(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.
§ 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.