SYNTHECEL DURA REPLACEMENT DEVICES

K113071 · Synthes · GXQ · Jan 9, 2012 · Neurology

Device Facts

• Record ID: K113071
• Device Name: SYNTHECEL DURA REPLACEMENT DEVICES
• Applicant: Synthes
• Product Code: GXQ · Neurology
• Decision Date: Jan 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.

Device Story

SyntheCel® Dura Replacement Devices consist of biosynthesized cellulose and water; non-woven, interconnected fiber construction. Functions as mechanical layer to protect/repair dura mater; prevents CSF leakage. Non-resorbable; immunologically inert. Used in surgical settings by neurosurgeons for dural defect repair. Onlay version placed without sutures; Substitute version sutured into place. Provides physical barrier to support healing and reduce risk of CSF fistula or pseudomeningocele.

Clinical Evidence

Prospective clinical study of 99 patients (62 investigational, 37 control) across 8 sites. Primary endpoint: success defined as absence of CSF fistula and pseudomeningocele within 6 months post-op via radiographic/physical exam. Results showed SyntheCel® non-inferior to control group.

Technological Characteristics

Biosynthesized cellulose and water; non-woven, interconnected fiber structure. Non-resorbable. Biocompatibility per ISO 10993. Endotoxin levels < 0.06 EU/ml per FDA guidance. Mechanical properties include tensile strength, burst strength, and suture pull-out strength comparable to predicate devices.

Indications for Use

Indicated for adults requiring repair of dural defects. SyntheCel® Dura Onlay is for sutureless placement; SyntheCel® Dura Substitute is for sutured placement.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• Bio-Vascular's Dura-Guard (K950956, K973706, K982282)
• Integra Lifescience's DuraGen (K982180)
• Gore - Preclude MVP (K021477)

Submission Summary (Full Text)

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# K113071

JAN - 9 2012

### 1.0 SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS [510(k) Summary] per the requirements 21 CFR 807.92

Page I of 3 Date Prepared January 03, 2012 Submitter SYNTHES 1301 Goshen Parkway West Chester, PA 19380 United States of America Contact Andrea M. Tasker [e-mail] phone: [phone] Trade Name SyntheCel® Dura Replacement Devices, SyntheCel® Dura Onlay, SyntheCel® Dura Substitute Common Name Dura Replacement Device Classification Dura Substitute Name Classification 21 CFR 882.5910 Device Class I I Review Panel Neurology Product Code(s) GXQ Predicate Devices Bio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) SyntheCel® Dura Replacement Devices (Onlay and Substitute) are Device Description composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Replacement Devices function as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Replacement Devices are immunologically inert and have demonstrated minimal foreign body response. They are non-resorbable. Intended Use SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.

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# K113071

## 510(k) Summary (continued)

| Technological<br>Characteristics | The SyntheCel® Dura Replacement Devices are similar to the three<br>predicate devices (Bio-Vascular-Dura-Guard, Integra Lifesciences-<br>DuraGen, and Gore-Preclude MVP) in terms of intended use. All three<br>are intended for dura replacement for the repair of dura mater.<br>The SyntheCel® Dura Replacement Devices are similar to the two<br>predicate devices (Bio-Vascular-Dura-Guard, Integra Lifesciences-<br>DuraGen) in terms of physical properties (form, size, physical integrity,<br>thickness, suturability, drapability, conformability).<br>The SyntheCel® Dura Replacement Devices are similar to the predicate<br>device (Gore-Preclude MVP) in terms of resorbability. Both are non-<br>resorbable. |
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| Clinical Testing<br>Data | Clinical data were collected to evaluate the safety and effectiveness of<br>the SyntheCel® Dura Replacement Devices as compared to the Control.<br>The objective of this study was to demonstrate that the SyntheCel® Dura<br>Replacement Devices are substantially equivalent to other dura<br>replacement products that were previously cleared for marketing by<br>FDA. A total of 99 patients were enrolled, randomized and treated (62<br>in the investigational SyntheCel® treatment group and 37 in the control<br>group) at 8 clinical sites.<br>Patients were evaluated intra-operatively and immediately post-<br>operatively (1 - 10 days) followed by evaluations at one (1) month, three<br>(3) months and six (6) months. Complications and adverse events,<br>device-related or not, were evaluated over the course of the clinical trial.<br>At each evaluation time-point, the primary and secondary clinical<br>outcome parameters were evaluated. Safety and effectiveness was assessed in all randomized subjects.<br>Primary Efficacy Endpoint: The primary endpoint was based on the<br>findings up to and including the 6 month follow-up visit. An individual<br>patient's treatment was considered successful if and only if the following<br>criterion was met:<br>Success was defined as absence of CSF fistula (drainage from wound or<br>sinus) and pseudomeningocele within 6 months post-operatively<br>confirmed by radiographic evaluation and physical examination of<br>surgical site.<br>The results of overall success analyses indicate that the SyntheCel® is<br>non-inferior to the dura replacement control group. |
| Non-Clinical<br>Testing Data | Mechanical testing was performed for tensile strength, burst strength,<br>and suture pull-out strength on samples of SyntheCel® Dura<br>Replacement Devices and the predicates, DuraGen and Dura-Guard. All<br>samples were prepared per respective instructions. SyntheCel® Dura<br>Replacement Device performance was found to be comparable in tensile<br>strength, burst strength, and suture pull-out strength.<br><br>An animal study was performed comparing the SyntheCel® Dura<br>Replacement Devices and predicate devices in a Rabbit Durotomy<br>Implant Study. The results noted at necropsy show no meningitis, CSF<br>leakage, evidence of infection, hydrocephalus, device vascularization,<br>nor significant hemorrhage in any of the animals regardless of the<br>implant type. Overall, the SyntheCel® Dura Substitute performed no<br>different than the other predicate dura substitute materials.<br><br>An additional Rabbit Durotomy Implant Study Model was performed<br>using SyntheCel® Dura Replacement Devices. This study was<br>conducted by NAMSA following GLPs. According to the conclusion,<br>the SyntheCel® Dura Replacement Devices showed no evidence of a<br>toxic leachable or local adverse effect.<br><br>Biocompatibility testing according to standards set forth in ISO 10993<br>demonstrated that the material is non-irritating, non-sensitizing, non-<br>mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic.<br><br>Pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL)<br>test on the final sterilized SyntheCel® device and found to be less than<br>0.06 EU/ml (Endotoxin Units / ml) per FDA's Guidance Document for<br>Dura Substitute Devices. All SyntheCel® Dura Replacement Device<br>lots will be tested to ensure they are less than 0.06 EU/ml and will be<br>labeled non-pyrogenic. |
| Substantial<br>Equivalence to<br>Predicate Devices | Based on the information presented in this submission, which includes<br>mechanical testing, pre-clinical testing, animal testing, and clinical<br>testing, the SyntheCel® Dura Replacement Devices do not raise new<br>questions of safety and effectiveness. Therefore, it can be concluded<br>that the SyntheCel® Dura Replacement Devices are substantially<br>equivalent to the predicate devices for dura replacement devices in<br>commercial distribution for use as a dura replacement for the repair of<br>dura mater. |

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510(k) Summary (continued)

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(end of summary)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN - 9 2012

Synthes c/o Ms. Andrea M. Tasker CMF Regulatory Affairs Manager, Synthes 1301 Goshen Parkway West Chester, PA 19380

Re: K113071

Trade/Device Name: SyntheCel® Dura Replacement Devices Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXO Dated: October 14, 2011 Received: October 18, 2011

Dear Ms. Tasker:

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. 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 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of K Part 607), accimig (21 CFR 803); good manufacturing practice requirements as set do records and the overse oversion (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 n you 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 note the 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

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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

K113071 510(k) Number (if known):_

SyntheCel® Dura Replacement Devices Device Name:

Indications For Use:

SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)

ision of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

K11307 510(k) Number