(112 days)
Not Found
No
The summary describes a collagen-glycosaminoglycan wound dressing and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is indicated for the management of various types of wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, and more. It is a wound dressing designed to maintain and support a healing environment, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is a "wound dressing" intended for "management of wounds" and "maintains and supports a healing environment." It does not mention diagnosis of any condition.
No
The device description clearly states it is a "collagen-glycosaminoglycan wound dressing," which is a physical material, 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 applying the device directly to the wound to support healing.
- Device Description: The description identifies it as a "collagen-glycosaminoglycan wound dressing." This is a topical application, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases. The focus is entirely on wound care.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
INTEGRA® Wound Matrix (Thin) is indicated 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, second-degree burns, 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
INTEGRA® Wound Matrix (Thin) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Thin) is supplied sterile and is intended for one-time use. The device is provided in a thinner form than the predicate, K022127.
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)
All test results were acceptable. In addition to biocompatibility testing, the product is tested to meet the following performance characteristics: pore size, collagen nativity-FTIR test of denaturing, chondroitin-6-sulfate content, and degree of cross-linking. Furthermore, the history of clinical use of similar collagen products, including the predicate device, manufactured and marketed by Integra LifeSciences Corporation has been cited in this 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Integra LifeSciences Corporation 510(k) Premarket Notification INTEGRA® Wound Matrix (Thin)
FFB - 9 2012
510(K) SUMMARY
INTEGRA® Wound Matrix (Thin)
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Stephen Beier Specialist, Regulatory Affairs Telephone: 609.936.5436 609.275.9445 Fax:
Date Summary was prepared:
January 11, 2012
Name of the device:
Proprietary Name: Common Name: Classification Name: Product Code:
INTEGRA® Wound Matrix (Thin) Collagen Wound Dressing Not Classified KGN
Substantial Equivalence:
INTEGRA® Wound Matrix (Thin) is substantially equivalent in function and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K022127 | KGN | INTEGRA® Matrix | |
| Wound Dressing | Integra LifeSciences | ||
| Corporation |
Device Description:
INTEGRA® Wound Matrix (Thin) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Thin) is supplied sterile and is intended for one-time use. The device is provided in a thinner form than the predicate, K022127.
Intended Use:
INTEGRA® Wound Matrix (Thin) is indicated 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, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.
Substantial Equivalence Comparison:
INTEGRA® Wound Matrix (Thin) has the same design, materials, and chemical composition as the predicate device (K022127). The only difference between the two products will be the device thickness. All technological characteristics (i.e. pore size, collagen-nativity, extent of collagen
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K113104 page 2/2
Integra LifeSciences Corporation 510(k) Premarket Notification INTEGRA® Wound Matrix (Thin)
cross-linking, and glycosaminoglycan content) are the same for INTEGRA® Wound Matrix (Thin) and the predicate device.
Testing and Test Results:
INTEGRA® Wound Matrix (Thin) and INTEGRA® Matrix Wound Dressing (K022127) are comprised of identical materials and are sterilized by identical methods.
All test results were acceptable. In addition to biocompatibility testing, the product is tested to meet the following performance characteristics: pore size, collagen nativity-FTIR test of denaturing, chondroitin-6-sulfate content, and degree of cross-linking. Furthermore, the history of clinical use of similar collagen products, including the predicate device, manufactured and marketed by Integra LifeSciences Corporation has been cited in this 510(k) Premarket Notification.
Conclusion:
The modified INTEGRA® Wound Matrix (Thin) is substantially equivalent to the commercially marketed device, INTEGRA® Matrix Wound Dressing (K022127).
The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Stephen Beier Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
FEB - 9 2012
Re: K113104
Trade/Device Name: INTEGRA® Wound Matrix (Thin) Regulation Name: Unclassified Product Code: KGN Dated: January 11, 2012 Received: January 12, 2012
Dear Mr. Beier:
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 (reporting of medical device-related 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.
3
Page 2 - Mr. Stephen Beier
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/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html
Sincerely vours.
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):
Device Name: INTEGRA™ Wound Matrix (Thin)
Indications For Use: INTEGRA™ Wound Matrix (Thin) is indicated 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, skin tears) and draining wounds. The device 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)
Dai for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K113104
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