(95 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical equivalence to existing bioresorbable membranes, with no mention of AI or ML.
Yes
The device aids in bone regeneration, augmentation, and regeneration of periodontal tissue components, which are clearly therapeutic indications.
No
Explanation: The device, a bioresorbable matrix barrier, is described as aiding in bone and tissue regeneration and acting as a stable barrier. Its function is to facilitate healing and provide structural support, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical, bioresorbable matrix barrier, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for bone and tissue regeneration in oral surgery. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical barrier implanted in the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the GUIDOR® Bioresorbable Matrix Barrier is a surgical device used for tissue regeneration, not an IVD.
N/A
Intended Use / Indications for Use
GBR Configurations
To aid in bone regeneration and augmentation in oral surgery for:
- Extraction socket site preservation
- Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired,
- Ridge augmentation
- Sinus elevation
- Stable barrier for the containment of bone grafting materials
GTR Configurations
To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment the reparative process following scaling and root planing for:
- Class II furcations
- intrabony defects
- recession type defects
Product codes (comma separated list FDA assigned to the subject device)
NPK
Device Description
The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix. This reduces the risk of infection and inflammation to the immature, regenerated tissue'. For guided bone regeneration (GBR), the GUIDOR® Bioresorbable Marrix Barrier is intended to aid in bone regeneration and augmentation, such as: extraction socket site preservation, immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired, ridge augmentation, sinus elevation, and function as a stable barrier for the containment of bone grafting materials.
When used for guided tissue regeneration, (GTR), the GUIDOR® Matrix is intended to aid in the regeneration and integration of periodontal tissue components. It is also for use as an adjunct in periodontal surgical treatment the reparative process following scaling and root planing for Class II furcations, intrabony defects, and recession type defects.
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)
Summary of Nonclinical Testing
Performance testing is not necessary to support the proposed modifications for use and instructions for use, as substantial equivalence of the device is demonstrated through the material properties and technical characteristics. Results of biocompatibility and sterility testing conclude that the GUIDOR® Bioresorbable Matrix Barrier is biologically safe for its intended use.
Summary of Clinical Testing
Results from retrospective clinical data and human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes support that the GUIDOR® Bioresorbable Matrix Barrier is substantially equivalent to those of the previously accepted and clinically successfully used bioresorbable membranes for similar indications.
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.
K912724, K051267, K033074, K050446, K993610, K053260
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
510(K) SUMMARY 5
The following information is provided as required by 21 CFR § 807.87 for the GUIDOR® Bioresorbable Matrix Barrier 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Sunstar Americas, Inc. Sponsor: 4635 W. Foster Avenue Chicago, IL 60630
OCT 2 9 2013
Contact: M Squared Associates, Inc. Deborah Lavoie Grayeski, Regulatory Consultant 575 8th Ave., Suite 1212 New York, NY 10018 Ph. 703-562-9800 Ext 250 Fax. 703-562-9797
| Date of Submission: | July 24, 2013 |
|---|---|
| Proprietary Name: | GUIDOR® Bioresorbable Matrix Barrier |
| Common Name: | Barrier, Synthetic, Intraoral |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 872.3930 |
| Product Codes: | NPK |
| Predicate Device(s): | Guidor™, Sunstar Suisse SA (originally submitted by Procordia OraTech AB) |
| (K912724) | |
| Resolut® Adapt LT Regenerative Membrane, WL Gore (K051267) | |
| Inion GTR Biodegradable Membrane System, Inion Ltd (K033074) | |
| Bio-Gide Resorbable Bilayer Membrane, Ed. Geistlich Soehne Ag Fuer | |
| Chemische Industrie (K050446) | |
| Cytoplast™ Resorb, Osteogenics Biomedical, Inc. (K993610) | |
| Ossix Plus, ColBar LifeScience Ltd. (K053260) |
Device Description:
The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration
1
and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix. This reduces the risk of infection and inflammation to the immature, regenerated tissue'. For guided bone regeneration (GBR), the GUIDOR® Bioresorbable Marrix Barrier is intended to aid in bone regeneration and augmentation, such as: extraction socket site preservation, immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired, ridge augmentation, sinus elevation, and function as a stable barrier for the containment of bone grafting materials.
When used for guided tissue regeneration, (GTR), the GUIDOR® Matrix is intended to aid in the regeneration and integration of periodontal tissue components. It is also for use as an adjunct in periodontal surgical treatment the reparative process following scaling and root planing for Class II furcations, intrabony defects, and recession type defects.
Indications for Use:
GBR Configurations
To aid in bone regeneration and augmentation in oral surgery for:
- Extraction socket site preservation
- Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire,
- Ridge augmentation
- Sinus elevation
- Stable barrier for the containment of bone grafting materials
GTR Configurations
To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment the reparative process following scaling and root planning for:
- -Class II furcations
- intrabony defects -
- recession type defects -
1 Lundgren D. Mathisen T. Gottlow J. The development of a bioresorbable barrier for guided tissue regeneration. J Swed Dent Assoc 1994; 86:741-756.
2
Technological characteristics
The GUIDOR® Bioresorbable Matrix Barrier has the same technical characteristics and operaing principles as the Guidor™ predicate (K912724). Both are composed of two layers, similar to the Inion GTR Biodegradable Membrane System (K033074), Bio-Gide Resorbable Bilayer Membrane (K050446), and Cytoplast™ Resorb (K993610) predicates which are all multi-layer products. The GUIDOR® Matrix Barrier is composed of synthetic materials similar to the Guidor™ predicate (K912724), Inion GTR Biodegradable Membrane System (K033074), and Resolut® Adapt LT Regenerative Membrane (K051267) predicates, while the remaining predicates are composed of collagen. The applicant and predicate devices have all been designed to be bioresorbable and sterile.
Summary of Nonclinical Testing
Performance testing is not necessary to support the proposed modifications for use and instructions for use, as substantial equivalence of the device is demonstrated through the material properties and technical characteristics. Results of biocompatibility and sterility testing conclude that the GUIDOR® Bioresorbable Matrix Barrier is biologically safe for its intended use.
Summary of Clinical Testing
Results from retrospective clinical data and human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes support that the GUIDOR® Bioresorbable Matrix Barrier is substantially equivalent to those of the previously accepted and clinically successfully used bioresorbable membranes for similar indications.
Conclusion
The GUIDOR® Bioresorbable Matrix Barrier is as safe and effective as the predicate devices. The GUIDOR® Matrix Barrier has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. Therefore, the GUIDOR® Matrix Barrier is substantially equivalent to the predicate devices and may be used for guided bone regeneration (GBR), to aid in bone regeneration and augmentation, such as: extraction socket site preservation, immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired, ridge augmentation, sinus elevation, as a stable barrier for the containment of bone grafting materials. When used for guided tissue regeneration, (GTR), the GUIDOR® Matrix is intended to aid in the regeneration of periodontal tissue components. It is also for use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planing for Class II furcations, intrabony defects, and recession type defects.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2013
Sunstar Americas, Incorporated c/o Ms. Deborah Lavoie Graveski Regulatory Consultant M Squared Associates, Incorporated 575 8th Avenue, Suite 1212 New York, New York 10018
Re: K132325
Trade/Device Name: GUIDOR® Bioresorbable Matrix Barrier Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: September 27, 2013 Received: September 30, 2013
Dear Ms. Grayeski:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
4
Page 2 - Ms. Grayeski
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image contains the name "Mary S. Bunner -S" in a bold, sans-serif font. The letters are closely spaced, and the text appears to be a signature or label. The overall impression is clean and legible, with a focus on clarity and simplicity.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4 INDICATIONS FOR USE STATEMENT
To be assigned K132325 510(k) Number:
GUIDOR® Bioresorbable Matrix Barrier Device Name:
Indications for Use:
GBR Configurations
To aid in bone regeneration and augmentation in oral surgery for:
- Extraction socket site preservation
- Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire,
- Ridge augmentation
- Sinus elevation
- Stable barrier for the containment of bone grafting materials
GTR Configurations
To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for:
- Class II furcations -
- intrabony defects -
- recession type defects -
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I 2013.10.2
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