(50 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical components of the fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of various spinal instabilities and conditions, indicating a therapeutic purpose.
No
The device is a fixation system used for treating spine instability, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of titanium alloy (plates, screws, lock plate) and standard orthopedic instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The Life Spine Anterior Lumbar Fixation System (Presidio) is a system of plates and screws made from titanium alloy. These are physical implants intended to be surgically placed within the body to stabilize the spine.
- Intended Use: The intended use is to treat spine instability resulting from various conditions by providing fixation. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant used for structural support within the body, which is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (Ti-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis. scoliosis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The Presidio Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. 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 options including lengths of 32mm-53mm lengths and curvature of R 50mm, 100mm, and 250mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and lengths of 18mm-40mm. The lock plate is manufactured in one size to fit with all plate lengths. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Presidio Anterior Lumbar Fixation System also 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
thoracic and thoracolumbar (Ti-LS) spine, lumbar and lumbosacral (LI-S1) 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)
Static compression, static torsion, dynamic compression and screw push out testing per ASTM F1717 was presented to demonstrate the substantial equivalency of the Life Spine Anterior Lumbar Fixation System (Presidio).
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
| Submitted By: | Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | OCT 08 2013 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Contact: | Randy Lewis
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | |
| Date Prepared: | August 15th, 2013 | |
| Trade Name: | Anterior Lumbar Plate System (Presidio) | |
| Common Name: | Spinal Fixation System | |
| Classification: | KWQ, CFR 888.3060, Class II | |
| Predicate Device: | Life Spine Anterior Lumbar Fixation System (K093200)
Blackstone Unity Anterior Lumbar Fixation System (K043548) | |
510(k) Summary Life Spine Anterior Lumbar Plate System (Presidio)
Device Description:
The Presidio Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. 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 options including lengths of 32mm-53mm lengths and curvature of R 50mm, 100mm, and 250mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and lengths of 18mm-40mm. The lock plate is manufactured in one size to fit with all plate lengths. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Presidio Anterior Lumbar Fixation System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
1
Intended Use of the Device:
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (Ti-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis. scoliosis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
Technological Characteristics:
The Life Spine Anterior Lumbar Fixation System (Presidio) is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.
Material:
The Life Spine Compression Plate material is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile. single use components.
Performance Data:
Static compression, static torsion, dynamic compression and screw push out testing per ASTM F1717 was presented to demonstrate the substantial equivalency of the Life Spine Anterior Lumbar Fixation System (Presidio).
Conclusion:
The information presented demonstrates the substantial equivalency of the Life Spine Anterior Lumbar Fixation System (Presidio)
2
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2013
Life Spine, Incorporated Mr. Randy Lewis Director of RA/ OA 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
Re: K132589
Trade/Device Name: Life Spine Anterior Lumbar Fixation System (Presidio™) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 6, 2013 Received: September 9, 2013
Dear Mr. Lewis:
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 10 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 docs 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 - Mr. Randy Lewis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safety/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.
Erini Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132589
Device Name: Life Spine Anterior Lumbar Fixation System (Presidio™)
Indications for Use:
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
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