(447 days)
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No
The provided text describes a synthetic bone void filler made of bioactive glass granules. There is no mention of any software, algorithms, data processing, or learning capabilities, which are characteristic of AI/ML technologies. The description focuses solely on the material composition and biological interaction of the bone graft.
Yes.
The device is indicated for bony voids or gaps and acts as a bone void filler that resorbs and is replaced with bone during the healing process, indicating a therapeutic purpose.
No
The device is a bone void filler designed to be implanted to aid in bone repair, not to diagnose a condition.
No
The device description clearly states it is a synthetic bioactive bone graft supplied as irregular synthetic granules, indicating a physical material, not software.
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 void filler" for "bony voids or gaps of the skeletal system." This describes a device used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a "synthetic bioactive bone graft" that is "implanted in living tissue." This further confirms its use within the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens outside the body.
Therefore, Interface Bone Void Filler is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (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.
Product codes
MQV
Device Description
Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. The elemental composition of Interface Bone Void Filler granules is Si, Ca, Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
skeletal system (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
The radiographic, morphometric and histologic performance of the subject Interface Bone Void Filler device were compared to that of the predicate NovaBone device in an animal model. The results of the study demonstrated that the performance of the subject Interface Bone Void Filler device was equivalent to that of the predicate NovaBone device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Summary
Interface Bone Void Filler
510(k) Summary
BioStructures, LLC
NOV - 9 2010
Interface Bone Void Filler
October 1, 2010
ADMINISTRATIVE INFORMATION
Manufacturer Name:
BioStructures, LLC 3700 Campus Drive, Suite 204 Newport Beach, CA 92660 Telephone: +1 (949) 553-1717 +1 (949) 553-0407 Fax:
Official Contact:
Russell Cook, CEO
Representative/Consultant:
Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name:
Common Name: Classification Regulations:
Product Code: Classification Panel Reviewing Branch
Interface Bone Void Filler
Filler, bone void, calcium compound Resorbable calcium salt bone void filler device 21 CFR 888.3045 Class II MQV Orthopaedic and Rehabilitation Devices Panel Restorative Devices Branch
1
K09A54/
510(k) Summary
INTENDED USE
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (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.
DEVICE DESCRIPTION
Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. The elemental composition of Interface Bone Void Filler granules is Si, Ca, Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.
EQUIVALENCE TO MARKETED DEVICE
BioStructures, LLC demonstrated that for the purposes of FDA's regulation of medical devices, Interface Bone Void Filler is substantially equivalent in indications and design principles to NovaBone Resorbable Bone Graft Substitute from NovaBone Products, LLC, cleared under K021336.
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject device and the predicate device are synthetic granules of bioactive glass with elemental composition of Si, Ca, Na, and P. The subject device and the predicate device have similar particle sizes, and are packaged in similar materials and sterilized using similar methods.
To demonstrate equivalence detailed side-by-side material characterization was performed including chemical composition, physical properties and performance characteristics, Chemical composition was analyzed by scanning electron microscopy with energy dispersive x-rav analysis (SEM/EDXA). Trace elemental analysis was performed by inductively coupled plasma/optical emission spectroscopy (ICP/OES). Crystallinity was analyzed by Fourier Transform Infrared Spectroscopy (FT-IR) and X-ray Diffraction (XRD). Physical properties were evaluated by scanning electron microscopy and particle size was determined by laser diffraction. Dissolution testing was performed by monitoring the concentration of calcium in
2
510(k) Summary
media by a calcium-specific electrode in an appropriate dissolution apparatus. The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the Interface Bone Void Filler and the NovaBone Resorbable Bone Graft Substitute devices.
The radiographic, morphometric and histologic performance of the subject Interface Bone Void Filler device were compared to that of the predicate NovaBone device in an animal model. The results of the study demonstrated that the performance of the subject Interface Bone Void Filler device was equivalent to that of the predicate NovaBone device.
Overall, Interface Bone Void Filler has the following similarities to the predicate devices:
- . has the same intended use,
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same processes. .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BioStructures, LLS % Mr. Rusell Cook, CEO 3700 Campus, Drive Suite 204 Newport Beach, California 92660
Re: K092541
NOV - 9 2010
Trade/Device Name: Interface Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 1, 2010 Received: October 4, 2010
Dear Mr. Cook:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical device-related 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.
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Page 2 - Mr. Rusell Cook, CEO
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Boncomp.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K092541
NOV - 9 2010
Device Name: Interface Bone Void Filler
Indications for Use:
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign= Division of Surgical, Orthopedic,
Restorative Devices
510(k) Number K092541
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