Geistlich Fibro-Gide

K171050 · Geistlich Pharma AG · NPL · Nov 9, 2017 · Dental

Device Facts

• Record ID: K171050
• Device Name: Geistlich Fibro-Gide
• Applicant: Geistlich Pharma AG
• Product Code: NPL · Dental
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for: - Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants - Alveolar ridge reconstruction for prosthetic treatment - Recession defects for root coverage

Device Story

Geistlich Fibro-Gide is a fully resorbable, porous, porcine-derived collagen matrix (spongious consistency). Implanted by licensed dentists in clinical settings for soft tissue augmentation. Device acts as a scaffold; porous structure enables cell invasion and soft tissue ingrowth; provides volume stability while withstanding mechanical stresses post-wound closure. Degrades over time via natural resorption, eliminating need for removal. Wettability and suturability facilitate integration into surrounding tissue. Benefits include increased keratinized tissue, ridge reconstruction, and root coverage, utilizing patient's own healing capacity.

Clinical Evidence

Evidence includes biocompatibility testing (ISO 10993), bench testing, animal studies (rat/dog models), and a controlled, parallel, randomized clinical study. Animal studies confirmed tissue integration and comparable degradation rates to the predicate. Clinical study in patients with insufficient soft tissue volume demonstrated safety and effectiveness for the indicated uses. All biocompatibility endpoints (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, pyrogenicity) passed.

Technological Characteristics

Resorbable porcine collagen matrix (Type I/III collagen, elastin). Chemically cross-linked with EDC and NHS. Porosity >90%. Dimensions: 15x20mm, 20x40mm (approx. 6mm thick). Sterile (Gamma-irradiation, SAL 10^-6). Standards: ISO 10993 (biocompatibility), ISO 11137 (sterilization), ISO 11607 (packaging), ISO 22442 (animal tissues), ASTM F1980 (aging), ASTM F2450-10 (tissue engineering).

Indications for Use

Indicated for soft tissue augmentation in patients requiring localized gingival augmentation to increase keratinized tissue around teeth and implants, alveolar ridge reconstruction for prosthetic treatment, or treatment of recession defects for root coverage.

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

• Geistlich Mucograft® (K102531)

Reference Devices

• Geistlich Mucograft® and Geistlich Mucograft® Seal (K140518)
• Geistlich Mucograft® (K073711)
• Geistlich Mucograft® (K012423)
• GENOSS Collagen Membrane (K102307)

Submission Summary (Full Text)

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November 9, 2017

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Geistlich Pharma AG % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K171050

Trade/Device Name: Geistlich Fibro-Gide Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: October 12, 2017 Received: October 12, 2017

Dear Janice Hogan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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#### Page 2 - Janice Hogan

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

#### K171050

Device Name

Indications for Use (Describe)

Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for:

- Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants A
- Alveolar ridge reconstruction for prosthetic treatment A
- Recession defects for root coverage A

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

#### GEISTLICH FIBRO-GIDE®

#### SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

| Contact Person: | Marco Steiner |
|-----------------|----------------------------|
| Company: | Geistlich Pharma AG |
| Phone Number: | Direct 011 41 41 492 67 64 |
| | Company 011 41 492 55 55 |
| E-mail: | [e-mail] |
| Date Prepared: | November 9, 2017 |

#### DEVICE NAME

| Proprietary Name: | Geistlich Fibro-Gide® |
|----------------------|-----------------------------------------|
| Common/Usual Names: | Porcine Collagen Matrix |
| Classification Name: | Barrier, animal source, intraoral (NPL) |

#### PREDICATE DEVICES

Geistlich Mucograft® (K102531) (Primary predicate device)

Geistlich Mucograft® and Geistlich Mucograft® Seal (K140518) (Reference device)

Geistlich Mucograft® (K073711, K012423) (Reference devices)

GENOSS Collagen Membrane (K102307) (Reference device)

#### DEVICE DESCRIPTION

Geistlich Fibro-Gide® is a fully resorbable, porous, collagen matrix of porcine origin of a spongious consistency. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The collagen scaffold is weakly crosslinked. Geistlich Fibro-Gide® is sterilized in double packaging by Gamma-irradiation.

Geistlich Fibro-Gide® is an implantable device intended for use in soft tissue augmentation procedures. As described in more detail below, the device is indicated

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specifically for insufficient tissue volume at the alveolar ridge and for soft tissue recession. It has mechanical properties appropriate to withstand the mechanical stresses that occur after wound closure in soft tissue augmentation procedures, i.e., it has good volume stability and it withstands early resorption to allow the formation of new soft tissue and degrades over time. In addition, the matrix is designed with an appropriate thickness to provide sufficient space for the ingrowth of new soft tissue. Due to its good wettability, suturability and biological properties, the device becomes well integrated into the surrounding soft tissue.

## INTENDED USE AND INDICATIONS FOR USE

Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for:

- > Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants
- Alveolar ridge reconstruction for prosthetic treatment A
- > Recession defects for root coverage.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Geistlich Fibro-Gide® and its primary predicate device Geistlich Mucograft® are implantable, collagen matrices (scaffolds) used in dental soft tissue augmentation procedures. Both devices consist of collagen fibers in a loose, porous arrangement to enable cell invasion and settlement, providing an environment to allow for soft tissue growth by using the patient's own healing capacities. Both devices are fully resorbable and do not require a second intervention for removal. Like its reference device, Geistlich Fibro-Gide® is cross-linked. The device dimensions are similar and both devices require adaptation to fit the defect size.

Bench testing was conducted to compare Geistlich Fibro-Gide® against its predicate device in terms of its appearance, porosity, amino acid and protein composition, capillarity and wettability, as well as trimming, suturing and degradation capabilities.

| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft<br>(K102531 – Predicate<br>device; K140518, K073711,<br>K012423 – Reference<br>devices) | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | | | |
| Intended Use | Soft Tissue Augmentation | Soft Tissue Augmentation | |
| Indications for Use | Geistlich Fibro-Gide® is | | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft<br>(K102531 - Predicate<br>device; K140518, K073711,<br>K012423 - Reference<br>devices) | |
| | intended for soft tissue<br>augmentation. It is indicated<br>for:<br>Localized gingival<br>augmentation to<br>increase keratinized<br>tissue (KT) around<br>teeth and implants Alveolar ridge<br>reconstruction for<br>prosthetic treatment Recession defects<br>for root coverage | Covering of implants<br>placed in immediate<br>or delayed extraction<br>sockets Localized gingival<br>augmentation to<br>increase keratinized<br>tissue (KT) around<br>teeth and implants Alveolar ridge<br>reconstruction for<br>prosthetic treatment Recession defects<br>for root coverage | |
| Physical Characteristics | | | |
| Dimensions | 15x20 mm, 20x40mm<br>(thickness app. 6mm) | 15x20 mm, 20x30 mm<br>(K102531)<br>30x40 mm (K073711,<br>K012423)<br>(thickness app. 2.5 - 5 mm) | |
| Form | Sponge-like matrix | Sponge-like matrix | |
| Color | White to almost white | Almost white | |
| Porosity | Very porous materials with<br>average pore values of 90%<br>or more. The average<br>surface area and the bulk<br>density of Geistlich Fibro-<br>Gide® is almost identical to<br>that of Geistlich Mucograft. | Very porous materials with<br>average pore values of 90%<br>or more. The average<br>surface area and the bulk<br>density of Geistlich<br>Mucograft is almost identical<br>to that of Geistlich Fibro-<br>Gide. | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft<br>(K102531 - Predicate<br>device; K140518, K073711,<br>K012423 - Reference<br>devices) | |
| Capillarity and wettability | Spontaneously wettable and<br>completely soaked in<br>aqueous solution in less<br>than one minute | Spontaneously wettable and<br>completely soaked in<br>aqueous solution in less<br>than one minute | |
| Cross-linking | Chemically cross-linked with<br>EDC and NHS | Not chemically cross-linked | |
| Easy to trim with surgical<br>instruments (to fit a<br>template) | Can be cut with surgical<br>instruments | Can be cut with surgical<br>instruments | |
| Can be sutured | Can be fixed with sutures,<br>as demonstrated by<br>sutureability testing | Can be fixed with sutures,<br>as demonstrated by<br>sutureability testing | |
| Composition Materials | | | |
| Raw Material | Porcine connective tissue, | Porcine connective tissue, | |
| | Porcine skin tissue | Porcine skin tissue | |
| Composition | Porcine collagen: Product is<br>produced from the same<br>intermediate collagenous<br>products | Porcine collagen: Product is<br>produced from the same<br>intermediate collagenous<br>products | |
| Collagen / Elastin | Major protein components<br>Collagen I and Collagen III<br>(no Collagen II) and Elastin | Major protein components<br>Collagen I and Collagen III<br>(no Collagen II) and Elastin | |
| Amino Acid Composition | Very similar with equal<br>amounts of amino acids | Very similar with equal<br>amounts of amino acids | |
| Fat | Trace (less than 0.5%) | Trace (less than 0.5%) | |
| Glycosaminoglycans | Trace (less than 0.5%) | Trace (less than 0.5%) | |
| Other proteins > 0.5% | None | None | |
| pH | 3-7 | 3-7 | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft<br>(K102531 - Predicate<br>device; K140518, K073711,<br>K012423 - Reference<br>devices) | |
| Other Characteristics | | | |
| Source of raw material | Identical porcine tissue | Identical porcine tissue | |
| Manufacture | Multistage validated, SOP<br>controlled purification<br>process | Multistage validated, SOP<br>controlled purification<br>process | |
| Manufacturing conditions | Quality systems regulation<br>(CFR Part 820) | Quality systems regulation<br>(CFR Part 820) | |
| Packaging | Conforms to ISO 11607,<br>Parts 1 and 2.<br>Sterile double layer<br>packaging, including<br>aluminum layer to protect<br>against vapor penetration. | Conforms to ISO 11607,<br>Parts 1 and 2.<br>Sterile double layer<br>packaging, in aluminum<br>pouch to protect against<br>vapor penetration. | |
| Manufacture / Packaging<br>location | Geistlich Pharma AG,<br>Wolhusen,<br>Switzerland | Geistlich Pharma AG,<br>Wolhusen,<br>Switzerland | |
| Sterilization location | Synergy Health, Daeniken,<br>Switzerland | Synergy Health, Daeniken,<br>Switzerland | |
| Sterility | Gamma irradiation<br>SAL 10-6; Device provided<br>sterile, for single use only | Gamma irradiation<br>SAL 10-6; Device provided<br>sterile, for single use only | |
| User | Restricted to licensed<br>dentists | Restricted to licensed<br>dentists | |
| Principles of Operation | | | |
| Principles of Operation | Implantable resorbable<br>collagen matrix (scaffold)<br>consisting of collagen fibers<br>in a loose, porous | Implantable resorbable<br>collagen matrix (scaffold)<br>consisting of collagen fibers<br>in a loose, porous | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft<br>(K102531 - Predicate<br>device; K140518, K073711,<br>K012423 - Reference<br>devices)…