(216 days)
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
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.
The provided text describes a 510(k) premarket notification for a medical device called Geistlich Fibro-Gide®. This document focuses on demonstrating substantial equivalence to a predicate device (Geistlich Mucograft®) rather than establishing novel safety and effectiveness criteria. Therefore, the information provided does not contain traditional "acceptance criteria" for a new device's absolute performance against a set standard, but rather criteria for demonstrating similarity to an already approved device.
Here's an analysis based on the categories you provided:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device. The performance shown is a comparison to that predicate.
| Characteristic | Predicate (Geistlich Mucograft®) Performance (Implicit Acceptance Criteria) | Geistlich Fibro-Gide® Reported Performance |
|---|---|---|
| Intended Use | Soft Tissue Augmentation | Soft Tissue Augmentation |
| Indications for Use | - Covering of implants- Localized gingival augmentation (KT) - Alveolar ridge reconstruction- Recession defects for root coverage | - Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants - Alveolar ridge reconstruction for prosthetic treatment - Recession defects for root coverage |
| Dimensions | 15x20 mm, 20x30 mm (K102531), 30x40 mm (K073711, K012423) (thickness app. 2.5 - 5 mm) | 15x20 mm, 20x40mm (thickness app. 6mm) |
| Form | Sponge-like matrix | Sponge-like matrix |
| Color | Almost white | White to almost white |
| Porosity | Very porous materials with average pore values of 90% or more. The average surface area and the bulk density are almost identical. | 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. |
| 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 | Not chemically cross-linked | Chemically cross-linked with EDC and NHS |
| Easy to trim | 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 |
| Raw Material | Porcine connective tissue, Porcine skin tissue | Porcine connective 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 | None (>0.5%) | None |
| pH | 3-7 | 3-7 |
| 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 | ISO 11607, Parts 1 and 2 compliant. Sterile double layer packaging in aluminum pouch. | Conforms to ISO 11607, Parts 1 and 2. Sterile double layer packaging, including aluminum layer to protect against vapor penetration. |
| Sterilization | Gamma irradiation SAL 10-6; sterile, single use | Gamma irradiation SAL 10-6; Device provided sterile, for single use only |
| User | Restricted to licensed dentists | Restricted to licensed dentists |
| Biocompatibility | (Implicitly passed the same ISO 10993 tests as the subject device) | Passed all tests: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Pyrogenicity, Genotoxicity (Bacterial reverse mutagenicity, Chromosomal aberration, Micronucleus study), Local tissue response after implantation (4, 12, 26-week subcutaneous), Subchronic systemic toxicity, Chronic systemic toxicity, Leachables. |
| Animal Study Effectiveness | (Implied safe and effective based on predicate's approval) | Demonstrated tissue integration, continuous resorption, and comparable degradation rate to predicate. Acceptable safety profile for distal organs, hematologic parameters, and clinical chemistries. Demonstrated substantial equivalence in soft tissue augmentation and local tissue effects. |
| Clinical Data (Effectiveness/Safety) | (Implied safe and effective based on predicate's approval) | Demonstrated product safety and effectiveness in the product's indications for use. |
Key finding regarding acceptance criteria: The acceptance criteria for Geistlich Fibro-Gide® are defined by its ability to demonstrate substantial equivalence to Geistlich Mucograft® across various characteristics, including physical properties, composition, manufacturing, and performance in biocompatibility, animal, and clinical studies. The "performance" is that it "passes" these comparative tests.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Bench Testing: No specific sample sizes are provided for the bench tests. The data provenance is not explicitly stated as country of origin, but the sponsor and manufacturing/sterilization locations are in Switzerland. The testing is assumed to be prospective, undertaken for this submission.
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of L929 fibroblast cultures, rabbits, guinea pigs, mice, rats) are not explicitly stated in this summary. The tests adhere to ISO 10993 standards, suggesting standard methods and sample sizes for these types of studies. The provenance of these animal studies is generally considered prospective, conducted for regulatory submission.
- Animal Studies (Rat and Dog): "a rat and in a dog study" – exact number of animals is not provided. These were conducted "compliant with 21 CFR Part 58" (Good Laboratory Practice for Nonclinical Laboratory Studies), indicating prospective and controlled studies. The country is not specified, but given the sponsor and manufacturing locations, it is likely Europe (Switzerland) or a contracted lab.
- Clinical Data: "The clinical data from a controlled, parallel and randomized study in patients presenting insufficient soft tissue volume." The sample size (number of patients) is not provided. This describes a prospective study design. The country of origin for the clinical data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This document does not describe the establishment of a "ground truth" by experts in the context of diagnostic accuracy, which is common for AI/imaging devices. Instead, the ground truth for this medical device is:
- Bench testing: Established by laboratory measurements and adherence to scientific standards.
- Biocompatibility: Established by adherence to ISO 10993 standards and generally accepted biological endpoints.
- Animal studies: Established by histological examination, physiological measurements, and comparison to the predicate, likely reviewed by veterinary pathologists or relevant scientists.
- Clinical study: The "ground truth" for safety and effectiveness is derived from the clinical outcomes of the study itself, assessed by the investigators and clinicians involved in the trial.
There is no mention of a panel of experts specifically establishing a "ground truth" for the test sets in the way an imaging device might rely on expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method for disagreements among experts is described, as the studies primarily involve objective measurements (benchmarks, lab results) or clinical trial outcomes rather than subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a collagen matrix for soft tissue augmentation, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers improve with AI vs without AI assistance" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implantable medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission consists of:
- Bench testing results: Objective measurements of physical, chemical, and functional properties.
- Histopathology and physiological data from animal studies: Pathological findings and biological responses in animal models.
- Clinical outcomes data: Measurements and assessments of patient safety and effectiveness endpoints from a clinical trial.
8. The sample size for the training set:
Not applicable. This device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. (See #8)
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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 (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
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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: | 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
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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(K102531 – Predicatedevice; K140518, K073711,K012423 – Referencedevices) | |
|---|---|---|---|
| Intended Use | |||
| Intended Use | Soft Tissue Augmentation | Soft Tissue Augmentation | |
| Indications for Use | Geistlich Fibro-Gide® is | ||
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft(K102531 - Predicatedevice; K140518, K073711,K012423 - Referencedevices) | |
| intended for soft tissueaugmentation. It is indicatedfor:Localized gingivalaugmentation toincrease keratinizedtissue (KT) aroundteeth and implants Alveolar ridgereconstruction forprosthetic treatment Recession defectsfor root coverage | Covering of implantsplaced in immediateor delayed extractionsockets Localized gingivalaugmentation toincrease keratinizedtissue (KT) aroundteeth and implants Alveolar ridgereconstruction forprosthetic treatment Recession defectsfor 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 withaverage pore values of 90%or more. The averagesurface area and the bulkdensity of Geistlich Fibro-Gide® is almost identical tothat of Geistlich Mucograft. | Very porous materials withaverage pore values of 90%or more. The averagesurface area and the bulkdensity of GeistlichMucograft is almost identicalto that of Geistlich Fibro-Gide. | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft(K102531 - Predicatedevice; K140518, K073711,K012423 - Referencedevices) | |
| Capillarity and wettability | Spontaneously wettable andcompletely soaked inaqueous solution in lessthan one minute | Spontaneously wettable andcompletely soaked inaqueous solution in lessthan one minute | |
| Cross-linking | Chemically cross-linked withEDC and NHS | Not chemically cross-linked | |
| Easy to trim with surgicalinstruments (to fit atemplate) | Can be cut with surgicalinstruments | Can be cut with surgicalinstruments | |
| Can be sutured | Can be fixed with sutures,as demonstrated bysutureability testing | Can be fixed with sutures,as demonstrated bysutureability testing | |
| Composition Materials | |||
| Raw Material | Porcine connective tissue, | Porcine connective tissue, | |
| Porcine skin tissue | Porcine skin tissue | ||
| Composition | Porcine collagen: Product isproduced from the sameintermediate collagenousproducts | Porcine collagen: Product isproduced from the sameintermediate collagenousproducts | |
| Collagen / Elastin | Major protein componentsCollagen I and Collagen III(no Collagen II) and Elastin | Major protein componentsCollagen I and Collagen III(no Collagen II) and Elastin | |
| Amino Acid Composition | Very similar with equalamounts of amino acids | Very similar with equalamounts 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 - Predicatedevice; K140518, K073711,K012423 - Referencedevices) | |
| Other Characteristics | |||
| Source of raw material | Identical porcine tissue | Identical porcine tissue | |
| Manufacture | Multistage validated, SOPcontrolled purificationprocess | Multistage validated, SOPcontrolled purificationprocess | |
| 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 layerpackaging, includingaluminum layer to protectagainst vapor penetration. | Conforms to ISO 11607,Parts 1 and 2.Sterile double layerpackaging, in aluminumpouch to protect againstvapor penetration. | |
| Manufacture / Packaginglocation | Geistlich Pharma AG,Wolhusen,Switzerland | Geistlich Pharma AG,Wolhusen,Switzerland | |
| Sterilization location | Synergy Health, Daeniken,Switzerland | Synergy Health, Daeniken,Switzerland | |
| Sterility | Gamma irradiationSAL 10-6; Device providedsterile, for single use only | Gamma irradiationSAL 10-6; Device providedsterile, for single use only | |
| User | Restricted to licenseddentists | Restricted to licenseddentists | |
| Principles of Operation | |||
| Principles of Operation | Implantable resorbablecollagen matrix (scaffold)consisting of collagen fibersin a loose, porous | Implantable resorbablecollagen matrix (scaffold)consisting of collagen fibersin a loose, porous | |
| Characteristic | Geistlich Fibro-Gide® | Geistlich Mucograft(K102531 - Predicatedevice; K140518, K073711,K012423 - Referencedevices) | |
| arrangement to enable cellinvasion | arrangement to enable cellinvasion | ||
| 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 (SterilizationVal)- ISO 11137-2 (SterilizationDose)- 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 (RiskManagement)- ISO 22441-1 (AnimalTissues)- ISO 22442-2 (AnimalTissues)- ISO 22442-3 (ViralClearance)- USP 39 NF34 <151>:Pyrogen test- USP 39 NF34 85:Endotoxin test- ASTM F1980 (AcceleratedAging)- ASTM F2450-10 (TissueEngineering) | - 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 (SterilizationVal)- ISO 11137-2 (SterilizationDose)- 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 (RiskManagement)- ISO 22441-1 (AnimalTissues)- ISO 22442-2 (AnimalTissues)- ISO 22442-3 (ViralClearance)- USP 39 NF34 <151>:Pyrogen test- USP 39 NF34 85:Endotoxin test- ASTM F1980 (AcceleratedAging)- ASTM F2450-10 (TissueEngineering) |
Comparison Table
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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 cellculture 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 themouse | Pass |
| Pyrogenicity (USP <151>) | Rabbit pyrogen test | Pass |
| Genotoxicity (ISO 10993-3) | Bacterial reverse mutagenicity assayin Salmonella typhimurium andEscherichia coli (Ames test)In vitro chromosomal aberration studyin human lymphocytesMouse peripheral blood micronucleusstudy | Pass |
| Local tissue response afterimplantation (ISO 10993-6) | 4-week subcutaneous implantation inrats | Pass |
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| 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.
§ 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.