(65 days)
No
The description focuses on mechanical components (screws, hooks, rods, cables) for spinal fusion and stabilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The GALAXY™ 3.2 Spinal System is intended to promote fusion and provide stabilization of spinal segments, indicating its use in treating medical conditions related to the spine.
No
The GALAXY™ 3.2 Spinal System is described as a system of implants (screws, hooks, rods, and connecting components) intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the GALAXY™ 3.2 Spinal System consists of physical components such as screws, hooks, rods, and connecting components fabricated from medical grade titanium or titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to promote fusion and provide stabilization of the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, hooks, rods, and cables made of titanium. These are all physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. Its purpose is to physically support and stabilize the spine.
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 intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
Product codes
KWP
Device Description
The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.
Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.
The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.
The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, thoracic spine (C1-T3)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
GALAXY™ 3.2 Spinal System Summary of Safety and Effectiveness October 2004
Medtronic Sofamor Danek, Inc. USA 1. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: GALAXY(M 3.2 Spinal System II.
III. Spinal Interlaminal Fixation Orthosis
IV. Product Description
The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.
Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.
The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.
The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
V. Indications
When intended to promote fusion of the cervical spine and the thoracic spinc, (CI-T3), the GALAXYTM 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Page 1 of 2
0000005
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Screws/Connectors
The use of screws is limited to placement in T1-T3 only. Screws are not labeled to be placed in the posterior cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
VI. Substantial Equivalence
VI. substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K042402.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Mr. Richard Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Re: K043020
Trade/Device Name: Galaxy™ 3.2 Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: November 1, 2004 Received: November 3, 2004
Dear Dr. Treharne:
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, 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 - Richard W. Treharne, Ph.D.
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 presticated 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,
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
4
510(k) Number (if known): | 043020
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K043020 0000003