(576 days)
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).
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 F136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
The provided document is a 510(k) Premarket Notification for a spinal fixation system (4CIS® Chiron Spinal Fixation System). It focuses on demonstrating substantial equivalence to previously marketed devices through mechanical testing and comparison of design features and indications for use.
Crucially, this document does NOT contain information about an AI/ML-driven medical device or any study involving human readers, ground truth establishment by experts, or performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves a device meets them for an AI/ML product based on this document. The document describes a traditional medical device (implantable hardware) and its clearance pathway, which relies on engineering and mechanical testing, not software performance studies.
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June 1, 2022
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Solco Biomedical Co., Ltd. Soo-Min Hong Official Correspondent 154 Seotan-ro. Seotan-myeon Pyeongtaek, Gyeonggi-do 17704 Korea, South
Re: K203233
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: May 3, 2022 Received: May 3, 2022
Dear Soo-Min Hong:
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
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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,
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) K203233
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Solco Life & Science. The word "SOLCO" is in large, bold, dark blue letters. To the right of the word is a red dot. Underneath the word "SOLCO" is the phrase "LIFE & SCIENCE" in smaller, light-colored letters.
510(k) Summary
| Submitter | Solco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983 | Predicate Device | 4CIS® Chiron Spinal Fixation System (K190471)[SolcoBiomedical Co., Ltd.] - Primary Predicate |
|---|---|---|---|
| Contact Person | Soo-Min HongSolco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone: +82)31-610-4079Fax: +82)31-663-8983 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2SYSTEM (K111136) [DEPUY SPINE, INC.] – ReferencePredicate | |
| Submission Date | June 09, 2020 | MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUYAcroMed Inc.] - Reference Predicate | |
| Trade / Proprietaryname | 4CIS® Chiron Spinal Fixation System | SYNERGY™ TI INTEGRAL OPEN SCREW SYSTEM(K012871) [Interpore Cross International, LLC] - ReferencePredicate | |
| Common / UsualName | Spinal Fixation System | LDR Spine Easyspine Posterior Spinal System (K123134)[LDR Spine USA] – Reference Predicate | |
| Classification NameClassification CodeRegulatory ClassRegulation Number | Thoracolumbosacral pedicle screw systemNKB, KWPClass II888.3070 | Description of Device | The Spinal Fixation System is a top-loading posterior spinalfixation system which consists of pedicle screws, rods, nuts,transverse (cross) link and associated instruments. Rigidfixation is provided by pedicle screws inserted into thevertebral body through pedicle of the lumbar spine viaposterior approach. This system will allow surgeons to builda spinal implant construct to stabilize and promote spinalfusion through open surgery or minimally invasive surgery.Implant components can be rigidly locked into a variety ofdifferent configurations to suit the individual pathology andanatomical conditions of the mature patient. The implantcomponents are supplied non-sterile single use and arefabricated from titanium alloy (Ti-6A1-4V ELI) thatconforms to ASTM F136 and Cobalt Alloy (Co-28Cr-6Mo)per ASTM F1537. Also, Specialized instruments areavailable for the application and removal of the SpinalFixation System. |
| Indications for Use | The 4CIS® Chiron spinal fixation system is intended toprovide immobilization and stabilization of spinal segmentsin skeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilitiesor deformities of the thoracic, lumbar and sacral spine:1. Degenerative disc disease (defined as discogenic backpain with degeneration of the disc confirmed by history andradiographic studies); |
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Image /page/4/Picture/1 description: The image shows the logo for Solco Life & Science. The word "SOLCO" is written in large, bold, blue letters. Below that, the words "LIFE & SCIENCE" are written in smaller, thinner, black letters.
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Image /page/5/Picture/1 description: The image shows the logo for SOLCO Life & Science. The word "SOLCO" is in large, bold, dark blue letters. Below that, in smaller letters, is the phrase "LIFE & SCIENCE" also in dark blue. To the right of the word "SOLCO" is a red dot.
| 2. Spondylolisthesis;3. Trauma (i.e., fracture or dislocation);4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/orlordosis);5. Tumor;6. Stenosis;7. Failed previous fusion (pseudoarthrosis). | |
|---|---|
| Comparison ofTechnologicalCharacteristics withthe Predicate Devices | The 4CIS® Chiron Spinal Fixation System and all thepredicates have the same or similar indications for usestatements. The system is composed of the same material as thepredicate devices conforming to recognized industry standardsfor permanent implants and surgical orthopedic instruments.The 4CIS® Chiron Spinal Fixation System and cited predicatedevices share similar basic design features and functions aswell as their dimensions. Also they are provided non-sterile forsingle use only. Mechanical testing confirmed the 4CIS®Chiron Spinal Fixation System demonstrated equivalentperformance to the cited predicate device under the same testconditions. |
| Performance Data | Non-clinical mechanical testing (ASTM F1717 staticcompression bending, ASTM F1798 axial grip) was conducted.Test results demonstrate substantial equivalence of thesubject device to the predicate devices. |
| Conclusion | The overall technology characteristics and mechanicalperformance data lead to the conclusion that the subject deviceis substantially equivalent to legally marketed predicatedevices. |
§ 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.