(30 days)
Not Found
No
The summary describes a collagen matrix for dural repair and does not mention any AI or ML components or functionalities.
Yes
The device is used for the repair of dura mater, which is a medical treatment for a physiological condition.
No
Explanation: The device is an absorbable implant used for the repair of dura mater, not for diagnosing medical conditions.
No
The device description clearly states it is an "absorbable implant" and a "porous collagen matrix," indicating it is a physical, material-based 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 for repair of dural defects." This is a physical material implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) 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 II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Product codes
GXQ
Device Description
DuraGen II Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen II Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. DuraGen II Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen II Dural Regeneration Matrix may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.
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
Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen II 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
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
JAN 12 2005
K043427
page 1/1
DuraGen II Dural Regeneration Matrix 510(K) SUMMARY
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana M. Bordon Manager, Regulatory Affairs, (609) 936-2240
December 10, 2004 Date:
Name of the device:
| Proprietary Name: | DuraGen II |
|---|---|
| Common Name: | Dural Regeneration Matrix |
| Classification Name: | Dura Substitute, Product Code 84GXQ |
| Class II | |
| Regulation Number 882.5910 |
Substantial Equivalence:
DuraGen II Dural Regeneration Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen Plus™ Dural Regeneration Matrix (K032693).
Intended Use:
DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Device Description:
DuraGen II Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen II Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. DuraGen II Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen II Dural Regeneration Matrix may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.
Conclusion:
Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen II 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
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K043427
Trade/Device Name: DuraGen II Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: December 10, 2004 Received: December 13, 200
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.
2
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K043427 510(k) Number (if known):
Device Name: DuraGen II Dural Regeneration Matrix
Indications For Use:
DuraGen II 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K043427
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