(86 days)
Not Found
Not Found
No
The description focuses on the material composition and biological function of the device, with no mention of AI or 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 actions.
No
This device is a regenerative material designed to aid in the healing of periodontal defects and provides a favorable environment for bone regeneration, making it a therapeutic or restorative device, not a diagnostic one.
No
The device description clearly states it is a bioabsorbable, implantable material composed of physical structures (fiber and membrane), indicating it is a hardware device, 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 for bone graft containment. This is a therapeutic and regenerative purpose, not a diagnostic one.
- Device Description: The description details a surgically implanted material designed to facilitate tissue regeneration and act as a barrier. This is a physical implant, not a device used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
GORE RESOLUT™ XT 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, GORE RESOLUT™ XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
GORE RESOLUT™ XT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer 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. GORE RESOLUT™ XT 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. GORE RESOLUT™ XT Regenerative Material is surgically placed beneath the 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical studies conducted in critical size defects of the rat mandible indicate (1) that GORE RESOLUT™ XT Regenerative Material provided space maintenance and a tissue tolerance suitable for regeneration of intramembranous bone. The functional integrity and time to absorption of this material are consistent with the clinical goals of GTR.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
DEC 17 1997
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
TAB I
Applicant Name, Address: 1.
W.L. Gore & Associates, Inc. 3750 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 860023-0900
Contact Person, Telephone:
John W. Nicholson (520)779-2771
Date of Summary:
August 15, 1997
- Classification Name: Common or Usual Name: Proprietary Name:
Resorbable Barrier Membrane Regenerative Material GORE RESOLUT™ XT Regenerative Material
Device Description: 4.
GORE RESOLUT™ XT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer 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. GORE RESOLUT™ XT 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
1
occlusive, spacemaking, and clinically manageable, and allow for tissue integration. GORE RESOLUT™ XT Regenerative Material is surgically placed beneath the 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:
GORE RESOLUTm XT 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, GORE RESOLUT™ XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
6. · Technological Characteristics:
GORE RESOLUT™ XT 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, space-making, and clinically manageable, and allow for tissue integration.
7. Assessment of Performance Data:
Preclinical studies conducted in critical size defects of the rat mandible indicate (1) that GORE RESOLUT™ XT Regenerative Material provided space maintenance and a tissue tolerance suitable for regeneration of intramembranous bone. The functional integrity and time to absorption of this material are consistent with the clinical goals of GTR.
63
2
Conclusion: 8.
The modified GORE RESOLUT™ XT Regenerative Material has the same indication statement as the current GORE RESOLUT™ Regenerative Material. Their intended use is the same: the modified GORE RESOLUT™ XT Regenerative Material acts as a barrier intended to allow controlled tissue regeneration and thus allow repair of bone/periodontal ligament defects in the oral cavity. It may also be used as a membrane for bone graft containment. Trimethylene carbonate has been added to the manufacture of the modified GORE RESOLUT™ XT Regenerative Material, and trimethylene carbonate has a long history of safe and effective use in bioabsorbable, implantable medical devices. Thus, the modified GORE RESOLUT™ XT Regenerative Material is substantially equivalent to the current GORE RESOLUT™ Regenerative Material.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. John W. Nicholson Requlatory Affairs W.L. Gore & Associates, Incorporated Medical Products Division 3750 West Kiltie Lane 86002-0900 Flagstaff, Arizona
K973594 Re : Gore Resolut XT Regenerative Material Trade Name: Regulatory Class: Unclassified Product Code: LYC September 19, 1997 Dated: Received: September 22, 1997
Dear Mr. Nicholson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Nicholson
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K973594
GORE RESOLUT XT Regenerative Material Device Name: __
Indications For Use:
CORE RESOLUT XT 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, CORE RESOLUT XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospita 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
・・
Over-The-Counter Use_
(Optional Format 1-2-96)