(28 days)
Not Found
Not Found
No
The summary describes a mechanical spinal implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to replace diseased or fractured vertebral bodies and restore spinal height, which are therapeutic interventions.
No
The device, the Solitaire Anterior Spinal System, is indicated for use in replacing diseased vertebral bodies and treating fractures, restoring biomechanical integrity. It is an implantable device used for treatment and structural support, not for diagnosing conditions.
No
The device description and intended use clearly describe a physical implantable device (anterior spinal system) used for spinal surgery, not a software application.
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 or support vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No mention of biological samples: IVDs are used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. There is no mention of this in the provided text.
- Anatomical Site: The device is used directly on the spine, not to analyze samples from the spine.
Therefore, the Solitaire Anterior Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System 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.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T10 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)
Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance. The design requirements were established based on those of the previously cleared 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.
-Interpore Cross International Anterior Fixation Device (AFD), -Interpore Cross International Expandable PEEK VBR System, -EBI ESL Spine Spacer System
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
K062-810 1/2
EBI, L.P./Biomet Spine
Solitaire" Anterior Spinal System
OCT 1 7 2006
| SUBMITTER: | EBI, L.P. |
|---|---|
| ADDRESS: | 100 Interpace Parkway |
| Parsippany, NJ 07054 | |
| PHONE: | (973) 299-9300 |
| FAX: | (973) 257-0232 |
| CONTACT PERSON: | Debra L. Bing |
| Director, Regulatory Affairs | |
| SUBMISSION PREPARED BY: | Jennifer P. Harakal |
| DATE PREPARED: | September 8, 2006 |
| TRADE NAME: | Solitaire™ Anterior Spinal System |
| COMMON NAME: | Vertebral Body Replacement |
| CLASSIFICATION NAME: | Vertebral Body Replacement |
| PREDICATE DEVICE: | -Interpore Cross International Anterior Fixation Device |
| (AFD) | |
| -Interpore Cross International Expandable PEEK VBR | |
| System | |
| -EBI ESL Spine Spacer System |
INTENDED/INDICATIONS FOR USE:
The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System 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.
TECHNOLOGICAL CHARACTERISTICS:
Performance Testing
Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance. The design requirements were established based on those of the previously cleared predicate devices.
1
Substantial Equivalence
The Solitaire Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and basic principles of operation. This premarket notification is being submitted to address a design modification, as well operation. This premarker notification is being system. As demonstrated by performance data, as to renect additional components to assess any hew issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EBI, LP % Ms. Debra Bing Director, Regulatory Affairs 100 Interpace parkway Parsippany, New Jersey 07054
OCT 1 7 2006
Re: K062810
Trade/Device Name: Solitaire™ Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Fixation Device Regulatory Class: Class II Product Code: MQP Dated: September 15, 2006 Received: September 19, 2006
Dear Ms Bing:
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, and 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 - Ms. Debra Bing
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 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 Buchm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
11
Indications for Use Statement
510(k) Number (if known):
Device Name: Solitaire™ Anterior Spinal System i
Indications for Use:
The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., TIA to L.S) to replace a diseased vertebral body resected or excised for the treament of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the thoracis achieve anterior decompression of the Spinar core tax indicated for treating fractures of the thoracity of the collapsed vertebral body. The Sollaire System is designed to restore the biomechanical integrity of the and lumbar spine. The Soltane System is dosigned to reneve of fusion for a prolonged period.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
K06.2810(koubaue Pueeuno
(Division Sign-Of Division of General. Restorative, and Neurological Devices
510(k) Number K062810