(29 days)
Geistlich Bio-Gide® is intended for the following uses:
- 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; and
- guided tissue regeneration procedures in periodontal defects.
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.
- guided bone regeneration in dehiscence defects.
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.
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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; and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge;
- filling of periodontal defects;
- filling of defects after root resection, apicoectomy, and cystectomy;
- filling of extraction sockets to enhance preservation of the alveolar ridge;
- elevation of the maxillary sinus floor;
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:
- 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; and
- recession defects for root coverage.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, 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.
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 14 mm x 24 mm, respectively.
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.
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, 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 size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.
Here's an analysis of the acceptance criteria and supporting study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For all listed devices (Geistlich Bio-Gide®, Geistlich Bio-Gide® Shape, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft® and Geistlich Mucograft® Seal), the acceptance criteria are not explicitly stated as numerical thresholds. Instead, the criterion for acceptance is that the material properties remain unchanged when using an alternate supplier of porcine raw material compared to the predicate devices. The reported device performance is that these properties did remain unchanged.
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Material properties remain unchanged with alternate raw material supplier. | Material properties remained unchanged (demonstrated via performance studies). |
| Does not raise different questions of safety and effectiveness. | No new questions of safety and effectiveness were raised. |
| Substantial Equivalence to predicate device. | Device determined to be substantially equivalent to predicate. |
Specific Performance Studies Conducted:
- Elongation: Verified to be unchanged.
- Suture pull-out test: Verified to be unchanged.
- Swelling: Verified to be unchanged.
- Differential Scanning Calorimetry (DSC): Verified to be unchanged.
- Collagenase digestion (to assess degradation): Verified to be unchanged.
- Scanning Electron Microscopy (SEM) (to assess optical differences): Verified to be unchanged.
- Viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007: Verified (leveraged from K171050).
- Biocompatibility, sterilization, shelf-life, and clinical performance: Leveraged from the applicant's own predicate devices, implying these aspects also remained consistent.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the performance studies were conducted on "representative product" for each device to verify material properties. The provenance of this "representative product" is not specified (e.g., country of origin). The studies appear to be laboratory-based and not involving patient data, so the terms "retrospective" or "prospective" are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed are physical and chemical characterizations of the material, not clinical evaluations requiring expert interpretation of results. The "ground truth" for these tests would be the established scientific methods and parameters for each test.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the physical and chemical tests, it's unlikely a human-based adjudication method (like 2+1 or 3+1) would be used. The results of these tests are typically objectively measured and compared to established specifications or to the predicate device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a material change (alternate raw material supplier) and not a new diagnostic or therapeutic device requiring human interpretation of results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical bone grafting material/membrane, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on objective physical and chemical material properties and standards. The performance of the modified devices (with the alternate raw material supplier) was compared to the known performance and characteristics of the predicate devices. The determination of "unchanged" would rely on laboratory measurements meeting predefined specifications or falling within an acceptable range relative to the predicate device.
8. The Sample Size for the Training Set
This question is not applicable. This submission is about a physical medical device and a change in its raw material supplier. There is no machine learning model or "training set" involved.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML model.
§ 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.