← Product Code [GXQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ) · K092388 # DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO (K092388) _Integra LifeSciences Corporation · GXQ · Jan 21, 2010 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K092388 ## Device Facts - **Applicant:** Integra LifeSciences Corporation - **Product Code:** [GXQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ.md) - **Decision Date:** Jan 21, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5910 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use DuraGen Plus® Dural Regeneration Matrix Spinal Matrix is indicated as a dura substitute for the repair of dura mater. Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater. ## Device Story Absorbable, soft, white, pliable, nonfriable, porous collagen matrix implant; used for repair of dural defects. Device supplied sterile, non-pyrogenic, for single-use. Packaging modification allows two units of 1 inch by 3 inch collagen matrix to be supplied in a single sterile blister tray with two wells. Implanted by surgeons during spinal procedures to serve as a dural substitute. Benefits include ease of handling and support for dural regeneration. ## Clinical Evidence No clinical data presented. Substantial equivalence supported by physical property testing, packaging validation, shipping validation, and design validation. ## Technological Characteristics Absorbable collagen matrix; 1 inch x 3 inch dimensions; porous structure. Supplied sterile in double-peel packaging. No electronic components or software. ## Regulatory Identification A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain). ## Predicate Devices - DuraGen Plus® Dural Regeneration Matrix ([K032693](/device/K032693.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JAN 9 1 2010 ## 510(K) SUMMARY DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and IntegraTM SpinalMendTM Dural Regeneration Matrix #### Submitter's name and address: ン Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA #### Contact person and telephone number: Candice Arner Regulatory Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA Phone: (609) 936-2387 Fax: (609) 275-9445 candice.arner@integra-ls.com Date: July 31, 2009 #### Name of the device: | Proprietary Name: | DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™
SpinalMend™ Dural Regeneration Matrix | |----------------------|---------------------------------------------------------------------------------------------------------------| | Common Name: | Dural Graft Matrix | | Classification Name: | Dura Substitute, Product Code GXQ
Class II
Regulation Number 882.5910 | ## Substantial Equivalence: DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are substantially equivalent in function and intended use to the currently marketed DuraGen Plus® Dural Regeneration Matrix (K032693). #### Device Description: DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are absorbable implants for the repair of dural defects. They are easy to handle, soft, white, pliable, nonfriable, porous collagen matrices. DuraGen Plus® Spinal Matrix and Integrating SpinalMend™ are supplied sterile, non-pyrogenic, for single-use. The package iji {1}------------------------------------------------ contains two (2) 1 inch (2.5 cm) by 3 inch (7.5 cm) DuraGen Plus® devices in double peel packages. ### Intended Use: - 1. DuraGen Plus® Dural Regeneration Matrix Spinal Matrix is indicated as a dura substitute for the repair of dura mater. - 2. Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater. ### Comparison to Predicate: DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are substantially equivalent in function and intended use to the currently marketed DuraGen Plus® Dural Regeneration Matrix (K032693) as delineated in Table 1. | Feature | Predicate :
DuraGen Plus® Dural
Regeneration Matrix | DuraGen Plus® Dural Regeneration
Matrix – Spinal Matrix and
Integra™ SpinalMend™ Dural
Regeneration Matrix | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Integra LifeSciences Corporation | Integra LifeSciences Corporation | | 510(k) | 510(k) K032693 | Not yet assigned | | Indications for Use | Dura Substitute
DuraGen Plus® Dural Regeneration
Matrix is indicated as a dura
substitute for the repair of dura
mater. | Same | | Feature | Predicate:
DuraGen Plus® Dural
Regeneration Matrix | DuraGen Plus® Dural Regeneration
Matrix - Spinal Matrix and
Integra™ SpinalMend™ Dural
Regeneration Matrix | | Contraindications | DuraGen Plus® Dural Regeneration
Matrix is not designed, sold or
intended for use except as described
in the indications for use and is
contraindicated in the following
situations:

For patients with a known
history of hypersensitivity to bovine
derived materials.

For repair of spinal neural tube
defects; anterior spinal surgery with
dural resection (e.g., transoral
surgery).

Should be used with caution in
infected regions.

Not recommended to cover
dural defects involving mastoid air
cells.

Not recommended for large
defects at the skull base following
surgery. | Same | | Design | | | | Physical Structure | Collagen matrix that is 1 inch
(2.5cm) x 3 inch (7.5cm) in
dimension (average of 3.5mm in
height), that is packaged in a single
sterile inner blister tray with one (1)
well to hold the device, and sealed
within an outer blister tray. | Configuration comprised of two (2)
units of the currently marketed 1 inch
(2.5cm) x 3 inch (7.5cm) predicate
collagen matrix, in which the two (2)
units are packaged together in a single
sterile inner blister tray with two (2)
wells to hold each device, and sealed
within an outer blister tray. | ## Table 1: Substantial Equivalence Chart {2}------------------------------------------------ # Assessment of Performance Data: Since DuraGen Plus® Spinal Matrix and Integra™ SpinalMend™ are identical to DuraGen Plus® Dural Regeneration Matrix, except for modifications relating to the packaging configuration, testing in support of the modifications included a packaging validation, shipping validation, and design validation. {3}------------------------------------------------ #### Conclusion: . Valid scientific evidence through physical property testing and upon review of published clinical evidence provide reasonable assurance that the DuraGen Plus® Dural Regeneration Matrix -Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are safe and effective under the proposed conditions of use, and are, with respect to intended use and technological characteristics, substantially equivalent to the predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Integra Lifesciences Corporation c/o Ms. Candice Arner Regulatory Affairs Associate 311 Enterprise Drive Plainsboro, NJ 08536 JAN 2 1 2010 Re: K092388 Trade/Device Name: DuraGen Plus® Dural Regeneration Matrix – Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 18, 2009 Received: December 22, 2009 Dear Ms. Arner: 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 the Federal Food, Drug, You may, therefore, market the device, subject to the 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 mistranding 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, Thie 21, Parts 800 to 89%. In addition 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 registration and listing in CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medica {5}------------------------------------------------ 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. 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.htm. Sincerely yours. sincerely, yours, Kesia Alexander for Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## INDICATIONS FOR USE # 510(k) Number: Kt92388 Device Name: DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ and SpinalMendTM Dural Regeneration Matrix Indications for Use: DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix is indicated as a dura substitute for the repair of dura mater Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) 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) e (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 1 of 1 510(k) Number K092386 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K092388](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K092388) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com