(84 days)
GORE-TEX Regenerative Material is intended to provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. GORE-TEX Regenerative Material is a passive, non-load bearing material. It is NOT intended for use in load bearing, articulating situations such as temporal mandibular joint reconstruction.
The Titanium Reinforced Configurations of GORE-TEX Regenerative Material are 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. The materials used in the manufacture of the Titanium Reinforced Configurations do not alter the biology of GTR therapy or the application for which the product is presently used.
GORE-TEX Regenerative Material is surgically placed beneath the mucoperiosteum to aid in the regenerative healing of (1) bone or (2) bone/periodontal ligament defects of the oral cavity. The material is designed to be a passive barrier which excludes epithelial and gingival connective tissue from the defect site so that only the desirable cells repopulate the space, allowing regeneration to occur.
The material is designed to be stiff enough to create and maintain a protected defect space into which new hard and soft tissues can form, but supple enough to drape smoothly over the defect margin. It is non-absorbable, thereby allowing for predictable isolation of the defect site.
This document is a 510(k) Summary of Safety and Effectiveness for the Gore-Tex Regenerative Material Titanium Reinforced Configurations. It aims to demonstrate substantial equivalence to a predicate device. However, it does not contain a detailed study with acceptance criteria and specific performance data in the format requested.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
What can be extracted:
- Device Name: Gore-Tex Regenerative Material Titanium Reinforced Configurations
- Predicate Device: Gore-Tex Periodontal Material -- Titanium Reinforced Configurations
- Intended Use: To provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. It is a passive, non-load bearing material. Not intended for use in load bearing, articulating situations.
- Key Technological Characteristic (modified): The modified configurations have been designed according to the same five design criteria as the predicate device. The additional raw material has reduced the complexity of the manufacturing process.
- Performance Data Mentioned: Lamination bond strength was tested. The bond values for the modified configurations are comparable to or better than those of the current (predicate) configurations.
- Conclusion: Substantially equivalent to the current Titanium Reinforced Configurations of Gore-Tex Regenerative Material in design, manufacturing process, materials, and intended use.
What is explicitly missing from this document regarding a study, acceptance criteria, and detailed performance data:
The document describes the device, its intended use, and states that testing was performed on "lamination bond strength" found to be "comparable to or better than" the predicate. However, it does not provide:
- A specific table of acceptance criteria and reported device performance with numerical values.
- Sample sizes used for any test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size.
- Standalone (algorithm-only) performance (not applicable, as this is a physical medical device, not AI).
- Type of ground truth used (if clinical data was collected, which is not detailed here).
- Sample size for the training set (not applicable, as this is a physical medical device, not AI).
- How the ground truth for the training set was established (not applicable, as this is a physical medical device, not AI).
Summary of available information vs. missing information:
| Information Requested | Available in Document |
|---|---|
| 1. Table of Acceptance Criteria & Device Performance | No. Only a qualitative statement: "Lamination is an important characteristic and testing of the lamination bond strength was performed. The bond values for the modified Titanium Reinforced Configurations are comparable to or better than those of the current Titanium Reinforced Configurations." |
| 2. Sample size & Data Provenance (test set) | No. |
| 3. Number & Qualifications of Experts (ground truth) | No. (Not applicable for physical device's technical testing documentation mentioned) |
| 4. Adjudication Method (test set) | No. (Not applicable for physical device's technical testing documentation mentioned) |
| 5. MRMC Comparative Effectiveness Study & Effect Size | No. (Not applicable for this type of device and submission) |
| 6. Standalone Algorithm Performance Study | No. (Not applicable; this is a physical medical device) |
| 7. Type of Ground Truth Used | No details. The "ground truth" for the lamination bond strength would be the measured physical properties based on standardized test methods, but the specifics are not provided. |
| 8. Sample Size for Training Set | No. (Not applicable) |
| 9. How Ground Truth for Training Set Was Established | No. (Not applicable) |
In conclusion, this document primarily serves as a 510(k) summary for substantial equivalence and refers to testing done on lamination bond strength without providing the detailed numerical acceptance criteria or performance results usually found in a comprehensive study report.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Ms. Jacqueline Kalbach Regulatory Affairs Associate W.L. Gore & Associates, Incorporated 1500 North Fourth Street Flagstaff, Arizona 86001
Re: K960292
Trade Name: Gore-Tex Regenerative Material Titanium Reinforced Configurations Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: January 19, 1996 Received: January 22, 1996
Dear Ms. Kalbach:
This letter corrects our substantially equivalent letter of April 15, 1996.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I varted to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sudite Y. Michien Dard.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/1/Picture/7 description: The image is a black and white circular seal. The seal has the letters "FDA" in large bold font in the center. Above the letters, the seal reads "1906-2006". The word "Centennial" is written below the letters. The seal also has the words "Food and Drug Administration" written around the border.
Protecting and Promoting Public Health
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Kx609a
Applicant Name, Address: W.L. Gore & Associates, Inc. 1. 1500 North Fourth Street P.O. Box 2500 Flagstaff AZ 86003-2500
PR 1 5 1996
Contact Person, Telephone: Jacqueline Kalbach (520)527-2295
Date of Summary:
January 19, 1996
- Nonresorbable Barrier Membrane Classification Name: Regenerative Material Common or Usual Name: GORE-TEX Regenerative Material --Proprietary Name: Titanium Reinforced Configurations
GORE-TEX Periodontal Material --3. Predicate Device: Titanium Reinforced Configurations
Device Description: 4.
The Titanium Reinforced Configurations of GORE-TEX Regenerative Material are 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. The materials used in the manufacture of the Titanium Reinforced Configurations do not alter the biology of GTR therapy or the application for which the product is presently used.
GORE-TEX Regenerative Material is surgically placed beneath the mucoperiosteum to aid in the regenerative healing of (1) bone or (2) bone/periodontal
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ligament defects of the oral cavity. The material is designed to be a passive barrier which excludes epithelial and gingival connective tissue from the defect site so that only the desirable cells repopulate the space, allowing regeneration to occur.
The material is designed to be stiff enough to create and maintain a protected defect space into which new hard and soft tissues can form, but supple enough to drape smoothly over the defect margin. It is non-absorbable, thereby allowing for predictable isolation of the defect site.
ട. Intended Use:
GORE-TEX Regenerative Material is intended to provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. GORE-TEX Regenerative Material is a passive, non-load bearing material. It is NOT intended for use in load bearing, articulating situations such as temporal mandibular joint reconstruction.
റ. Technological Characteristics:
The modified Titanium Reinforced Configurations of GORE-TEX Regenerative Material have been designed according to the same five design criteria as the predicate device, GORE-TEX Periodontal Material -- Titanium Reinforced Configurations. The additional raw material has reduced the complexity of the manufacturing process.
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7. Assessment of Performance Data:
Lamination is an important characteristic and testing of the lamination bond strength was performed. The bond values for the modified Titanium Reinforced Configurations are comparable to or better than those of the current Titanium Reinforced Configurations.
Conclusion: 8.
The modified Titanium Reinforced Configurations of GORE-TEX Regenerative Material are substantially equivalent to the current Titanium Reinforced Configurations of GORE-TEX Regenerative Material in design, manufacturing process, materials, and intended use.
§ 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.