(15 days)
Not Found
No
The summary describes a collagen matrix for dural repair and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes
The device is used to repair dura mater, which is a therapeutic function.
No
The device is described as an absorbable implant used for the repair of dura mater, indicating its function as a therapeutic or restorative device rather than a diagnostic one.
No
The device description clearly states it is an "absorbable implant" and a "porous collagen matrix," indicating it is a physical, hardware-based medical 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 "as a dura substitute for the repair of dura mater." This describes a surgical implant used directly on a patient's tissue.
- Device Description: The description details a "porous collagen matrix" that is an "absorbable implant." This is a physical material intended for surgical placement.
- 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.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
DuraGen XSTM Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Product codes
GXP
Device Description
DuraGen XS™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects and is to be used as sutureless onlay graft. DuraGen XS™ Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with increased mass and density. DuraGen XSTM Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
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)
Valid scientific evidence through physical property testing provides reasonable assurance that DuraGen XS™ Dural Regeneration Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the text "K072207" at the top, followed by the word "CONFIDENTIAL" in bold and capital letters. To the right of "CONFIDENTIAL" is the text "page 1/1" in a handwritten font. A horizontal line is at the bottom of the image.
DuraGen XSTM Dural Regeneration Matrix 510(k) Summary
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536 USA
Contact person and telephone number:
AUG 2 3 2007
Peter Allan Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 (609) 936- 2237
Date prepared: August 7, 2007
Name of device:
DuraGen XS™ Dural Regeneration Matrix Proprietary Name: Dural Graft Matrix Common Name: Classification Name: Dura Substitute
Substantial Equivalence:
The DuraGen XSTM Dural Regeneration Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen Plus® Dural Regeneration Matrix (K032693).
Intended Use:
DuraGen XSTM Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Device Description:
DuraGen XS™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects and is to be used as sutureless onlay graft. DuraGen XS™ Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with increased mass and density. DuraGen XSTM Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Conclusion:
Valid scientific evidence through physical property testing provides reasonable assurance that DuraGen XS™ Dural Regeneration Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
1
Public Health Service
Image /page/1/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integra LifeSciences Corporation % Mr. Peter Allan Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536
AUG 2 3 2007
Re: K072207
Trade/Device Name: DuraGen XS™ Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXP Dated: August 7, 2007 Received: August 8, 2007
Dear Mr. Allan:
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.
2
Page 2 – Mr. Peter Allan
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 yours
p.p
DSP Dig
8/23/07
Mark N. Melkerson
Mark N. Melkerson 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):
Device Name: DuraGen XSTM Dural Regeneration Matrix
Indications For Use:
DuraGen XS™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
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) |
|---|
| -------------------------------------------------------- |
| Division Sign-Off | · Page 1 of 1 |
|---|---|
| ------------------- | --------------- |
Division of General, Restorative, and Neurological Devices *
| 510(k) Number | 672267 |
|---|---|
| --------------- | -------- |
B-001