(75 days)
Not Found
No
The device description and performance studies focus on mechanical components and engineering analysis, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is described as a "pedicle screw system" intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions, indicating a direct role in treating medical conditions.
No
The device description indicates that the U.L.I.S.™ and LUMIS™ systems are composed of pedicle screws and fixation rods intended for immobilization and stabilization of spinal segments, which are therapeutic functions, not diagnostic.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. It is used to stabilize and immobilize spinal segments in patients with various spinal conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a system of pedicle screws and fixation rods, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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
• 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
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)
Product codes (comma separated list FDA assigned to the subject device)
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 new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Type: Performance Evaluation
Key Results: The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ 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, 2004. No mechanical data is presented: no mechanical test is required for the added components. Performance evaluations were previously conducted on constructs, representing the worst case components (static and dynamic axial compression and static torsion per ASTM F1717). Engineering analysis and design validation/verification were used to support substantial equivalence of the proposed components.
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.
K133575, K130302/K112607, K050461/K052761/K060361/K060748/K071373/K113666, K061520/K111571/K090648/K102701, K041119/K062174/K090230/K090799
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
§ 888.3070 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized human figure with three faces in profile, stacked one behind the other.
April 4, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SpineVision, S.A. Ms. Helene Plas Quality Assurance and Regulatory Affairs Manger 10 rue de la Renaissance Bâtiment E 92160 Antony FRANCE
Re: K160124
Trade/Device Name: SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System, SpineVision U.L.I.S.™ Pedicle Screw Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWO, KWP Dated: February 19, 2016 Received: March 7, 2016
Dear Ms. Plas:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/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/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K160124
Device Name
Spine Vision LUMISTM Cannulated Pedicle Screw Fixation System Spine Vision U.L.I.S.TM Pedicle Screw Fixation System
Indications for Use (Describe)
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, 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
- · Tumors
- · Failed previous fusion (pseudoarthrosis)
The U.L.I.S. TM and LUMISTM 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
- · Spinal tumor
- · Failed previous fusion (pseudoarthrosis)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| Date | February 19, 2016 |
|---|---|
| Submitter | SpineVision, S.A. |
| 10 rue de la Renaissance | |
| Bâtiment E | |
| 92160 Antony | |
| France | |
| Tel. +33(0)1 53 33 25 25 | |
| Fax +33(0)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 | |
| 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 | Primary Predicate: |
| U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation System | |
| (K133575) | |
| Additional predicates: | |
| U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation System | |
| (K130302/K112607) | |
| 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) | |
| 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 new devices: | |
| the U.L.I.S.™ Multi-Axial Reduction Screws, additional | |
| instruments to the U.L.I.S.™ System; additional lengths for | |
| the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal | |
| Rods with U.L.I.S.™ System. | |
| Material | Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO |
| 5832-3). | |
| 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 | |
| • 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 | |
| • Spinal tumor | |
| • Failed previous fusion (pseudoarthrosis) |
4
5
| Summary of
Technological
Characteristics | The SpineVision Universal Lumbar Intuitive System
(U.L.I.S.™ System), and Lumbar Universal Minimally
Invasive System (LUMIS™ System) instrumentations are
manufactured in Titanium Ti-6Al-4V ELI complying with
ASTM F136. 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). |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | The SpineVision® Universal Lumbar Intuitive System
(U.L.I.S.™ System), and Lumbar Universal Minimally
Invasive System (LUMIS™ 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, 2004.
No mechanical data is presented: no mechanical test is
required for the added components. Performance
evaluations were previously conducted on constructs,
representing the worst case components (static and
dynamic axial compression and static torsion per ASTM
F1717).
Engineering analysis and design
validation/verification were used to support substantial
equivalence of the proposed components. |
| Substantial
equivalence | No clinical data is presented.
SpineVision Universal Lumbar Intuitive System (U.L.I.S.™
System), and Lumbar Universal Minimally Invasive System
(LUMIS™ System) are substantially equivalent to their
predicate devices in terms of intended use, material,
design, mechanical properties and function. |
| Conclusion | SpineVision Universal Lumbar Intuitive System (U.L.I.S.™
System), and Lumbar Universal Minimally Invasive System
(LUMIS™ System) are equivalent to the predicate devices. |