(30 days)
Not Found
No
The description focuses on the material properties and intended use of a bone void filler, with no mention of AI or ML capabilities.
No
The device is a bone void filler used to fill defects in the skeletal system, which aids in the healing process by providing a scaffold for new bone formation, rather than directly treating a disease or health condition.
No
The device is described as a bone void filler used for treatment (filling bony voids), not for diagnosing conditions.
No
The device description clearly states it is a "moldable, self-setting, gradually resorbable, calcium phosphate bone void filler," which 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 Vivorté Trabexus is a "bone void filler" used to fill bony defects in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description reinforces that it's a "calcium phosphate bone void filler."
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are designed for this purpose.
- Anatomical Site: The device is applied directly to the skeletal system, which is a treatment rather than a diagnostic process.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples for diagnostic purposes. Vivorté Trabexus is a material implanted into the body to aid in bone healing.
N/A
Intended Use / Indications for Use
Vivorté Trabexus" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" 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 Trabexus™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus" is resorbed and remodeled by the body as new bone formation occurs during the healing process.
Product codes
MQV
Device Description
Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. The device is provided in kit sizes of 3 cc, 5 cc, and 10 cc, 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)
Performance testing according to the design verification test methods indicated by the risk analysis was conducted. A summary of the test results is included below.
Test Method: Extrudability; Subject Device Test Results: Not applicable
Test Method: Biocompatibility; Subject Device Test Results: Pass
Test Method: Bubble leak test; Subject Device Test Results: Pass
Test Method: Heat seal strength of primary packaging; Subject Device Test Results: Pass
The performance testing demonstrates that the subject device meets the acceptance criteria per the design verification test methods identified by the risk analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2015
Vivorté, Incorporated % Stephen J. Peoples, VMD, MS Peoples & Associates 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K143549
Trade/Device Name: Vivorté Trabexus™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 12, 2014 Received: December 15, 2014
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 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
1
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 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.
Mark N. Melkerson -S
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 K143549
Device Name: Vivorté Trabexus™
Indications for Use:
Vivorté Trabexus" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" 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 Trabexus™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus" is 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)
Page 1 of 1
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510(k) Summary
This 510(k) Summary is provided per the requirements of 21 CFR 807.92.
Submitter Information:
| Name: | Vivorté, Inc. |
|---|---|
| Address: | 1044 E. Chestnut Street |
| Louisville, KY 40204 | |
| Telephone: | (502) 693-2432 |
| Fax: | (502) 714-7235 |
| Contact Person: | Robert Burden |
| Date Prepared: | December 12, 2014 |
Device Information:
Trade Name: Vivorté Trabexus™ Common Name: Calcium bone void filler Classification: Class II Regulation Number and Description: 21 CFR 888.3045 - Resorbable calcium salt bone void filler device Product Code: MQV
Predicate Device:
The predicate device is Vivorté BVF™ Lite™ that was cleared via 510(k) K131133 on August 12, 2013.
Device Description:
Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. The device is provided in kit sizes of 3 cc, 5 cc, and 10 cc, corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
Indications for Use:
Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" 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 Trabexus™ may be manually applied to the defect or
4
applied to the defect through a cannula. Vivorté Trabexus™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Comparison to Predicate Device:
The subject Vivorté Trabexus™ is essentially the same as the predicate device. The only difference between the predicate and the subject device is that the subject device includes an additional accessory, a delivery cannula to deliver the calcium phosphate bone filler to the bone defect site as specified in the indications for use cleared in K131133. The primary packaging was modified to accommodate the additional accessory and the Instructions for Use were modified to instruct the physician how to use the additional accessory delivery cannula. The changes made to the Instructions for Use do not affect the intended use.
Non-Clinical Testing:
Performance testing according to the design verification test methods indicated by the risk analysis was conducted. A summary of the test results is included below.
| Test Method | Subject Device Test |
|---|---|
| Results | |
| Extrudability | Not applicable |
| Biocompatibility | Pass |
| Bubble leak test | Pass |
| Heat seal strength of | Pass |
| primary packaging |
Comparative Testing
Substantial Equivalence:
In establishing substantial equivalence to the predicate device. Vivorté evaluated the intended use and indications for use, materials, basic design, fundamental scientific technology, labeling. packaging materials and configuration, shelf life, and sterilization processes. The performance testing demonstrates that the subject device meets the acceptance criteria per the design verification test methods identified by the risk analysis. Based on the information presented, the proposed delivery cannula accessory does not impact the device safety and effectiveness and Vivorté Trabexus is substantially equivalent to the predicate Vivorté BVF Lite cleared via K131133 on August 12, 2013.