(30 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the material properties and sterilization of a wound dressing, with no mention of AI or ML.
Yes.
The device is intended for the management of various types of wounds, indicating it is used for the treatment or amelioration of a disease or injury.
No
This device is a wound dressing intended for the management of various types of wounds, which is a therapeutic rather than a diagnostic function. Its description focuses on its composition and use in wound care, not on identifying or assessing a medical condition.
No
The device description clearly states it is a physical wound dressing derived from porcine liver tissue, not a software product.
Based on the provided information, the Miro3D Fibers Wound Matrix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing made from porcine liver tissue. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to provide diagnostic information.
Therefore, the Miro3D Fibers Wound Matrix falls under the category of a medical device used for wound management, not an IVD.
N/A
Intended Use / Indications for Use
The Miro3D Fibers 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 Miro3D Fibers 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 into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.
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
Physician or other clinician trained in wound care.
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)
The following performance testing was completed for the subject device:
- Package Integrity Testing
- Package and Product Stability Testing
- Collagen Denaturation
- Sterilization Validation
- Bacterial Endotoxin
The following prior testing was leveraged by equivalence to the predicate device:
- Rehydration
- Residual Sodium Dodecyl Sulfate (SDS)
- Residual DNA
- Biocompatibility
- Viral Inactivation
- MR Testing
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
April 19, 2024
Reprise Biomedical, Inc. % Kathy Herzog Sr. Regulatory, Ouality, and Compliance Consultant DuVal & Associates 1820 Medical Arts Building Suite 1820 Minneapolis, Minnesota 55402
Re: K240753
Trade/Device Name: Miro3D Fibers Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: March 19, 2024 Received: March 20, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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-regulatory-
assistance/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, Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240753
Device Name Miro3D Fibers Wound Matrix
Indications for Use (Describe)
The Miro3D Fibers 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)
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."
4
510(k) Summary
This 510(k) summary is prepared in accordance with the requirements of 21 CFR §807.92:
SUBMITTER I.
Reprise Biomedical, Inc. 17400 Medina Road, Suite 100 Plymouth, MN 55447 763-284-6795
Contact Person: Erin Badali, Regulatory Affairs Product Specialist Date Prepared: March 19, 2024
II. DEVICE
| Trade/Proprietary Names: | Miro3D Fibers Wound Matrix |
|---|---|
| Common Name: | Animal-derived, extracellular matrix wound care produc |
| Device Class: | Unclassified |
| Product Code: | KGN |
| Panel: | General & Plastic Surgery |
III. PREDICATE DEVICE
Miro3D Wound Matrix (K223257). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The Miro3D Fibers 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 into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.
V. INDICATIONS FOR USE
The Miro3D Fibers Wound Matrix is indicated for the following:
The Miro3D Fibers Wound Matrix is intended for the management of wounds including:
5
- 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)
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Miro3D Fibers Wound Matrix has the identical intended use and similar technological characteristics as the predicate Miro3D Wound Matrix. Both the subject and the predicate are made from porcine liver that is decellularized using the identical perfusion process, materials, and concentrations. For the predicate, the prepared liver is dried and cut into four rectangular cube sizes using a scalpel. For Miro3D Fibers Wound Matrix, the prepared liver is dried and cut into fibers using blender blades and is available in four sizes based on weight. The change in wound matrix configuration does not change the principle of operation of the collagen wound matrices to provide a protective environment for wound management. The predicate is packaged dry and rehydrated prior to use. The subject is also packaged dry but due to the small fiber size, the product may be used dry or rehydrated using the same solutions as used for the predicate. Miro3D Fibers Wound Matrix uses the same tray packaging material and outer foil pouch as the predicate and is sterilized by the same sterilization method, e-beam irradiation. The predicate packaging includes a Tyvek lid seal to cover notches in the tray lid, which is not required for Miro3D Fibers Wound Matrix which has a solid lid without notches.
| Feature | Miro3D Fibers Wound Matrix
(Subject Device) | Miro3D Wound Matrix
(Predicate Device) K223257 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Unclassified
(pre-amendment) | Unclassified
(pre-amendment) |
| Product Code | KGN | KGN |
| Intended Use | Wound management | Wound management |
| Indications For
Use | The Miro3D Fibers Wound Matrix is
intended for the management of
wounds including:
• Partial and full thickness wounds
• Pressure ulcers | The Miro3D Wound Matrix is intended
for the management of wounds
including:
• Partial and full thickness wounds
• Pressure ulcers |
| Table 1: Subject vs. Predicate Wound Matrix Comparison | |||
|---|---|---|---|
| Feature | Miro3D Fibers Wound Matrix | ||
| (Subject Device) | Miro3D Wound Matrix | ||
| (Predicate Device) K223257 | |||
| • Venous ulcers | • Venous ulcers | ||
| • Chronic vascular ulcers | • Chronic vascular ulcers | ||
| • Diabetic ulcers | • Diabetic ulcers | ||
| • Tunneled, undermined wounds | • Tunneled, undermined wounds | ||
| • Trauma wounds (abrasions, | |||
| lacerations, partial thickness burns, | |||
| and skin tears) | • Trauma wounds (abrasions, | ||
| lacerations, partial thickness burns, | |||
| and skin tears) | |||
| • Draining wounds | • Draining wounds | ||
| • Surgical wounds (donor sites/grafts, | |||
| post-Mohs' surgery, post-laser | |||
| surgery, podiatric, wound dehiscence) | • Surgical wounds (donor sites/grafts, | ||
| post-Mohs' surgery, post-laser | |||
| surgery, podiatric, wound dehiscence) | |||
| 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 | |||
| Material | Perfusion-decellularized porcine liver | Perfusion-decellularized porcine liver | |
| Resorbable | Yes | Yes | |
| Collagen fibers provided in four sizes | |||
| by weight (Model Number) | Three-dimensional collagen scaffold | ||
| provided in four sizes (W x L), all 2cm | |||
| thick (Model Number) | |||
| Wound Matrix | |||
| Configuration | |||
| and Sizes | • 100mg (4000) | • 2cm x 2cm (3000) | |
| • 250mg (4005) | • 3cm x 3cm (3005) | ||
| • 500mg (4010) | • 5cm x 5cm (3010) | ||
| • 700mg (4015) | • 10cm x 5cm (3015) | ||
| Wound Matrix | |||
| Preparation | May be used dry or rehydrated in either | ||
| saline or Lactated Ringer's solution | Rehydrate a minimum of five minutes | ||
| in either sterile saline or Lactated | |||
| Ringer's solution | |||
| Singe 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 tray and snap-on lid | Device package: Packaged dry in a | ||
| PETG tray and snap-on lid with Tyvek | |||
| lid seal | |||
| Sterile barrier: Aluminum laminate | |||
| foil pouch | Sterile barrier: Aluminum laminate | ||
| foil pouch | |||
| Shelf box: Cardboard | Shelf box: Cardboard | ||
| Feature | Miro3D Fibers Wound Matrix | ||
| (Subject Device) | Miro3D Wound Matrix | ||
| (Predicate Device) K223257 | |||
| MR | |||
| Compatibility | MR Safe | MR Safe | |
| Shelf Life | 22 months; may be extended with | ||
| additional real-time aging | 25 months; may be extended with | ||
| additional real-time aging | |||
| Storage | |||
| Conditions | No special storage conditions required | No special storage conditions required |
6
7
VII. PERFORMANCE DATA
The following performance testing was completed for the subject device:
- Package Integrity Testing
- Package and Product Stability Testing ●
- Collagen Denaturation
- Sterilization Validation
- . Bacterial Endotoxin
The following prior testing was leveraged by equivalence to the predicate device:
- Rehydration
- Residual Sodium Dodecyl Sulfate (SDS) ●
- Residual DNA ●
- Biocompatibility ●
- Viral Inactivation ●
- MR Testing
CONCLUSIONS VIII.
The subject Miro3D Fibers Wound Matrix has the same Intended Use as the predicate Miro3D Wound Matrix for wound management. The differences in technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate. Therefore, the subject Miro3D Fibers Wound Matrix device is substantially equivalent to the predicate Miro3D Wound Matrix device (K223257).