(60 days)
No
The summary describes a bone graft substitute composed of physical materials and does not mention any computational or algorithmic components, including AI or ML.
Yes
The device is described as a "Bone Graft Substitute" and "bone void filler" that "resorbs and is replaced with bone during the healing process," directly supporting the body's natural healing and structural restoration.
No
This device is a bone graft substitute, a material designed to fill bony voids and promote bone growth, not to diagnose a condition. Its intended use is therapeutic, providing a structural and biological scaffold.
No
The device description clearly states the product is composed of physical components (bioactive glass components and bovine type I collagen) and is intended to be mixed with autogenous bone marrow aspirate and autograft. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system, specifically the posterolateral spine. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a bone graft substitute composed of bioactive glass and collagen, intended to be implanted into the body. This is consistent with a medical device used for treatment or repair, not for diagnosing a condition.
- Performance Studies: The performance studies focus on the device's ability to promote bone healing and its biocompatibility when implanted in an animal model. This evaluates the device's function within the body, not its ability to detect or measure substances in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the FIBERGRAFT® BG Matrix is a medical device used for surgical implantation 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). 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
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 product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
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)
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
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 biocompatibility of the FIBERGRAFT® BG Matrix is demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. 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 quidelines.
The FIBERGRAFT® BG Matrix product was evaluated in a rabbit study to further support device performance for its indications for use. 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. 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.
Key Metrics
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
Prosidyan, Inc. % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K171284
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: May 1, 2017 Received: May 1, 2017
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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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). 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: June 29, 2017
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 Device
- Stryker/Orthovita Inc, Vitoss Bioactive Bimodal (K103173) .
Reference Device
- NovaBone Products LLC, Novabone MacroFORM (K140946) ●
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). 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 product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
Technological Characteristics
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. After hydrating with BMA, the BG Matrix must be mixed with autograft.
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The same M-45 granules have previously been 510(k) cleared in Prosidyan's FIBERGRAFT BG Morsels (K141956, K132805, and K151154) and FIBERGRAFT BG Putty (K143533). The MS-45 microspheres included in the proposed device have also been cleared in the company's FIBERGRAFT BG Puttv (K143533),
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 glass 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 quidelines.
The FIBERGRAFT® BG Matrix product was evaluated in a rabbit study to further support device performance for its indications for use. 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 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.
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 and reference devices. The minor technological differences between BG Matrix and its predicate device do not raise any new issues of safety or effectiveness. The data demonstrate that BG Matrix is substantially equivalent to the predicate device.
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.
5
Performance testing, including in vivo data, demonstrated that the device functions as intended
without raising new safety or effectiveness questions.