(148 days)
Not Found
No
The device description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as providing "immobilization and stabilization of spinal segments... as an adjunct to fusion" for various acute and chronic instabilities or deformities, which falls under the definition of a therapeutic intervention.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization as an adjunct to fusion. It is a surgical implant, not a tool for diagnosis.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, nuts, and instruments, fabricated from titanium and CoCr alloy. It is a hardware-based spinal fixation system.
No, 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, tissue) to provide information about a person's health.
- Device Description: The 4CIS® Chiron Spinal Fixation System is a system of implants (screws, rods, nuts, etc.) designed to be surgically implanted into the spine to provide structural support and stabilization.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments in vivo (within the body) as an adjunct to fusion.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The 4CIS® Chiron Spinal Fixation System is 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
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)
Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) was conducted in accordance with ASTM F1717.
Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device to the predicate devices.
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.
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July 24, 2019
Solco Biomedical Co., Ltd. % Hwi-Geun Yu 154, Seotan-ro, Seotan-myeon Pyeongtaek-si, Gyeonggi-do Republic of Korea 17704
Re: K190471
Trade/Device Name: 4CIS® Chiron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 8, 2019 Received: July 11, 2019
Dear Hwi-Geun Yu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190471
Device Name
4CIS® Chiron Spinal Fixation System
Indications for Use (Describe)
The 4CIS® Chiron Spinal Fixation System is 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis; and 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) |
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510(k) Summary
| Submitter | Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do,
17704 Republic of Korea
Phone. +82-31-664-4101
Fax. +82-31-663-8983 |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Hwi-geun Yu
Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do,
17704 Republic of Korea
Phone: +82)31-610-4091
Fax: +82)31-663-8983 |
| Submission Date | Feb 22, 2019 |
| Trade / Proprietary name | 4CIS® Chiron Spinal Fixation System |
| Common / Usual Name | Spinal Fixation System |
| Classification Name
Classification Code
Regulatory Class
Regulation Number | Thoracolumbosacral pedicle screw system
NKB
Class II
888.3070 |
| Predicate Device | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
(K111136) [DEPUY SPINE, INC.] - Primary Predicate
MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUY AcroMed Inc.]
- Reference Predicate
SYNERGY™ TI INTEGRAL OPEN SCREW SYSTEM (K012871)
[Interpore Cross International, LLC] - Reference Predicate |
| Description of Device | The Spinal Fixation System is a top-loading posterior spinal fixation
system which consists of pedicle screws, rods, nuts, transverse
(cross) link and associated instruments. Rigid fixation is provided by
pedicle screws inserted into the vertebral body through pedicle of the
lumbar spine via posterior approach. This system will allow surgeons
to build a spinal implant construct to stabilize and promote spinal
fusion through open surgery or minimally invasive surgery.
Implant components can be rigidly locked into a variety of different
configurations to suit the individual pathology and anatomical
conditions of the mature patient. The implant components are
supplied non-sterile single use and are fabricated from titanium alloy
(Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy per
ASTM F1537. Also, Specialized instruments are available for the
application and removal of the Spinal Fixation System. |
| Indication for Use | The 4CIS® Chiron Spinal Fixation System is 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: degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or
curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis;
and failed previous fusion (pseudoarthrosis). |
| Comparison of
Technological
Characteristics with the
Predicate Devices | The 4CIS® Chiron Spinal Fixation System and all the predicates have
the same or similar indications for use statements. The system is
composed of the same material as the predicate devices conforming to
recognized industry standards for permanent implants and surgical
orthopedic instruments. The 4CIS® Chiron Spinal Fixation System and
cited predicate devices share similar basic design features and functions
as well as their dimensions. Also they are provided non-sterile for single
use only. Mechanical testing confirmed the 4CIS® Chiron Spinal
Fixation System demonstrated equivalent performance to the cited
predicate device under the same test conditions. |
| Performance Data | Mechanical testing (static and dynamic compression bending, static
tension bending, static torsion) was conducted in accordance with
ASTM F1717.
Above non-clinical performance data in the form of a comprehensive
literature review was provided in support of substantial equivalence of
the subject device to the predicate devices. |
| Conclusion | The overall technology characteristics and mechanical performance data
lead to the conclusion that Spinal Fixation System is substantially
equivalent to legally marketed predicate devices for intended use,
material composition, principles of operation, and design. |
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