(189 days)
Not Found
No
The summary describes a bone graft substitute made of bioactive glass granules. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties, animal studies, and biocompatibility.
Yes
The device is a bone graft substitute used to fill bony voids or gaps, which is a therapeutic function aimed at treating bone defects and promoting healing.
No
This device is a bone graft substitute, indicated for filling bony voids or gaps. It is a treatment device, not a diagnostic one, as it does not perform any disease detection, diagnosis, or monitoring functions.
No
The device description clearly states that BG Morsels is a physical bone graft substitute made from crystalline 45S5 bioactive glass granules. It is a material intended to be packed into bony voids, not a software program.
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 BG Morsels is a bone graft substitute indicated for filling bony voids or gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the material (bioactive glass) and its function in promoting bone formation and resorption. This is consistent with a medical device used for treatment or repair within the body.
- Performance Studies: The performance studies focus on evaluating the device's physical properties, biocompatibility, and ability to promote bone formation in an animal model. These are typical evaluations for a medical device intended for implantation or use within the body, not for an IVD which would focus on analyzing samples from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. BG Morsels is directly applied to the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BG Morsels 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.
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
BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute 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 which has a compositional range that allows the formation of hydroxyapatite (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 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
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)
Physical property evaluations, functional animal studies, and biocompatibility tests were performed for the BG Morsels device. Specifically, simulated distribution, whole package intecrity 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. The Prosidyan 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 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.
Therefore, performance testing demonstrated that the BG Morsels device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices.
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.
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
MAR 1 4 2014
510(k) SUMMARY
Prosidyan, Inc.'s BG Morsels - Bone Graft Substitute
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Prosidvan, Inc. 3 Rosemont Court Basking Ridge, NJ 07920 Phone: (908) 326-6263 Contact Person: Charanpreet S. Bagga
Date Prepared: February 27, 2014
Name of Device and Name
BG Morsels Bone Graft Substitute
Common or Usual Name
Bone Void Filler
Classification Name/CFR Regulation/Product Code
Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV, Class II
Predicate Devices
NovaBone Products, LLC's NovaBone Resorbable Bone Graft Substitute (K052494) and NovaBone Putty (K112773)
Intended Use / Indications for Use
BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BG Morsels 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.
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.
Technological Characteristics
BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute 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 which has a compositional range that allows the formation of hydroxyapatite (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 phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an
1
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 BG Morsels device. Specifically, simulated distribution, whole package intecrity 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. The Prosidyan 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 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.
Therefore, performance testing demonstrated that the BG Morsels device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices.
Substantial Equivalence
BG Morsels is as safe and effective as the NovaBone predicate devices. BG Morsels has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between BG Morsels and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that BG Morsels is as safe and effective as the NovaBone predicate devices. Thus, BG Morsels is substantially equivalent.
Conclusion
The BG Morsels is an osteoconductive, resorbable, biocompatible bone graft substitute composed of crystalline bioactive glass. The BG Morsels is as safe and as effective as its
2
predicate devices for its intended use as a synthetic bone void filler, and is substantially equivalent to the predicate devices. Performance testing, including in vivo data, demonstrated that the device functions as intended without raising new safety or effectiveness questions.
.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
Prosidyan, Incorporated % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K132805
Trade/Device Name: 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: January 28, 2014 Received: January 28, 2014
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
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Page 2 - Ms. Janice Hogan
(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 (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.
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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -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)
K132805 Device Name
BG Morsels Bone Graft Substitute
Indications for Use (Describe)
BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BG Morsels 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 provides a bone void filler that resorbs and is replaced with bone during the healing process.
BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal stabilization techniques must be followed to obtain rigid stabilization.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
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) (Signalure)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132805
FORM FDA 3881 (1/14)