(194 days)
No
The 510(k) summary describes a bone graft substitute made of bioactive glass. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML. The performance studies focus on material properties, animal models, and biocompatibility, not on algorithmic performance.
Yes
The device is a bone graft substitute intended to fill bony voids and promote bone growth, which are therapeutic actions.
No
Explanation: The device is described as a bone graft substitute used to fill bone voids or gaps. Its function is to resorb and be replaced by bone during healing, acting as a structural filler rather than a tool for diagnosis.
No
The device description clearly states it is a physical bone graft substitute made from crystalline 45S5 bioactive glass fibers and microspheres. It is a physical material intended to be packed into bony voids.
Based on the provided information, 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 and structural application, not a diagnostic one.
- Device Description: The description details the material composition and physical properties of the bone graft substitute. It does not mention any components or functions related to analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is implanted in vivo (inside the body) to aid in bone healing.
N/A
Intended Use / Indications for Use
FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The FIBERGRAFT™BG Morsels provide an osteoconductive, resorbable, biocompatible bone graft substitute that is to be gently packed into defect sites. The FIBERGRAFT™BG Morsels are made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses that has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.
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)
Physical property evaluations, functional animal studies, and biocompatibility tests were performed for the FIBERGRAFT™BG Morsels device. Specifically, simulated distribution, whole package integrity and seal strength were tested on the defined packaging configuration. Accelerated and real time aging tests were also performed with passing results. The biocompatibility of the BG Morsels 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 Morsels is composed of the same bioactive glass material with the same chemical composition and the same type and duration of patient contact as the NovaBone predicates. The physical functions and bioactivity of the BG Morsels were also evaluated. and results met the testing requirements. The device is considered bioactive based on in vitro studies that show apatite layer formation on the surface of the implant following immersion in simulated body fluid (SBF). These results have not been correlated to clinical performance.
Animal testing demonstrated evidence of new bone formation in critical size defects, consistent with FDA's recommendations for Class II synthetic bone graft substitutes. Two separate animal studies were conducted. The Prosidyan FIBERGRAFT™ BG Morsels product was evaluated and compared to a positive control, the predicate device (NovaBone Putty), and to a negative sham control (untreated defect) in an ovine model. The animal study evaluated the device performance in critical sized cancellous bone defects in the lateral distal femurs from 58 skeletally mature sheep, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the BG Morsels in the ovine model is representative of the indications for use and range of anatomical sites proposed for the subject device. In addition, the study was conducted for a duration of 24 weeks with several interim evaluation points (i.e., 4, 8, 12, and 24 weeks), including a minimum of 3 animals per time point per treatment group. The results of the study demonstrated that the FIBERGRAFT™BG Morsels device performs as safely and as effectively as the predicate device, and any differences between the results of the device groups do not raise new types of safety or effectiveness concerns.
In addition, the FIBERGRAFT BG Morsels product was also evaluated in a rabbit study to further support device performance for its indications for use. The FIBERGRAFT™ BG Morsels product was compared to its predicate device as well as autograft (positive) control. The animal study evaluated device performance in a rabbit posterolateral spine fusion model with 41 skeletally mature rabbits, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT ™ BG Morsels 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 Morsels device performs substantially equivalently to the predicate device, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns. The device was compared to autograft in animal performance testing in order to demonstrate substantial equivalence to the predicate. ISO 10993-6 testing was also conducted, and results supported substantial equivalence of the FIBERGRAFT BG Morsels compared to its predicate. Fluid absorbability testing further confirmed the use of BMA and the of the product.
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.
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.
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
§ 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
November 10, 2015
Prosidyan Incorporated % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K151154
Trade/Device Name: FIBERGRAFT™ BG Morsels - Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 18, 2015 Received: September 18, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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 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 vours.
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) K151154
Device Name
FIBERGRAFT™ BG Morsels - Bone Graft Substitute
Indications for Use (Describe)
FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
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
Subpart C
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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's FIBERGRAFT™ BG Morsels
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Prosidyan, Inc. 30 Technology Drive Warren, NJ 07059 Phone: (908) 517-3666 Facsimile: (908) 325-0058 Contact Person: Charanpreet S. Bagga
Date Prepared: October 28, 2015
Name of Device and Name/Address of Sponsor
FIBERGRAFT™ BG Morsels Bone Graft Substitute
Common or Usual Name
Bone Void Filler
Classification Name
Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV
Predicate and Reference Devices
Predicate Devices: NovaBone Products, LLC's NovaBone Putty (K112773) (Primary Predicate); Prosidyan Inc., FIBERGRAFT™ BG Morsels Bone Graft Substitute (K141956, K132805) Reference Device: NovaBone Resorbable Bone Graft Substitute (K052494)
Intended Use / Indications for Use
FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
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Technological Characteristics
The technological characteristics of the FIBERGRAFT™BG Morsels have not changed since the prior clearances of the product. The FIBERGRAFT™BG Morsels provide an osteoconductive, resorbable, biocompatible bone graft substitute that is to be gently packed into defect sites. The FIBERGRAFT™BG Morsels are made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses that has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.
Performance Data
Physical property evaluations, functional animal studies, and biocompatibility tests were performed for the FIBERGRAFT™BG Morsels device. Specifically, simulated distribution, whole package integrity and seal strength were tested on the defined packaging configuration. Accelerated and real time aging tests were also performed with passing results. The biocompatibility of the BG Morsels 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 Morsels is composed of the same bioactive glass material with the same chemical composition and the same type and duration of patient contact as the NovaBone predicates. The physical functions and bioactivity of the BG Morsels were also evaluated. and results met the testing requirements. The device is considered bioactive based on in vitro studies that show apatite layer formation on the surface of the implant following immersion in simulated body fluid (SBF). These results have not been correlated to clinical performance.
Animal testing demonstrated evidence of new bone formation in critical size defects, consistent with FDA's recommendations for Class II synthetic bone graft substitutes. Two separate animal studies were conducted. The Prosidyan FIBERGRAFT™ BG Morsels product was evaluated and compared to a positive control, the predicate device (NovaBone Putty), and to a negative sham control (untreated defect) in an ovine model. The animal study evaluated the device performance in critical sized cancellous bone defects in the lateral distal femurs from 58 skeletally mature sheep, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the BG Morsels in the ovine model is representative of the indications for use and range of anatomical sites proposed for the subject device. In addition, the study was conducted for a duration of 24 weeks with several interim evaluation points (i.e., 4, 8, 12, and 24 weeks), including a minimum of 3 animals per time point per treatment group. The results of the study demonstrated that the FIBERGRAFT™BG Morsels device performs as safely and as effectively as the predicate device, and any differences between the results of the device groups do not raise new types of safety or effectiveness concerns.
In addition, the FIBERGRAFT BG Morsels product was also evaluated in a rabbit study to further support device performance for its indications for use. The FIBERGRAFT™ BG Morsels product was compared to its predicate device as well as autograft (positive) control. The animal study evaluated device performance in a rabbit posterolateral spine fusion
5
model with 41 skeletally mature rabbits, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT ™ BG Morsels 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 Morsels device performs substantially equivalently to the predicate device, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns. The device was compared to autograft in animal performance testing in order to demonstrate substantial equivalence to the predicate. ISO 10993-6 testing was also conducted, and results supported substantial equivalence of the FIBERGRAFT BG Morsels compared to its predicate. Fluid absorbability testing further confirmed the use of BMA and the of the product.
Therefore, performance testing demonstrated that the FIBERGRAFT™ BG Morsels device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices.
Substantial Equivalence
As demonstrated in performance testing, the FIBERGRAFT™ BG Morsels product is substantially equivalent to its predicate devices. FIBERGRAFT™ BG Morsels has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. Thus, FIBERGRAFT™ BG Morsels is substantially equivalent.
Conclusions
FIBERGRAFT™ BG Morsels is an osteoconductive, resorbable, biocompatible bone graft substitute composed of bioactive glass. The product is substantially equivalent to its predicate devices for its intended use as a synthetic bone void filler and bone graft extender. Performance testing, including bench and in vivo data, demonstrated that the device functions as intended without raising new safety or effectiveness questions.