BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION

K042197 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPL · Nov 15, 2004 · Dental

Device Facts

• Record ID: K042197
• Device Name: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
• Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
• Product Code: NPL · Dental
• Decision Date: Nov 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIO-GIDE® is recommended for: . Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; . Augmentation around implants placed in immediate extraction sockets; . Augmentation around implants placed in delayed extraction sockets; . Localized ridge augmentation for later implantation; . Alveolar ridge reconstruction for prosthetic treatment; Filling of bone defects after root resection, cystectomy, removal of retained teeth; ● . Guided bone regeneration in dehiscence defects; and Guided tissue regeneration procedures in periodontal defects,

Device Story

BIO-GIDE® is a resorbable bilayer membrane derived from porcine collagen (Type I and III). It functions as a physical barrier for guided tissue and bone regeneration in dental surgery. The bilayer structure features a porous surface facing the bone to facilitate bone-forming cell ingrowth and a dense surface facing soft tissue to prevent fibrous tissue infiltration. The device is implantable, cell-occlusive, and hemostatic. It is used by dental clinicians in clinical settings to enhance regeneration of the periodontal apparatus and bone defects. The membrane is provided sterile via gamma irradiation and resorbs over time, eliminating the need for surgical removal.

Clinical Evidence

Clinical evidence consists of multiple peer-reviewed studies evaluating the use of BIO-GIDE® in periodontal and bone regeneration. Studies include comparative clinical trials, histological evaluations, and controlled re-entry studies (e.g., Romagna-Genon 2001, Camelo et al. 1998/2001, Sculean et al. 2003). These studies demonstrate the device's effectiveness in treating intrabony defects, molar furcations, and periodontal regeneration when used in combination with bone grafting materials or as a barrier membrane.

Technological Characteristics

Resorbable bilayer membrane composed of porcine-derived Type I and Type III collagen. Bilayer structure: porous side for bone cell ingrowth, dense side for soft tissue occlusion. No cross-linking or chemical treatment. Sterilized via gamma irradiation. Dimensions/form factor: membrane. Standalone device. Non-pyrogenic and biocompatible.

Indications for Use

Indicated for patients requiring guided tissue and bone regeneration in dental procedures, including implant placement (immediate/delayed extraction sockets), ridge augmentation, alveolar ridge reconstruction, filling of bone defects (post-root resection, cystectomy, tooth removal), dehiscence defects, and periodontal defects.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• BIO-GIDE® (K960724)
• BioMend Extend® (K99216)

Submission Summary (Full Text)

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K042197

## 510(k) Summary

# BIO-GIDE®

#### 1. SPONSOR

Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND

Contact Person: Peter S. Reichertz, [phone] Date Prepared: August 12, 2004

#### 2. DEVICE NAME

| Proprietary Name: | BIO-GIDE® |
|----------------------|------------------------------------------------------------------------|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone<br>Regeneration |
| Classification Name: | Dental Bone Grafting Material |

#### 3. PREDICATE DEVICES

BIO-GIDE® (K960724)

BioMend Extend® (K99216)

#### 4. INTENDED USE

BIO-GIDE® is recommended for:

- . Simultaneous use of GBR-membrane (BIO-GIDE®) and implants;
- . Augmentation around implants placed in immediate extraction sockets;
- . Augmentation around implants placed in delayed extraction sockets;
- . Localized ridge augmentation for later implantation;
- . Alveolar ridge reconstruction for prosthetic treatment;
- Filling of bone defects after root resection, cystectomy, removal of retained teeth; ●
- . Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal defects,

#### ડ. DEVICE DESCRIPTION

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to BIO-GIDE® (K960724), but labeled with an additional indication; guided tissue regeneration in periodontal defects. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic

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reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is substantially equivalent to Geistlich's existing product, BIO-GIDE® (K960724), and BioMend Extend™ (K992216). The only difference between the new product and the BIO-GIDE® product previously cleared is the additional indication for guided tissue regeneration in periodontal defects. ("GTR"). The following is a table comparing BIO-GIDE® to BioMend Extend™, a collagen membrane cleared for GTR.

# Table I: BioMend Extend™ Absorbable Collagen Membrane (Predicate Device) vs. BIO-GIDE® Resorbable Bilayer Membrane Comparison Chart

| | BioMend Extend™<br>Absorbable Collagen<br>Membrane | BIO-GIDE® Resorbable<br>Bilayer Membrane |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. |
| Incorporate Same Basic<br>Design | Yes | Yes |
| Utilizes the Same Operating<br>Principle | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic |
| Incorporates Same<br>Materials? | Yes, Type I Collagen | Yes, Type I and Type III<br>Collagen |
| Sterilization Process | ETO | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 24 Months | 36 Months |

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## Studies Submitted:

Romagna-Genon, C., Comparative Clinical Study of Guided Tissue Regeneration with a Bioabsorbable Bilayer Collagen Membrane and Subepithelial Connective Tissue Graft, J. Periodontol, 72 (9), p. 1258-1264, (2001)

Lekovic, V., et. al., Effectiveness of a Combination of Platelet-Rich Plasma, Bovine Porous Bone Mineral and Guided Tissue Regeneration in the Treatment of Mandibular Grade II Molar Furcations in Humans, J. Clin. Periodontol, (30), p. 746-51. (2003)

Houser, B.E., et. al., Clinical Evaluation of Anorganic Bovine Bone Xenograft with a Bioabsorbable Collagen Barrier in the Treatment of Molar Furcation Defects, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 161-69. (2001)

Camargo, P.M., et. al., A Controlled Re-Entry Study on the Effectiveness of Boyine Porous Bone Mineral Used in Combination with a Collagen membrane of Porcine Origin in the Treatment of Intrabony Defects in Humans, J. Clin. Periodontol (27), p. 889-896. (2000)

Sculean, A., et. al., Healing of Intrabony Defects Following Treatment with a Bovine Derived Xenograft and Collagen Membrane, J. Clin. Periodontol (30), p. 73-80. (2003)

Tonetti, M.S., et. al., Clinical Outcomes Following Treatment of Human Intrabony Defects with GTR/Bone Replacement Material or Access Flap Alone, J. Clin. Periodomol (To Be Published)

Camelo, M., Nevins, M.L., et. al., Clinical, Radiographic, and Histologic Evaluation of Human Periodontal Defects Treated with BIO-OSS® and BIO-GIDE®, The Int'l J. of Periodontics & Restorative Dentistry, 18(4), p. 321-331. (1998)

Camelo, M., Periodontal Regeneration with an Autogenous Bone-BIO-OSS® Composite Graft and a BIO-GIDE® Membrane, The Int'l J. of Periodontics & Restorative Dentistry, 21(2), p. 109-119. (2001)

Yamada, Satoru, Effect of Porous Xenographic Bone Graft with Collagen Barrier Membrane on Periodontal Regeneration, The Int'l J. of Periodontics & Restorative Dentistry, 22(4), p. 389-397. (2002)

Nevins, M.L., et. al., Evaluation of Periodontal Regeneration Following Grafting Intrabony Defects with BIO-OSS® Collagen: A Human Histologic Report, The Int'l J. of Periodontics & Restorative Dentistry, 23(1), p. 9-17. (2003)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

# OCT 1 0 2007

Ed. Geistlich Soehne Ag Fur Chemische Industrie C/O Mr. Peter S. Reichertz Official Correspondent/U.S. Agent Sonnenschein Nath & Rosenthal LLP 1301 K Street NW, Suite 600 Washington, D.C. 20005

Re: K042197

Trade Name: BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: August 12, 2004 Received: August 18, 2004

Dear Mr. Reichertz:

This letter corrects our substantially equivalent letter of November 15, 2004.

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 (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.

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.

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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); 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.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Guyte Y. Mchaine Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Protesting and Promoting Public Health

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510(k) Number (if known): KC42097

- BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Device Name: Regeneration. Simultaneous use of GBR-membrane and implants; augmentation around Indications for Use: implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal defects.
Seven Runor

(Division Sich-Off (Division Sirn-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Control, Dental De 510(k) Number: J

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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