(34 days)
Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; 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.
MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to MUCOGRAFT® resorbable bilayer membrane (K012423), but labeled with an additional indication: guided tissue regeneration in periodontal defects. MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.
This is a 510(k) premarket notification for a medical device called MUCOGRAFT®, a resorbable bilayer membrane used for guided tissue and bone regeneration. The submission aims to establish substantial equivalence to previously cleared predicate devices, specifically BIO-GIDE® (K960724; K042197; and K050446) and MUCOGRAFT® (K012423), with an additional indication for "guided tissue regeneration procedures in periodontal defects."
The document states that the new MUCOGRAFT® is physically identical to the previously cleared MUCOGRAFT® (K012423), and the primary basis for substantial equivalence is the existing clearances and the comparison to BIO-GIDE® (K042197) which already includes the new indication sought for guided tissue regeneration in periodontal defects.
Therefore, the submission does not describe a new study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence principle, asserting that the device is essentially the same as already cleared devices, particularly the predicate device BIO-GIDE® for the new indication.
Given this, many of the requested details about acceptance criteria and study design are not present in this 510(k) summary. I can, however, extract the comparative information presented in lieu of specific acceptance criteria from a new study.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present a formal table of "acceptance criteria" against newly generated "reported device performance" from a dedicated study for the MUCOGRAFT® device. Instead, it demonstrates substantial equivalence to predicate devices based on product characteristics and intended use. The table provided is a comparison of MUCOGRAFT® to its predicate device, BIO-GIDE®, highlighting their similarities, which serves as the basis for regulatory acceptance.
| Feature | BIO-GIDE® Resorbable Bilayer Membrane (Predicate Device) | MUCOGRAFT® Resorbable Bilayer Membrane (Proposed Device) | Basis of Acceptance / Statement |
|---|---|---|---|
| Intended Use | Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. | ||
| (Also other GBR indications from K042197) | Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. | ||
| (Also other GBR indications from K012423) | Identical Intended Use (for the specific indication sought). The new indication for MUCOGRAFT® mirrors that of the previously cleared BIO-GIDE® for which it is claiming equivalence. | ||
| Incorporates Same Basic Design | Yes | Yes | Identical Design. |
| Utilizes Same Operating Principle | Cell occlusive, Implantable, Resorbable, Hemostatic | Cell occlusive, Implantable, Resorbable, Hemostatic | Identical Operating Principle. Both are bilayer collagen membranes with a cell-occlusive layer and a porous layer. |
| Incorporates Same Materials? | Yes, Type I and Type III Collagen | Yes, Type I and Type III Collagen | Identical Materials. Both are derived from porcine collagen Type I and III. |
| Sterilization Process | Gamma Irradiation | Gamma Irradiation | Identical Sterilization Process. |
| Biocompatible | Yes | Yes | Identical Biocompatibility. Assumed due to identical materials and processing for a previously cleared device. |
| Non-pyrogenic | Yes | Yes | Identical Non-pyrogenicity. Assumed due to identical materials and processing for a previously cleared device. |
| Shelf Life | 36 Months | 36 Months | Identical Shelf Life. |
2. Sample size used for the test set and the data provenance
- Not applicable. The submission does not describe a new test set or study conducted for this specific 510(k) submission. It relies on the equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new study for ground truth establishment is described.
4. Adjudication method for the test set
- Not applicable. No new test set or adjudication method is described.
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 resorbable membrane, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a resorbable membrane, not an algorithm.
7. The type of ground truth used
- Not applicable (for this submission). For the original clearance of the predicate devices (BIO-GIDE® and initial MUCOGRAFT®), the ground truth for their effectiveness would have been established through pre-clinical testing, animal studies, and potentially clinical trials (outcomes data, histological evidence of regeneration, etc.) as required for their initial 510(k) clearances. This specific submission relies on referencing those prior clearances.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm-based device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.