(76 days)
Not Found
No
The device description and performance studies focus on the biological properties and physical characteristics of the extracellular matrix material, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is intended for the management of various topical wounds, indicating its use in treating diseases or injuries.
No
The device is intended for the management (treatment) of topical wounds, not for diagnosing them. It is used to aid in wound healing.
No
The device description clearly states it is composed of porcine-derived extracellular matrix scaffolds, which are physical materials, 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 that MicroMatrix® is for the "management of topical wounds." This describes a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition or provide information about a patient's health status.
- Device Description: The description details a physical material (porcine-derived extracellular matrix scaffolds) applied directly to a wound. This is consistent with a wound dressing or regenerative medicine product, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes typical of IVDs, such as reagents, assays, analysis of biological samples (blood, urine, tissue, etc.), or the generation of diagnostic results.
- Performance Studies: The performance studies described focus on biocompatibility and hydration uptake, which are relevant to a wound care product, not the analytical or clinical performance of a diagnostic test.
In summary, MicroMatrix® is a device intended for the treatment and management of wounds, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
MicroMatrix® is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined 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 (comma separated list FDA assigned to the subject device)
KGN
Device Description
MicroMatrix® is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied as a dry, absorbant, white to off-white particulate with two particle distributions, specifically
N/A
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
ACell, Inc % Mr. John Smith Hogan Lovells 555 13th St., NW Washington, DC 20004
Re: K153754 Trade/Device Name: Micromatrix Regulatory Class: Unclassified Product Code: KGN Dated: February 19, 2016 Received: February 19, 2016
Dear Mr. Smith:
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 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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) K153754
Device Name MicroMatrix®
Indications for Use (Describe)
MicroMatrix® is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined 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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510(k) SUMMARY
Date Prepared: March 10, 2016
Manufacturer Name: Submitted by:
ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046
Contact Person:
Salman Elmi Vice President, Deputy General Counsel ACell, Inc. Phone: (410) 953-8500 Email: salelmi@acell.com Fax: (240) 465-8187
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | MicroMatrix® |
|---|---|
| Common/Usual Name: | Animal-derived, extracellular matrix wound care product |
| Regulation Name: | Collagen Wound Dressing |
| Device Class: | Unclassified |
| Product Code: | KGN |
| Reviewing Panel: | General & Plastic Surgery |
PREDICATE DEVICE
Predicate Device: ACell Powder Wound Dressing (K060888)
DEVICE DESCRIPTION
MicroMatrix® is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied as a dry, absorbant, white to off-white particulate with two particle distributions, specifically