(29 days)
Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - 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). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.
Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis.
The provided text describes the Fortitude™ Vue Vertebral Body Replacement Device. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Data | Not explicitly stated as acceptance criteria, but implied to demonstrate substantial equivalence to the predicate device in design and performance. | "Laboratory and bench testing results demonstrate that the proposed Fortitude Vue is substantially equivalent to the predicate device." |
| Clinical Data | Not explicitly stated as part of acceptance criteria. The submission indicates clinical data were not needed, implying that substantial equivalence was sufficiently demonstrated through non-clinical means. | "Clinical data and conclusions were not needed for this device." (This implies it met the criteria for not needing clinical data, likely due to substantial equivalence to a previously cleared device). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The document states, "Clinical data and conclusions were not needed for this device." The non-clinical testing results demonstrating substantial equivalence do not quantify a "test set" in the context of clinical or performance data from a specific number of devices.
- Data provenance: Not applicable for clinical data. For non-clinical (laboratory and bench testing), the provenance is not specified, but it would have been conducted as part of the manufacturer's development and testing processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as clinical data and a test set requiring expert ground truth were not part of the submission. The "ground truth" for substantial equivalence was based on engineering analysis and comparative mechanical testing to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical test set requiring adjudication was not used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a spinal implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for a clinical ground truth. The "ground truth" for the device's performance was its demonstrated equivalency in laboratory and bench testing against the predicate device, Fortitude™ Titanium (K031914).
8. The sample size for the training set
Not applicable, as there is no "training set" in the context of this device. The device is a physical implant, not an artificial intelligence model.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
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051000
2
SPINAL CONCEPTS INC. SUMMARY OF SAFETY AND EFFECTIVENESS
.
.
MAY 1 9 2005
| SUBMITTER: | Spinal Concepts, Inc. (an Abbott Laboratories Company) |
|---|---|
| ESTABLISHMENT REGISTRATION NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch |
| Specialist, Regulatory Affairs | |
| Telephone: | 512.533.1840 |
| Fax: | 512.918.2784 |
| DATE: | April 19, 2005 |
| TRADE NAME: | Fortitude™ Vue Vertebral Body Replacement Device |
| PRODUCT CODE: | MQP |
| CLASSIFICATION NAME: | Spinal Vertebral Body Replacement Device |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3060 |
| PREDICATE DEVICE: | Fortitude™ Titanium manufactured by Spinal Concepts Inc., K031914, cleared August 12, 2003. |
| DEVICE DESCRIPTION: | Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis. |
| INDICATIONS: | Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - 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). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft. |
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COMPARISON TO PREDICATE DEVICE:
Fortitude Vue is substantially equivalent in design to the predicate device, and has the same intended use. The subject device is the result of a material change and minor design modifications to the predicate.
PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL):
Non-Clinical Performance and Conclusions:
Laboratory and bench testing results demonstrate that the proposed Fortitude Vue is substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K051000
ﭘ Trade Name: Fortitude™ Vue VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 19, 2005 Received: April 20, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prox to they 2018 sified in accordance with the provisions of the Federal Food, Drug, de necs that have been reciase at require approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general of the brown of active, 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 If your device is elassinod (ontrols. Existing major regulations affecting your device can may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Noah Bartsch
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilsed that I DF o lessan that your device complies with other requirements of the Act that I Dr I has intes 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); good manufacturing practice requirements as set Of R rate 6077, accems (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. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premation holicated. " 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 other general mixermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hyat Ruvda
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KASIOOO 510(k) Number (if known):
Device Name:
Spinal Concepts Inc. Fortitude™ Vue Vertebral Body Replacement System
Indications for Use:
Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral and/or thoracolumbal spile (15 - E3) to replace a vertebrectomy procedures) due to tumor or body resected or exclude (ite), partial es designed to restore the biomechanical integrity of the trauna (f.e., Hucture). Tornale in as solumn even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.
Prescription Use _X (Part 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 General, Restorative,
and Neurological Devices
| 510(k) Number | K051000 |
|---|---|
| --------------- | --------- |
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§ 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.