LogoFDA 510(k) Search
K Number
K090954
Device Name
ATLAS WOUND MATRIX
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2009-07-30

(115 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K161902
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ATLAS Wound Matrix devices intended use is for the management of wounds including:

  • partial and full thickness wounds,
    • pressure ulcers,
    • venous ulcers,
  • diabetic ulcers.
  • chronic vascular ulcers,
  • tunneled/undermined wounds.
  • surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
  • trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
  • draining wounds.

The device is supplied sterile and is intended for one-time use.

Device Description

The ATLAS Wound Matrix is a sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, which is rehydrated at the time of implant, is designed to be thin enough to conform to the wound it will cover. The matrix material will be made available in a variety of sizes depending on surgical use.

AI/ML Overview

This 510(k) summary describes a medical device, the ATLAS Wound Matrix, which is a processed porcine collagen dermal material used for wound management. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, and therefore does not require a new scientific study with specific acceptance criteria to prove its performance.

Therefore, I cannot fulfill your request for the following information based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not provided because the submission relies on substantial equivalence.
  2. Sample size used for the test set and the data provenance: No performance testing data is presented.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for performance testing is discussed.
  4. Adjudication method 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: This device is a wound matrix, not an AI-powered diagnostic tool, so this type of study is irrelevant.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an algorithm, but a physical medical device.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for performance testing is discussed.
  8. The sample size for the training set: Not applicable as this is not an AI/algorithmic device with a training set.
  9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its approval process:

  • Device Name: ATLAS Wound Matrix
  • Intended Use: Management of various wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.
  • Device Description: Sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, rehydrated at the time of implant, thin and conformable to the wound.
  • Approval Basis: Substantial Equivalence to previously cleared predicate devices. The document states: "The intended use, type of interface, operating principles, shelf life, and design features of the ATLAS Wound Matrix are substantially equivalent to the previously cleared predicates. Additionally, the safety and effectiveness of the ATLAS Wound Matrix is adequately supported by the substantial equivalent information and materials data provided within this Premarket Notification."

In essence, this 510(k) summary is a declaration that the new device is sufficiently similar to existing approved devices that it doesn't require new, independent clinical trials with performance acceptance criteria.

{0}------------------------------------------------

K090954
Page 1 of 2

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 80 2009

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ATLAS Wound Matrix.

Submitted By:Wright Medical Technology, Inc.
Date:March 30, 2009
Contact Person:Ryan M. Belaney
Sr. Regulatory Affairs Specialist/Product DevelopmentEngineer
Proprietary Name:ATLAS Wound Matrix
Common Name:Animal-derived, extra-cellular matrix wound careproduct
Classification Name and Reference:Unclassified
Device Product Code and Panel Code:General and Plastic Surgery/KGN

DEVICE INFORMATION

A. INTENDED USE

The ATLAS Wound Matrix devices intended use is for the management of wounds including:

  • partial and full thickness wounds,
    • pressure ulcers,
    • venous ulcers,
  • diabetic ulcers.
  • chronic vascular ulcers,
  • tunneled/undermined wounds.
  • surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
  • trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
  • draining wounds.

The device is supplied sterile and is intended for one-time use.

B. DEVICE DESCRIPTION

The design features of the ATLAS Wound Matrix are substantially equivalent to the design features of the predicate devices. A brief description of the ATLAS Wound Matrix is provided below.

IMPLANT DESCRIPTION

The ATLAS Wound Matrix is a sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, which is rehydrated at the time of implant, is designed to be thin enough to conform to the wound it will cover. The matrix material will be made available in a variety of sizes depending on surgical use.

{1}------------------------------------------------

K090954
page 2 of_

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the ATLAS Wound Matrix are substantially equivalent to the previously cleared predicates. Additionally, the safety and effectiveness of the ATLAS Wound Matrix is adequately supported by the substantial equivalent information and materials data provided within this Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a horizontal line extending from the rightmost profile.

SEP 9 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. % Mr. Ryan Belaney Biologics Development Engineer 5677 Airline Road Arlington, Tennessee 38002

Re: K090954

Trade/Device Name: ATLAS Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: July 1, 2009 Received: July 2, 2009

Dear Mr. Belaney:

This letter corrects our substantially equivalent letter of July 30, 2009.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Ryan Belaney

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.

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/ucm115809.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/cdrh/mdr/ 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For

Peter D. Ruisen
Dep D.R.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): Ko 90954

Device Name: ATLAS Wound Matrix

Indications For Use:

The ATLAS Wound Matrix 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,
  • surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . podiatric, wound dehiscence),
  • . trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
  • draining wounds. .

The ATLAS Wound Matrix is a collagen wound dressing that provides an environment that supports wound healing.

The device is supplied sterile and is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MXM

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090954

1 of 1

N/A