(216 days)
Geistlich Mucograft® (K102531)
No
The description focuses on the material properties and biological function of a collagen matrix for soft tissue augmentation. There is no mention of AI or ML.
Yes.
The device is intended for soft tissue augmentation, including gingival augmentation and alveolar ridge reconstruction, which are therapeutic procedures aimed at treating or correcting medical conditions or defects.
No
This device is an implantable collagen matrix intended for soft tissue augmentation, not for diagnosing medical conditions. Its purpose is to provide structural support for tissue growth.
No
The device description clearly states it is a "fully resorbable, porous, collagen matrix of porcine origin" and an "implantable device," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Geistlich Fibro-Gide®'s Intended Use: The intended use of Geistlich Fibro-Gide® is for soft tissue augmentation through implantation. It is a physical material used to build up or replace tissue, not to analyze a sample from the body.
- Device Description: The description clearly states it is an implantable device intended for use in surgical procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids or tissues, providing diagnostic information, or using any methods typically associated with IVDs (like chemical analysis, immunological tests, or molecular diagnostics).
Geistlich Fibro-Gide® is a medical device, specifically an implantable device, used in surgical procedures for tissue augmentation.
N/A
Intended Use / 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 A
Product codes (comma separated list FDA assigned to the subject device)
NPL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around teeth and implants (gingival); Alveolar ridge (for prosthetic treatment); Recession defects (for root coverage).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Restricted to licensed dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All relevant biocompatibility tests were conducted as required according to Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing included Cytotoxicity, Irritation, Sensitization, Acute System Toxicity, Genotoxicity, Subchronic System Toxicity, Chronic System Toxicity, Implantation, Pyrogenicity, and Leachables. Other testing included viral clearance studies and residual chemical testing and toxicological assessment. Results indicate that the device is biocompatible.
Geistlich Fibro-Gide® was tested in a rat and in a dog study compliant with 21 CFR Part 58 to demonstrate substantial equivalence, safety and performance to its predicate device. The studies confirmed tissue integration, continuous resorption and comparable degradation rate of Geistlich Fibro-Gide® and the predicate devices. Further, the investigation of distal organs, hematologic parameters and clinical chemistries confirmed that the safety profile is acceptable. The dog study also investigated soft tissue augmentation and local tissue effects after several soft tissue augmentation periods in Geistlich Fibro-Gide® and the predicate device Geistlich Mucograft®. In all instances, the subject device was demonstrated to be substantially equivalent to the predicate device.
The clinical data from a controlled, parallel and randomized study in patients presenting insufficient soft tissue volume demonstrated product safety and effectiveness in the product's indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Geistlich Mucograft® (K102531)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Geistlich Mucograft® and Geistlich Mucograft® Seal (K140518), Geistlich Mucograft® (K073711), Geistlich Mucograft® (K012423), GENOSS Collagen Membrane (K102307)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.
0
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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: | marco.steiner@geistlich.ch |
| 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
4
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
(K102531 – Predicate
device; K140518, K073711,
K012423 – Reference
devices) | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | | | |
| Intended Use | Soft Tissue Augmentation | Soft Tissue Augmentation | |
| Indications for Use | Geistlich Fibro-Gide® is | | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft
(K102531 - Predicate
device; K140518, K073711,
K012423 - Reference
devices) | |
| | 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 | Covering of implants
placed in immediate
or delayed extraction
sockets Localized gingival
augmentation to
increase keratinized
tissue (KT) around
teeth and implants Alveolar ridge
reconstruction for
prosthetic treatment Recession defects
for root coverage | |
| Physical Characteristics | | | |
| Dimensions | 15x20 mm, 20x40mm
(thickness app. 6mm) | 15x20 mm, 20x30 mm
(K102531)
30x40 mm (K073711,
K012423)
(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
average pore values of 90%
or more. The average
surface area and the bulk
density of Geistlich Fibro-
Gide® is almost identical to
that of Geistlich Mucograft. | Very porous materials with
average pore values of 90%
or more. The average
surface area and the bulk
density of Geistlich
Mucograft is almost identical
to that of Geistlich Fibro-
Gide. | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft
(K102531 - Predicate
device; K140518, K073711,
K012423 - Reference
devices) | |
| Capillarity and wettability | Spontaneously wettable and
completely soaked in
aqueous solution in less
than one minute | Spontaneously wettable and
completely soaked in
aqueous solution in less
than one minute | |
| Cross-linking | Chemically cross-linked with
EDC and NHS | Not chemically cross-linked | |
| Easy to trim with surgical
instruments (to fit a
template) | Can be cut with surgical
instruments | Can be cut with surgical
instruments | |
| Can be sutured | Can be fixed with sutures,
as demonstrated by
sutureability testing | Can be fixed with sutures,
as demonstrated by
sutureability testing | |
| Composition Materials | | | |
| Raw Material | Porcine connective tissue, | Porcine connective tissue, | |
| | Porcine skin tissue | Porcine skin tissue | |
| Composition | Porcine collagen: Product is
produced from the same
intermediate collagenous
products | Porcine collagen: Product is
produced from the same
intermediate collagenous
products | |
| Collagen / Elastin | Major protein components
Collagen I and Collagen III
(no Collagen II) and Elastin | Major protein components
Collagen I and Collagen III
(no Collagen II) and Elastin | |
| Amino Acid Composition | Very similar with equal
amounts of amino acids | Very similar with equal
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
(K102531 - Predicate
device; K140518, K073711,
K012423 - Reference
devices) | |
| Other Characteristics | | | |
| Source of raw material | Identical porcine tissue | Identical porcine tissue | |
| Manufacture | Multistage validated, SOP
controlled purification
process | Multistage validated, SOP
controlled purification
process | |
| Manufacturing conditions | Quality systems regulation
(CFR Part 820) | Quality systems regulation
(CFR Part 820) | |
| Packaging | Conforms to ISO 11607,
Parts 1 and 2.
Sterile double layer
packaging, including
aluminum layer to protect
against vapor penetration. | Conforms to ISO 11607,
Parts 1 and 2.
Sterile double layer
packaging, in aluminum
pouch to protect against
vapor penetration. | |
| Manufacture / Packaging
location | Geistlich Pharma AG,
Wolhusen,
Switzerland | Geistlich Pharma AG,
Wolhusen,
Switzerland | |
| Sterilization location | Synergy Health, Daeniken,
Switzerland | Synergy Health, Daeniken,
Switzerland | |
| Sterility | Gamma irradiation
SAL 10-6; Device provided
sterile, for single use only | Gamma irradiation
SAL 10-6; Device provided
sterile, for single use only | |
| User | Restricted to licensed
dentists | Restricted to licensed
dentists | |
| Principles of Operation | | | |
| Principles of Operation | Implantable resorbable
collagen matrix (scaffold)
consisting of collagen fibers
in a loose, porous | Implantable resorbable
collagen matrix (scaffold)
consisting of collagen fibers
in a loose, porous | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft
(K102531 - Predicate
device; K140518, K073711,
K012423 - Reference
devices) | |
| | arrangement to enable cell
invasion | arrangement to enable cell
invasion | |
| Performance Standards | | | |
| Conformity to standards | - ISO 10993-1
(Biocompatibility)
- 10993-2 (Animal Welfare)
- 10993-3 (Genotoxicity)
- 10993-6 (Local Effects)
- 10993-10 (Irritation /
Sensitization) - 10993-11 (Systemic Tox.)
- 10993-12 (Sample Prep.)
- ISO 11137-1 (Sterilization
Val) - ISO 11137-2 (Sterilization
Dose) - ISO 11607-1 (Sterilization)
- ISO 11607-2 (Sterilization)
- ISO 11737-1 (Sterilization)
- ISO 11737-2 (Sterilization)
- ISO 11737-3 (Sterilization)
- ISO 11607 (Packaging)
- ISO 14698-1
(Cleanrooms) - ISO 14971 (Risk
Management) - ISO 22441-1 (Animal
Tissues) - ISO 22442-2 (Animal
Tissues) - ISO 22442-3 (Viral
Clearance) - USP 39 NF34 :
Pyrogen test - USP 39 NF34 85:
Endotoxin test - ASTM F1980 (Accelerated
Aging) - ASTM F2450-10 (Tissue
Engineering) | - ISO 10993-1
(Biocompatibility) - 10993-2 (Animal Welfare)
- 10993-3 (Genotoxicity)
- 10993-6 (Local Effects)
- 10993-10 (Irritation /
Sensitization) - 10993-11 (Systemic Tox.)
- 10993-12 (Sample Prep.)
- ISO 11137-1 (Sterilization
Val) - ISO 11137-2 (Sterilization
Dose) - ISO 11607-1 (Sterilization)
- ISO 11607-2 (Sterilization)
- ISO 11737-1 (Sterilization)
- ISO 11737-2 (Sterilization)
- ISO 11737-3 (Sterilization)
- ISO 11607 (Packaging)
- ISO 14698-1
(Cleanrooms) - ISO 14971 (Risk
Management) - ISO 22441-1 (Animal
Tissues) - ISO 22442-2 (Animal
Tissues) - ISO 22442-3 (Viral
Clearance) - USP 39 NF34 :
Pyrogen test - USP 39 NF34 85:
Endotoxin test - ASTM F1980 (Accelerated
Aging) - ASTM F2450-10 (Tissue
Engineering) | |
Comparison Table
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7
8
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PERFORMANCE DATA
All relevant biocompatibility tests were conducted as required according to Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing included Cytotoxicity, Irritation, Sensitization, Acute System Toxicity, Genotoxicity, Subchronic System Toxicity, Chronic System Toxicity, Implantation, Pyrogenicity, and Leachables. Other testing included viral clearance studies and residual chemical testing and toxicological assessment. Results indicate that the device is biocompatible.
| Test (Standard) | Test method/ model | Results |
|---|---|---|
| Cytotoxicity (ISO 10993-5) | In vitro mouse L929 fibroblast cell | |
| culture assay | Pass | |
| Irritation (ISO 10993-10) | Intracutaneous reactivity in the rabbit | Pass |
| Sensitization (ISO 10993-10) | Guinea pig maximization test | Pass |
| Acute systemic toxicity (ISO 10993-11) | Acute systemic toxicity test in the | |
| mouse | Pass | |
| Pyrogenicity (USP ) | Rabbit pyrogen test | Pass |
| Genotoxicity (ISO 10993-3) | Bacterial reverse mutagenicity assay | |
| in Salmonella typhimurium and | ||
| Escherichia coli (Ames test) | ||
| In vitro chromosomal aberration study | ||
| in human lymphocytes | ||
| Mouse peripheral blood micronucleus | ||
| study | Pass | |
| Local tissue response after | ||
| implantation (ISO 10993-6) | 4-week subcutaneous implantation in | |
| rats | Pass |
10
| 12-week subcutaneous implantation in rats | Pass | |
|---|---|---|
| 26-week subcutaneous implantation in rats | Pass | |
| Subchronic systemic toxicity (ISO 10993-11) | 4-week subcutaneous implantation in rats, with systemic toxicity endpoint | Pass |
| Chronic systemic toxicity (ISO 10993-11) | 26-week subcutaneous implantation in rats, with systemic toxicity endpoint | Pass |
| Leachables (ISO 10993-17) | GC/MS fingerprint and ICP analysis | Pass |
Geistlich Fibro-Gide® was tested in a rat and in a dog study compliant with 21 CFR Part 58 to demonstrate substantial equivalence, safety and performance to its predicate device. The studies confirmed tissue integration, continuous resorption and comparable degradation rate of Geistlich Fibro-Gide® and the predicate devices. Further, the investigation of distal organs, hematologic parameters and clinical chemistries confirmed that the safety profile is acceptable. The dog study also investigated soft tissue augmentation and local tissue effects after several soft tissue augmentation periods in Geistlich Fibro-Gide® and the predicate device Geistlich Mucograft®. In all instances, the subject device was demonstrated to be substantially equivalent to the predicate device.
The clinical data from a controlled, parallel and randomized study in patients presenting insufficient soft tissue volume demonstrated product safety and effectiveness in the product's indications for use.
The biocompatibility testing, in combination with the bench testing, animal studies, and published clinical data included in this submission, demonstrates the substantial equivalence of Geistlich Fibro-Gide® to its predicate device, Geistlich Mucograft®.
CONCLUSION
Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Fibro-Gide® is substantially equivalent to the predicate device Geistlich Mucograft® with regard to intended use and indications for use, technological characteristics, including principles of operation, and performance characteristics as shown in a series of biocompatibility, bench, animal, and clinical testing. Thus, the subject device is substantially equivalent.