(84 days)
GORE-TEX Periodontal Material -- Titanium Reinforced Configurations
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No
The summary describes a passive, non-load bearing material used as a barrier for guided tissue regeneration. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes.
This device is intended to aid in the regenerative healing of bone or bone/periodontal ligament defects in the oral cavity for therapeutic purposes.
No
Explanation: The device is intended to facilitate tissue regeneration and is surgically placed to aid healing; it does not diagnose a condition.
No
The device description clearly states it is a "material" and describes its physical properties and surgical placement, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and body excretions, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or inborn abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- Device Function: The GORE-TEX Regenerative Material is a surgically implanted material used to physically guide tissue regeneration in bony defects. It acts as a barrier and provides space for tissue ingrowth.
- Lack of Specimen Examination: The device does not examine any specimens from the human body in vitro. It is a physical implant used within the body.
- Purpose: Its purpose is to facilitate tissue regeneration through physical means, not to provide diagnostic information based on the analysis of biological samples.
Therefore, the description clearly indicates a surgical implant for tissue regeneration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NPK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, alveolar ridges
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GORE-TEX Periodontal Material -- Titanium Reinforced Configurations
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
3
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.