(119 days)
Not Found
No
The 510(k) summary describes a passive implant (vertebral body replacement) made of PEEK. There is no mention of software, image processing, AI, ML, or any other technology that would suggest the use of AI/ML. The performance studies are mechanical tests and biocompatibility, typical for an implantable device.
Yes
The device is described as achieving "decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body," which is a rehabilitative function.
No
The Paramount™ VBR is a vertebral body replacement device used for structural support and height restoration, not for diagnosing medical conditions.
No
The device description explicitly states it is a single piece device made of PEEK-Optima® and is an implant, indicating it is a physical hardware device, not software.
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 a vertebral body in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of PEEK-Optima®, designed to be surgically placed within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is used within the body (thoracolumbar spine), which is typical for a surgical implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens 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 Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Product codes
MQP
Device Description
The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
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
Prescription Use
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)
The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated.
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
JAN 1 2 2007
510(k) SUMMARY
DATE: November 17, 2006 SUBMITTER: Innovative Spinal Technologies, Inc. 111 Forbes Blvd. Mansfield, MA 02048 Telephone: 508/452-3520 Fax: 508/452-3600 CONTACT PERSON: Gina Yeh TRADE NAME: Paramount™ Vertebral Body Replacement System FDA CLASSIFICATION/ CODE: 888. 3060. MQP
DEVICE DESCRIPTION: The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
INTENDED USE: The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Spinal Concepts Inc. TRAXIS™ (K033517), Pioneer® PREDICATE DEVICES: Vertebral Spacer (K043206), and SpineVision Spacevision™ Cage (K042930).
PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innovative Spinal Technologies, Inc. % Ms. Gina Yeh Program Manager, Regulatory Affairs 111 Forbes Boulevard Mansfield, Massachusetts 02048
JAN 1 2 2007
Re: K062759
Trade/Device Name: Paramount™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 22, 2006 Received: December 26, 2006
Dear Ms. Yeh:
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 misbrandijne 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, U.A.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.
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Page 2 - Ms. Gina Yeh
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) 276-0210 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 vours.
Sorban Buckun
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number:_ K062759
Device Name: Paramount™ VBR System
Indications:
The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Prescription Use _ × or (21 CFR 801 Subpart D)
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)
Hubace Buchur
. Restorative. and Neurological Devices
510(k) Number Ko63759