(115 days)
Not Found
Not Found
No
The summary describes a collagen wound matrix and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for the management of various types of wounds, indicating a therapeutic purpose.
No
The device description and intended use refer to the management and coverage of wounds, indicating it is a therapeutic or repair device, not one that identifies or diagnoses a condition.
No
The device description explicitly states it is a "sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material," which is a physical, biological product, not software.
Based on the provided information, the ATLAS Wound Matrix device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of wounds. This involves applying the device directly to the wound for healing purposes.
- Device Description: The description details a sterile, processed porcine collagen dermal material designed to be applied to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve testing samples outside the body.
The ATLAS Wound Matrix is a therapeutic device intended for direct application to a wound to aid in the healing process.
N/A
Intended Use / Indications for 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.
Product codes
KGN
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.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K090954
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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 Development | |
| Engineer | |
| Proprietary Name: | ATLAS Wound Matrix |
| Common Name: | Animal-derived, extra-cellular matrix wound care |
| product | |
| 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.
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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
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