(70 days)
No
The device description and intended use focus on the material composition and physical properties of the wound matrix, with no mention of AI or ML capabilities.
Yes
The device is indicated for the management of wounds and provides a scaffold for cellular invasion and capillary growth, which are therapeutic actions.
No
The device, INTEGRA™ Flowable Wound Matrix, is described as an "advanced wound care device" that provides a "scaffold for cellular invasion and capillary growth" for the management of various wounds. Its intended use focuses on treatment and healing, not diagnosing a condition.
No
The device description clearly states it is comprised of physical materials (granulated cross-linked bovine tendon collagen and glycosaminoglycan) and includes physical components (syringes, connector, injector). It is a physical wound care device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound matrix applied directly to the wound. It provides a scaffold for healing. This is a treatment, not a test performed on a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
INTEGRA™ Flowable Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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
KGN
Device Description
INTEGRA™ Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagenglycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and capillary growth. INTEGRA™ Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
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
Results of physical testing, biocompatibility studies and clinician evaluation have demonstrated the collagen-glycosaminoglycan matrix in INTEGRA Flowable Wound Matrix to be safe and effective for the management of wounds.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K072113 Page 1/1
510(K) SUMMARY
INTEGRA™ Flowable Wound Matrix
OCT 1 0 2007
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:
Date Summary was prepared:
July 27, 2007
Name of the device:
| Proprietary Name: | INTEGRA™ Flowable Wound Matrix |
|---|---|
| Common Name: | Collagen Wound Dressing |
| Classification Name: | Not Classified |
| Product Code: | KGN |
Substantial Equivalence:
INTEGRA™ Flowable Wound Matrix is substantially equivalent in function and intended use to INTEGRAIM Matrix Wound Dressing (K022127) and Medifi® Particles K910944.
Device Description:
INTEGRA™ Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagenglycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and capillary growth. INTEGRA™ Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
Intended Use:
INTEGRATM Flowable Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, seconddegree burns, skin tears) and draining wounds. The device is intended for one-time use.
Testing and Test Results:
Results of physical testing, biocompatibility studies and clinician evaluation have demonstrated the collagen-glycosaminoglycan matrix in INTEGRA Flowable Wound Matrix to be safe and effective for the management of wounds.
Conclusion:
INTEGRA Flowable Wound Matrix is safe and effective under the proposed conditions of use and substantially equivalent to its predicate devices.
Poy.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three curved lines representing the wings and a simple representation of the head and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integra LifeSciences Corporation % Ms. Diana M. Bordon Manager, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
OCT ] 0 2007
Re: K072113
Trade/Device Name: INTEGRA™ Flowable Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: July 31, 2007 Received: August 1, 2007
Dear Ms. Bordon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Diana M. Bordon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours Mark N. Melke
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
INTEGRA™ Flowable Wound Matrix Device Name:
Indications For Use: INTEGRA™ Flowable Wound Matrix 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 | AND/OR | Over-The-Counter Use ______ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDH: Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K072113 |
|---|---|
| --------------- | --------- |
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