(18 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as providing "temporary stabilization until a solid spinal fusion develops" and lists several specific medical conditions it is intended to address, such as Degenerative Disc Disease, Pseudoarthrosis, Stenosis, and spinal deformities, which indicates a therapeutic purpose.
No.
The device is a spinal fixation system intended for temporary stabilization and fusion, not for diagnosing conditions.
No
The device description explicitly states the system consists of rods and segmental sublaminal wiring made of stainless steel, which are physical hardware components.
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 for stabilizing the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details rods and wires made of stainless steel, which are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
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 properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis.
- Stenosis
- Spondylolisthesis.
- Spinal deformities such as scoliosis and lordosis.
- Fracture.
- Unsuccessful previous fusion surgery.
- Tumor resection.
Product codes
KWP
Device Description
The MSD WIRE System construct consists of rods and segmental sublaminal wiring, being pre-formed and put in place by simple, commonly used, instrumentation. The purpose of this submission is to change the name of the system to the MSD WIRE System and to add previously cleared rods to the MSD WIRE System. The implant components are made of stainless steel as described by ASTM Standard F138 or ISO 5832-1. Stainless steel and titanium implant components must not be used together in a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral levels of the spine
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)
A Risk Analysis was performed on the MSD WIRE System and was included in this submission.
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
page 1 of 1
FEB 2 6 2002
Medtronic Sofamor Danek MSD WIRE System 510(k) Summary
| Submitter: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Treharne |
| Trade Name: | MSD WIRE System |
| Classification Name: | Spinal Fixation Orthosis, Class II |
| Predicate Device(s): | The MSD WIRE System is substantially equivalent to itself, the ORFIL Spine
Fixation System, which was cleared in K934007 on June 06, 1994. |
| Device Description: | The MSD WIRE System construct consists of rods and segmental sublaminal
wiring, being pre-formed and put in place by simple, commonly used,
instrumentation. The purpose of this submission is to change the name of the
system to the MSD WIRE System and to add previously cleared rods to the
MSD WIRE System. The implant components are made of stainless steel as
described by ASTM Standard F138 or ISO 5832-1. Stainless steel and titanium
implant components must not be used together in a construct. |
| Intended Use: | When properly used, this system will provide temporary stabilization until a
solid spinal fusion develops. This system is intended for use only in the
thoracic, lumbar and sacral levels of the spine. This system is not for use in the
cervical spine. Specific indications include: |
| 1.
2.
3.
4.
5.
6.
7.
8. | Degenerative Disc Disease (DDD as defined as back pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic studies).
Pseudoarthrosis.
Stenosis
Spondylolisthesis.
Spinal deformities such as scoliosis and lordosis.
Fracture.
Unsuccessful previous fusion surgery.
Tumor resection. |
| Functionality &
Safety Testing: | A Risk Analysis was performed on the MSD WIRE System and was included
in this submission. |
| Conclusion: | The subject components contained in this submission are substantially
equivalent to the original ORFIL Spine Fixation System (K934007). |
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 a stylized image of an eagle with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
K020426 Re:
Trade Name: MSD™ Wire System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: February 5, 2002 Received: February 8, 2002
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Section 310(k) nother or or alent (for the indications for use stated in and we have determined the device is substantially of the enatment date the enclosure) to devices marketed in intersale contact reclassified in accordance with the of the Medical Device Amendinenes, or to actives and Cosmetic Act (Act). You may, therefore, market the other warranisians of provisions of the Federal Food, Drug, and Cosmone Free (. The general controls provisions of the device, subject to the general controls provision, 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 (Premarket If your device is classified (SCC above) into entrols. Existing major regulations affecting your Approval), it may be subject to sach additions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirelient, as set form in the Quant) by over couple (QS) inspections, the Food and Drug
and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 DA) will verty such assample the rannouncements concerning and concernatification may result in Tegulatory action. In addition, 1277 this response to your premarket notification your device in the Federal Register. Trease note: the response is 1 through 542 of the Act
submission does not affect any obligation you might have under sections 542 of the Submission docs not arrect any congation you might
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Dr. Richard Treharne
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication: "The PDF moung of sustian 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) additionally 609110 101 m. The promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your responsionines and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
R. Mark N. Millikan
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
510(k) Number (if known): K020426
Device Name: MSD WIRE SYSTEM
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration l . of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis. 2.
- Stenosis 3.
- Spondylolisthesis. 4.
- Spinal deformities such as scoliosis and lordosis. રું :
- ર્ભ. Fracture.
- Unsuccessful previous fusion surgery. 7.
- Tumor resection. 8.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
Over-the-counter Use __
Mark A. Millerson
Division of General. Restorative and Neurological Devic
510(k) Number K020926