(625 days)
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No
The provided text describes a physical implant (intervertebral pillar prosthesis) and its intended use for spinal surgery. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes
The device is described as a "prosthesis" intended to "replace and restore the height of a diseased vertebral body" and "facilitate anterior decompression of the spinal cord and neural tissues," which are therapeutic actions.
No
The device is described as a "prosthesis" intended to "replace and restore the height of a diseased vertebral body" and "facilitate anterior decompression," which are therapeutic and reconstructive functions, not diagnostic ones.
No
The device description clearly indicates a physical implant (prosthesis) intended for surgical implantation in the spine, which is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided text describes a Levante Intervertebral Pillar prosthesis, which is a physical implant intended to replace or restore vertebral bodies in the spine. This is a surgical implant used inside the body.
- Intended Use: The intended use clearly states the device is for surgical implantation in the thoracolumbar spine to replace vertebral bodies and facilitate decompression and reduction of deformities. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
Therefore, based on the provided information, the Levante Intervertebral Pillar prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.
- To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
- To facilitate anterior decompression of the spinal cord and neural structure
- To facilitate the reduction of kyphotic deformities
Product codes
MQP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracolumbar spine (i.e., T1 to L5)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, stacked vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2000
Mr. M. Laine Mashburn Ionics Medical Corporation 702 13th Street, #108 Miami Beach, Florida 33139
Re: K983667
Trade Name: Levante Intervertebral Pillar Regulatory Class: II Product Code: MQP Dated: April 5, 2000 Received: April 6, 2000
Dear Mr. Mashburn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. M. Laine Mashburn
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Lila Witt
Salia M. Witt, Ph.D., M.D.
. Witten, Ph.D., M.D. Celia N Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT B (Amendment)
INDICATIONS FOR USE (CDRH/ ODE Optional Format published 1/02/96)
510 (k) Number: K983667
Device Name:
Ionics Levante Intervertebral Pillar, Expandable (from Ionics Medical Corporation)
Indications (as amended June/19/00):
-
The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.
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To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
-
To facilitate anterior decompression of the spinal cord and neural structure
-
To facilitate the reduction of kyphotic deformities
(PLEASE DO NOT WRITE BELOW THIS LINE)
Image /page/2/Figure/12 description: The image shows a table with the text "Concurrence of CDRH, Office of Device Evaluation (ODE)" below it. The table has three columns, but they are all empty. The text is centered below the table. The table is surrounded by a thick black border.
Elin Watt
(Division Sign-Off)
gn-Off Division of General Restorative Devices 510(k) Number
Prescription Use (Per 21 CFR 801. 109)
(CDRH/ODE Optional Format 1/02/96)