(86 days)
No
The summary describes a bone graft substitute composed of physical materials and does not mention any computational or analytical functions that would involve AI/ML.
Yes.
The device is a bone void filler that resorbs and is replaced with bone during the healing process, indicating its use in treating a condition (bony voids or gaps) to promote healing.
No.
The device is described as a bone graft substitute and bone void filler, intended to be implanted to replace bone during the healing process, not to diagnose a condition.
No
The device description clearly states the product is composed of physical components (bioactive glass and bovine type I collagen) and is applied as a physical matrix or putty. It is a physical bone graft substitute, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone graft substitute for filling bony voids and gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition of the material (bioactive glass and collagen) and how it is applied to the defect site. This aligns with a bone graft substitute, not a diagnostic test.
- Performance Studies: The performance studies focus on the device's ability to promote bone healing and its biocompatibility in animal models. This is relevant to a bone graft substitute, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the FIBERGRAFT® BG Matrix is a medical device used for surgical intervention and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
Product codes
MOV, MQV
Device Description
FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline or blood can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio.
The FIBERGRAFT® BG Matrix product was previously cleared in K171284. There has not been any change to the device since the last clearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis)
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)
The performance of the FIBERGRAFT® BG Matrix has been established by undertaking physical and chemical property evaluation studies, functional performance animal studies and biocompatibility tests. The physical and chemical property studies confirmed the in vitro functionality and bioactivity of the BG Matrix. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT® BG Matrix is demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive dlass material for the same intended use. In addition, the BG Matrix is composed of the same bioactive glass material and the same type and duration of patient contact as the predicates. Packaging evaluations, shelf life testing and real time aging testing were performed with passing results. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines.
The FIBERGRAFT® BG Matrix product was evaluated in a rabbit posterolateral spine fusion study to further support device performance for its indications for use in posterolateral spine. The FIBERGRAFT® BG Matrix product was compared to its predicate device as well as controls. The animal study evaluated device performance in critical sized cancellous bone in the posterolateral spine of 53 skeletally mature rabbits. The performance was evaluated using radiographic, histological, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT® BG Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 week follow up demonstrated the performance of the FIBERGRAFT® BG Matrix device.
The FIBERGRAFT® BG Matrix product was also evaluated in a critical size distal femur defects in skeletally mature rabbits to further support device performance for its indications for use in extremities and pelvis applications. The FIBERGRAFT® BG Matrix product was compared to its predicate device as well as controls. The animal study evaluated device performance in critical sized defects in the distal femur of 42 skeletally mature rabbits. The performance was evaluated using radiographic, histomorphometric, and biomechanical data, Testing of the FIBERGRAFT® BG Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 week follow up demonstrated that the FIBERGRAFT® BG Matrix device performs substantially equivalently to the predicate device and positive control, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns.
Therefore, performance testing demonstrated that the FIBERGRAFT® BG Matrix device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
April 6, 2018
Prosidyan, Inc. % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K180080
Trade/Device Name: FIBERGRAFT® BG Matrix Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 10, 2018 Received: January 10, 2018
Dear Ms. Hogan:
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 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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K180080 Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
FIBERGRAFT® BG Matrix Bone Graft Substitute
Indications for Use (Describe)
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
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510(k) SUMMARY
Prosidyan, Inc.'s FIBERGRAFT® BG Matrix - Bone Graft Substitute
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Prosidvan. Inc. 30 Technology Drive Warren, NJ 07059 Phone: (610)-945-5640 Facsimile: (908) 396-1151 Contact Person: Charanpreet S. Bagga
Date Prepared: March 7, 2018
Name of Device and Name
FIBERGRAFT® BG Matrix Bone Graft Substitute
Common or Usual Name
Bone Void Filler
Classification Name/CFR Requlation/Product Code
Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV
Predicate Devices
- . Novabone Products LLC, Novabone MacroFORM (K140946) (Primary predicate device)
- . Prosidyan Inc, FIBERGRAFT BG Matrix (K171284) (Reference device)
- . Prosidyan Inc, FIBERGRAFT BG Putty (K143533, K170306) (Reference device)
Intended Use / Indications for Use
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
Device Description
FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline or blood can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion
4
applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio.
The FIBERGRAFT® BG Matrix product was previously cleared in K171284. There has not been any change to the device since the last clearance.
Technological Characteristics
FIBERGRAFT® BG Matrix is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute. The product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix hydrated with saline or blood can be applied to the defect site or can be used as a moldable and malleable material that can be placed at the defect site. In addition, for posterolateral spine fusion applications, the product can be mixed with autograft.
The addition of collagen creates a single piece bone graft in a shape and size that is clinically relevant for ease of use during implantation.
Performance Data
The performance of the FIBERGRAFT® BG Matrix has been established by undertaking physical and chemical property evaluation studies, functional performance animal studies and biocompatibility tests. The physical and chemical property studies confirmed the in vitro functionality and bioactivity of the BG Matrix. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT® BG Matrix is demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive dlass material for the same intended use. In addition, the BG Matrix is composed of the same bioactive glass material and the same type and duration of patient contact as the predicates. Packaging evaluations, shelf life testing and real time aging testing were performed with passing results. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines .
The FIBERGRAFT® BG Matrix product was evaluated in a rabbit posterolateral spine fusion study to further support device performance for its indications for use in posterolateral spine. The FIBERGRAFT® BG Matrix product was compared to its predicate device as well as controls. The animal study evaluated device performance in critical sized cancellous bone in the posterolateral spine of 53 skeletally mature rabbits. The performance was evaluated using radiographic, histological, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT® BG Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 week follow up demonstrated the performance of the FIBERGRAFT® BG Matrix device.
The FIBERGRAFT® BG Matrix product was also evaluated in a critical size distal femur defects in skeletally mature rabbits to further support device performance for its indications for use in extremities and pelvis applications. The FIBERGRAFT® BG Matrix product was compared to its predicate device as well as controls. The animal study evaluated device performance in critical sized defects in the distal femur of 42 skeletally mature rabbits. The performance was evaluated using radiographic, histomorphometric, and biomechanical data, Testing of the FIBERGRAFT® BG Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 week follow up demonstrated that the FIBERGRAFT® BG Matrix device performs substantially equivalently to the predicate device and positive control, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns.
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Therefore, performance testing demonstrated that the FIBERGRAFT® BG Matrix device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate device.
Substantial Equivalence
As demonstrated in performance testing, the FIBERGRAFT® BG Matrix has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between BG Matrix and its predicate devices do not raise any new issues of safety or effectiveness. The data demonstrate that BG Matrix is substantially equivalent to the predicate devices.
Conclusion
FIBERGRAFT® BG Matrix is an osteoconductive, resorbable, biocompatible bone graft substitute composed of bioactive glass, mixed with Type I collagen. The FIBERGRAFT® BG Matrix is substantially equivalent to its predicate device for its intended use as a synthetic bone void filler. Performance testing, including in vivo data, demonstrated that the device functions as intended without raising new safety or effectiveness questions.