(84 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not validation of algorithmic performance.
Yes.
The device is described as a spinal fixation system intended to provide "immobilization and stabilization of spinal segments" and is used "as an adjunct to fusion" for various spinal conditions, indicating a direct therapeutic purpose.
No
Explanation: The Revolution™ Spinal Fixation System is described as a system for immobilization and stabilization of spinal segments, an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities. Its components are physical implants used to fix the spine, not to diagnose conditions.
No
The device description clearly outlines physical components made of Ti-6Al-4V ELI alloy, such as bone screws and connectors, and the performance studies focus on mechanical testing of these physical components. There is no mention of software as a component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details mechanical components like screws, connectors, and locking nuts, all designed for physical fixation within the body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical testing (strength, fatigue) of the implant components, which is typical for surgical devices, not IVDs.
Therefore, the Revolution™ Spinal Fixation System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Product codes
NKB, MNI, MNH
Device Description
The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws.
This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire.
The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors.
The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivotingslide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise.
All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical, posterior spine in the thoracic, lumbar, and sacral spine.
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Mechanical Testing:
To validate the strength and safety of the additional system components, testing was conducted according to methods defined in ASTM F 1798-13, "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants", and ASTM F 1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".
Testing per ASTM F1798-13:
- Axial Torsion Strength
- Static Flexion-Extension Strength
- Anterior Posterior (A-P) Pullout Strength
Testing per ASTM F1717-15:
- Static Compression Bending
- Static Torsional Bending
- Dynamic Compression Bending
The testing revealed that the mechanical properties of the multi-level components for the Revolution™ Spinal Fixation System were comparable to published values on plate and rod systems.
Summary: Based on the mechanical testing that was performed and the composition of the device, the Revolution™ Spinal Fixation System multi-level components were found to have a safety and effectiveness profile similar to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061364, K142939, K023415, K013196
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected or overlapping. The profiles are black against a white background. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
April 22, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Intelligent Implant Systems, LLC Mr. Michael Nutt Chief Operating Officer 3300 International Airport Drive. Suite 1100 Charlotte, North Carolina 28208
Re: K160216
Trade/Device Name: Revolution™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: January 29, 2016 Received: January 29, 2016
Dear Mr. Nutt:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Mr. Michael Nutt
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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.
Sincerelv 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 Statement
510(k) Number (if known): K160216
Device Name: Revolution™ Spinal Fixation System
Intended Use / Indications for Use:
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Prescription Use X (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)
3
K160216 Page 1 of 4
510(k) SUMMARY
Intelligent Implant Systems' Revolution™ Spinal Fixation System
| I. Submitter: | Intelligent Implant Systems, LLC
3300 International Airport Drive, Suite 110
Charlotte, NC 28208
(704) 424-1009
(704) 424-1011 (FAX) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Nutt
Chief Operations Officer
(704) 424-1009 |
April 20, 2016
II. Device
Date Prepared:
Name of Device: Revolution™ Spinal Fixation System
Common or Usual Name: Spinal Fixation System
Classification Name: Pedicle Screw Spinal System (21 CFR 888.3070)
Regulatory Class: III
Product Codes: MNI, MNH, NKB
III. Predicate Devices
Primary Predicate: LifeSpine PILOT®-P Posterior Lumbar Plating System (K061364)
Additional Predicates: Intelligent Implant Systems: Revolution™ Spinal System (K142939) Medtronic Sofamor Danek: Dynalok Classic™ Spinal System (K023415) Spinal Innovations Ascend with Shadow Spinal Fixation System (K013196)
4
IV. Device Description
The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws.
This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire.
The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors.
The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivotingslide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise.
All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.
5
V. Intended Use / Indications for Use
Intended Use:
The Revolution™ Spinal Fixation System implants are intended to be used as a construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of monoaxial bone screws joined with a connector.
Indications for Use:
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
VI. Comparison of Technological Characteristics with the Predicate Devices
The Revolution™ Spinal Fixation System and the predicate devices are all posterior systems utilizing pedicle fixation for stabilization of spinal segments. At a high level, the subject and predicate devices all have the following technological characteristics:
- . Bone thread used to implant bone screws in pedicles
- Lock nuts or bolts used to attach bone screws to plates or rods
- Torque is applied to lock nuts or bolts to secure assemblies
The following technological differences exist between the subject and predicate devices:
- . The multi-level components provide two connector attachment posts at one level, which are then used to attach to multiple connectors instead of using longer plates or rods attached by additional bolts or screws.
VII. Performance Data
The following performance data were provided on the multi-level components in support of the substantial equivalence determination:
Mechanical Testing:
To validate the strength and safety of the additional system components, testing was conducted according to methods defined in ASTM F 1798-13. "Standard Test Method for Evaluating the
6
Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants", and ASTM F 1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The types of testing performed on the multi-level components are listed below:
Testing per ASTM F1798-13
-
- Axial Torsion Strength
-
- Static Flexion-Extension Strength
-
- Anterior Posterior (A-P) Pullout Strength
Testing per ASTM F1717-15
-
- Static Compression Bending
-
- Static Torsional Bending
-
- Dynamic Compression Bending
The testing revealed that the mechanical properties of the multi-level components for the Revolution™ Spinal Fixation System were comparable to published values on plate and rod systems.
Materials: All components of the Revolution™ Spinal Fixation System are machined from Ti-6Al-4V ELI, conforming to ASTM F-136.
Summary: Based on the mechanical testing that was performed and the composition of the device, the Revolution™ Spinal Fixation System multi-level components were found to have a safety and effectiveness profile similar to the predicate devices.
VIII. Conclusions
The design of the Revolution™ Spinal Fixation System, with multi-level components, is similar to the predicate devices, it functions in a similar manner, and its mechanical properties are comparable. Thus, the Revolution™ Spinal Fixation System multi-level components should perform as intended in the specified use conditions.