Partial and full thickness wounds
Pressure ulcers
Venous ulcers
Chronic vascular ulcers
Diabetic ulcers
Tunneled, undermined wounds
Trauma wounds (abrasions, lacerations, partial thickness 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

This document describes the regulatory submission for the Miro3D Wound Matrix, a medical device. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.

The provided text does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

Instead, this document is a 510(k) summary for a biomedical device (wound matrix) that is based on animal-derived tissue. The key points from the provided text are:

Device: Miro3D Wound Matrix (a sterile, single-use, non-crosslinked acellular wound dressing derived from porcine liver tissue).
Purpose of Submission (K223257): To add MR Safe information and symbols to the labeling of the existing Miro3D Wound Matrix.
Predicate Device: Miro3D Wound Matrix (K221520), which is explicitly stated to be the identical product to the subject device, with the only difference being the labeling for MR Safe information.
Performance Data: The performance data provided are specifically related to MR (Magnetic Resonance) testing to support the "MR Safe" claim. This includes adherence to ASTM standards for MR image artifacts, magnetically induced displacement force, magnetically induced torque, radio frequency induced heating, and marking for safety in the MR environment.
No AI/ML Component: There is no mention of any AI or machine learning component in the device or its intended use. The performance data and acceptance criteria relate solely to the physical and material properties of the wound matrix, particularly its compatibility with MRI.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the input document is not about an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 21, 2022

Reprise Biomedical % Kathy Herzog Sr. Regulatory, Quality, and Compliance Consultant DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402

Re: K223257

Trade/Device Name: Miro3D Wound Matrix Regulatory Class: Not Classified Product Code: KGN Dated: October 21, 2022 Received: October 21, 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

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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 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 (QS) 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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K223257

Device Name Miro3D Wound Matrix

Indications for Use (Describe) 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
Pressure ulcers
Venous ulcers
· Chronic vascular ulcers
· Diabetic ulcers
· Tunneled, undermined wounds
· Trauma wounds (abrasions, lacerations, partial thickness 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)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K223257

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

Contact Person: Carrie Powers 763-284-6780 cpowers@reprisebio.com

Date Prepared: November 17, 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

Miro3D Wound Matrix, K221520 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

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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.

INDICATIONS FOR USE V.

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The subject and predicate Miro3D Wound Matrix are identical product. The only difference is the labeling for the subject device includes MR Safe information and symbols. This modification does not change the intended use or the technological characteristics of the device.

Feature	Miro3D Wound Matrix(Subject Device)	MiroDerm Wound Matrix(Predicate Device)
K Number	K223257	K221520
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 Miro3D is intended for themanagement of wounds including:• Partial and full thickness wounds
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, partial thicknessburns, and skin tears)• Draining wounds• Surgical wounds (donorsites/grafts, post-Mohs' surgery,post-laser surgery, podiatric,wound dehiscence)	• 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 (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 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 ofOperation	Provide a protective environmentfor wound healing	Provide a protective environmentfor wound healing
Material	Perfusion-decellularized porcineliver	Perfusion-decellularized porcineliver
Resorbable	Yes	Yes
Configuration	Three-dimensional collagenscaffold provided in four sizes (Wx L), all 2 cm thickness (ModelNumber)• 2 cm x 2 cm (3000)• 3 cm x 3 cm (3005)• 5 cm x 5 cm (3010)• 10 cm x 5 cm (3015)	Three-dimensional collagenscaffold provided in four sizes (Wx L), all 2 cm thickness (ModelNumber)• 2 cm x 2 cm (3000)• 3 cm x 3 cm (3005)• 5 cm x 5 cm (3010)• 10 cm x 5 cm (3015)
Wound MatrixPreparation	Rehydrate a minimum of fiveminutes in either sterile saline orlactated Ringer's solution; cut/trimthe wound matrix to fit wound	Rehydrate a minimum of fiveminutes in either sterile saline orlactated Ringer's solution; cut/trimthe wound matrix to fit wound
Feature	Miro3D Wound Matrix(Subject Device)	MiroDerm Wound Matrix(Predicate Device)
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 dry in a PETG plastic tray and snap-on lid with Tyvek lid seal Sterile barrier: Aluminum laminate foil pouch Shelf box: Cardboard
MRCompatibility	MR Safe	MR Not Evaluated
Shelf Life	25 months (as of this submissiondate; real-time aging will continueto support 3-year shelf life)	25-months based on real-time agingtest results (was 18 months at thetime of K221520 submission)
StorageConditions	No special storage conditionsrequired	No special storage conditionsrequired

Table 1: Subject Miro3D vs. Predicate MiroDerm

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PERFORMANCE DATA VII.

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

1. MR Testing was completed in compliance with the following FDA-recognized consensus standards:
- ASTM F2119-07 (Reapproved 2013): Standard Test Method for Evaluation of . MR Image Artifacts from Passive Implants
- ASTM F2052-21: Standard Test Method for Measurement of Magnetically . Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- . ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2182-19e2: Standard Test Method for Measurement of Radio Frequency ● Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- . ASTM F2503-20: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

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Shelf-life/stability, performance testing, and biocompatibility end points evaluation were leveraged from the predicate device since there is no change in the materials and manufacturing processes except the addition of MR safe labeling.

CONCLUSIONS VIII.

The subject Miro3D Wound Matrix has the same intended use as the predicate Miro3D Wound Matrix to provide a protective environment for wound healing. The subject and predicate devices are the same product and thus have the same technological characteristics as the modification to labeling to add MR Safe language and symbols does not change the intended use, indications for use, or technological characteristics of the device. Performance testing provides evidence the Miro3D device is MR Safe. Therefore, the subject device, Miro3D Wound Matrix is as safe, and as effective, as the predicate Miro3D Wound Matrix (K221520).

Regulation Number and Section

N/A