(38 days)
No
The 510(k) summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which directly addresses a medical condition and aims to restore function or provide relief.
No
This device is a vertebral body replacement (VBR) system designed to replace a damaged vertebral body, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical implantable device made of material with a specific shape and features, and the performance studies involve mechanical testing of this physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the patient's body.
Therefore, the Choice Spine Vertebral Body Replacement (VBR) System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.
Product codes
MQP
Device Description
The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with a hollow center for placement of bone graft. The superior & inferior surfaces have ridges, or 'teeth' for resisting migration. The devices are available in an assortment of heights & multiple angles of lordosis to accommodate different anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
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
Mechanical testing was performed according to the guidelines outlined in ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" & ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices". Testing parameters executed were static compression, dynamic compression, static torsion, dynamic torsion, subsidence, & expulsion.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) Summary
Preparation Date
22 February 2012
Sponsor
Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 p: 865.246.3333 f: 865.588.4045
Contact
Mark Bekkala
Trade Name
Choice Spine Vertebral Body Replacement (VBR) System
Common Name
Spinal Vertebral Body Replacement Device
Regulatory Classification & Device Product Codes
888.3060 MQP – Spinal intervertebral body fixation orthosis
Predicate Devices
Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426)
Device Description
The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with a hollow center for placement of bone graft. The superior & inferior surfaces have ridges, or 'teeth' for resisting migration. The devices are available in an assortment of heights & multiple angles of lordosis to accommodate different anatomic requirements.
Intended Use
The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.
Choice Spine VBR System
1
510(k) Summary (continued)
Materials
The Choice Spine Vertebral Body Replacement (VBR) System is manufactured from Polyetheretherketone (PEEK OPTIMA® from Invibio®) per ASTM F2026. Integral radiopaque markers are manufactured from tantalum per ASTM F560.
Technological Characteristics
The Choice Spine Vertebral Body Replacement (VBR) System consists of implant devices with a range of depths, widths, heights, & angles of lordosis similar to the identified predicate systems.
The Intended Use of the Choice Spine Vertebral Body Replacement (VBR) System is identical to the predicate systems. The Choice Spine Vertebral Body Replacement (VBR) System materials are similar to the predicate systems.
Substantial Equivalence
Documentation was provided that demonstrates the Choice Spine Vertebral Body Replacement (VBR) System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, materials, & performance. Mechanical testing was performed according to the guidelines outlined in ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" & ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices". Testing parameters executed were static compression, dynamic compression, static torsion, dynamic torsion, subsidence, & expulsion.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Choice Spine, LP % Mr. Mark Bekkala 400 Erin Drive Knoxville, Tennessee 37919
APR - 5 2012
Re: K120570
Trade/Device Name: Choice Spine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 19, 2012 Received: March 20, 2012
Dear Mr. Bekkala:
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 or any I 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 de rice related adverse overals) (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Mark Bekkala
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): _ K120570
Device Name: Choice Spine Vertebral Body Replacement (VBR) System
Indications for Use:
The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.
Prescription Use _ × (21 CFR 801 Subpart D)
and/or Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
: Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K120570 510(k) Number.