(27 days)
Not Found
No
The summary describes a physical implant (vertebral body replacement) and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is intended for surgical correction and stabilization of the spine to replace or restore height of a collapsed, diseased, or unstable vertebral body. These are therapeutic actions.
No.
The Valeo™ VBR is a vertebral body replacement device used for surgical correction and stabilization of the spine, acting as a spacer. It is a treatment device, not a diagnostic one.
No
The device description clearly states the Valeo™ VBR is a physical device manufactured from a ceramic material intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Valeo™ VBR is a physical implant designed to replace or restore a vertebral body in the spine. It is used in vivo (within the body) during surgery. Its purpose is structural support and stabilization, not diagnostic testing of biological samples.
The description clearly indicates a surgical implant for structural support in the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Valeo™ VBR 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. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Valeo™ VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial or total corpectomy. The Valeo™ VBR is manufactured from MC2, a ceramic material. The Valeo M VBR is for single level anterior spinal use from T1-L5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to 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 performed indicates that the Valeo™ VBR is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
5. 510(k) Summary
| Contact: | Adam Herder
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Trade Name: | Valeo™ VBR | JAN - 9 2008 |
| Manufacturer: | Amedica Corp.
615 Arapeen Drive, Suite 302
Salt Lake City, UT 84108 | |
| Common Name: | Spinal intervertebral body fixation orthosis | |
| Classification: | 21 CFR §888.3060 | |
| Class: | II | |
| Product Code: | MQP | |
Indications For Use:
The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Valeo™ VBR 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. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.
Device Description:
The Valeo™ VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial or total corpectomy. The Valeo™ VBR is manufactured from MC2, a ceramic material. The Valeo M VBR is for single level anterior spinal use from T1-L5.
1 .f-2-
(100)
1
Predicate Device(s):
The Valeo™ VBR was shown to be substantially equivalent to the Amedica Valeo™ VBR System cleared in K073125 and the ARX Spinal System cleared in K051525.
Performance Standards:
.
Testing performed indicates that the Valeo™ VBR is substantially equivalent to predicate devices.
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0029
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
JAN - 9 2008
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Amedica Corp. % Musculoskeletal Clinical & Regulatory Advisers, LLC Mr. Adam Herder 1331 H Street NW, 12th Floor Washington, DC 20005
K073505 Re: Trade/Device Name: Valco™ VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: December 11, 2007 Received: December 13, 2007
Dear Mr. Herder:
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.
3
Page 2 - Mr. Ivan J. Wasserman
This 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Amedica Valeo™ VBR 510(k)
4. Indications for Use
510(k) Number (if known): K073505
Device Name: Amedica Valeo™ VBR
The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Valeo™ VBR 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. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brewer
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K073505
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