(181 days)
Not Found
No
The description focuses on the material composition and biological properties of the bone void filler, with no mention of AI or ML.
Yes.
The device is indicated for use to fill bony voids or defects, gradually resorbs, and is remodeled by the body as new bone formation occurs, which is a therapeutic action.
No
The device is a bone void filler intended for use in the skeletal system to fill bony voids or defects. It is a treatment device, not a diagnostic one.
No
The device is described as a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone. This description clearly indicates a physical material intended for implantation, not a software-only device.
Based on the provided information, Vivorté BVF™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to fill bony voids or defects in the skeletal system. This is a therapeutic application, directly treating a physical condition within the body.
- Device Description: The device is a bone void filler that is implanted into the body and gradually resorbed as new bone forms. This is an in-vivo application.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Vivorté BVF™ does not perform this function.
The device is a bone graft substitute intended for surgical implantation, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MBP, MQV
Device Description
Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities, 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)
Non-Clinical Testing:
- Chemical, physical and mechanical testing
- Biocompatibility and toxicity (ISO 10993; ASTM; USP)
- Animal testing
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ and 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.
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510(k) Summary
510(k) SPONSOR: Vivorté, Inc. 1044 E. Chestnut Street Louisville, KY 40204 Contact: Robert Burden Email: rburden@vivorte.com Telephone: (502) 693 - 2432 FAX: (502) 714 - 7235
SEP 12 2013
Vivorté BVFTM TRADE NAME:
Calcium phosphate bone void filler; bone void filler COMMON NAME:
| Product | Regulation and
Description | Product Code | Device | Device Class |
|--------------|----------------------------------------------------------------------------|--------------|----------------------------------------------------------------------|--------------|
| Vivorté BVF™ | 21 CFR 888.3045
- Resorbable
calcium salt bone
void filler device | MBP | Filler, bone void,
osteoinductive
(w/o human
growth factor) | II |
| | | MQV | Filler, bone void,
calcium compound | II |
ETEX EquivaBone® Osteoinductive Bone Graft Substitute PREDICATE DEVICES: (K090855)
Synthes® Norian® SRS® Bone Void Filler (K011897)
DEVICE DESCRIPTION:
Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually
1
resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.
INTENDED USE AND INDICATIONS FOR USE:
Vivorté BVF™ is a moldable, self-setting, resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is resorbed and remodeled by the body as new bone formation occurs during the healing process.
BASIS FOR SUBSTANTIAL EQUIVALENCE:
Vivorté BVF™ is chemically and physically substantially equivalent to the ETEX EquivaBone® Osteoinductive Bone Graft Substitute device. Both of these devices are synthetic calcium phosphate based bone void fillers containing osteoinductive demineralized bone matrix. The Vivorté BVF™ and the ETEX EquivaBone® Osteoinductive Bone Graft Substitute devices are both intraoperatively prepared by mixing similar components together to produce self-hardening calcium phosphate bone void fillers that, when implanted in a bony defect, are resorbed and remodeled by the body as new bone formation occurs during the healing process. Both devices have comparable mixing, handling/working, and setting times and, when fully hardened, are composed primarily of apatites that have similar chemical, physical, and mechanical characteristics and properties. The Vivorté BVF™ device and the ETEX EquivaBone® Osteoinductive Bone Graft Substitute device have similar indications for use.
Vivorté BVFTM is also chemically and physically substantially equivalent to the Synthes® Norian® SRS® Bone Void Filler. Both the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler are composed of synthetic calcium phosphate materials that are virtually identical; however, the Synthes® Norian® SRS® Bone Void Filler does not contain any demineralized bone matrix. Both the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler devices are intraoperatively prepared by mixing similar components together to produce self-hardening calcium phosphate bone void fillers that, when implanted in a bony defect, are resorbed and remodeled by the body as new bone formation occurs during the healing process. Both devices have comparable mixing, handling/working, and setting times; and both of these devices, when fully hardened, are composed primarily of hydroxyapatite that have similar chemical, physical, and mechanical characteristics and properties. The indications for use of the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler are similar with the
2
exception that the Synthes® Norian® SRS® Bone Void Filler does not contain DBM and therefore is not labeled as osteoinductive.
The Vivorté BVF™ and the ETEX and Synthes® predicate devices are provided packaged sterile and are intended as prescription use only single use devices.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of Vivorté BVFTM to the predicate devices.
- . Chemical, physical and mechanical testing
- . Biocompatibility and toxicity (ISO 10993; ASTM; USP)
- Animal testing .
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between Vivorté BVFTM and the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that form the shape of a person, and the text is written in a simple, sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
September 12. 2013
Vivorté. Incorporated % Peoples & Associates Stephen J. Peoples, VMD. MS 5010 Lodge Pole Lanc Fort Wayne, Indiana 46814
Re: K130703
Trade/Device Name: Vivorté I3VFTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: June 26, 2013 Received: July 10. 2013
Dear Dr. Peoples:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warrenties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class 111 (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
4
Page 2 -Stephen J. Peoples. VMD. MS
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 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/Reportal?roblem/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 vours.
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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Indications for Use Statement
510(k) Number: K130703
Device Name: Vivorté BVFTM
Indications for Use:
Vivorté BVFTM is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130703
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