(252 days)
Not Found
No
The device description and intended use clearly define a mechanical spinal plating system made of titanium alloy. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies are focused on mechanical testing (static and dynamic compression, torsion), which is typical for this type of implant.
Yes
The device is indicated to provide temporary stabilization as an adjunct to fusion for a variety of spinal conditions, treating abnormalities and maintaining function.
No
The device is a lumbar plating system intended for temporary stabilization and fusion assistance, not for diagnosing conditions.
No
The device description explicitly states that the system consists of physical components (plates and screws) made of titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to provide temporary stabilization in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as plates and screws made of titanium alloy, designed for surgical implantation. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform these functions.
- Performance Studies: The performance studies described are mechanical tests (static and dynamic compression, torsion) to assess the structural integrity of the implant, which is typical for surgical devices. IVD performance studies would focus on analytical and clinical performance related to diagnostic accuracy.
In summary, the Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System is a surgical implant intended for spinal stabilization, not a device used to diagnose a condition.
N/A
Intended Use / Indications for Use
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (T1-L5). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (L1-S1) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusion using a lateral approach in skeletally mature patients for the treatment of the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis, kyphosis, and or lordosis), spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System consists of a variety of plates and screws. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
The plates are manufactured in a variety of configurations with lengths of 21 to 33mm in a single level plate and 64 to 76mm in a two level plate. Additionally, the non-locking screws are provided in diameters of 5.5mm with lengths of 25 - 50mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5), lumbosacral (L1-S1) spine
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)
Nonclinical testing was performed to demonstrate that the Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System is substantially equivalent to other predicate devices. The following testing was performed: Static and dynamic axial compression testing per ASTM F1717 Static torsion testing per ASTM F 1717 The results of these studies show that the subject Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
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.
K922543, K972718, K061789, K082070, K091071
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.
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2014 2 6 2014
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System is provided below.
| Date Summary Prepared | June 11, 2014 |
|---|---|
| Manufacturer/Distributor/Spons or | Eminent Spine, LLC |
| 7200 N 1-35 Building #1 | |
| Georgetown, TX 46037 | |
| Phone 512-868-5980 | |
| Fax 512-864-1462 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| 855-MED-DEV1 (office) | |
| LGB@SecureBME.com | |
| Trade Name | Black / Red Diamond Rattlesnake Lumbar Plating System |
| Common Name | Spinal intervertebral body fixation orthosis |
| Code -Classification | KWQ 21 CFR 888.3060: Class II |
| Predicate Devices | Medtronic Z-Plate (K922543) |
| Acromed M-2 Plate (K972718) | |
| Nuvasive Lateral Plate System (K061789, K082070, K091071) | |
| Predicate Device - 2 Hole | |
| Lateral Plate | Nuvasive Lateral Plate System K091071 |
| Predicate - Anterior Plate | Medtronic Z-Plate (K922543) |
| Acromed M-2 Plate (K972718) | |
| Device Description | The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System |
| consists of a variety of plates and screws. All components are fabricated | |
| and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. |
The plates are manufactured in a variety of configurations with lengths of
21 to 33mm in a single level plate and 64 to 76mm in a two level plate.
Additionally, the non-locking screws are provided in diameters of 5.5mm
with lengths of 25 - 50mm. The responsible surgeon will determine the
correct size of the implant in accordance with the size of the individual
patient.
The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System
utilizes a variety of standard orthopedic instruments to assist in the
placement of the devices. |
| Intended Use | The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated
for use via a lateral / anterolateral surgical approach above the great vessels in the
treatment of the thoracolumbar spine (T1-L5). The Eminent Spine Red Diamond
Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical
approach below the bifurcation of the great vessels in the treatment of the
lumbosacral (L1-S1) spine. The Diamond Rattlesnake System is intended to provide
temporary stabilization as an adjunct to fusion using a lateral approach in skeletally
mature patients for the treatment of the following acute and chronic instabilities
and deformities: degenerative disc disease (DDD, defined as back pain of discogenic
origin with degeneration of the disc confirmed by patient history and radiographic
studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis,
kyphosis, and or lordosis), spinal stenosis, fracture (including dislocation and
subluxation), tumor, or failed previous spine surgery. |
| Technological Characteristics | As was established in this submission, the subject Eminent Spine Black / Red
Diamond Rattlesnake Lumbar Plating System is substantially equivalent to
the predicate systems in terms of design, intended use, material
composition, function, and range of sizes. |
| Non-Clinical Performance
Testing Conclusion | Nonclinical testing was performed to demonstrate that the Eminent Spine
Black / Red Diamond Rattlesnake Lumbar Plating System is substantially
equivalent to other predicate devices. The following testing was performed:
Static and dynamic axial compression testing per ASTM F1717 Static torsion testing per ASTM F 1717 The results of these studies show that the subject Eminent Spine Black / Red
Diamond Rattlesnake Lumbar Plating System meets or exceeds the
performance of the predicate device, and the device was therefore found to be substantially equivalent. |
| Substantial Equivalence
Summary (Conclusion) | The information presented demonstrates the substantial equivalency of the
Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
Eminent Spine, LLC % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K133194
Trade/Device Name: Black / Red Diamond Rattlesnake Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 22, 2014 Received: May 28, 2014
Dear Dr. Braddon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Linda Braddon, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please-note the requlation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133194
Device Name
Black / Red Diamond Rattlesnake Lumbar Plating System
Indications for Use (Describe)
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the thoracolumbar spine (TI-LS). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the great vessels in the treatment of the lumbosacral (LI-SI) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusjon using a lateral approach in skeletally mature patients for the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), poeudarthrosis, spondylolisthesis, deformity (scollosis, kyphosis, and or lordosis), spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
.. . . .
A. W. FABER
Division of Orthopedic Devices
:
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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