(274 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and testing of spinal implants, with no mention of AI or ML.
Yes
The device is described as instrumentation (pedicle screws and fixation rods) used to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal conditions and deformities. These actions directly address a health condition or restore proper function, qualifying it as a therapeutic device.
No
The provided text describes a medical device used for spinal fusion and stabilization, not for diagnosing medical conditions. Its purpose is treatment, not diagnosis.
No
The device description explicitly states the device is composed of physical components like pedicle screws and fixation rods made from titanium alloy. The performance studies also describe testing of these physical components according to ASTM standards.
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 U.L.I.S.TM and LUMISTM systems are "pedicle screws and fixation rods" and "instrumentations" used for "immobilization and stabilization of spinal segments." These are physical implants and surgical tools used directly on the patient's body during surgery.
- Intended Use: The intended use describes the conditions for which the device is used in spinal surgery (degenerative disc disease, spondylolisthesis, fracture, etc.) and how it functions (providing immobilization and stabilization). This is a therapeutic and structural function, not a diagnostic one performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, the U.L.I.S.TM and LUMISTM systems are surgical implants and instruments, not In Vitro Diagnostic devices.
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.TM 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.TM 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)
NKB, MNI, MNH, KWQ, KWP
Device Description
The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are composed of cannulated (LUMISTM) and non-cannulated (U.L.I.S.TM) pedicle screws and fixation rods (Spine Vision Unithread TM rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. These constructs are assembled using specific instruments.
The components of the U.L.I.S.TM and LUMISTM systems are made from ASTM F136 titanium alloy (Ti-6Al-4V ELI) complying with ASTM F136 (ISO 5832-3).
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)
- Study Type: Non-Clinical Testing
- Study Design: The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations were tested (worse case) according to the following standards:
- ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- ASTM F1798 - Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Key Results: Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device.
- Sterilization validation: according to the following standards:
- ANSI/AAMI/ISO 17665-1:2006
- ANSI/AAMI ST79:2010, A1:2010 and A2:2011
- Clinical Data: Published retrospective clinical data for devices similar to the SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) devices were provided in support of this application. This clinical data demonstrated pedicle screws posed no new risks to pediatric patients.
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.
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
JUN - 7 2012
6. 510(k) Summary
Manufacturer:
Date:
May 28, 2010
Orgenix LLC
111 Hill Road
+1-646-460-2984
Fixation System
CS 70001
Submitted by:
SpineVision, S.A.
SpineVision, S.A: Antony Parc II
10 Place du General de Gaulle
Antony Cedex 92184, France
Company Contact
Helene Plas RA&QA Manager +33 1 53 33 25 25 +33 1 53 33 25 39 (FAX)
Mr. Donald W. Guthner
Douglassville, PA 19518
+1-484-363-5879 (FAX)
Pedicle Screw Spinal System
Rod and Screw Spinal Instrumentation
F2193 and ASTM F 1798 (current versions).
US Agent Information
Classification Name:
Common/Usual Name:
Proprietary Name:
Performance standards:
Classification no .:
21 CFR 888.3070 NKB, MNI, MNH, KWQ, KWP - Pedicle Screw Spinal System Class III
SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw
SpineVision U.L.I.S.TM Polyaxial Pedicle Screw Fixation System
The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations were mechanically tested to the following standards - ASTM F1717, ASTM F543, ASTM
Substantial Equivalence:
Substantial equivalence for the SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations is
Page 1 of 4
Att. 2 - Page 13
1
based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions:
- K033508 SpineVision PLUS System with Multi-axial Screws .
- K111479 Globus Medical Revere® Crosstop™ Spinal . Stabilization System.
· The subject device is substantially equivalent to similar previously cleared devices.
The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are composed of cannulated (LUMISTM) and non-cannulated (U.L.I.S.TM) pedicle screws and fixation rods (Spine Vision Unithread TM rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. These constructs are assembled using specific instruments.
The components of the U.L.E.S.TM and LUMISTM systems are made from ASTM F136 titanium alloy (Ti-6Al-4V ELI) complying with ASTM F136 (ISO 5832-3
When used for anterior screw fixation or as a posterior, nonpedicle system of the non-cervical spine, the U.L.I.S.TM 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-. SI 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.TM and LUMISTM systems are pedicle systems intended to provide immobilization and screw stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and
Page 2 of 4
Att. 2 - Page 14
Predicate Devices:
Device Description:
Intended Use:
2
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)
The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are manufactured in Titanium alloy complying with ASTM 136. 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).
Non-Clinical Testing
Summary of
Technological
Characteristics
Supporting Documentation
•
•
Conclusion
The SpineVision Universal Lumbar Intuitive System (U.L.I.S. TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations were tested (worse case) according to the following standards:
ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F1798 - Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device.
Sterilization validation according to the following standards:
-
ANSI/AAMI/ISO 17665-1:2006
-
ANSI/AAMI ST79:2010, A1:2010 and A2:2011
Published retrospective clinical data for devices similar to the SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) devices were provided in support of this application. This clinical data demonstrated pedicle screws posed no new risks to pediatric patients.
The discussed above demonstrates information that the Universal Lumbar Intuitive System (U.L.I.S. TM SpineVision
Page 3 of 4
Att. 2 - Page 15
3
112607
System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) devices are effective and perform as well as or better than the predicate devices.
i
・
Page 4 of 4
Att. 2-Page 16
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is black. The background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
SpineVision, S.A. c/o Orgenix LLC Mr. Donald W. Guthner Consultant 111 Hill Road Douglassville, Pennsylvania 19518
Re: K112607
Trade/Device Name: Spinevision LUMIS Cannulated Polyaxial Pedicle Screw Fixation System and ULIS Polyaxial Pedicle Screw Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Pedicle screw spinal system Regulatory Class: Class III
Product Code: NKB, MNH, MNI, KWQ, KWP Dated: May 28, 2012
Received: May 30, 2012
Dear Mr. Guthner:
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
5
Page 2 - Mr. Donald W. Guthner
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r touse of action and 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 or any I 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 er it i art 607), accember (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 rothing the qualify of brovisions (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 11 70 a doo!//www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 I ba may 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,
for Patt
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K//2607
5. Indications for Use
510(k) Number (if known): K112607
Device Name: SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw Fixation System Spine Vision U.L.I.S.TM Polyaxial Pedicle Screw Fixation System
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.TM 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.TM 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)
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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K112607 510(k) Number_