(59 days)
Not Found
No
The summary describes a bioabsorbable implantable material and its physical properties and clinical performance. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
Yes
The device is intended to aid in the healing of periodontal defects and provides a favorable environment for bone regeneration, which are therapeutic functions.
No
The document describes a material intended for healing periodontal defects and bone graft containment, which are therapeutic functions, not diagnostic ones.
No
The device is described as a bioabsorbable, implantable material composed of physical structures (porous structure and occlusive membrane) made of synthetic polymers. This clearly indicates a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implantable material intended to aid in the healing of periodontal defects" and "used as a membrane for bone graft containment." This describes a device that is placed within the body to facilitate a biological process (healing and regeneration).
- Device Description: The description details the physical composition and function of the material as a barrier and scaffold for tissue regeneration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a therapeutic and regenerative aid.
N/A
Intended Use / Indications for Use
RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
Product codes
Not Found
Device Description
RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. Like CAPSET Calcium Sulfate Bone Graft Barrier, it has been shown to provide a favorable environment for bone regeneration.
In the first clinical study, the investigators used a comparative histological study to evaluate the regenerative capabilities of both resorbable and non-resorbable barrier membranes in defects associated with endosseous implant placement.
The second clinical study tests their hypothesis further and utilized autogenous bone grafts to maintain an adequate space under the barrier membranes. The overall study results showed a highly significant reduction in defect (p
§ 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.
0
Ka70884
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant Name, Address: W.L. Gore & Associates, Inc. 1500 North Fourth Street P.O. Box 2500 Flagstaff, AZ 86003-2500
MAY -8 1997
Contact Person, Telephone: John W. Nicholson (520) 779 - 2771
Date of Summary: March 6, 1997
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- Classification Name:Resorbable Barrier Membrane Common or Usual Name: Regenerative Material Proprietary Name: RESOLUT Regenerative Material
- RESOLUT Regenerative Material, CAPSET .3. . Predicate Device Calcium Sulfate Bone Graft Barrier, and Micro Titanium Augmentation Mesh.
Device Description: 4.
RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.
1
RESOLUT Regenerative Material is surgically placed beneath the mucoperiosteum to aid in the regenerative healing of bone/periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.
Intended Use: 5.
RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
റ. Technological Characteristics:
RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.
7. Assessment of Performance Data:
A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. Like CAPSET Calcium Sulfate Bone Graft Barrier, it has been shown to provide a favorable environment for bone regeneration.
In the first clinical study, the investigators used a comparative histological study to evaluate the regenerative capabilities of both resorbable and non-resorbable barrier membranes in defects associated with endosseous implant placement. Additionally, they included untreated controls (i.e., no barrier membrane) in this study. They found that there was bone regeneration in the membrane-treated sites, but there was more in the defects treated with the non-resorbable barrier RESOLUT BONE GRAFT
2
membrane. However, they concluded that "to achieve complete regeneration, it may be necessary to use resorbable membranes in association with osteoconductive/osteoinductive space maintaining material, such as autogenous grafts". The importance of the first clinical study is that it provides histological evidence of bone regeneration.
The second clinical study tests their hypothesis further and utilized autogenous bone grafts to maintain an adequate space under the barrier membranes. The overall study results showed a highly significant reduction in defect (p