(222 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design modifications of spinal implants (screws and rods). There is no mention of software, algorithms, image processing, AI, ML, or any data-driven functionality.
Yes
The device is a medical implant intended to provide immobilization and stabilization of spinal segments for various conditions, which aligns with the definition of a therapeutic device.
No
The device described is a pedicle screw system intended for spinal immobilization and stabilization as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states it is composed of "cannulated and non-cannulated pedicle screws and fixation rods," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the device is composed of "cannulated and non-cannulated pedicle screws and fixation rods." These are physical implants used in spinal surgery.
- Intended Use: The intended use describes the conditions for which the device is used in surgery (e.g., degenerative disc disease, fracture, scoliosis) and how it is used to provide "immobilization and stabilization of spinal segments." This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of testing bodily samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:
• Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumors
• Failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):
• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• Fracture
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)
Product codes
MNI, MNH, KWQ, KWP
Device Description
The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine, L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar, and sacral spine (T10-S1)
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
Mechanical testing was conducted per ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in Vertebrectomy Model" and ASTM F1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Testing according to ASTM F1717-13 includes Static Compression, Static Torsion and Dynamic Compression. ASTM F1798-13 testing was Transverse Test Apparatus for Subassembly. Results demonstrate comparable mechanical properties to the predicate devices.
No clinical data has been presented.
Key Metrics
Not Found
Predicate Device(s)
K112607, K130302, K013301, K062912, K050461, K052761, K060361, K060748, K071373, K113666, K061520, K111571, K090648, K102701, K041119, K062174, K090230, K090799, K955348, K071890
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
JUN 3 0 2014
| Date | June 27, 2014 |
|---|---|
| Submitter | SpineVision, S.A. |
| Antony parc II | |
| 10 place du Général de Gaulle | |
| CS70001 | |
| Antony Cedex 92184, France | |
| Tel: +33 1 53 33 25 25 | |
| Fax : + 33 1 53 33 25 39 | |
| SpineVision Contact | Helene PLAS, QA&RA Manager |
| Tel: +33 1 53 33 25 25 | |
| Fax : + 33 1 53 33 25 39 | |
| corp.quality@spinevision.com | |
| US Regulatory Contact | Mr. J.D. WEBB |
| Tel: +1 512-388-0199 | |
| Fax: +1 512-692-3699 | |
| ortho.medix@sbcglobal.net | |
| Trade Name | SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System |
| SpineVision U.L.I.S.™ Pedicle Screw Fixation System | |
| Common Name | |
| Classification Name | Pedicle Screw Spinal System |
| Product code | MNI, MNH, KWQ, KWP |
| CFR section | 888.3070, 888.3050 |
| Legally marketed | |
| predicate devices | LUMIS™ Pedicle Screw Fixation System (K112607/K130302) |
| U.L.I.S.™ Pedicle Screw Fixation System (K112607/K130302) | |
| UNI-THREAD Spinal System(K013301) | |
| Scient'x Polyaxial LP (K062912) | |
| Xia Spinal System (K050461/K052761/K060361/K060748/K071373/K113666) | |
| VIPER® System, VIPER®2 system (K061520/K111571/K090648/K102701) | |
| EXPEDIUM® Spine System (K041119/K062174/K090230/K090799) | |
| DePuy Spine - Moss Miami-titanium (K955348) | |
| Alphatec Zodiac (K071890) | |
| Description | The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile. |
| The purpose of this submission is to include design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods. | |
| Material | Titanium Ti-6Al-4V ELI per ASTM F136 (ISO 5832-3) |
| Cobalt Chromium (CoCr) alloy per ASTM F1537 | |
| When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for: | |
| • Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) | |
| • Spondylolisthesis | |
| • Fracture | |
| • Spinal stenosis | |
| • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) | |
| • Tumors | |
| • Failed previous fusion (pseudoarthrosis) | |
| Intended use | The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who: |
| • have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; | |
| • receive fusions using autogenous bone graft only; | |
| • have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and | |
| • have the device removed after the development of a solid fusion. | |
| In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to | |
| fusion in the treatment of the following acute and chronic | |
| instabilities or deformities of the thoracic, lumbar, and sacral spine | |
| (T10-S1): | |
| • Degenerative spondylolisthesis with objective evidence of | |
| neurologic impairment | |
| • Fracture | |
| • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) | |
| • Spinal tumor | |
| • Failed previous fusion (pseudoarthrosis) | |
| Summary of | |
| Technological | |
| Characteristics | The SpineVision Universal Lumbar Intuitive System |
| (U.L.I.S.TMSystem), and Lumbar Universal Minimally Invasive | |
| System (LUMISTM System) instrumentations are manufactured in | |
| Titanium Ti-6Al-4V ELI complying with ASTM F136 and CoCr | |
| complying with ASTM F1537. The LUMISTM Pedicle screw system is | |
| cannulated. The devices provide correction and rigid stabilization | |
| of the spine during development of solid bone fusion following | |
| corrective spine surgery for a number of indications (listed above). | |
| The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.TM | |
| System), and Lumbar Universal Minimally Invasive System | |
| (LUMISTM System) conform to special control established for | |
| Pedicle Screw Spinal System and to "Spinal System 510(k)s - | |
| Guidance for Industry and FDA Staff Document" issued on May 3, |
-
|
| Performance data | Mechanical testing was conducted per ASTM F1717-13 "Standard
Test Methods for Spinal Implant Constructs in Vertebrectomy
Model" and ASTM F1798-13 "Standard Test Method for Evaluating
the Static and Fatigue Properties of Interconnection Mechanisms
and Subassemblies Used in Spinal Arthrodesis Implants. Testing
according to ASTM F1717-13 includes Static Compression, Static
Torsion and Dynamic Compression. ASTM F1798-13 testing was
Transverse Test Apparatus for Subassembly. Results demonstrate
comparable mechanical properties to the predicate devices.
No clinical data has been presented. |
| Substantial equivalence | SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM
System), and Lumbar Universal Minimally Invasive System
(LUMISTM System) are substantially equivalent to their predicate
devices in terms of intended use, material, design, mechanical
properties and function. |
| Conclusion | Engineering analysis and design validation/verification were used
to support substantial equivalence. SpineVision Universal Lumbar
Intuitive System (U.L.I.S.™ System), and Lumbar Universal
Minimally Invasive System (LUMIS™ System) are equivalent to |
| | the predicate devices. |
510(k) SUMMARY
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Spine Vision, S.A., % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: KI33575
Trade/Device Name: SpineVision U.L.I.S.TM Pedicle Screw Fixation System and LUMIS™ Cannulated Pedicle Screw Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNH, KWP, KWQ Dated: June 10, 2014 Received: June 13, 2014
Dear Mr. Webb:
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
5
Page 2 - Mr. J.D. Webb
forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic 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 regulation 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133575
Device Name
SpineVision U.L.I.S.TM Pedicle Screw Fixation System and LUMIS™ Cannulated Pedicie Screw Fixation System
Indications for Use (Describe)
When used for anterior screw fixation or as a posterior, non-pedicle system of the U.L.I.S.™ and LUMISTM systems are indicated for:
· degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- · spondylolisthesis
- · fracture
- · spinal stenosis
- · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- tumors
- · failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
- · have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- · receive fusions using autogenous bone graft only;
- · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- · have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):
- · degenerative spondylolisthesis with objective evidence of neurologic impairment
- · fracture
- · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- · spinal tumor
- · failed previous fusion (pseudoarthrosis)
Type of Use (Select one or both, as applicable)
2 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)
7
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