Toxicity, Genotoxicity)	"Biocompatibility testing or justification for all applicable biological endpoints per ISO 10993-1:2018 were completed." (Specific results not detailed but implied adherence to standards).
Sterilization Assurance Level (SAL)	10^-6	Reported as 10^-6 for e-beam irradiation.
Viral Inactivation	Manufacturing process capable of inactivating four viruses.	"Manufacturing process is capable of inactivating four viruses."
Package Stability	Meets specified ASTM and ISO standards (ASTM F988-09, ASTM F2096, ISO 11607-1:2019, ASTM F2825-18, ASTM D4169-16, and ASTM F2096-11).	Package Stability Testing was conducted and presumably met the standards, allowing for the stated shelf life.
Product Testing (Bench)	Meets established specifications for: - Collagen denaturation temperature - Mechanical properties - Dimensions - Rehydration properties - Residual detergent - Residual DNA - Bacterial endotoxin - Viral inactivation	The listed bench tests were conducted. The implication is that the results demonstrated the device's conformance to its specifications and comparability to the predicate.
Wound Healing Performance (Animal Study)	Comparable performance to predicate device (MiroDerm) in a porcine full-thickness wound healing model.	"The study results indicated that Miro3D performed comparably to MiroDerm in all aspects evaluated."
Shelf Life	Ability to support 18 months shelf life (initial), with real-time aging supporting 3 years.	"18 months (as of this submission date; real-time aging will continue to support 3 year shelf life)"

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set (Animal Study): A "GLP compliant animal study to evaluate Miro3D compared to MiroDerm on healing of porcine full thickness wounds" was conducted. The specific sample size (number of animals or wounds) is not explicitly stated in the provided text.
Data Provenance: The animal study was "GLP compliant," implying a controlled laboratory setting. The country of origin is not specified but given the FDA submission, it would typically be conducted in a country adhering to GLP standards (e.g., U.S. or equivalent). The study was prospective in nature, as it intentionally compared the subject device to the predicate in a living model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The "ground truth" for this device's performance was established through objective laboratory testing (bench tests) and direct biological observation/measurement in an animal model, not through expert radiological or diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable as there were no human readers interpreting data that required adjudication. The animal study would have involved histological, photographic, and perhaps gross morphological assessments, likely by qualified veterinary pathologists or researchers, but no "adjudication method" in the sense of reconciling human reader disagreements on diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human interpretation of diagnostic images. The Miro3D Wound Matrix is a physical medical device, not a diagnostic AI system.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. There is no algorithm or AI model being evaluated for standalone performance.

7. The Type of Ground Truth Used

For Bench Testing: The ground truth was based on objective measurement against predefined specifications (e.g., specific values for residual DNA, collagen analysis, dimensions, endotoxin levels) and adherence to industry standards (e.g., ISO, ASTM).
For Animal Study (Proxy for in vivo performance): The ground truth was established through direct observation and measurement of wound healing parameters in the porcine model, comparing the subject device (Miro3D) against the predicate (MiroDerm). This would involve histological analysis, macroscopic assessment of wound closure, and potentially other biomarkers, confirmed by veterinary professionals.

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound matrix, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML algorithm, there is no training set or associated ground truth establishment process in this context.

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 julie.morabito@fda.hhs.gov.

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 (1-800-638-2041 or 301-796-7100).

Sincerely,

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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

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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	Miro3DWound Matrix(Subject Device)	MiroDermWound 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 ForUse	The Miro3D Wound Matrix isintended for the management ofwounds including:	The Miromatrix Wound Matrixis intended for the managementof wounds including:
Feature	Miro3DWound Matrix(Subject Device)	MiroDermWound Matrix(Predicate Device)
	• Partial and full thicknesswounds• Pressure ulcers• Venous ulcers• Chronic vascular ulcers• Diabetic ulcers• Tunneled, undermined wounds• Trauma wounds (abrasions,lacerations, second-degreeburns, and skin tears)• Draining wounds• Surgical wounds (donorsites/grafts, post-Mohs'surgery, post-laser surgery,podiatric, wound dehiscence)	• Partial and full thicknesswounds• Pressure ulcers• Venous ulcers• Chronic vascular ulcers• Diabetic ulcers• Tunneled, undermined wounds• Trauma wounds (abrasions,lacerations, second-degreeburns, and skin tears)• Draining wounds• Surgical wounds (donorsites/grafts, post-Mohs'surgery, post-laser surgery,podiatric, wound dehiscence)
Type of Use	Wound management	Wound management
User	Physician or other cliniciantrained in wound care	Physician or other cliniciantrained in wound care
Intended UseEnvironment	Surgical suite, hospital,ambulatory surgery center orout-patient clinic	Surgical suite, hospital,ambulatory surgery center orout-patient clinic
Description	Animal-sourced, non-crosslinked, acellular collagentissue matrix	Animal-sourced, non-crosslinked, acellular collagentissue matrix
Principle ofOperation	Provide a protectiveenvironment for woundhealing	Provide a protectiveenvironment for woundhealing
Material	Perfusion-decellularizedporcine liver	Perfusion-decellularizedporcine liver
Resorbable	Yes	Yes
Configuration	Three-dimensional collagenscaffold 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 innine sizes (W x L), thicknessranging 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	Miro3DWound Matrix(Subject Device)	MiroDermWound 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 MatrixPreparation	Rehydrate a minimum of fiveminutes in either sterile saline orlactated Ringer's solution;cut/trim the wound matrix to fitwound	Soak for two minutes in eithersterile saline or lactated Ringer'ssolution; cut/trim wound matrixto fit wound
Single Use orReusable	Single Use	Single Use
SterilizationMethod	Electron beam irradiation	Electron beam irradiation
SterilizationAssurance 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 submissiondate; real-time aging willcontinue to support 3 year shelflife)	3 years
StorageConditions	No special storage conditionsrequired	No special storage conditionsrequired
Biocompatibility	Biocompatibility testing orjustification for all applicable	Biocompatibility testing orjustification for all applicable
Feature	Miro3DWound Matrix(Subject Device)	MiroDermWound Matrix(Predicate Device)
	biological endpoints per ISO10993-1:2018 were completed	biological endpoints per ISO10993-1:2009 were completed
ViralInactivation	Manufacturing process iscapable of inactivating fourviruses	Manufacturing process iscapable of inactivating fourviruses
Bench Testing	The following tests wereconducted:● Residual DNA● Collagen analysis● Endotoxin● Expiration dating● Residual detergent● Dimensions● Rehydration	The following tests wereconducted:● Residual DNA● Collagen analysis● Endotoxin● Expiration dating● Residual detergent
Animal WoundHealing Study	GLP Study to evaluate Miro3Dcompared to MiroDerm as acontrol article in a porcine fullthickness 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
- 1. Mechanical testing Dimensional
- 1. Rehvdration
- 1. Residual detergent
- 1. Residual DNA
- 1. Bacterial endotoxin testing, ST72:2019
- 1. 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).

Regulation Number and Section

N/A