LYOPLANT ONLAY

K122791 · Aesculap, Inc. · GXQ · Jun 4, 2013 · Neurology

Device Facts

• Record ID: K122791
• Device Name: LYOPLANT ONLAY
• Applicant: Aesculap, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Jun 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lyoplant Onlay is indicated as a dura substitute for the repair of the dura mater.

Device Story

Lyoplant Onlay is a sterile, flexible, single-use collagen implant derived from bovine pericardium and bovine split hide. Used by neurosurgeons during surgical procedures to repair dura mater defects. The device is applied directly to the defect site, either as an onlay or sutured in place, depending on surgeon preference. Once implanted, the collagen matrix is enzymatically degraded and replaced by the patient's own connective tissue. The device provides a barrier to cerebrospinal fluid (CSF) leakage and supports tissue integration. It is supplied in various sizes that can be trimmed to fit the specific defect area. By facilitating dural repair, the device helps prevent CSF leaks and promotes natural healing.

Clinical Evidence

Animal study (n=34 pigs) compared Lyoplant Onlay to Suturable DuraGen and autologous periosteum. Endpoints included safety, efficacy, handling, CSF tightness, and tissue integration at 1 and 6 months. Results showed superior handling for Lyoplant Onlay and Suturable DuraGen compared to periosteum, with a trend for better adhesion and CSF tightness for Lyoplant Onlay. All devices showed complete integration by 6 months. No implant rejection observed. Bench testing included thickness, tensile strength, suture retention, burst strength, shrink temperature, and chemical characterization. Biocompatibility testing followed ISO 10993-1.

Technological Characteristics

Material: Pure collagen from bovine pericardium and bovine split hide. Form: Flexible, sterile, single-use sheets. Properties: CSF impermeable, tear-resistant. Sterilization: Ethylene Oxide (EtO). Biocompatibility: Tested per ISO 10993-1.

Indications for Use

Indicated for repair of the dura mater in patients requiring dural reconstruction. Contraindicated in infected areas, open cranial trauma, open spina bifida, as a replacement for mechanically stressed connective tissue, as a substitute for arterial or cardiac wall parts, and in patients with known allergies to bovine-derived proteins.

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

• Lyoplant (K970851)
• Suturable DuraGen (K043247)
• Durepair (K041000)

Submission Summary (Full Text)

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# K122791 Page 1 of 3

C. 510(K) SUMMARY As required by 21 CFR 807.92

JUN 0-4 2013

## LYOPLANT® ONLAY

September 10, 2012

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Registration No .: 2916714

CONTACT: Denise R. Adams, Requlatory Affairs Specialist 610-984-9076 (phone) 610-791-6882 (fax) [e-mail] (email)

| TRADE NAME: | Lyoplant® Onlay |
|---------------|-----------------|
| COMMON NAME: | Dura Substitute |
| REGULATION: | Dura Substitute |
| CLASS: | II |
| PRODUCT CODE: | GXQ |
| REGULATION: | 882.5910 |
| REVIEW PANEL: | Neurology |

#### INTENDED USE

Lyoplant Onlay is indicated as a dura substitute for the repair of the dura mater.

### DEVICE DESCRIPTION

Lyoplant Onlay is a dura substitute implant made of pure collagen that is obtained from bovine pericardium and bovine split hide.

Lyoplant Onlay can be laid on the defect, or sutured depending upon surgeon preference. After implantation, it is gradually broken down enzymatically and is replaced by the body's own connective tissue. The appropriate size implant is selected depending on the area of application and is cut to size depending on the size of the defect. Lyoplant Onlay is supplied sterile and packaged as a single piece.

#### TECHNOLOGICAL CHARACTERISTICS

Lyoplant Onlay is available as single use, sterile, flexible sheets of pure collagen with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute as described in FDA's quidance document for Dura Substitute Devices.

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K122791

Page 2 of 3

## PERFORMANCE DATA

Physical, mechanical, and biocompatibility testing have been performed on Lyoplant Onlay in accordance with the FDA quidance for industry for Dura Substitute Devices and has demonstrated the performance of Lyoplant Onlay as a dura substitute.

The following tests were conducted as recommended in the FDA quidance on Dura Substitute Devices:

- Device Thickness .
- Tensile Strength .
- Suture Retention Strenath .
- . Burst Strength
- Shrink Temperature Range .
- Surface Structure .
- Delamination .
- Chemical Characterization .

The following biocompatibility testing was conducted in accordance with ISO 10993-1:

- Cytotoxicity .
- . Maximization Sensation Study
- . Intracutaneous Study
- Systematic Toxicity .
- Genotoxicity .
- . Hemolysis
- Muscle Implantation .

Additionally, an animal study was conducted using thirty-four (34) pigs. The study was designed to investigate the safety and efficacy of Lyoplant® Onlay as a dura onlay graft in an in vivo model. Suturable DuraGen" and autologous periosteum were used as control materials. Animals were sacrificed at one (1) month and six (6) months at which time gross and histologic assessment was made. Results of the study demonstrate superior handling of Lvoplant® Onlay and Suturable DuraGen™ over periosteum with a trend for better adhesion to dura and CSF tightness for Lyoplant® Onlay. Periosteum, which was sutured, had the highest intraoperative CSF tightness. Duraplasty time with periosteum was significantly higher (14.4±2.7 min) compared with Lyoplant® Onlay (2.8±0.8 min) or Suturable DuraGen™ (3.0±0.5 min). Tissue integration by fibroblast infiltration was observed after one (1) month for all devices. More adhesions between graft and cortex were observed with Suturable DuraGen ™ compared with Lyoplant® Onlay and periosteum. No relevant adhesions between leptomeninges and Lyoplant® Onlay were observed and all devices showed comparable lymphocytic reaction of the brain. All devices were completely integrated after six (6) months. Lyoplant® Onlay and Suturable DuraGen™ showed a trend for an enhanced lymphocytic reaction of the brain parenchyma compared with periosteum. Implant rejection was not observed in any animals but several deaths occurred overall in the periosteum (n=3) and Suturable DuraGen™(n=4) cohorts.

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K122791

Results of in vitro, in vivo, and biocompatibility testing demonstrate that Lyoplant Onlay performs in accordance with its specifications and is substantially equivalent in safety and effectiveness to the predicate devices Lyoplant , Suturable DuraGen, and Durepair,

## SUBSTANTIAL EQUIVALENCE

Lyoplant Onlay, Lyoplant, Suturable DuraGen, and Durepair have similar technological characteristics. These devices are available as single use, sterile, flexible sheets of pure collagen with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.

The device modifications described in this premarket notification are substantially equivalent to the predicate device Lyoplant Dura Substitute cleared via K970851. Suturable DuraGen cleared via K043427, and Durepair cleared via K041000. Anv technological differences between Lyoplant Onlay and the predicate devices do not raise new types of safety or effectiveness issues.

| | Lyoplant Onlay<br>(subject device) | Lyoplant K970891<br>Aesculap | Suturable DuraGen<br>K043247 Integra<br>LifeSciences | Durepair K041000<br>Medtronic |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Lyoplant Onlay is<br>indicated as a dura<br>substitute for the<br>repair of the dura<br>mater. | Intended as a dura<br>mater substitute in<br>neurological<br>procedures for soft<br>tissue reconstruction<br>of damaged, impaired,<br>or missing tissue. | Indicated as a dura<br>substitute for the repair<br>dura mater | Durepair® is<br>indicated as a dura<br>substitute for the<br>repair of the dura<br>mater. |
| Contra-<br>indications | • Infected areas<br>• Open cranial trauma<br>• Open spina bifida<br>• As a replacement for<br>mechanically stressed<br>connective tissue<br>structures<br>• As a substitute for<br>parts in the arterial<br>system or the cardiac<br>wall<br>• If there are known<br>allergies to proteins of<br>bovine origin | • Infected areas<br>• Open cranial trauma<br>• Open spina bifida<br>• As a replacement for<br>mechanically stressed<br>connective tissue<br>structures<br>• As a substitute for<br>parts in the arterial<br>system or the cardiac<br>wall | • For patients with a<br>known history of<br>hypersensitivity to<br>bovine derived materials<br>• Should be used with<br>caution in infected<br>regions | • Durepair is not<br>designed, sold, or<br>intended for use<br>except as indicated.<br>• Durepair should not<br>used for patients<br>with a known history<br>of hypersensitivity to<br>collagen products.<br>• Durepair should be<br>used with caution in<br>regions where an<br>infection exists. |
| Type of<br>Collagen | bovine pericardium<br>and bovine split hide | bovine pericardium | bovine Achilles tendon | bovine skin |
| Application | Onlay or suture | Suture | Onlay or suture | Onlay or suture |
| Sterilization | EtO | EtO | EtO | EtO |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with outstretched wings, with three wavy lines below it, possibly representing water or waves.

June 4, 2013

Public Health Service

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

Aesculap, Inc. % Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

Re: K122791

Trade/Device Name: Lyoplant® Onlay Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: April 29, 2013 Received: April 30, 2013

Dear Ms. Adams

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Denise R. Adams

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Kesia Y Alexander -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Genter-for-Devices-and-Radiological-Health

Enclosure

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Page 1 of 1

## A. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K122791

Device Name: Lyoplant® Onlay

Indication for Use:

Lyoplant® Onlay is indicated as a dura substitute for the repair of the dura mater.

Prescription Use X Over-the-Counter Use or (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> Tieuvi Hī 2013.05.22 22

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) 510 (k) Number K122791