(170 days)
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.
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 porcine-derived 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.
The provided FDA 510(k) summary for the MicroMatrix® Flex device does not describe specific acceptance criteria in the typical sense of a diagnostic device (e.g., sensitivity, specificity, AUC). Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MicroMatrix® UBM Particulate) by showing that the new device has identical intended use, similar technological characteristics, and similar principles of operation, with minor differences not raising new safety or effectiveness issues.
The "acceptance criteria" here are therefore related to demonstrating that the new device performs equivalently to the predicate in various aspects.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Identical material (porcine-derived extracellular matrix from urinary bladder matrix) and particle size to predicate. | The particulate component is composed of porcine-derived extracellular matrix (urinary bladder matrix) and is identical to the particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of <1000 um. |
| Manufacturing Process | Processed and sterilized by identical methods as the predicate device. | "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." "The particulate manufacturing process and methods remain unchanged from the previously cleared device." |
| Biocompatibility | Compliant with ISO 10993-1, demonstrating non-toxicity, non-sensitization, non-irritation, non-pyrogenicity, etc. | Biocompatibility was tested in compliance with ISO 10993-1, covering endpoints such as cytotoxicity, sensitization, irritation/intracutaneous reactivity, material mediated pyrogenicity, acute systemic toxicity, subchronic toxicity, genotoxicity, intramuscular implantation (local effects after 2, 4, and 8 weeks), and biological and toxicological risk assessments. (Results are stated as compliant/completed). |
| Stability | Demonstrated stability of packaging and device. | "Furthermore, packaging and device stability...testing were completed." (Results imply it met criteria, though specific metrics are not provided). |
| Sterilization | Demonstrated effective sterilization (E-beam). Identical to predicate. | "Sterilization...testing were completed." (Implies successful sterilization). Both devices use E-beam sterilization. |
| Usability | Demonstrated functional usability (e.g., paste preparation and dispensing). | "Usability testing was 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." |
| Performance (Bench) | Met design verification specifications for particle size, onset temperature, and tip bending. | "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." |
| Intended Use | Identical intended use as the predicate device. | MicroMatrix® Flex has identical intended use as the predicate MicroMatrix® UBM Particulate device. |
| Indications for Use | Similar indications for use (minor difference: partial thickness burns vs. second-degree burns). | MicroMatrix® Flex has similar indications for use. The only minor difference is that the MicroMatrix® UBM Particulate predicate device was cleared with the indication for second degree burns, while MicroMatrix® Flex is indicated for partial thickness burns. |
| Package/Delivery System | Demonstrated functional equivalence despite packaging change (syringe vs. vial). | The main difference is the modification to the primary packaging – the use of a syringe rather than a vial. The device's technological features describe preparing a paste in a dual syringe system, indicating functionality. |
Study Information for Device Performance
This 510(k) submission does not describe a clinical study comparing device effectiveness in patients, as is common for many AI/diagnostic devices. Instead, it relies on bench (design verification) testing and biocompatibility studies to demonstrate equivalence to a previously cleared device. Therefore, many of the typical questions for AI/diagnostic device studies are not applicable.
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical cases. The "test set" here refers to samples of the device and its components used for biocompatibility and bench testing. Specific sample sizes for each bench test (e.g., number of devices tested for tip bending, number of samples for particle size analysis) are not disclosed in this summary.
- Data Provenance: Not applicable for a clinical study. The data provenance would be from laboratory testing conducted by or for ACell, Inc.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. Ground truth, in the sense of expert consensus on patient cases, is not relevant for this type of submission focused on material and functional equivalence. The "ground truth" for bench tests would be established by validated measurement methods and equipment.
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Adjudication Method for the Test Set: Not applicable. There is no expert adjudication process described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This device is a wound care product, not an imaging or diagnostic AI device that would typically involve human readers.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance): Not applicable. This is not an algorithm-based device. Performance tests involve bench testing of the physical properties and functional aspects of the device itself.
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Type of Ground Truth Used:
- Biocompatibility: Established by reference to and compliance with ISO 10993-1 standards and associated test methods, which define acceptable thresholds for biological responses.
- Bench Testing (Design Verification): Established by engineering specifications and validated measurement techniques (e.g., particle size analysis, temperature measurements, force measurements for tip bending).
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Sample Size for the Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the Ground Truth for the Training Set Was Established: Not applicable.
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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
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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
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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) |
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510(k) SUMMARY
MicroMatrix® Flex
| Submitter: | ACell, Inc. (subsidiary of Integra LifeSciences Corp.)6640 Eli Whitney DriveColumbia, 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.
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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.
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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 pasteconsistency using saline in a dualsyringe-to-syringe connector and thendispensed through an optional tip. | Particulate is applied directly to thewound either hydrated with saline intoa 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).
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| Subject Device | Predicate Device | |
|---|---|---|
| Indications forUse | MicroMatrix® Flex is intended for themanagement of wounds including:partial and full-thickness wounds,pressure ulcers, venous ulcers, diabeticulcers, chronic vascular ulcers,tunneled/undermined wounds, surgicalwounds (donor sites/grafts, post-Mohssurgery, post-laser surgery, podiatric,wound dehiscence), trauma wounds(abrasions, lacerations, partialthickness burns, skin tears), drainingwounds. The device is intended for onetime use. | MicroMatrix® UBM Particulate isintended for the management ofwounds including: partial and full-thickness wounds, pressure ulcers,venous ulcers, diabetic ulcers, chronic vascular ulcers,tunnel/undermined wounds, surgicalwounds (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-timeuse. |
| Packaging | Preformed rigid tray with die-cut lid | Foil: PET Preformed Chevron PeelPouch |
| Sterilization | E-beam | E-Beam |
| Storage | Store in a clean, dry environment atroom temperature in an unopened andundamaged package. Protect fromfreezing, excessive heat, and highhumidity. | Store in a clean, dry environment atroom temperature in an unopened andundamaged package. Protect fromfreezing, excessive heat, and highhumidity. |
N/A