(30 days)
No reference devices were used in this submission.
No
The device description and intended use focus on a biological wound dressing material and its application, with no mention of AI/ML technologies or related concepts like image processing, data analysis, or algorithmic decision-making.
Yes
The MiroDry Wound Matrix is intended for the management of various types of wounds, indicating that its purpose is to treat or provide therapy for these conditions.
No
The device is described as an acellular wound dressing intended for the management of various types of wounds, not for diagnosing conditions.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This involves applying the device directly to the wound for therapeutic purposes.
- Device Description: The description details a "sterile, single use, non-crosslinked acellular wound dressing" derived from porcine liver tissue. This is a physical material applied to the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
The MiroDry Wound Matrix is a therapeutic device intended for direct application to wounds, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The MiroDry 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
KGN
Device Description
The MiroDry 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 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 MiroDry Wound Matrix is provided in six 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
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)
No performance testing was completed as prior testing of Miro3D was leveraged for MiroDry based on identical material and processing equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
Reprise Biomedical, Inc. % Kathy Herzog Sr. Regulatory, Quality, and Compliance Consultant DuVal & Associates 1820 Medical Arts Building, Suite 1820 Minneapolis, Minnesota 55402
Re: K240277
Trade/Device Name: MiroDry Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: January 31, 2024 Received: January 31, 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" (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).
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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 QS 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.
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,
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
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Indications for Use
510(k) Number (if known) K240277
Device Name MiroDry Wound Matrix
Indications for Use (Describe)
The MiroDry 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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510(k) Summary
This 510(k) summary is prepared 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: Erin Badali, Regulatory Affairs Product Specialist Date Prepared: January 31, 2024
II. DEVICE
| Trade/Proprietary Names: | MiroDry Wound Matrix |
|---|---|
| Common Name: | Animal-derived, extracellular matrix wound care product |
| 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 MiroDry 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 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 MiroDry Wound Matrix is provided in six sizes that may be cut to fit a wound size prior to application.
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V. INDICATIONS FOR USE
The MiroDry Wound Matrix is indicated for the following:
The MiroDry 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 devices have the same technological characteristics as the change to a thinner thickness and additional rectangular sizes 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 MiroDry as compared to Miro3D. The subject and predicate devices have identical intended use, Indications for Use, material/chemical composition, principles of operation, clinical use, manufacturing process, biocompatibility, packaging, and sterilization.
| Feature | MiroDry 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 MiroDry Wound Matrix is
intended for the management of
wounds including:
• Partial and full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers | 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 |
| Feature | MiroDry Wound Matrix
(Subject Device) | Miro3D Wound Matrix
(Predicate Device) K223257 |
| | • 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) | • 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) |
| 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 |
| Manufacturing
process | • Perfusion decellularize porcine liver
• Dry
• Cut to size | • Perfusion decellularize porcine liver
• Dry
• Cut to size |
| Wound Matrix
Configuration
and Sizes | Collagen sheet scaffold provided in six sizes (W x L), all 0.6cm thick (Model Number)
• 2cm x 2cm (6000)
• 3cm x 3cm (6005)
• 4cm x 4cm (6010)
• 5cm x 5cm (6015)
• 10cm x 3cm (6020)
• 10cm x 5cm (6025) | Three-dimensional collagen scaffold provided in four sizes (W x L), all 2cm thick (Model Number)
• 2cm x 2cm (3000)
• 3cm x 3cm (3005)
• 5cm x 5cm (3010)
• 10cm x 5cm (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 |
| Singe Use or
Reusable | Single Use | Single Use |
| Sterilization
Method | Electron beam irradiation | Electron beam irradiation |
| Sterilization
Assurance Level
(SAL) | 10-6 | 10-6 |
| Feature | MiroDry Wound Matrix
(Subject Device) | Miro3D Wound Matrix
(Predicate Device) K223257 |
| Packaging | Device package: Packaged dry in a
PETG 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 tray and snap-on lid with Tyvek
lid seal
Sterile barrier: Aluminum laminate
foil pouch
Shelf box: Cardboard |
| MR
Compatibility | MR Safe | MR Safe |
| Shelf Life | 25 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 |
Table 1: Subject vs. Predicate Wound Matrix Comparison
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VII. PERFORMANCE DATA
No performance testing was completed as prior testing of Miro3D was leveraged for MiroDry based on identical material and processing equivalence.
CONCLUSIONS VIII.
The subject MiroDry 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 Miro3D. Therefore, the subject MiroDry Wound Matrix device is substantially equivalent to the predicate Miro3D Wound Matrix device (K223257).