(222 days)
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)
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.
The provided text describes a medical device submission (K133575) for the SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System and U.L.I.S.™ Pedicle Screw Fixation System. The submission focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not through clinical or AI-powered studies. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, and AI-specific metrics) are not applicable or cannot be extracted directly from this document.
Here's the information that can be extracted and a clear indication where certain information is not provided:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SpineVision LUMIS™ and U.L.I.S.™ systems are primarily based on demonstrating comparable mechanical properties to legally marketed predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties Comparability: Must demonstrate mechanical properties comparable to predicate devices. This is assessed via specific ASTM standards. | Met. Mechanical testing was conducted per ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in Vertebrectomy Model" (including Static Compression, Static Torsion, and Dynamic Compression) and ASTM F1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants" (Transverse Test Apparatus for Subassembly). The results "demonstrate comparable mechanical properties to the predicate devices." |
| Material Compliance: Materials used must conform to specified ASTM and ISO standards for biocompatibility and strength. | Met. The devices are manufactured in Titanium Ti-6Al-4V ELI per ASTM F136 (ISO 5832-3) and Cobalt Chromium (CoCr) alloy per ASTM F1537. |
| Special Control Conformance: Must conform to special controls established for Pedicle Screw Spinal Systems and to the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004. | Met. The devices conform to these guidelines. |
| Substantial Equivalence: Device must be substantially equivalent to predicate devices in terms of intended use, material, design, mechanical properties, and function. | Met. The submission concludes "[the devices] are substantially equivalent to their predicate devices in terms of intended use, material, design, mechanical properties and function." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided. The study involved mechanical testing of device components, not a test set of patient data.
- Data Provenance: Not applicable in the context of mechanical testing. The testing was conducted in a laboratory setting as part of the device's engineering analysis and design validation/verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "ground truth" derived from expert consensus on patient data. The "truth" in this context is established by engineering standards and measurements from mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human-reviewed data, not mechanical testing results where outcomes are quantifiable and objectively measured against engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a pedicle screw fixation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted, and the concept of "human readers improve with AI" is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the device's safety and effectiveness relies on engineering standards and direct measurements from mechanical testing. The comparability to predicate devices, as assessed through these tests, serves as the basis for the substantial equivalence determination. There is no clinical ground truth (like pathology or outcomes data) mentioned in this summary for the purpose of demonstrating equivalence.
8. The sample size for the training set
Not applicable. This submission concerns a physical medical device and its mechanical properties, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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JUN 3 0 2014
| Date | June 27, 2014 |
|---|---|
| Submitter | SpineVision, S.A.Antony parc II10 place du Général de GaulleCS70001Antony Cedex 92184, FranceTel: +33 1 53 33 25 25Fax : + 33 1 53 33 25 39 |
| SpineVision Contact | Helene PLAS, QA&RA ManagerTel: +33 1 53 33 25 25Fax : + 33 1 53 33 25 39corp.quality@spinevision.com |
| US Regulatory Contact | Mr. J.D. WEBBTel: +1 512-388-0199Fax: +1 512-692-3699ortho.medix@sbcglobal.net |
| Trade Name | SpineVision LUMIS™ Cannulated Pedicle Screw Fixation SystemSpineVision U.L.I.S.™ Pedicle Screw Fixation System |
| Common NameClassification Name | Pedicle Screw Spinal System |
| Product code | MNI, MNH, KWQ, KWP |
| CFR section | 888.3070, 888.3050 |
| Legally marketedpredicate 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 chronicinstabilities or deformities of the thoracic, lumbar, and sacral spine(T10-S1): | |
| • Degenerative spondylolisthesis with objective evidence ofneurologic impairment | |
| • Fracture | |
| • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) | |
| • Spinal tumor | |
| • Failed previous fusion (pseudoarthrosis) | |
| Summary ofTechnologicalCharacteristics | The SpineVision Universal Lumbar Intuitive System(U.L.I.S.TMSystem), and Lumbar Universal Minimally InvasiveSystem (LUMISTM System) instrumentations are manufactured inTitanium Ti-6Al-4V ELI complying with ASTM F136 and CoCrcomplying with ASTM F1537. The LUMISTM Pedicle screw system iscannulated. The devices provide correction and rigid stabilizationof the spine during development of solid bone fusion followingcorrective spine surgery for a number of indications (listed above). |
| The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.TMSystem), and Lumbar Universal Minimally Invasive System(LUMISTM System) conform to special control established forPedicle Screw Spinal System and to "Spinal System 510(k)s -Guidance for Industry and FDA Staff Document" issued on May 3,2004. | |
| Performance data | Mechanical testing was conducted per ASTM F1717-13 "StandardTest Methods for Spinal Implant Constructs in VertebrectomyModel" and ASTM F1798-13 "Standard Test Method for Evaluatingthe Static and Fatigue Properties of Interconnection Mechanismsand Subassemblies Used in Spinal Arthrodesis Implants. Testingaccording to ASTM F1717-13 includes Static Compression, StaticTorsion and Dynamic Compression. ASTM F1798-13 testing wasTransverse Test Apparatus for Subassembly. Results demonstratecomparable mechanical properties to the predicate devices.No clinical data has been presented. |
| Substantial equivalence | SpineVision Universal Lumbar Intuitive System (U.L.I.S.TMSystem), and Lumbar Universal Minimally Invasive System(LUMISTM System) are substantially equivalent to their predicatedevices in terms of intended use, material, design, mechanicalproperties and function. |
| Conclusion | Engineering analysis and design validation/verification were usedto support substantial equivalence. SpineVision Universal LumbarIntuitive System (U.L.I.S.™ System), and Lumbar UniversalMinimally 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
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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
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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)
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§ 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.