MATRISTEM WOUND MATRIX

• K Number: K112409
• Device Name: MATRISTEM WOUND MATRIX
• Manufacturer: ACELL, INC
• Date Cleared: 2011-08-29 ( 7 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Special
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K092926
• Predicate For: K152721 , K181330

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.

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.

AI/ML Overview

This document is a 510(k) summary for the MatriStem® Wound Matrix, which is a medical device for wound management. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not involve setting acceptance criteria or conducting a performance study in the way one would for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (for an AI/ML device) is not applicable to this 510(k) submission for the MatriStem® Wound Matrix.

Here's a breakdown of why and what information is available:

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Rationale for Non-Applicability of AI/ML Study Criteria:

The MatriStem® Wound Matrix is described as a "sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix sheet." It is a biological/material-based medical device, not an AI/ML software device. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device based on characteristics like:

• Indications for Use: Are they the same or very similar?
• Technological Characteristics: Is the raw material, design, manufacturing process, packaging, sterilization, and shelf life similar?
• Performance Data: This typically involves biocompatibility testing, sterility testing, and sometimes bench testing or animal studies to show the device performs as intended, but not in the sense of predictive accuracy or diagnostic performance evaluated against ground truth established by experts, as is common for AI/ML.

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Information Applicable to this 510(k) Summary:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: For a 510(k) of this nature, the primary "acceptance criteria" isn't a numerical performance metric like sensitivity/specificity, but rather that the device is substantially equivalent to the predicate device.

  • The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act applicable to this device."

• Reported Device Performance: The document states:
  | Criteria for Substantial Equivalence | MatriStem® Wound Matrix Performance |
  |:-------------------------------------|:------------------------------------|
  | Indications for Use | Substantially equivalent to predicate device (MatriStem® Wound Sheet K092926) |
  | Raw Material | Substantially equivalent to predicate device |
  | Dimensions and Configuration | Substantially equivalent to predicate device |
  | Manufacturing Processes | Substantially equivalent to predicate device |
  | Packaging | Substantially equivalent to predicate device |
  | Sterilization | Substantially equivalent to predicate device |
  | Shelf Life | Substantially equivalent to predicate device |

  • The "performance" here refers to demonstrating that the new device shares fundamental characteristics and intended use with the predicate, rather than providing quantitative data on, for example, wound healing rates compared to a control.

The following points are NOT APPLICABLE to this 510(k) submission for a non-AI/ML device:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This device is not an AI/ML algorithm that uses a "test set" of data for performance evaluation in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No "ground truth" establishment by experts in this manner is described for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (extracellular matrix for wound care) to a previously cleared predicate device. The framework for evaluating AI/ML algorithms, which involves acceptance criteria based on metrics like sensitivity/specificity, extensive testing with annotated datasets, and human-in-the-loop studies, simply does not apply to this type of device and submission.

Summary

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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: [phone] Fax: [phone] Website: www.acell.com

510(k) Summary

Submitted by:	ACell, Inc.6640 Eli Whitney Drive, Suite 200Columbia, MD 21046
Contact Person:	Deborah Baker-Janis, M.S.E.E.Senior Regulatory Affairs SpecialistEmail: [e-mail]: [phone]Fax: [phone]
Date Summary Prepared:	August 19, 2011
Trade Name:Common Name:Class/Product Code/Panel:	MatriStem® Wound MatrixAnimal-derived, extracellular matrix wound care productUnclassified / KGN / General & Plastic Surgery
Predicate Device:	MatriStem® Wound Sheet (K092926)
Performance Standards:	No performance standards have been established under Section514 of the Food, Drug, and Cosmetic Act applicable to thisdevice.
Device Description:	MatriStem® Wound Matrix is a sterile, porcine-derived,naturally-occurring lyophilized extracellular matrix sheet thatmaintains and supports a healing environment for woundmanagement.
Intended Use:	MatriStem® Wound Matrix is intended for the management ofwounds including: partial and full-thickness wounds, pressureulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,tunnel/undermined wounds, surgical wounds (donor sites/grafts,post-Mohs surgery, post-laser surgery, podiatric, wounddehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The deviceis intended for one-time use.
Substantial Equivalence:	MatriStem® Wound Matrix is substantially equivalent to thepredicate device with respect to the indications for use, rawmaterial, dimensions and configuration, manufacturingprocesses, packaging, sterilization, and shelf life.

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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

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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 [phone] or [phone] 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

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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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Regulation Number and Section

N/A