(150 days)
Geistlich Bio-Gide® Shape is indicated for:
- 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.
- quided bone regeneration in dehiscence defects.
Geistlich Bio-Gide® Compressed is indicated for:
- auqmentation 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.
- guided tissue regeneration procedures in periodontal defects
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14mm x 24mm, respectively. With the exception of the size and shape, Geistlich Bio-Gide® Shape is the same as its predicate device, Geistlich Bio-Gide® Perio (K112575).
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm. With the exception of the size and a minor difference during manufacturing to mark the dense surface of the membrane, which should face the soft tissue, Geistlich Bio-Gide® Compressed is the same as its predicate device, Geistlich Bio-Gide® Perio.
The provided text describes Geistlich Bio-Gide® Shape and Geistlich Bio-Gide® Compressed, which are collagen membranes used as bone grafting materials. The 510(k) submission argues for their substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new device's performance metrics. As such, explicit acceptance criteria with numerical targets and a study designed to prove the device meets those new acceptance criteria (as would be typical for novel devices with distinct performance claims) are not presented in this document.
Instead, the documentation focuses on demonstrating that the new devices are substantially equivalent to existing legally marketed predicate devices by showing they have:
- The same intended use.
- Similar technological characteristics.
- Similar performance and safety profiles.
The "studies" described are primarily to support this claim of substantial equivalence by showing that material properties, biocompatibility, and clinical outcomes are consistent with the predicate and reference devices.
Therefore, for this specific submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Since the submission is for substantial equivalence, formal acceptance criteria in the traditional sense of a new performance threshold are not explicitly stated for Geistlich Bio-Gide® Shape or Geistlich Bio-Gide® Compressed. Instead, the "acceptance criteria" are implied to be "demonstrates substantial equivalence to the predicate device" based on the following characteristics and their performance relative to the predicate:
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Geistlich Bio-Gide® Shape/Compressed) |
|---|---|---|
| Intended Use | Same as predicate device (Geistlich Bio-Gide® Perio) | Same intended use, with Geistlich Bio-Gide® Shape having a subset of the predicate's indications. |
| Material Composition | Identical (Native collagen 85-100%, Amino Acid as standard, Fat ≤ 1.0%) | Identical. Lot testing confirmed specifications equivalent to Geistlich Bio-Gide®. |
| Manufacturing Process | Same, with minor modifications (cutting, marking) | Same, with minor cutting for shape (Shape) or marking for orientation (Compressed). Viral inactivation step is identical. |
| Physical & Chemical Tests | Meets predicate specifications (appearance, pH, sterility, endotoxins) | Lot testing confirmed that devices meet specifications and are equivalent to Geistlich Bio-Gide®. Sterility confirmed per ISO 11137, ISO 11737. |
| Biocompatibility | Meets ISO 10993 standards (cytotoxicity, genotoxicity, etc.) | Evaluated per ISO 10993 standards (cytotoxicity, genotoxicity, carcinogenicity, irritation, sensitization, acute/subchronic/chronic toxicity, implantation). Results demonstrated biocompatibility. |
| Pre-Clinical Performance | Equivalent to predicate/reference device in GBR | Animal study results (from reference device K960724 Geistlich Bio-Gide®) showed improved decrease of defect size and histomorphometry. |
| Clinical Performance/Safety | Equivalent to predicate/reference device, no serious adverse events | Clinical data from reference devices (K960724, K042197) showed effectiveness in bone regeneration and periodontal defects with no serious adverse events. Minor/moderate inflammation noted, likely surgical. |
2. Sample Size Used for the Test Set and Data Provenance:
- Geistlich Bio-Gide® Shape & Compressed (for testing against predicate):
- Test Set Sample Size: Not applicable in the context of a new efficacy study. The "test set" here refers to the actual manufactured devices (Geistlich Bio-Gide® Shape and Compressed) subjected to physical/chemical, sterility, biocompatibility, and usability testing to confirm they meet specifications and are comparable to the predicate. The exact number of units tested for each characteristic is not specified.
- Data Provenance: The manufacturing and testing data are from Geistlich Pharma AG, Switzerland. This is directly related to the newly submitted devices.
- Clinical Data (from reference devices):
- An animal study related to Geistlich Bio-Gide® (K960724).
- A clinical study of 75 patients examining Geistlich Bio-Gide® as a barrier membrane for guided bone regeneration in simultaneous implant placement.
- Another clinical study involving 15 patients and 16 Geistlich Bio-Gide membranes for defect filling.
- Several clinical studies on Geistlich Bio-Gide® for guided tissue regeneration procedures in periodontal defects:
- Recession defects: 20 patients (pairs of defects).
- Furcation defects: 52 grade II mandibular molar furcation defects; 21 patients with 31 furcation defects.
- Intrabony defects: 22 paired intrabony defects; 28 patients (each with one intrabony defect); 124 patients (each with at least one intrabony defect); two studies with 4 intrabony defects each.
- Data Provenance for Clinical Studies: The specific countries of origin for these clinical studies are not provided in the document. They are generally referenced as "clinical testing data from the K960724 and K042197 reference devices," implying these studies were conducted prior to this submission and are being cited to support the equivalence claim. The studies appear to be prospective clinical trials assessing the performance of the reference device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not directly applicable. "Ground truth" in this context would typically refer to a definitive diagnosis or outcome for a diagnostic device. For these devices (bone grafting materials), the assessment criteria are objective (e.g., meeting chemical specifications, biocompatibility, histological evaluation in animal models, and clinical outcomes reported in existing literature).
- The clinical studies referenced would have involved clinicians (dentists, periodontists) who assessed the outcomes and established the "truth" for those studies. However, the exact number and qualifications of these experts are not provided in this summary.
4. Adjudication Method for the Test Set:
- Not applicable as this is not a diagnostic device requiring human adjudication in the described testing. Assessment involves laboratory tests, biocompatibility assays, and clinical outcomes from human studies, not consensus of human readers on images or test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic accuracy or efficiency.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. These devices are physical materials (collagen membranes) for bone grafting, not algorithms or software. Their performance is assessed through material properties, biocompatibility, and clinical outcomes, not as a standalone algorithm.
7. Type of Ground Truth Used:
- For material and biocompatibility testing: Laboratory Assay Results, Chemical Specifications, Histological Evaluation (animal study).
- For clinical studies (referenced for Geistlich Bio-Gide® family): Clinical Outcomes (e.g., gain of root coverage, decrease of recess depth, pocket reduction, gain in clinical attachment level (CAL), vertical/horizontal defect fill, radiographic appearance, and histological evaluation in some cases), and Safety Data (adverse events). These are objective clinical measurements and observations.
8. Sample Size for the Training Set:
- Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets. The "training" for these devices would be the extensive research and development and prior clinical experience with similar collagen membranes.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as this is not an AI/ML device that uses a training set.
{0}------------------------------------------------
October 30, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Geistlich Pharma AG % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K171643
Trade/Device Name: Geistlich Bio-Gide Shape. Geistlich Bio-Gide Compressed Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: September 25, 2017 Received: September 25, 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Geistlich Bio-Gide® Shape
Indications for Use (Describe)
Geistlich Bio-Gide® Shape is indicated for:
- 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.
- quided bone regeneration in dehiscence defects.
Type of Use (Select one or both, as applicable)
ا Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K171643
Device Name
Geistlich Bio-Gide® Compressed
Indications for Use (Describe)
Geistlich Bio-Gide® Compressed is indicated for:
- auqmentation 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.
- guided tissue regeneration procedures in periodontal defects
Type of Use (Select one or both, as applicable)
ഗ് Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
2. 510(k) Summary
GEISTLICH BIO-GIDE® SHAPE
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
| Contact Person: | Marco Steiner |
|---|---|
| Company: | Geistlich Pharma AG |
| Phone Number: | 011 41 41 492 67 64 (direct)011 41 41 492 55 55 (company) |
| E-mail: | marco.steiner@geistlich.ch |
Date Prepared: October 26, 2017
DEVICE NAME
| Proprietary Name: | Geistlich Bio-Gide® Shape |
|---|---|
| Common/Usual Names: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Product Code: | NPL |
PREDICATE DEVICE
Geistlich Bio-Gide® Perio (K112575)
REFERENCE DEVICE
Geistlich Bio-Gide® (K960724, K042197, K112572)
DEVICE DESCRIPTION
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14mm x 24mm, respectively. With the exception of the size and shape, Geistlich Bio-Gide® Shape is the same as its predicate device, Geistlich Bio-Gide® Perio (K112575).
{5}------------------------------------------------
Available Products: Geistlich Bio-Gide® Shape 14 x 24 mm (pre-shaped form)
INTENDED USE
Geistlich Bio-Gide® Shape is indicated for:
- 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.
- quided bone regeneration in dehiscence defects.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Geistlich Bio-Gide® Shape has the similar technological characteristics (e.g., similar design, identical material) as the predicate device Geistlich Bio-Gide® Perio. Geistlich Bio-Gide® Shape has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively, whereas the predicate device, Geistlich Bio-Gide® Perio, is rectangular and has a size of 16 x 22 mm, this difference does not affect the determination of substantial equivalence, as supported by the performance data.
| Characteristic | Geistlich Bio-Gide® Perio(K112575) | Geistlich Bio-Gide® Shape(Proposed) |
|---|---|---|
| Intended Use | ||
| Intended Use/Indicationsfor Use | Geistlich Bio-Gide® Perio isintended to be used for:- augmentation around implantsplaced in immediate extractionsockets.- augmentation around implantsplaced in delayed extractionsockets.- localized ridge augmentation forlater implantation.- alveolar ridge reconstruction forprosthetic treatment.- filling of bone defects after rootresection, cystectomy, removal ofretained teeth.- guided bone regeneration indehiscence defects.- guided tissue regenerationprocedures in periodontaldefects. | Geistlich Bio-Gide® Shape isintended to be used for:- augmentation around implantsplaced in immediate extractionsockets.- augmentation around implantsplaced in delayed extractionsockets.- localized ridge augmentation forlater implantation.- alveolar ridge reconstruction forprosthetic treatment.- filling of bone defects after rootresection, cystectomy, removal ofretained teeth.- guided bone regeneration indehiscence defects. |
{6}------------------------------------------------
| Characteristic | Geistlich Bio-Gide® Perio(K112575) | Geistlich Bio-Gide® Shape(Proposed) |
|---|---|---|
| Physical characteristics | ||
| Form | membrane | membrane |
| Dimensions | 16 x 22 mm | 14 x 24 mm (specifically shaped) |
| Composition Materials | ||
| Native collagen | 85 – 100% | 85 – 100% |
| Amino Acid Composition | As standard | As standard |
| Fat | Not more than 1.0% | Not more than 1.0% |
| pH (finished product) | 5.0 - 8.5 | 5.0 - 8.5 |
| Manufacture | ||
| Manufacturing conditions | Same manufacturing conditions | Same manufacturing conditions |
| Viral inactivation | Same viral inactivation step | Same viral inactivation step |
| Packaging | Double blister format. Inner andouter blister made of A-PET.Outer blister covered withpolyethylene Tyvek foil. | Double blister format. Inner andouter blister made of A-PET.Outer blister covered withpolyethylene Tyvek foil. |
SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE
Geistlich Bio-Gide® Shape is made of the same raw materials and manufactured with the same manufacturing process (except for the cutting step to create the modified shape) hence, the material properties are identical. Further, the same release testing as performed for the predicate is conducted for the subject device and includes determination of appearance, dry residue, sulphated ash, nitrogen total content, nitrogen amide content, fat content, pH value, native collagen, amino acid analysis, sterility test and bacterial endotoxins. Lot testing confirmed that the Geistlich Bio-Gide® Shape meets the specification and is equivalent to Geistlich Bio-Gide®. Usability tests with Geistlich Bio-Gide® Shape confirmed that the device is easy to use for procedures in extraction sockets. Sterilization of the subject device is based on the predicate and reference devices Geistlich Bio-Gide® Perio and Geistlich Bio-Gide® conducted according to the standards ISO 11137-1, ISO 11137-2, ISO 11137-3. ISO 11737-1 and ISO 11737-2, which showed that the devices meet the sterility specification. A viral clearance study in accordance with the requirements of ICH Q5A and ISO 22442-3 was conducted and confirmed sufficient viral clearance capacity of the manufacturing process of the Geistlich Bio-Gide® family of products.
The following biological risks were evaluated according to ISO 10993: cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), carcinogenicity (ISO 10993-3), irritation (ISO 10993-10), sensitization (ISO 10993-10), acute toxicity (ISO 10993-11), subchronic and chronic toxicity (ISO 10993-11) and implantation (local effects; ISO 10993-6). The results demonstrated that the device is biocompatible.
{7}------------------------------------------------
SUMMARY OF ANIMAL STUDY DATA
An in vivo animal study was conducted to evaluate the performance of Geistlich Bio-Gide® in facilitating guided bone regeneration around exposed implant threads (K960724). The results showed that treatment with Geistlich Bio-Gide® improved the decrease of defect size after 6 months, as evaluated histologically and by histomorphometry.
SUMMARY OF CLINICAL STUDY DATA
The clinical performance of the Geistlich Bio-Gide® family of products has been established based on clinical testing data from the K960724 and K042197 reference devices. A total of 75 patients were recruited in a study to examine the effectiveness and tolerability of Geistlich Bio-Gide® as a barrier membrane for quided bone regeneration in simultaneous implant placement. The results demonstrated the performance of Geistlich Bio-Gide® in combination with Geistlich Bio-Oss for bone regeneration in defects around implants. No serious adverse event or antigenic reaction was observed. Only minor or moderate signs of inflammation, including pain, swelling, redness, hematoma or wound dehiscences were noted and were probably related to the surgical procedure.
Another clinical study involved 15 patients and the application of 16 Geistlich Bio-Gide membranes, which similarly showed that Geistlich Bio-Gide® can be used in defect filling in combination with bone grafting material Geistlich Bio-Oss®.
CONCLUSION
Geistlich Bio-Gide® Shape has same subset of indications and identical material properties as the predicate device, Geistlich Bio-Gide® Perio.
Thus, Geistlich Bio-Gide® Shape has the same intended use and similar technological characteristics as the predicate device.
Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the predicate device, Geistlich Bio-Gide® Perio (K112575), and the reference device, Geistlich Bio-Gide® (K112572).
{8}------------------------------------------------
GEISTLICH BIO-GIDE® COMPRESSED
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
| Contact Person: | Marco Steiner |
|---|---|
| Company: | Geistlich Pharma AG |
| Phone Number: | 011 41 41 492 67 64 (direct)011 41 41 492 55 55 (company) |
| E-mail: | marco.steiner@geistlich.ch |
Date Prepared: October 26, 2017
DEVICE NAME
| Proprietary Name: | Geistlich Bio-Gide® Compressed |
|---|---|
| Common/Usual Names: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Product Code: | NPL |
PREDICATE DEVICE
Geistlich Bio-Gide® Perio (K112575)
REFERENCE DEVICE
Geistlich Bio-Gide® (K960724, K042197, K112572)
DEVICE DESCRIPTION
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm. With the exception of the size and a minor difference during manufacturing to mark the dense surface of the membrane, which should face the soft tissue, Geistlich Bio-Gide® Compressed is the same as its predicate device, Geistlich Bio-Gide® Perio.
Available Products: Geistlich Bio-Gide® Compressed 13 x 25 mm Geistlich Bio-Gide® Compressed 20 x 30 mm
{9}------------------------------------------------
INTENDED USE
Geistlich Bio-Gide® Compressed is indicated for:
- 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.
- guided tissue regeneration procedures in periodontal defects.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Geistlich Bio-Gide® Compressed has the similar technological characteristics (e.g., similar design, identical material) as the predicate device, Geistlich Bio-Gide® Perio. A manufacturing step has been added that marks the dense surface to indicate that it should face the soft tissue. In addition, the size of Geistlich Bio-Gide® Compressed has been modified. However, this difference does not affect the determination of substantial equivalence, as supported by the performance data and the company's cleared reference device
| Characteristic | Geistlich Bio-Gide® Perio(K112575) | Geistlich Bio-Gide®Compressed(Proposed) |
|---|---|---|
| Intended Use | ||
| IntendedUse/Indications for Use | Geistlich Bio-Gide® Perio isintended to be used for:– augmentation around implantsplaced in immediate extractionsockets.– augmentation around implantsplaced in delayed extractionsockets.– localized ridge augmentationfor later implantation.– alveolar ridge reconstruction forprosthetic treatment.– filling of bone defects after rootresection, cystectomy, removal ofretained teeth.– guided bone regeneration indehiscence defects.– guided tissue regenerationprocedures in periodontaldefects. | Geistlich Bio-Gide® Compressedis intended to be used for:– augmentation around implantsplaced in immediate extractionsockets.– augmentation around implantsplaced in delayed extractionsockets.– localized ridge augmentationfor later implantation.– alveolar ridge reconstruction forprosthetic treatment.– filling of bone defects after rootresection, cystectomy, removal ofretained teeth.– guided bone regeneration indehiscence defects.– guided tissue regenerationprocedures in periodontaldefects. |
{10}------------------------------------------------
| Characteristic | Geistlich Bio-Gide® Perio(K112575) | Geistlich Bio-Gide®Compressed(Proposed) |
|---|---|---|
| Physical characteristics | ||
| Form | membrane | membrane |
| Dimensions | 16 x 22 mm | 13 x 25 mm20 x 30 mm |
| Composition Materials | ||
| Native collagen | 85 – 100% | 85 – 100% |
| Amino AcidComposition | As standard | As standard |
| Fat | Not more than 1.0% | Not more than 1.0% |
| pH (finished product) | 5.0 - 8.5 | 5.0 - 8.5 |
| Manufacture | ||
| Manufacturingconditions | Same manufacturing conditions | Same manufacturing conditions |
| Viral inactivation | Same viral inactivation step | Same viral inactivation step |
| Packaging | Double blister format. Inner andouter blister made of A-PET.Outer blister covered withpolyethylene Tyvek foil. | Double blister format. Inner andouter blister made of A-PET.Outer blister covered withpolyethylene Tyvek foil. |
SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE
Geistlich Bio-Gide® Compressed is made of the same raw materials and manufactured with the same manufacturing process (except for the cutting step and marking the device with "UP") as the predicate device. Hence, the material properties are identical. Further, the same release testing is conducted for the subject and predicate devices, which includes determination of appearance, dry residue, sulphated ash, nitrogen total content, nitrogen amide content, fat content, pH value, native collagen, amino acid analysis, sterility test and bacterial endotoxins. Lot testing confirmed that Geistlich Bio-Gide® Compressed meets the specification and is equivalent to Geistlich Bio-Gide®. Usability tests confirmed that Geistlich Bio-Gide® Compressed has appropriate handling properties and is easy to use. Sterilization of the subject device is based on the predicate and reference devices Geistlich Bio-Gide® Perio and Geistlich Bio-Gide® conducted according to the standards ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1 and ISO 11737-2, which showed that the devices meet the sterility specification. A viral clearance study in accordance with the requirements of ICH Q5A and ISO 22442-3 was conducted and confirmed sufficient viral clearance capacity of the manufacturing process of the Geistlich Bio-Gide® family of products.
The following biological risks were evaluated according to ISO 10993: cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), carcinogenicity (ISO 10993-3), irritation (ISO 10993-10), sensitization (ISO 10993-10), acute toxicity (ISO 10993-11), subchronic and chronic toxicity (ISO
{11}------------------------------------------------
10993-11) and implantation (local effects; ISO 10993-6). The results demonstrated that the device is biocompatible.
SUMMARY OF ANIMAL STUDY DATA
An in vivo animal study was conducted to evaluate the performance of Geistlich Bio-Gide® in facilitating guided bone regeneration around exposed implant threads (K960724). The results showed that treatment with Geistlich Bio-Gide® improved the decrease of defect size after 6 months, as evaluated histologically and by histomorphometry.
SUMMARY OF CLINICAL STUDY DATA
The clinical performance of the Geistlich Bio-Gide® family of products has been established based on clinical testing data from the K960724 and K042197 reference devices. A total of 75 patients were recruited in a study to examine the effectiveness and tolerability of Geistlich Bio-Gide® as a barrier membrane for guided bone regeneration in simultaneous implant placement. The results demonstrated the performance of Geistlich Bio-Gide® in combination with Geistlich Bio-Oss for bone regeneration in defects around implants. No serious adverse event or antigenic reaction was observed. Only minor or moderate signs of inflammation, including pain, swelling, redness, hematoma or wound dehiscences were noted and were probably related to the surgical procedure.
Another clinical study involved 15 patients and the application of 16 Geistlich Bio-Gide membranes, which similarly showed that Geistlich Bio-Gide® can be used in defect filling in combination with bone grafting material Geistlich Bio-Oss®.
In addition, the performance of Geistlich Bio-Gide® in guided tissue regeneration procedures in periodontal defects was evaluated in several clinical studies, as summarized below:
| Defect Type | Subjects | Key Findings |
|---|---|---|
| Recessiondefects | 20 patients, each contributing apair of Miller Class I or II buccalgingival recessions | Treatment with Geistlich Bio-Gide® resulted in asignificant gain of root coverage at 3 months anddecrease of recess depth at 6 months. |
| Furcationdefects | A total of 52 grade II mandibularmolar furcation defects | The experimental group combined Bio-Oss® andBio-Gide® presented with significantly greaterpocket reduction, gain in clinical attachment level(CAL), vertical defect fill and horizontal defect fillcompared to the control group (SCTG). |
| 21 patients with 31 furcationdefects | There was a statistically significant improvement inmost clinical indices for the Bio-Oss®/ Bio-Gide®group. |
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| Intrabonydefects | 22 paired intrabony defects | Postoperative pocket depths, attachment levels andtransoperative bone measurements were similar forcontrol (open-flap debridement) and experimental(bovine porous bone mineral and Geistlich Bio-Gide®) sites. |
|---|---|---|
| 28 patients suffering fromchronic periodontitis, and eachof whom displayed oneintrabony defect | No differences in any of the investigated parametersat baseline between Bio-Gide® treatment andaccess flap surgery (AFS). At 1 year after surgeryboth therapies resulted in significant gains of clinicalattachment level (CAL) and probing depth (PD)reductions. The Bio-Gide® treatment group resultedin significantly higher CAL gains than treatment withAFS. | |
| 124 patients with advancedchronic periodontitis, each withat least one intrabony defect ofno less than 3mm | The Bio-Gide® test group showed a significantlyhigher gain in CAL and pocket reduction comparedto the controls. | |
| 4 intrabony defects, tworeceived Geistlich Bio-Gide®alone and two were treated witha combination of Bio-Oss®/ Bio-Gide® | Both treatments were shown to significantly improveclinical probing depths and attachment levels, andthe radiographic appearance suggested osseous fill.The regenerative effect was more pronounced withBio-Gide®. Histologic evaluation revealed that bothtreatments produced new cementum with insertingcollagen fibers and new bone formation on thesurface of the graft particles. | |
| 4 intrabony defects, tworeceived Geistlich Bio-Gide®alone and two were treated witha combination of Bio-Oss®/ Bio-Gide® | Use of Bio-Oss® in combination with / Bio-Gide®resulted in a complete new attachment apparatus,evidencing periodontal regeneration that varied withdefect morphology. |
The above studies also showed a favorable safety profile for Geistlich Bio-Gide®, with no serious adverse events noted.
CONCLUSION
In summary, Geistlich Bio-Gide® Compressed has the same indications and identical material properties as the predicate device, Geistlich Bio-Gide® Perio. The sizes of Geistlich Bio-Gide® Compressed have been modified and a marking step is included during manufacture, but these differences are minor and do not affect the performance of the device, as supported by the testing conducted.
Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the Geistlich Bio-Gide® Perio, the predicate device.
§ 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.