(71 days)
No
The description focuses on the mechanical components and intended use as a temporary implant for stabilization and fracture repair. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as a temporary implant for stabilization and to aid in the repair of bone fractures, used in orthopedic surgeries. While it provides support during healing, its primary function is mechanical stabilization and not direct therapeutic action (like drug delivery, radiation, or stimulation) to treat a disease or condition in itself.
No
Explanation: The device is described as a temporary implant for providing stabilization and aiding in the repair of bone fractures in orthopedic surgery, indicating it is a therapeutic or supportive device, not one used for diagnosis.
No
The device description clearly states it is comprised of braided bands and clamps, which are physical hardware components, not software.
Based on the provided information, the NuVasive® VersaTie System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "temporary implant for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a device used within the body for structural support and repair.
- Device Description: The description details a "spinal fixation system" comprised of "braided bands and clamps" designed to be "secured around posterior vertebral structures." This further confirms its function as an implantable mechanical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The NuVasive® VersaTie System does not perform any such analysis of biological samples.
Therefore, the NuVasive® VersaTie System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive® VersaTie System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The NuVasive® VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium allov or cobalt-chromium allov rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5
Indicated Patient Age Range
patients 8 years of age and older
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
Nonclinical testing was performed to demonstrate that the subject NuVasive® VersaTie System is substantially equivalent to the predicate device. The following testing was performed:
- Static Band Tensile Testing
- Static and dynamic band pull-through, static rod-connector axial slip, static rodconnector axial moment per ASTM F1798
The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. 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 15, 2016
NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K161265
Trade/Device Name: NuVasive® VersaTie System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: May 3, 2016 Received: May 5, 2016
Dear Ms. Adams:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161265
Device Name Nu Vasive® VersaTie System
Indications for Use (Describe)
The NuVasive® VersaTie System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondy lolisthesis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with lines suggesting motion.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Cynthia Adams Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: May 2, 2016
B. Device Name
| Trade or Proprietary Name: | NuVasive® VersaTie System |
|---|---|
| Common or Usual Name: | Bone Fixation Cerclage, Sublamina |
| Classification Name: | Bone Fixation Cerclage |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3010 |
| Product Code: | OWI |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device Zimmere Universal Clamp Spinal Fixation System (K142053), and additional predicate device Implant, S.A. JAZZTM System (K151740). NuVasive Reline® System (K143684) is a reference device.
D. Device Description
The NuVasive® VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium allov or cobalt-chromium allov rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive® VersaTie System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction 2. of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
4
Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, also in gray.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.
F. Technological Characteristics
As was established in this submission, the subject NuVasive® VersaTie System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NuVasive® VersaTie System is substantially equivalent to the predicate device. The following testing was performed:
- Static Band Tensile Testing
- Static and dynamic band pull-through, static rod-connector axial slip, static rodconnector axial moment per ASTM F1798
The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.
Conclusions H.
The subject NuVasive® VersaTie System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.