(103 days)
Not Found
No
The summary describes a bone graft substitute made of bioactive glass and an absorbable binder. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on material properties, animal studies, and biocompatibility, not algorithmic performance.
Yes
The device is a bone graft substitute that is intended to fill bony voids or gaps and promote bone healing, falling under the definition of a therapeutic device.
No
Explanation: The device is a bone graft substitute used to fill bony voids or gaps, acting as a structural filler that is resorbed and replaced by bone during healing. It explicitly states under "Key Metrics" that it is "not a diagnostic device."
No
The device is a bone graft substitute, which is a physical material intended for implantation, not a software-only device.
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. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is a bone graft substitute, a material implanted into the body to aid in bone healing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information for diagnosis.
- Performance Studies: The performance studies focus on bone formation, biocompatibility, and physical/chemical properties, which are relevant to a therapeutic implant, not a diagnostic device.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The FIBERGRAFT™ BG Putty does not fit this description.
N/A
Intended Use / Indications for Use
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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 Putty 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 Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the 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 Putty 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 Putty. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT™ BG Putty 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 Putty is composed of the same bioactive glass material with the same bioactive glass chemical composition 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.
The functional performance of the FIBERGRAFT™ BG Putty was evaluated in critical size defects in an ovine model, consistent with FDA's recommendations for Class II synthetic bone graft substitutes. Animal testing demonstrated evidence of new bone formation in critical size defects, with substantially equivalent performance compared to the predicate device. A total of 58 tested samples were evaluated in the study from skeletally mature sheep, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the BG Putty 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 interim evaluation points. The results of the study demonstrated that the BG Putty 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.
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.
K141956, K132805, K060728, K080009, K101860, K110368, K112773
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
§ 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.
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Prosidyan, Incorporated % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K143533
Trade/Device Name: FIBERGRAFT™ BG Putty 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: February 10, 2015 Received: February 10, 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Janice M. Hogan
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 yours,
Lori A. Wiggins -S
for
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 Putty - Bone Graft Substitute
Indications for Use (Describe)
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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 Putty 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)
ال Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
_ Over-The-Counter Use (21 CFR 801
Subpart C)
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)
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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
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FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY
Prosidyan, Inc.'s BG Putty - 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: December 12, 2014
Name of Device and Name
FIBERGRAFT™ BG Putty 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
- Prosidyan, Inc.'s FIBERGRAFT™ BG Morsels Bone Graft Substitute (K141956, ● K132805).
- . NovaBone Products, LLC's NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773).
Intended Use / Indications for Use
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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 Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Device Description
The FIBERGRAFT™ BG Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
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Technological Characteristics
The technological characteristics of the FIBERGRAFT™ BG Putty are similar to the Prosidvan, Inc. FIBERGRAFT™ BG Morsels Bone Graft Substitute cleared per K141956. K132805 and to NovaBone Products, LLC's NovaBone Putty Bioactive Synthetic Bone Graft cleared per K060728, K08009, K101860, K110368, K112773. The device is designed as an osteoconductive space-filling device to be gently packed into defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device indications are the same as for the predicate.
FIBERGRAFT™BG Putty provides an osteoconductive, resorbable, biocompatible bone graft substitute made from 45S5 bioactive glass mixed with a polymer carrier. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hvdroxyapatite (HA) as a surface laver when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphatecontaining solution plays a significant role in forming a strong bond with natural bone. The bioactive glass in the FIBERGRAFT™ BG Putty is the same as the bioactive glass used in the FIBERGRAFT™ BG Morsels and Novabone Putty products. In addition, both the BG Putty and the Novabone Putty are provided in putty form using a resorbable polymer carrier.
Performance Data
The performance of the FIBERGRAFT™ BG Putty 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 Putty. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT™ BG Putty 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 Putty is composed of the same bioactive glass material with the same bioactive glass chemical composition and the same type and duration of patient contact as the predicates. Packaging evaluations, shelf life testing and real time aqing testing were performed with passing results.
The functional performance of the FIBERGRAFT™ BG Putty was evaluated in critical size defects in an ovine model, consistent with FDA's recommendations for Class II synthetic bone graft substitutes. Animal testing demonstrated evidence of new bone formation in critical size defects, with substantially equivalent performance compared to the predicate device. A total of 58 tested samples were evaluated in the study from skeletally mature sheep, including radiographic, histological, histomorphometric, and biomechanical data. Testing of the BG Putty 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 interim evaluation points. The results of the study demonstrated that the BG Putty 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.
Therefore, performance testing demonstrated that the BG Putty device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices.
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Substantial Equivalence
FIBERGRAFT™ BG Putty is substantially equivalent to the FIBERGRAFT™ BG Morsels and the Novabone Putty Bioactive Synthetic Bone Graft predicate devices. FIBERGRAFT™ BG Putty has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. In addition, the FIBERGRAFT™BG Putty is composed of the same bioactive glass material with the same chemical composition and the same type and duration of patient contact as the Prosidyan FIBERGRAFT™ BG Morsels Bone Graft Substitute and NovaBone predicates. The minor technological differences between BG Putty and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that BG Putty is equivalent to the predicate devices.
Conclusion
FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute composed of bioactive glass, mixed with a polymer carrier. The FIBERGRAFT™ BG Putty is substantially equivalent to its predicate devices 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.