(302 days)
No
The 510(k) summary describes a mechanical fixation system and instrumentation, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is indicated for patients requiring fusion to treat chronic conditions like pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis, or degenerative disc disease, which aligns with the definition of a therapeutic device.
No
The device is described as an axial fixation system, consisting of implantable components and instrumentation for spinal fusion. Its intended use is to treat existing conditions like pseudoarthrosis, spinal stenosis, or degenerative disc disease, rather than to diagnose them. It provides fixation, not diagnostic information.
No
The device description explicitly states it includes titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel, indicating it is a hardware-based system.
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 and Intended Use: The TranS1™ Axial Fixation System is described as a multi-component system of implantable devices (rods, screws, plugs) and instrumentation used for surgical fixation of the lumbar spine. Its intended use is to treat various spinal conditions requiring fusion.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is purely mechanical and structural within the body.
Therefore, the TranS1™ Axial Fixation System falls under the category of a surgical implant/device rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The TranS1™ Axial Fixation System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion.
The TranS1™ Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1™ Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.
Product codes
KWQ
Device Description
The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 spinal segment, lumbar spine at L5-S1
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
§ 888.3060 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
DEC 17 2004
Image /page/0/Picture/1 description: The image shows the text 'K040426' in a handwritten style. The text appears to be a code or identifier, with a combination of letters and numbers. The characters are bold and slightly uneven, giving it a casual, handwritten feel.
510 (k) Summary {As required by 21 CFR 807.92 (c)}
- Date of Summary 1. November 30, 2004
Submitter Information 2.
| Submitter's Name and Address | Submitter's Contact Person |
|---|---|
| TranS1 Incorporated | Cheryl Wagoner |
| 1800 Sir Tyler Drive, Suite 101 | Quality Manager |
| Wilmington, NC 28409 | Phone: 910-509-3100 |
| Establishment Registration #: 3004578806 | Fax: 910-509-3101 |
| Email: cwagoner@trans1inc.com |
Device Names 3.
| Proprietary Name: | TranS1 Axial Fixation System |
|---|---|
| Common/Usual Name: | Anterior spinal fixation device |
| Classification Name: | 21 CFR 888.3060, Spinal Intervertebral Body Fixation |
| Orthosis | |
| Regulatory Classification: | Class II, product code KWQ |
4. Predicate Device
The TranS1 Axial Fixation System is substantially equivalent to:
| Manufacturer | Device | 510 (k) | Cleared |
|---|---|---|---|
| Spineology Group, LLC | K-Centrum Anterior Spinal Fixation | ||
| System | K002371 | 09/15/2000 |
5. Device Description
The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.
Intended Use and Indications for Use 6.
The TranS1 Axial Fixation System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion.
The TranS1 Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2). or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1 Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features three curved lines resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Ms. Cheryl L. Wagoner TranS1 Incorporated 1800 Sir Tyler Drive Suite 101 Wilmington, North Carolina 28405
Re: K040426
Trade/Device Name: TranS1™ Axial Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 30, 2004 Received: December 1, 2004
Dear Ms. Wagoner:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaller broke 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 encreativent date of the Medical Device Amendments, or to conninered proc to ritty 20, 1978, as essordance with the provisions of the Federal Food, Drug, de vices mar nave occh routes and require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merclore, mains of the Act include requirements for annual registration, listing of general controll provision 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 exassinod (600 as controls. Existing major regulations affecting your device can may be subject to bach addent 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 r tease oc devilode that I Drivision that your device complies with other requirements of the Act that I Drivas Intactions 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.
2
Page 2 - Ms. Cheryl L. Wagoner
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,
Colin M. Witten, Ph.D., M.D.
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
510(k) Number (if known): K040426
Device Name: TranS1™ Axial Fixation System
Indications for Use:
The TranS1™ Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1™ Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.
Prescription Use _ V _ (Part 21 CFR801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) 1
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