(184 days)
Cytoflex® Tef-Guard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.
Cytoflex® Tef-Guard® Ti-Enforced membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a passive, non-load bearing material with a titanium frame enclosed within two exterior layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. The membranes are intended to be submerged and implanted for more than 30 days and up to 6 months. The membrane is supplied sterile and available in a variety of shapes and sizes for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cytoflex® Tef-Guard® Ti-Enforced Membrane:
Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical efficacy testing. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like human reader studies, ground truth establishment for a test set, etc.) are not applicable in this context. The acceptance criteria here largely revolve around device performance characteristics and biocompatibility, demonstrated through non-clinical bench testing.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for each test in a table format. Instead, it states that the device "was found to meet the requirements of the pre-defined acceptance criteria" for the listed ISO standards and that "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance."
However, based on the performance testing section and the comparison table with predicate devices, we can infer the types of criteria and the reported performance:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Material & Design Equivalence | - Thickness: Not to exceed a certain deviation from predicate (e.g., within 0.07mm difference). |
- Density: Not to exceed a certain deviation from predicate (e.g., within 0.5 g/dm² difference).
- Material Composition: ePTFE with Titanium frame.
- Design: Multi-layer, non-resorbable, space-making barrier, trimmable, flexible. | - Thickness: 0.25mm (Predicate 1: 0.23mm; Predicate 2: 0.3mm). Considered "Substantially Equivalent."
- Density: 3.5 g/dm² (Predicate 1: 4.0 g/dm²; Predicate 2: 3.5 g/dm²). Considered "Substantially Equivalent."
- Material Composition: ePTFE membranes reinforced with a Titanium frame. Considered "Substantially Equivalent."
- Design: A variety of configurations, trimmable and shaped to fit bony defect. Considered "Substantially Equivalent." |
| Functional Performance | - Tensile Loading: Performance similar to predicate. - Bending: Performance similar to predicate.
- Flexibility: Performance similar to predicate.
- Delaminating Potential: Performance similar to predicate. | "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance." (No specific quantitative values provided for the subject or predicate, just a statement of equivalence). |
| Biocompatibility | - Cytotoxicity: No evidence of cytotoxicity (ISO 10993-5). - Local Effects after Implantation: No adverse local effects (ISO 10993-6).
- Irritation & Skin Sensitization: No irritation or sensitization (ISO 10993-10).
- Systemic Toxicity: No systemic toxicity (ISO 10993-11). | "Found to meet the requirements of the pre-defined acceptance criteria" for ISO 10993-5, -6, -10, -11. "Biocompatible: Yes." |
| Sterility | - Sterility Assurance Level (SAL): SAL
§ 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.