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.

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.

AI/ML Overview

The provided document describes the K973594 submission for the GORE RESOLUT™ XT Regenerative Material. Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Material Composition	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.
Biocompatibility	Demonstrated in preclinical studies.
Cell Occlusivity	Designed to be cell occlusive.
Space-making capability	Designed to be space-making.
Clinical manageability	Designed to be clinically manageable.
Tissue integration	Designed to allow for tissue integration.
GTR Principles Adherence	Designed to act in accordance with accepted principles of wound healing and guided tissue regeneration (GTR).
Space Maintenance in Bone Regeneration	Preclinical studies in rat mandibles indicated GORE RESOLUT™ XT provided space maintenance suitable for regeneration of intramembranous bone.
Tissue Tolerance for Bone Regeneration	Preclinical studies in rat mandibles indicated GORE RESOLUT™ XT provided tissue tolerance suitable for regeneration of intramembranous bone.
Functional Integrity (Time to Absorption)	Consistent with clinical goals of GTR, as observed in preclinical studies.
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to the current GORE RESOLUT™ Regenerative Material based on shared indication statements and the long history of safe and effective use of trimethylene carbonate in bioabsorbable, implantable medical devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions preclinical studies conducted in critical size defects of the rat mandible.

Sample Size: Not explicitly stated.
Data Provenance: Retrospective, as these were animal studies. The country of origin is not specified, but given W.L. Gore & Associates, Inc. is an American company, it's highly likely the studies were conducted in the US or a region with similar regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the given document. The preclinical studies were likely evaluated by researchers and veterinary pathologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the given document. For preclinical animal studies, adjudication typically involves histological analysis and quantitative measurements performed by researchers, often with independent verification.

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:

An MRMC comparative effectiveness study was not performed. This device is a physical bioabsorbable material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

A standalone performance study as described (algorithm only without human-in-the-loop performance) was not applicable as this is a physical medical device and not an algorithm. The preclinical animal studies can be considered standalone performance assessments of the material itself.

7. The Type of Ground Truth Used:

The ground truth for the preclinical studies was likely based on direct histological examination and quantitative measurements of bone regeneration and tissue integration in the rat mandible defects. This falls under outcomes data and pathological analysis in an animal model.

8. The Sample Size for the Training Set:

This information is not provided in the given document. The concept of a "training set" is generally applicable to machine learning models, which is not what this device is. For a physical device, development and testing might involve multiple iterations, but the term "training set" doesn't directly apply in the same way.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided and is not directly applicable to this type of device. The development process would involve materials science, biomaterial testing, and potentially pilot animal studies to optimize the material's properties before definitive preclinical studies. The "ground truth" for these stages would be based on established scientific principles, laboratory measurements, and observations from early animal models.

Summary

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K973594

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.

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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.

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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.

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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

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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)

Regulation Number and Section

§ 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.