(28 days)
No
The device description focuses on the material composition and physical properties of a wound care product, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the management of various types of wounds, indicating a therapeutic purpose.
No
The device is described as a resorbable porcine-derived extracellular matrix scaffold intended for the management and healing of various types of wounds, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical, resorbable porcine-derived extracellular matrix (ECM) scaffold supplied as a dry particulate. It 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 is for the management of various types 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 device is a resorbable extracellular matrix material applied directly to wounds. It does not involve the analysis of biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples, detecting biomarkers, or providing diagnostic information.
The device is clearly intended for wound treatment and management, which falls under the category of medical devices used for therapeutic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
KGN
Device Description
The subject device is composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, specifically known as urinary bladder matrix (UBM). MicroMatrix devices are supplied as a dry, absorbent, white to off-white particulate with two particle size distributions, specifically
N/A
0
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July 11, 2024
ACell, Inc Simone Abramczyk Senior Specialist, Regulatory Affairs 6640 Eli Whitney Dr. Suite 200 Columbia, Maryland 21046
Re: K241706
Trade/Device Name: MicroMatrix® UBM Particulate Regulatory Class: Unclassified Product Code: KGN Dated: June 9, 2024 Received: June 13, 2024
Dear Simone Abramczyk:
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"
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(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.
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For comprehensive regulatory information about medical devices and radiation-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
Enclosure
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Indications for Use
510(k) Number (if known) K241706
Device Name
MicroMatrix® UBM Particulate
Indications for Use (Describe)
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.
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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Special 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name and Address | ACell, Inc. |
| 6640 Eli Whitney Drive Ste. 200 | |
| Columbia, MD 21046 | |
| Telephone number | (301) 789-5682 |
| Primary Contact | Simone Abramczyk |
| Date Summary Prepared | July 9, 2024 |
| Name of Device | |
| Trade or Proprietary Name | MicroMatrix® UBM Particulate |
| Device Class | Unclassified |
| Product Code | KGN |
| Predicate Information | |
| Predicate Device | MicroMatrix® UBM Particulate: K172399 |
| Device Description |
The subject device is composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, specifically known as urinary bladder matrix (UBM). MicroMatrix devices are supplied as a dry, absorbent, white to off-white particulate with two particle size distributions, specifically