(378 days)
Not Found
No
The 510(k) summary describes a bone graft material and its intended use. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the incorporation of such technologies. The performance studies are based on animal models and histological/radiographic analysis, not algorithmic performance metrics.
No
The device is described as an implant intended to fill bony voids or gaps of the skeletal system, functioning as a bone graft extender that resorbs and is replaced with bone during the healing process. Its purpose is structural support and regeneration within the skeletal system, rather than treating a disease or condition in the traditional sense of a therapeutic medical intervention.
No
The device is an implantable bone graft material used to fill bony voids, not to diagnose medical conditions.
No
The device description clearly states it is a "composite of synthetic hydroxyapatite and type I collagen" and is available in "particle forms, cylinders and blocks," indicating it is 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 Bongold is an "implant intended to fill bony voids or gaps of the skeletal system." This describes a device that is surgically placed within the body to perform a structural function.
- Device Description: The description details the material composition (hydroxyapatite and collagen) and physical forms (particles, cylinders, blocks) of the implant. It also mentions its resorbable and osteoconductive properties, which are relevant to bone healing in vivo.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with bodily specimens for diagnostic purposes.
In summary, Bongold is a surgical implant used for bone grafting, not a device used to perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MOV, MQV
Device Description
Bongold™ Bone Graft Material is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and type I collagen. The composite material is a resorbable, porous, osteoconductive bone graft matrix. It is available as a lyophilized matrix in particle forms, cylinders and blocks. This bone graft material contains approximately 45% mineral by weight. Bongold"10 device is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).
Bongold™ cylinders and blocks can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the particle form can be packed to fit the bone defect. The product is sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, extremities
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)
Performance studies supporting the product were bone repair studies in a cancellous bone defect model in rabbit. The device was compared to autograft in animal performance testing in order to demonstrate substantial equivalence to the predicate. Endpoint measurements included radiographs and histology at 4. 8 and 12 weeks. These studies demonstrated with respect to predicate device the safety and performance of the Bongold ™ Bone Graft Material in supporting bone growth in orthopedic applications.
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.
K012751, K052812, K082166, K032288
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
Beijing Allgens Medical Science & Technology Company, Ltd Helen Cui, Ph.D. Director of RA/OA 7 Liberty Ridge Road Basking Ridge, New Jersey 07920
Re: K141725
Trade/Device Name: Bongold™ Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 1, 2015 Received: June 5, 2015
Dear Dr. Cui:
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
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Page 2 - Helen Cui, Ph.D.
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.
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141725
Device Name Bongold Bone Graft Material
Indications for Use (Describe)
Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
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Chapter 5: 510(k) Summary
June 30, 2015
Applicant Name and Address: Beijing Allgens Medical Science & Technology Co., Ltd Beijing BDA IPE Building #2, Disheng Donglu #1 Beijing, 100176 China
Helen Cui, Ph.D., Director of RA/QA, CTO Contact Person: Tel: (908) 3924742 Fax: 732.453.3862 Date of Summary: March 20, 2015 Device Common Name: Bone Void Filler Device Trade Name: Bongold "M Bone Graft Material Device Classification Name: Filler, Bone Void, Calcium Compound Regulation Number: 888.3045 Product Code: MQV Device Class: Class II Predicate Device(s):
- HEALOS® Bone Graft Material (K012751) (Primary predicate)
- OssiMend Tm Bone Graft Material (K052812) (Reference predicate)
- MASTERGRAFT® Strip(K082166) (Reference predicate)
- Vitoss® Scaffold Foam Bone Graft Material (K032288) (Reference predicate)
Description of the Device
Bongold™ Bone Graft Material is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and type I collagen. The composite material is a resorbable, porous, osteoconductive bone graft matrix. It is available as a lyophilized matrix in particle forms, cylinders and blocks. This bone graft material contains approximately 45% mineral by weight. Bongold"10 device is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).
Bongold™ cylinders and blocks can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the particle form can be packed to fit the bone defect. The product is sterile and for single use only.
Intended Use
Bongold™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold™ must be used with autograft as a bone graft
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Beijing Allgens Medical Science & Technology Co., Ltd.
extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.
510(k) Summary of Safety and Effectiveness
Summary/Comparison of Technological Characteristics
(a) Technological Characteristics
Bongold TM Bone Graft Material and its predicates have the same key technological characteristics. In particular. Bone Graft Material and its predicates are the same with respect to intended use, design, material characterization, and product forms.
Bongold 110 Bone Graft Material and its predicates are designed as 3-dimensional, resorbable, porous, osteoconductive matrices intended to fill voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. The materials used are a combination of previously cleared and commercially marketed calcium phosphate mineral and type I collagen. The product was characterized by physical and chemical bench tests comparing its characteristics to those of the predicate devices. Such tests included mineral structure and content analysis, physical structure analysis, porosity and pore size analysis. Bongold ™ Bone Graft Material has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.
(b) Performance Data
Performance studies supporting the product were bone repair studies in a cancellous bone defect model in rabbit.
The device was compared to autograft in animal performance testing in order to demonstrate substantial equivalence to the predicate. Endpoint measurements included radiographs and histology at 4. 8 and 12 weeks. These studies demonstrated with respect to predicate device the safety and performance of the Bongold ™ Bone Graft Material in supporting bone growth in orthopedic applications.
(c) Conclusions Drawn from Nonclinical Tests
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and animal performance studies show that the Bongold™ Bone Graft Material is safe with respect to predicate device and substantially equivalent to its predicate device.