LYOPLANT DURA SUBSTITUTE(VARIOUS)

K970851 · Aesculap, Inc. · GXQ · Dec 9, 1997 · Neurology

Device Facts

• Record ID: K970851
• Device Name: LYOPLANT DURA SUBSTITUTE(VARIOUS)
• Applicant: Aesculap, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

Device Story

Lyoplant is a sterile, lyophilized dura mater substitute composed of pure bovine pericardium collagen. It is provided as thin, flexible sheets of varying sizes. During neurological surgery, the surgeon applies the patch to reconstruct damaged or missing dura mater. The device acts as a physical barrier to prevent cerebrospinal fluid (CSF) leakage. It is designed to be integrated into the host's connective tissue, promoting healing without triggering significant foreign body or immunological responses. The device is intended for use by neurosurgeons in clinical settings.

Clinical Evidence

Clinical investigation confirmed biocompatibility and handling properties. Implants demonstrated integration into connective tissue without immunological or adverse responses. Preclinical studies included sensitization, toxicity, and immunogenic testing, showing the device is non-sensitizing, non-toxic, and possesses weak/non-reactive immunogenic potential. Animal studies showed excellent tissue tolerance and absence of giant cells, indicating no foreign body reaction.

Technological Characteristics

Lyoplant consists of lyophilized pure collagen derived from bovine pericardium. It is supplied as a sterile, non-pyrogenic, thin, flexible sheet. Key characteristics include CSF impermeability, tear resistance, and biocompatibility. It is a passive implantable device.

Indications for Use

Indicated for patients undergoing neurological procedures requiring soft tissue reconstruction of damaged, impaired, or missing dura mater.

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

• Dura-Guard™ Dural Repair Patch (by Bio-Vascular, Inc.)
• Perl-Guard® Pericardium (by Bio-Vascular, Inc.)
• Neuro-Patch Dura Substitute
• Preclude Dura Substitute (by W.L. Gore)
• Dura Film (by Codman)
• Tutoplast® Dura substitute (by Biodynamics, Inc.)

Submission Summary (Full Text)

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K970851
DEC - 9 1997

# 510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

## Lyoplant® Dura Substitute
### March 6, 1997

**Submitted by:**
Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
**Contact:** Victoria Mackinnon
**Phone:** [phone] x346
**FAX:** [phone]

**Product Name:** Lyoplant® Dura substitute
**Common Name:** Dura substitute

## Device Description

The Lyoplant® device is a lyophilized dura substitute of pure collagen derived from bovine pericardium. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.

## Intended Use

Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

## Predicate Devices

Predicate devices are available in synthetic and organic materials (see table below).

| Device | Material Composition |
| --- | --- |
| Dura-Guard™ Dural Repair Patch (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovine pericardium. |
| Perl-Guard® Pericardium (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovine pericardium. |
| Neuro-Patch Dura Substitute | Polyesterurethane (PUR) |
| Preclude Dura Substitute (by W.L. Gore) | expanded polytetrafluoroethylene (ePTFE) |
| Dura Film (by Codman) | Silicone rubber sheet reinforced with Dacron® polyester. |
| Tutoplast® Dura substitute (by Biodynamics, Inc.) | Human dura composed of collagenous connective tissue. |

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]
004

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510(k) Premarket Notification
Lyoplant Dura Substitute

# LYOPLANT, S&E Summary, page 2.

## Technological Characteristics

Lyoplant and its predicates have similar technological characteristics. All of these devices are available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.

The technological differences between Lyoplant and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. Physical, laboratory, animal and human clinical test methods have been performed and have proven the ability of Lyoplant to function as a dura substitute.

## Performance Data

Performance data and test findings relative to the biocompatibility, pyrogenicity, toxicity, sterility and clinical safety have been performed and are provided in this document. A summary of these findings are noted below.

### 1. Preclinical Studies and Results

The biocompatibility of Lyoplant has been thoroughly evaluated and addressed in numerous preclinical studies.

Through various sensitization, toxicity, and immunogenic testing, Lyoplant was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic and possess a weak or virtually non-reactive immunogenic potential.

Animal studies have shown the Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.

### 2. Clinical Studies and Results

A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. The implants showed development of connective tissue with no immunological or adverse response.

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510(k) Premarket Notification
Lyoplant Dura Substitute

Lyoplant, S&E Summary, page 3.

3. Manufacturing and Final Product Quality Testing
Lyoplant is manufactured in compliance with Good Manufacturing Practice Regulations. In process and final product analytical, physical and microbiological testing assures that Lyoplant conforms to specifications prior to release.

The test data from the extensive *in vitro* and *in vivo* preclinical testing, and human clinical findings presented in the submission establish that Lyoplant is equivalent to predicate devices in its biocompatibility and its safety and effectiveness as a dura substitute.

006

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
DEC - 9 1997

Ms. Victoria Mackinnon
Manager, Regulatory Affairs
AESCULAP®
1000 Gateway Boulevard
South San Francisco, California 94080-7030

Re: K970851
Trade Name: Lyoplant Dura Substitute
Regulatory Class: II
Product Code: GXQ
Dated: September 29, 1997
Received: October 1, 1997

Dear Ms. Mackinnon

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Victoria Mackinnon

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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510(k) Premarket Notification
Lyoplant Dura Substitute
Page 1 of 1

# INDICATION FOR USE STATEMENT

510(k) Number (if known): N/A K970851

## Device Name:

Lyoplant Dura Substitute

## Indication for Use:

Lyoplant Dura Substitute presented in this submission is intended as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)


(Division Sign-Off)
Division of Cardiovascular Respiratory,
and Neurological Devices
510(k) Number K970851

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