(30 days)
Not Found
No
The summary describes a bioabsorbable membrane and its intended use and performance, with no mention of AI or ML technology.
No.
The device is a bioabsorbable membrane intended for guided bone regeneration, which supports the healing process and creates space for tissue regeneration, rather than directly treating a disease or condition for therapeutic purposes.
No
The device is described as a bioabsorbable membrane for guided bone regeneration and wound healing, not for diagnosing conditions.
No
The device description explicitly states it is composed of "synthetic resorbable copolymers" and is a "membrane," indicating a physical, hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during a surgical procedure (guided bone regeneration) to support tissue healing and regeneration. This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the membrane as a barrier and support for tissue growth. It doesn't mention any components or processes related to analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis of samples," "in vitro," etc.
- Performance Studies: The performance studies focus on bone formation and ease of use in a clinical setting, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used in the body during a surgical procedure.
N/A
Intended Use / Indications for Use
"It is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift)."
Product codes
NPK
Device Description
"These devices are composed of synthetic resorbable copolymers and have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
"A preclinical in vivo study was conducted to evaluate the ease of use. clinical performance, and efficacy of the synthetic resorbable membranes as compared to the predicate device, BIO-GIDE® Resorbable Bilayer Membrane. In this study, new bone formation in ridge defects treated with the synthetic resorbable membranes was statistically equivalent to or better than bone formation with the predicate device.
Results from human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes are consistent with the preclinical in vivo study. Both types of resorbable materials are effective as a barrier to aid in wound healing and regenerate bone around defects associated with dental implants, and for ridge augmentation and sinus procedures."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
W.L. Gore & Associates, Inc. May 2005
GORE BIOABSORBABLE Membranes Premarket Notification
JUN 1 5 2005
510(K) Summary of Safety and Effectiveness
| 1. | Applicant Name, Address: | W.L. Gore & Associates, Inc.
3450 W. Kiltie Lane
P.O. Box 900
Flagstaff, AZ 86002-0900 |
|----|--------------------------|-------------------------------------------------------------------------------------------------|
| | Contact Person: | Jacqueline Kalbach
(928)864-3731 |
| | Date of Summary: | May 12, 2005 |
| 2. | Classification Name: | Resorbable Barrier Membrane |
| | Common or Usual Name: | Regenerative Material |
Proprietary Names:
Common or Usual Name:
GORE RESOLUT® Regenerative Material, GORE RESOLUT® XT Regenerative Membrane, GORE OSSEOQUEST Regenerative Membrane, GORE RESOLUT® ADAPT Regenerative Membrane, and GORE RESOLUT® ADAPT LT Regenerative Membrane
3. Predicate Devices:
BIO-GIDE® Resorbable Bilayer Membrane (K960724), BIOBAR Biodegradable Collagen Membrane (K001598), and Collagen Dental Membrane (K011695).
4. Device Description:
These devices are composed of synthetic resorbable copolymers and have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing.
CONFIDENTIAL GORE INFORMATION
1
5. Intended Use:
The indication for use will be expanded for each applicant device to include the following: "It is intended for use during the process of quided bone regeneration as a bioabsorbable membrane for supporting: immediate augmentation around implants (e.q., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift). "
6. Technological Characteristics:
The applicant devices are composed of synthetic resorbable materials and the predicate devices are composed of resorbable collagen. The applicant and predicate devices have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy.
7. Assessment of Performance Data:
A preclinical in vivo study was conducted to evaluate the ease of use. clinical performance, and efficacy of the synthetic resorbable membranes as compared to the predicate device, BIO-GIDE® Resorbable Bilayer Membrane. In this study, new bone formation in ridge defects treated with the synthetic resorbable membranes was statistically equivalent to or better than bone formation with the predicate device.
Results from human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes are consistent with the preclinical in vivo study. Both types of resorbable materials are effective as a barrier to aid in wound healing and regenerate bone around defects associated with dental implants, and for ridge augmentation and sinus procedures.
CONFIDENTIAL GORE INFORMATION
2
8. Conclusion:
GORE RESOLUT Regenerative Material, GORE RESOLUT XT Regenerative Membrane, GORE OSSEOQUEST Regenerative Membrane, GORE RESOLUT ADAPT Regenerative Membrane, and GORE RESOLUT ADAPT LT Regenerative Membrane are substantially equivalent to the predicate devices and may be used during the process of guided bone regeneration as a bioabsorbable membrane for supporting: immediate augmentation around implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).
GORE, RESOLUT, OSSEOQUEST, and designs are trademarks of W.L. Gore & Associates, Inc. All other trademarks are the property of their respective owners.
CONFIDENTIAL GORE INFORMATION
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 its wings forming three curved lines. 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 MD 20850
MAY - 1 2007
Ms. Jacqueline Kalbach Regulatory Affairs Associate W.L. Gore & Associates, Incorporated 3450 West Kiltie Lane P.O. Box 500 Flagstaff, Arizona 86002-0900
Re: K051267
Trade/Device Name: GORE RESOLUT® Regenerative Material, GORE RESOLUT® XT Regenerative Membrane, GORE OSSEOQUEST Regenerative Membrane, GORE RESOLUT ADAPT Regenerative Membrane, and GORE RESOLUT® ADAPT LT Regenerative Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: May 12, 2005 Received: May 16, 2005
Dear Ms. Kalbach:
This letter corrects our substantially equivalent letter of June 15, 2005.
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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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 limited 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 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Suette y. Michael Omd.
Chiú Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Intended Use
_ of _________________________________________________________________________________________________________________________________________________________________________ Page (
510(k) Number (if known) _ Kosl Z67
Device Name:
GORE RESOLUT® Regenerative Material, GORE RESOLUT® XT Regenerative Membrane, GORE OSSEOQUEST Regenerative Membrane, GORE RESOLUT® ADAPT Regenerative Membrane, and GORE RESOLUT® ADAPT LT Regenerative Membrane
INDICATIONS FOR USE:
The following will be added to the current indications for use statement for each of the devices listed above:
It is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).
Please do not write BELOW this line - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | OR | Over-The-Counter Use ______ | ||
|---|---|---|---|---|
| See | ||||
| (Division Sign-Off) | ||||
| Division of Anesthesiology, General Hospital, | ||||
| Infection Control, Dental Devices | (Optional Format 1-2-96) | |||
| 510(k) Number: | K051267 |
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