(140 days)
Not Found
Not Found
No
The description focuses on the mechanical properties and materials of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is indicated for replacing a diseased vertebral body, treating tumors, achieving anterior decompression, restoring height, and treating fractures, all of which are therapeutic interventions.
No
The device is an implant designed to replace diseased or fractured vertebral bodies and restore spinal height and biomechanical integrity. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an implant constructed of physical materials (PEEK and tantalum) and is surgically inserted. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Expandable PEEK VBR Implant is a physical implant designed to be surgically inserted into the thoracolumbar spine. It is a medical device used for structural support and restoration of height, not for analyzing biological samples.
- Intended Use: The intended use clearly describes a surgical procedure to replace a diseased or fractured vertebral body, not a diagnostic test.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 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 Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant 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
MQP
Device Description
The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K04-09128
AUG 2 7 2004
510(k) SUMMARY
SUBMITTED BY
Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Vertebral Body Replacement Device |
|---|---|
| Common/Usual Name: | Vertebral Body Replacement Device |
| Product Classification: | Class II |
| Proprietary Name: | Expandable PEEK VBR Implant |
PREDICATE DEVICE
Predicate device information is included in this premarket notification.
INDICATIONS-FOR-USE
The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 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 Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant 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.
DEVICE DESCRIPTION
The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.
COMPARISON TO THE PREDICATE DEVICE
Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Expandable PEEK VBR Implant is considered substantially equivalent to the legally marketed predicate devices.
1
Image /page/1/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 an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 2004
Wendy Spielberger, RAC Lead, Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618
Re: K040928
Trade/Device Name: Expandable PEEK VBR Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 13, 2004 Received: August 16, 2004
Dear Ms. Spielberger:
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 stated in the enorosale) to regard) the enactment date of the Medical Device Amendments, or to commence pror to may 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been routes and in assee approval of a premarket approval application (PMA). alle Costience Act (71ct) that to nov requent to the general controls provisions of the Act. The I ou may, merceive, manel the Act include requirements for annual registration, listing of general connologic provisions 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 If your device is classified (600 a00 10) als. Existing major regulations affecting your device can Inay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast of advised that I DTT blisdains of our device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I cuchares und regulations and winned to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Wendy Spielberger, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premits touritication: The Prix manigstification 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 If you desire specific advice for your ac 1100 594-4692. Also, please note the regulation entitled, colliati the Office of Comphalled as (50 t notification" (21CFR Part 807.97). You may obtain Misblanding of Crefeired to premainters in the Act from the Division of Small other general information on your responsible in total free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the success in brokey Manufacturers, micrnational and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K040928 510(k) Number (if known):
Expandable PEEK VBR Device Name:
Indications-For-Use:
The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 I TIC Expandable I EER VDR anspiral body resected or excised for the treatment of tumors in to LD replace a anseason version of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also inclicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK multiated for treating tractares of as a biomechanical integrity of the anterior, middle and v DIC implain is absence of the absence of fusion for a prolonged period.
| 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)
__ and__, signature, Mark N. Millman
(Division Sign- Iff Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(K) Number K040928