Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

K161067 · Engineered Tissue Solutions, LLC · QSZ · Sep 15, 2016 · SU

Device Facts

• Record ID: K161067
• Device Name: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
• Applicant: Engineered Tissue Solutions, LLC
• Product Code: QSZ · SU
• Decision Date: Sep 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tumneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, first and second degree burns, skin tears) and draining wounds.

Device Story

Mirragen™ Advanced Wound Matrix is a resorbable fiber dressing composed of biocompatible borate glass fibers and particulates. Used in clinical settings for wound management; applied by healthcare professionals to cover wounds for 3-7 days. Porous structure absorbs wound fluid; material dissolves over approximately 45 days. Acts as a physical barrier/scaffold to support wound healing. Output is the physical dressing itself; clinical decision-making relies on visual assessment of wound healing progress. Benefits include effective wound coverage and fluid management in various chronic and acute wound types.

Clinical Evidence

Bench testing and animal studies only. Bench testing: X-ray fluorescence/diffraction for composition/crystallinity; SEM for fiber/particle size; dissolution testing (45-day aqueous); fluid absorption capacity. Animal study: Clinically relevant porcine model (full/partial thickness wounds) compared to predicates; endpoints included macroscopic assessment, planimetric wound closure measurement, histopathology, and histomorphometry. Biocompatibility: ISO 10993 testing including cytotoxicity, sensitization, irritation, sub-acute toxicity, and genotoxicity (Ames, chromosomal aberration, erythrocyte micronucleus). All results passed.

Technological Characteristics

Composition: Biocompatible, resorbable medical-grade borate glass fibers and particulates. Form factor: Resorbable fiber dressing. Porosity: Designed for fluid absorption. Dissolution: 45-day aqueous dissolution time. Biocompatibility: Tested per ISO 10993.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's, post-laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, 1st/2nd degree burns, skin tears), and draining wounds.

Regulatory Classification

Identification

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Predicate Devices

• Puracol® Plus Ag+ MicroScaffold™ Wound Dressing (K071552)
• GORE® BIO-A® Wound Matrix (K132397)

Submission Summary (Full Text)

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December 15, 2022

Engineered Tissue Solutions, LLC % Mr. Randy Prebula Partner Hogan Lovells US, LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20009

Re: K161067

Trade/Device Name: Mirragen™ Advanced Wound Matrix Regulatory Class: Unclassified Product Code: QSZ

Dear Mr. Randy Prebula:

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 September 15, 2016. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.

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, 240-402-3839, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

Engineered Tissue Solutions, LLC % Mr. Randy Prebula Partner Hogan Lovells US, LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20009

Re: K161067

Trade/Device Name: Mirragen™ Advanced Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2016 Received: August 19, 2016

Dear Mr. Randy Prebula:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801) please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161067

#### Device Name Mirragen™ Advanced Wound Matrix

#### Indications for Use (Describe)

The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tumneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, first and second degree burns, skin tears) and draining wounds.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY K161067

#### 1. Submitter Information:

Engineered Tissue Solutions, LLC 4030 Hypoint North Rolla, MO 65401 Phone: [phone] Fax: [phone] Contact Person: Mark Borden, Ph.D.

Date Prepared: September 15, 2016

#### 2. Contact Information:

Randy Prebula Hogan Lovells U.S., LLP 555 Thirteenth Street, NW Washington, DC 20004

#### 3. Device Name and Classification:

| Trade/Proprietary Name: | MirragenTM Advanced Wound Matrix |
|-------------------------|----------------------------------|
| Common/Usual Name: | Wound dressing |
| Classification Name: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
| Product Code: | FRO (Dressing, Wound, Drug) |
| Device Class: | Unclassified |

#### 4. Predicate Devices

- Medline Industries, Inc. Puracol® Plus Ag+ MicroScaffold™ Wound Dressing (K071552)
- · W.L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix (K132397)

#### 5. Intended Use / Indications for Use

The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.

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#### 6. Device Description

The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.

### 7. Performance Data

The company performed a variety of preclinical testing to support the safety and effectiveness of the Mirragen™ Advanced Wound Matrix for its intended use. This testing is described in full in the 510(k) submission, and is summarized below.

For characterization of the dressing, the volume, mass, and density of samples of the Mirragen™ dressing were first measured and recorded. Samples were also subjected to various functional tests, including X-ray fluorescence spectroscopy for composition analysis, X-ray diffraction to analyze the product's crystallinity, and physical manipulation (cutting and handling) to assess friability, durability, and ease of use. Further structural characterization was performed through SEM imaging and analysis that evaluated the distributions of fiber sizes and particle sizes in the dressing. In addition, the company measured weight loss from samples incubated in 37°C water at various time points, which established the dressing's 45-day aqueous dissolution time, and measured the weight of the dressing before and after fluid saturation to determine the fluid absorption capacity. Results showed that the device meets its specifications, which are similar to those of the predicate devices that have similar resorbable fiber structures. In all instances, the Mirragen™ dressing functioned as intended and the qualities observed were as expected.

The dressing was also tested against the predicate devices in full and partial thickness wounds in a clinically relevant porcine model. Wound healing analyses included macroscopic assessment of wound healing, planimetric measurement of wound closure, histopathology, and histomorphometry. Test results showed that the Mirragen™ Advanced Wound Matrix and the predicate devices had a similar wound healing response and exhibited no adverse tissue responses.

In accordance with ISO 10993, the company conducted the biocompatibility tests recommended for a surface device that is in prolonged contact with breached or compromised skin. This included tests for cytotoxicity, sensitization, and irritation/intracutaneous reactivity. The company also conducted additional tests per ISO 10993 to supplement the biocompatibility evaluation of the Mirragen™ dressing, including sub-acute toxicity and a variety of genotoxicity tests (Ames, chromosomal aberration, and erythrocyte micronucleus). All results were passing, demonstrating the biocompatibility of the Mirragen™ Advanced Wound Matrix.

## 8. Substantial Equivalence

The Mirragen™ Advanced Wound Matrix is as safe and effective as the Puracol® Plus Ag+ MicroScaffold™ Wound Dressing and the GORE® BIO-A® Wound Matrix. The subject device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Mirragen™

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Advanced Wound Matrix and its predicate devices raise no different questions of safety or effectiveness. Performance data further support the product's safety and effectiveness in comparison to the predicates. Thus, the Mirragen™ Advanced Wound Matrix is substantially equivalent.

#### 9. Conclusions

The Mirragen™ Advanced Wound Matrix has similar structure and principles of operation as the cleared predicate devices; bench and animal testing further support that the device performs as intended. Thus, the device is substantially equivalent to the predicate devices.