(31 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the material properties and physical characteristics of the wound matrix, with no mention of AI or ML.
Yes
The device is intended for the "management of wounds," which is a therapeutic purpose. It provides a "protective environment for wound healing" and aids in the repair of various types of wounds.
No
The device description clearly states it is an "acellular wound dressing" and its function is to provide a "protective environment for wound healing," indicating a therapeutic rather than diagnostic purpose.
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.
Based on the provided information, the Miro3D Wound Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description details a "sterile, single use, non-crosslinked acellular wound dressing" derived from porcine liver tissue. This is a therapeutic device applied to the body, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Anatomical Site: The anatomical site is "Wounds," which is a location on the body where the device is applied, not a source of a sample for analysis.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Miro3D Wound Matrix is a therapeutic device used to aid in wound healing.
N/A
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, partial thickness 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)
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
Key Results: Performance testing provides evidence the Miro3D device is MR Safe.
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.
Miro3D Wound Matrix, K221520
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
N/A
0
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
1
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
2
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.
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
4
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 For
Use | The Miro3D Wound Matrix is
intended for the management of
wounds including: | The Miro3D is intended for the
management 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 thickness
burns, and skin tears)
• Draining wounds
• Surgical wounds (donor
sites/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 (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) | 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) |
| 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 | Rehydrate a minimum of five
minutes in either sterile saline or
lactated Ringer's solution; cut/trim
the wound matrix to fit wound |
| Feature | Miro3D Wound Matrix
(Subject Device) | MiroDerm Wound Matrix
(Predicate Device) |
| 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 dry in a PETG plastic tray and snap-on lid with Tyvek lid seal Sterile barrier: Aluminum laminate foil pouch Shelf box: Cardboard |
| MR
Compatibility | MR Safe | MR Not Evaluated |
| Shelf Life | 25 months (as of this submission
date; real-time aging will continue
to support 3-year shelf life) | 25-months based on real-time aging
test results (was 18 months at the
time of K221520 submission) |
| Storage
Conditions | No special storage conditions
required | No special storage conditions
required |
Table 1: Subject Miro3D vs. Predicate MiroDerm
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6
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination:
-
- 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
7
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).