(55 days)
No
The summary describes a physical implantable device made of titanium alloys, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to replace a damaged vertebral body and restore biomechanical integrity to the spinal column, which are therapeutic actions.
No
Explanation: The device is a vertebral body replacement system, which is a therapeutic implant designed to restore spinal integrity, not to diagnose a condition.
No
The device description clearly states that the Spinal USA VBR System consists of physical implants made from medical grade titanium or titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace vertebral bodies in the spine due to tumor or trauma. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a vertebral body replacement device made of titanium, designed for implantation. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are related to the mechanical properties and equivalence to other spinal implants, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L.5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). In addition, the Spinal USA VBR System is intended for use with bone graw a
Product codes
MOP, MQP
Device Description
The Spinal USA VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system consists of a straight, curved, round, and trapezoidal implants. The various implants via shallsin, curved, curved, curved, the individual patient anatomy. All components are made from medical grade titanium or titanium or titanium or titanium or titanium or titanium or titanium or titanium or tit alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing in accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices" of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042201, K052384, K990148, K050449, K031757, K050348, K033109
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 of Safety and Effectiveness
| Date Summary Prepared: | June 20, 2006 |
|---|---|
| Submitter Information: | Spinal USA |
| 644 Lakeland East Drive Suite A | |
| Flowood, MS 39047 | |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-420-4244 |
| Fax: | 601-420-5501 |
| E-mail: | jeff@spinalusa.com |
| Device Trade Name: | Spinal USA VBR System |
| Common Name: | Vertebral Body Replacement |
| Regulatory Number: | 888.3060 |
| Classification: | Class II |
| Product Code: | MOP |
INTENDED USE:
The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L.5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). In addition, the Spinal USA VBR System is intended for use with bone graw a
DEVICE DESCRIPTION:
The Spinal USA VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system consists of a straight, curved, round, and trapezoidal implants. The various implants via shallsin, curved, curved, curved, the individual patient anatomy. All components are made from medical grade titanium or titanium or titanium or titanium or titanium or titanium or titanium or titanium or tit alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
EQUIVALENT DEVICE:
Testing in accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices" of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109).
1
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus in the logo is depicted with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2006
Spinal USA % Mr. Jeffrey Johnson Manager, Regulatory Affairs 644 Lakeland East Drive, Suite A Flowood. Mississippi 39232
Re: K061752
Trade/Device Name: Spinal USA VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 20, 2006 Received: June 21, 2006
Dear Mr. Johnson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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. This
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Page 2 – Mr. Jeffrey Johnson
letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological Devicesd Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Spinal USA VBR System
Indications for Use:
The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column
The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). In addition, the Spinal USA VBR System is intended for use with bone graft.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Василе Виели
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOG | 752