(90 days)
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No
The device description and intended use focus on the material properties and biological function of a bioabsorbable implant, with no mention of AI or ML capabilities.
Yes.
The device is intended to aid in the healing of periodontal defects and provides a favorable environment for bone regeneration, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an implantable material intended to aid in the healing of periodontal defects and act as a membrane for bone graft containment, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a "bioabsorbable, implantable material" composed of "glycolide polymer fiber" and "glycolide and lactide copolymer," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the healing of periodontal defects and as a membrane for bone graft containment. This is a therapeutic and structural function within the body.
- Device Description: The device is an implantable material composed of synthetic bioabsorbable polymers. It acts as a physical barrier and provides a favorable environment for tissue regeneration.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to provide diagnostic information. RESOLUT Regenerative Material is an implantable device used directly in the body for therapeutic and regenerative purposes.
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 healing.
Product codes
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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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 can provide a favorable environment for bone regeneration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
RESOLUT Regenerative Material, CAPSET Calcium Sulfate Bone Graft Barrier, Micro Titanium Augmentation Mesh.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT - 3 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Applicant Name, Address: W.L. Gore & Associates, Inc. 1. 1500 North Fourth Street P.O. Box 2500 Flagstaff, AZ 86003-2500
Contact Person, Telephone:
Jacqueline Kalbach (520)526-3030
Date of Summary:
July 3, 1996
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- Classification Name: Resorbable Barrier Membrane Common or Usual Name: Regenerative Material Proprietary Name: RESOLUT Regenerative Material
- .3. ************************************************************************************************************************************************************************** Predicate Device RESOLUT Regenerative Material, CAPSET 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.
5. Intended 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 healing.
Technological Characteristics: 6.
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 can provide a favorable environment for bone regeneration.
2
8. Conclusion:
. .
There have been no changes to RESOLUT Regenerative Material in terms of its design, manufacturing process, materials, and intended use. The modifications to the indications for use are substantially equivalent to the indications for use of CAPSET Calcium Sulfate Barrier Graft, Micro Titanium Augmentation Mesh, and the predicate RESOLUT Regenerative Material.