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 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 contains two (2) 1 inch (2.5 cm) by 3 inch (7.5 cm) DuraGen Plus® devices in double peel packages.

AI/ML Overview

The provided 510(k) summary is for a medical device called "DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix," which are Dural Graft Matrices intended as dura substitutes for the repair of dura mater.

This document does not describe a study to prove performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance evaluation. Instead, it argues for substantial equivalence to an existing predicate device (DuraGen Plus® Dural Regeneration Matrix, K032693). The core of the submission is that the new devices are identical to the predicate device except for modifications relating to the packaging configuration.

Therefore, most of the requested information (sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets) is not applicable or not provided because the submission methodology relies on substantial equivalence rather than de novo performance testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Formal, quantifiable acceptance criteria with a corresponding performance table are not presented in this document. The "performance" assessment is based on the devices being identical to a predicate device, with specific testing related to the packaging modifications.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	The devices are "substantially equivalent in function and intended use to the currently marketed DuraGen Plus® Dural Regeneration Matrix (K032693)."
Safety and Effectiveness under Proposed Conditions of Use	"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."
Technological Characteristics Equivalence to Predicate Device	The devices are "substantially equivalent ... to the predicate device" in terms of "technological characteristics." The only difference noted is the packaging configuration.
Packaging Validation	Testing included "packaging validation."
Shipping Validation	Testing included "shipping validation."
Design Validation	Testing included "design validation."

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is based on substantial equivalence to a predicate device, not on new clinical performance data from a test set. The changes relate to packaging, which would involve engineering/material testing, not a clinical "test set" in the context of diagnostic accuracy or clinical outcomes for a patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As there is no clinical test set in the traditional sense, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No clinical test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a dural graft matrix, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is a dural graft matrix, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the packaging, shipping, and design validation tests mentioned, the "ground truth" would likely be engineering specifications, material properties, sterility standards, and potentially regulatory guidelines for packaging integrity and device preservation during transit. No specific details are provided on what these "ground truths" were or how they were established, only that the testing was performed.

8. The sample size for the training set:

Not Applicable. This submission does not involve an algorithm with a training set.

9. How the ground truth for the training set was established:

Not Applicable. This submission does not involve an algorithm with a training set.

Summary

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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 GXQClass IIRegulation 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:

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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.
1. Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

Comparison to Predicate:

Feature	Predicate :DuraGen Plus® DuralRegeneration Matrix	DuraGen Plus® Dural RegenerationMatrix – Spinal Matrix andIntegra™ SpinalMend™ DuralRegeneration Matrix
Manufacturer	Integra LifeSciences Corporation	Integra LifeSciences Corporation
510(k)	510(k) K032693	Not yet assigned
Indications for Use	Dura SubstituteDuraGen Plus® Dural RegenerationMatrix is indicated as a durasubstitute for the repair of duramater.	Same
Feature	Predicate:DuraGen Plus® DuralRegeneration Matrix	DuraGen Plus® Dural RegenerationMatrix - Spinal Matrix andIntegra™ SpinalMend™ DuralRegeneration Matrix
Contraindications	DuraGen Plus® Dural RegenerationMatrix is not designed, sold orintended for use except as describedin the indications for use and iscontraindicated in the followingsituations:For patients with a knownhistory of hypersensitivity to bovinederived materials.For repair of spinal neural tubedefects; anterior spinal surgery withdural resection (e.g., transoralsurgery).Should be used with caution ininfected regions.Not recommended to coverdural defects involving mastoid aircells.Not recommended for largedefects at the skull base followingsurgery.	Same
Design
Physical Structure	Collagen matrix that is 1 inch(2.5cm) x 3 inch (7.5cm) indimension (average of 3.5mm inheight), that is packaged in a singlesterile inner blister tray with one (1)well to hold the device, and sealedwithin an outer blister tray.	Configuration comprised of two (2)units of the currently marketed 1 inch(2.5cm) x 3 inch (7.5cm) predicatecollagen matrix, in which the two (2)units are packaged together in a singlesterile inner blister tray with two (2)wells to hold each device, and sealedwithin an outer blister tray.

Table 1: Substantial Equivalence Chart

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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.

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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.

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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

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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

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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)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K092386

Regulation Number and Section

§ 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).