(40 days)
Not Found
No
The summary describes a mechanical pedicle screw fixation system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of AI/ML. The performance studies focus on substantial equivalence to previously cleared mechanical systems.
Yes
The device is indicated for conditions like degenerative spondylolisthesis, fracture, scoliosis, and kyphosis, which are medical conditions that the device is intended to treat or alleviate.
No
Explanation: The KOBRA™ GPS Fixation System is described as a "pedicle screw fixation system" and is intended to "provide immobilization and stabilization of spinal segments as an adjunct to fusion." This indicates it is a therapeutic device, not one used for diagnosis.
No
The device description explicitly states that the system consists of "a variety of cannulated rods and cannulated multi-axial screws" and "Instrumentation is also available to facilitate implantation of the device components," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system used for spinal fixation and stabilization in skeletally mature patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a system of rods and screws used to build a spinal construct. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is mechanical support and stabilization.
IVD devices are used to examine specimens derived 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
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWO
Device Description
The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, thoracic, lumbar, and/or sacral spine, fifth lumbar-first sacral (L5-S1) vertebral joint
Indicated Patient Age Range
skeletally mature patients
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): 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
NOV 2 4 2004
Medtronic Vertelink KOBRA™ GPS Fixation System Summary of Safety and Effectiveness October 2004
I. Company: Medtronic Vertelink, Inc 30 Hughes, Suite 206 Irvine, CA, 92618 (949) 455-1128
Contact: Samuel M. Shaolian Vice President, Product Development
- II. Proposed Proprietary Trade Name: Vertelink KOBRA™ Fixation System
- III. Classification Name: Spinal Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3060 and/or 888.3070) Class: Class II Product Code: MNH, MNI, KWO
IV. Product Description
The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
V. Indications
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
VI. Substantial Equivalence
Documentation, including test reports, was provided which demonstrated the Vertelink KOBRA™ GPS Fixation System to be substantially equivalent to the Vertelink KOBRA™ Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it, topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Mr. Samuel M. Shaolian Vice President, Product Development Medtronic Vertelink, Inc. 30 Hughes, Suite 206 Irvine, California 92618
Re: K042859
Ro42039
Trade/Device Name: Vertelink KOBRATM GPS Fixation System Regulation Number: 21 CFR 888.3060, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, MNI, MNH Dated: October 14, 2004 Received: October 15, 2004
Dear Mr. Shaolian:
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 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 he 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 sct 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 - Mr. Samuel M. Shaolian
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
fo Mark A. Millman
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
3
Indications for Use
510(k) Number (if known):_K042859
Device Name:_______________________________________________________________________________________________________
Indications For Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
× Prescription Use ___ (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)
Mark A. Millers
(Division Sign Off)
ral. Restorative. and Neurological Devices
Page 1 of __ 1 September 2004
510(k) Number K042854