← Product Code [KGN](/productcode/KGN) · K230980 # MicroMatrix® Flex (K230980) _Acell, Inc. · KGN · Sep 22, 2023 · SU · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K230980 ## Device Facts - **Applicant:** Acell, Inc. - **Product Code:** [KGN](/productcode/KGN.md) - **Decision Date:** Sep 22, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Indications for Use MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use. ## Device Story MicroMatrix® Flex is a dual-syringe system for mixing and delivering porcine-derived urinary bladder matrix (UBM) particulate as a wound management paste. The device consists of a particulate component identical to the predicate MicroMatrix® UBM Particulate (K172399), hydrated with saline via a dual-syringe-to-syringe connector and dispensed through an optional tip. Used in clinical settings for wound management; operated by healthcare providers. The paste is applied to the wound site to support management of various wound types. Benefits include ease of dispensability and consistent application compared to manual hydration methods. The device is terminally sterilized via electron beam irradiation and packaged in a nested tray system. ## Clinical Evidence Bench testing only. No clinical data. Performance testing included biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, genotoxicity, intramuscular implantation), packaging/device stability, sterilization validation, and design verification (particle size, onset temperature, tip bending, paste preparation/dispensing). ## Technological Characteristics Porcine-derived urinary bladder matrix (UBM) collagen extracellular matrix. Single-use, resorbable, non-crosslinked, decellularized. Dual-syringe delivery system. Terminally sterilized via electron beam irradiation. Packaged in nested rigid trays with die-cut lids. ## Predicate Devices - MicroMatrix® UBM Particulate ([K172399](/device/K172399.md)) ## Reference Devices - Flowable Wound Matrix ([K160136](/device/K160136.md)) - Integra Flowable Wound Matrix ([K072113](/device/K072113.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized image of a bird or eagle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. September 22, 2023 ACell, Inc. Simone Oliver Sr Specialist, Regulatory Affairs 6640 Eli Whitney Drive Suite 200 Columbia, Maryland 21046 Re: K230980 Trade/Device Name: MicroMatrix® Flex Regulatory Class: Unclassified Product Code: KGN Dated: August 21, 2023 Received: August 22, 2023 Dear Simone Oliver: 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 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 {1}------------------------------------------------ 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 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 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) K230890 Device Name MicroMatrix® Flex #### Indications for Use (Describe) MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | 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." {3}------------------------------------------------ #### 510(k) SUMMARY ### MicroMatrix® Flex | Submitter: | ACell, Inc. (subsidiary of Integra LifeSciences Corp.)
6640 Eli Whitney Drive
Columbia, MD 21046 | |----------------------|--------------------------------------------------------------------------------------------------------| | Contact Person: | Simone Oliver | | Contact Title: | Senior Regulatory Affairs Specialist | | Phone: | +1 (301) 789-5682 | | Email: | simone.oliver@integralife.com | | Date Prepared: | September 22, 2023 | | Trade Name: | MicroMatrix® Flex | | Common Name: | Animal-Derived, Extracellular Matrix Wound Product | | Classification Name: | Collagen Wound Dressing | | Regulation Number: | N/A | | Regulatory Class: | Unclassified | | FDA Product Code: | KGN | Predicate Device: MicroMatrix® UBM Particulate (K172399) ## Reference Devices: - Cook Biotech Inc. - Flowable Wound Matrix (K160136) - . Integra Lifesciences Corp. - Integra Flowable Wound Matrix (K072113) #### Device Description The MicroMatrix® Flex device is a dual-syringe system for the mixing and delivery of a paste for the management of wounds. The particulate component of the device is composed of porcinederived extracellular matrix known as urinary bladder matrix. The particulate component is identical to that particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of <1000 um. The device is packaged in a nested tray system with peel-open lids. The device is terminally sterilized using electron beam irradiation. {4}------------------------------------------------ #### Intended Use/Indications for Use MicroMatrix® Flex is intended for the management of wounds including: partial and fullthickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use. #### Summary of Technological Characteristics The technological characteristics of MicroMatrix® Flex are substantially equivalent to the cleared MicroMatrix® UBM Particulate (K172399). Both devices are single-use only, resorbable porcine animal tissue-derived collagen extracellular matrix (ECM) sheet devices. ### Comparison to Predicate Device MicroMatrix® Flex has identical intended use and indications for use as the predicate MicroMatrix® UBM Particulate device. The only minor difference is that the MicroMatrix® UBM Particulate predicate device (K172399) was cleared with the indication for second degree burns, while MicroMatrix® Flex is indicated for partial thickness burns. The particulate manufacturing process and methods remain unchanged from the previously cleared device. The main difference between MicroMatrix® Flex and MicroMatrix® UBM Particulate is the modification to the primary packaging - the use of a syringe rather than a vial as the primary package of the particulate and how the device is dispensed by the end user. In addition, the double Sterile Barrier System (SBS) consists of nested sealed preformed rigid trays with die-cut lids rather than preformed flexible chevron pouches. ## Performance Data The subject device, MicroMatrix® Flex, and the predicate device, MicroMatrix® UBM Particulate (K172399), are comprised of identical materials and are processed and sterilized by identical methods. Biocompatibility was tested in compliance with ISO 10993-1 and the following end points were tested: cytotoxicity, sensitization, irritation/ intracutaneous reactivity. material mediated pyrogenicity, acute systemic toxicity, sub chronic toxicity, genotoxicity, intramuscular implantation (local effects after 2, 4, and 8 weeks), and biological and toxicological risk assessments were completed. Furthermore, packaging and device stability, sterilization, and usability testing were completed. Design verification (bench) testing was completed for the following performance specifications: particle size, onset temperature, tip bending, and paste preparation and dispensing. The MicroMatrix® Flex device functioned as intended and the results demonstrate that the device is substantially equivalent to the predicate device. {5}------------------------------------------------ ### Conclusions The MicroMatrix® Flex device is as safe and effective as its predicate MicroMatrix® UBM Particulate (K172399). MicroMatrix® Flex has identical intended uses and similar indications (only difference is replacement of second degree burns with partial thickness burns), similar technological characteristics, and similar principles of operation as its predicate device. The minor technological differences between MicroMatrix® Flex and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that MicroMatrix® Flex is as safe and effective as the MicroMatrix® UBM Particulate (predicate). In addition, the substantial equivalence of MicroMatrix® Flex to the predicate device, MicroMatrix® UBM Particulate, is supported by the following reference devices: Flowable Wound Matrix (K160136, Cook Biotech, Inc.) and Integra Flowable Wound Matrix (K072113. Integra LifeSciences Corp.). Both the subject device and the reference devices are packaged in a similar syringe system to allow for easy dispensability. Thus, MicroMatrix® Flex is substantially equivalent to MicroMatrix® UBM Particulate. Table 6.1 below compares the key features of the subject and predicate device. | | Subject Device | Predicate Device | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | | ACell, Inc.
MicroMatrix® Flex | ACell, Inc.
MicroMatrix® UBM Particulate | | 510(k) No. | TBD | K172399 | | Device Class | Unclassified | Unclassified | | Product Code | KGN | KGN | | Classification | Dressing, Wound, Collagen | Dressing, Wound, Collagen | | Material Source | Porcine Urinary Bladder Matrix (UBM) | Porcine Urinary Bladder Matrix (UBM) | | Material Type | Collagen, Extracellular Matrix | Collagen, Extracellular Matrix | | Crosslinked Collagen | No | No | | Decellularized | Yes | Yes | | Resorbable | Yes | Yes | | Configuration | Particulate | Particulate | | Technological Features | Device is hydrated to a paste
consistency using saline in a dual
syringe-to-syringe connector and then
dispensed through an optional tip. | Particulate is applied directly to the
wound either hydrated with saline into
a paste like consistency or applied un-
hydrated | | Reusable | Single Use Device | Single Use Device | | Biocompatible | Yes | Yes | Table 6.1 Subject Device (MicroMatrix® Flex) comparison to Predicate Device (MicroMatrix® UBM Particulate). {6}------------------------------------------------ | | Subject Device | Predicate Device | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for
Use | MicroMatrix® Flex is intended for the
management of wounds including:
partial and full-thickness wounds,
pressure ulcers, venous ulcers, diabetic
ulcers, chronic vascular ulcers,
tunneled/undermined wounds, surgical
wounds (donor sites/grafts, post-Mohs
surgery, post-laser surgery, podiatric,
wound dehiscence), trauma wounds
(abrasions, lacerations, partial
thickness burns, skin tears), draining
wounds. The device is intended for one
time use. | MicroMatrix® UBM Particulate is
intended for the management of
wounds including: partial and full-
thickness wounds, pressure ulcers,
venous ulcers, diabetic ulcers, chronic vascular ulcers,
tunnel/undermined wounds, surgical
wounds (donor sites/grafts, post-
Mohs surgery, post-laser surgery,
podiatric, wound dehiscence),
trauma wounds (abrasions,
lacerations, second-degree burns,
and skin tears), and draining wounds.
The device is intended for one-time
use. | | Packaging | Preformed rigid tray with die-cut lid | Foil: PET Preformed Chevron Peel
Pouch | | Sterilization | E-beam | E-Beam | | Storage | Store in a clean, dry environment at
room temperature in an unopened and
undamaged package. Protect from
freezing, excessive heat, and high
humidity. | Store in a clean, dry environment at
room temperature in an unopened and
undamaged package. Protect from
freezing, excessive heat, and high
humidity. | --- **Source:** [https://fda-staging.innolitics.com/device/K230980](https://fda-staging.innolitics.com/device/K230980) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com