(539 days)
No
The device description and performance studies focus solely on the mechanical properties and components of a traditional spinal fixation system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions, indicating a therapeutic purpose.
No
This device is a spinal fixation system, used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one. The "Intended Use / Indications for Use" section lists conditions the device helps treat, not diagnose.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, nuts, and instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a spinal fixation system used to immobilize and stabilize spinal segments in the body as an adjunct to fusion. This is a surgical implant, not a device used to examine specimens outside the body.
- Device Description: The description details the components of a surgical implant (pedicle screws, rods, nuts, etc.) and how they are used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant used directly on the patient's spine during surgery.
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, kyphosis, and/or lordosis);
- Tumor;
- Stenosis;
- Failed previous fusion (pseudoarthrosis).
Product codes
NKB, KWP
Device Description
The 4CIS® Chiron 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 nonsterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, 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
surgeons
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 was performed including static and dynamic compression bending and static torsion testing per ASTM F1717 as well as axial and torsional grip testing and tulipdissociation testing per ASTM F1798. Mechanical testing confirmed the 4CIS® Chiron Spinal Fixation System demonstrated equivalent performance to the cited predicate device under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K203233, K111136, K030383, K012871, K123134
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.
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November 26, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Solco Biomedical Co., Ltd. Seo-Hee Koo RA & Exam Certification Team Researcher 154 Seotan-ro, Seotan-myeon Pyeongtaek-Si. 17704 South Korea
Re: K231655
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, KWP Dated: October 28, 2024 Received: October 28, 2024
Dear Seo-Hee Koo:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely, Digitally signed Eileen by Eileen Cadel -S
Date: Cadel -2024.11.26 S 13:56:02 -05'00' for
Colin O'Neill, M.B.E. 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) K231655
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, kyphosis, and/or lordosis)
-
Tumor
-
Stenosis
-
- Failed previous fusion (pseudoarthrosis)
Type of Use (Select one or both, as applicable)
- Failed previous fusion (pseudoarthrosis)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
| Submitter | Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,
17704 Republic of Korea
Phone. +82-31-664-4101
Fax. +82-31-663-8983 |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Seo-Hee Koo
Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,
17704 Republic of Korea
Phone: +82)31-610-4079
Fax: +82)31-663-8983 |
| Submission Date | May 25, 2023 |
| 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, KWP
Class II
888.3070 |
| | 4CIS® Chiron Spinal Fixation System (K203233)[Solco |
| Predicate Device | Biomedical Co., Ltd.] – Primary Predicate |
| | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2
SYSTEM (K111136) [DEPUY SPINE, INC.] – Additional
Predicate |
| | MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUY
AcroMed Inc.] – Additional Predicate |
| | SYNERGY™ TI INTEGRAL OPEN SCREW SYSTEM
(K012871) [Interpore Cross International, LLC] –
Additional Predicate |
| | LDR Spine Easyspine Posterior Spinal System (K123134)
[LDR Spine USA] – Additional Predicate |
| Description of Device | The 4CIS® Chiron 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 Cobalt
Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, 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; |
| | 3. Trauma (i.e., fracture or dislocation); |
| | 4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or
lordosis); |
| | 5. Tumor; |
| | 6. Stenosis; |
| | 7. 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 was performed including static and dynamic
compression bending and static torsion testing per ASTM
F1717 as well as axial and torsional grip testing and tulip-
dissociation testing per ASTM F1798. |
| Conclusion | The overall technology characteristics and mechanical
performance data lead to the conclusion that the subject device
is substantially equivalent to legally marketed predicate
devices. |
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