(111 days)
Not Found
No
The description focuses on the material properties and intended use of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a bone void filler that is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process, indicating a therapeutic function in addressing skeletal defects.
No
The device is described as a bone void filler used to fill bony defects, not to diagnose medical conditions or provide diagnostic information. Its purpose is therapeutic and structural, aiding in bone growth and healing.
No
The device description clearly states that Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler, which is a physical material intended for implantation. This is 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 clearly states that Vivorté BVF™ Lite™ is a bone void filler used to fill bony defects in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description reinforces its use as a bone void filler that hardens in vivo and provides a scaffold for bone healing.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used outside the body to test samples like blood, urine, or tissue to provide diagnostic information. Vivorté BVF™ Lite™ is implanted within the body for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ 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™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ 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)
MQV
Device Description
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ 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™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ 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 for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
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) for permanent implants.
- Animal testing.
Clinical Testing: Not necessary to determine substantial equivalence.
Conclusions: The nonclinical tests (i.e. chemical, physical, mechanical, biocompatibility, and animal tests) conducted demonstrate that Vivorté BVFTM Lite™ device is substantially equivalent to the cited predicate device and that the Vivorté BVF™ Lite™ device is therefore as safe, as effective, and performs as well as or better than the predicate device. No clinical tests were conducted or submitted in support of substantial equivalency.
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.
Synthes® Norian® SRS® Bone Void Filler (K011897)
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
AUG 1 2 2013
TRADE NAME: Vivorté BVFTM Lite™
COMMON NAME: Calcium phosphate bone void filler; bone void filler
| Product | Regulation and
Description | Product
Code | Device | Device
Class |
|---------------------|-------------------------------------------------------------------------|-----------------|----------------------------------------|-----------------|
| Vivorté BVFT™ Lite™ | 21 CFR 888.3045 -
Resorbable calcium salt
bone void filler device | MQV | Filler, bone void,
calcium compound | II |
PREDICATE DEVICES: Synthes® Norian® SRS® Bone Void Filler (K011897)
DEVICE DESCRIPTION:
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ 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™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ 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 for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
INTENDED USE AND INDICATIONS FOR USE:
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté BVF™ Lite™ 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™ Lite™ may be manually applied to the bony
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BASIS FOR SUBSTANTIAL EQUIVALENCE:
Vivorté BVF™ Lite™ is chemically and physically substantially equivalent to the Synthes® Norian® SRS® Bone Void Filler. Both the Vivorté BVF™ Lite™ and the Synthes® Norian® SRS® Bone Void Filler are composed of synthetic calcium phosphate materials that are virtually identical. Both the Vivorté BVFTM Lite™ and the Synthes® Norian® SRS® Bone Void Filler devices are intraoperatively prepared by mixing similar components together to produce selfhardening 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™ Lite™ and the Synthes® Norian® SRS® Bone Void Filler are similar.
The Vivorté BVF™ Lite™ and Synthes® predicate device 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 Lite™ to the predicate devices.
- Chemical, physical and mechanical testing .
- t Biocompatibility and toxicity (ISO 10993; ASTM; USP) for permanent implants
- . Animal testing
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ Lite™ and the predicate device.
CONCLUSIONS
The nonclinical tests (i.e. chemical, physical, mechanical, biocompatibility, and animal tests) conducted demonstrate that Vivorté BVFTM Lite™ device is substantially equivalent to the cited predicate device and that the Vivorté BVF™ Lite™ device is therefore as safe, as effective, and performs as well as or better than the predicate device. No clinical tests were conducted or submitted in support of substantial equivalency.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2013
Vivorté, Incorporated % Peoples & Associates Mr. Stephen J. Peoples 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K131133
Trade/Device Name: Vivorté BVF™ Lite™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 26, 2013 Received: July 1, 2013
Dear Mr. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Stephen J. Peoples
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" (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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin | Keith
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: K131133
Device Name: Vivorté BVFTM Lite™
Indications for Use:
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ 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™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ 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)
AND/OR
Over-The-Counter Use (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)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131133
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