(7 days)
No
The summary describes a biological matrix for wound management and makes no mention of AI or ML technology.
Yes
The device is described as "MatriStem® Wound Matrix 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." This indicates it is used for treating or managing a health condition (wounds), which aligns with the definition of a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for the "management of wounds," not for diagnosing conditions.
No
The device description clearly states it is a "porcine-derived, naturally-occurring lyophilized extracellular matrix sheet," indicating it is a physical, biological product, 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 the device is for the "management of wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description details a "sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix sheet." This is a material applied to the body, not a reagent or instrument used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic wound dressing.
N/A
Intended Use / Indications for Use
MatriStem® Wound Matrix 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
MatriStem® Wound Matrix is a sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix sheet that maintains and supports a healing environment for wound management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MatriStem® Wound Sheet (K092926)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for ACell, a regenerative medicine company. The logo features a cluster of seven teardrop-shaped cells on the left, followed by the text "ACell" in bold, sans-serif font. Below the text is the tagline "Healing Through Regenerative Medicine" in a smaller, italicized font. The logo is simple, clean, and professional, and it effectively communicates the company's focus on regenerative medicine.
AUG 2 9 2011
Toll Free: 800-826-2926 Phone: 410-715-1700 Fax: 410-715-4511 Website: www.acell.com
510(k) Summary
| Submitted by: | ACell, Inc.
6640 Eli Whitney Drive, Suite 200
Columbia, MD 21046 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Deborah Baker-Janis, M.S.E.E.
Senior Regulatory Affairs Specialist
Email: debbakerjanis@acell.com
Telephone: 410-953-8539
Fax: 410-953-7082 |
| Date Summary Prepared: | August 19, 2011 |
| Trade Name:
Common Name:
Class/Product Code/Panel: | MatriStem® Wound Matrix
Animal-derived, extracellular matrix wound care product
Unclassified / KGN / General & Plastic Surgery |
| Predicate Device: | MatriStem® Wound Sheet (K092926) |
| Performance Standards: | No performance standards have been established under Section
514 of the Food, Drug, and Cosmetic Act applicable to this
device. |
| Device Description: | MatriStem® Wound Matrix is a sterile, porcine-derived,
naturally-occurring lyophilized extracellular matrix sheet that
maintains and supports a healing environment for wound
management. |
| Intended Use: | MatriStem® Wound Matrix 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. |
| Substantial Equivalence: | MatriStem® Wound Matrix is substantially equivalent to the
predicate device with respect to the indications for use, raw
material, dimensions and configuration, manufacturing
processes, packaging, sterilization, and shelf life. |
، ﻟ
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ACell, Inc. % Deborah Baker-Janis, M.S.E.E. Senior Regulatory Affairs Specialist 6640 Eli Whitney Drive, Suite 200 Columbia, Maryland 21046
AUG 2 9 2011
Re: K112409
Trade/Device Name: MatriStem® Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: August 19, 2011 Received: August 22, 2011
Dear Ms. Baker-Janis:
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, Or ug 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 (11) he 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
2
Page 2 - Deborah Baker-Janis, M.S.E.E.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as as a 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 100-1060.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its tolli me
1900) 638 0041 - 1901 700 700 1100 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaQlt.htm.
ge/MedicalDevices/ResourcesforFlowIndustry/delegator.htm
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K112409
Device Name:
MatriStem® Wound Matrix
Indications for Use:
MatriStem® Wound Matrix 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.
Prescription Use__ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kune for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112409
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