(148 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, and/or lordosis); tumor; stenosis; and 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 F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
The provided text is a 510(k) Summary for a medical device called the "4CIS® Chiron Spinal Fixation System." It details the device's purpose, components, indications for use, and a comparison to predicate devices, including performance data. However, this document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The "Performance Data" section explicitly states:
"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."
This indicates that the performance data for this spinal fixation system is based on mechanical testing to ensure its structural integrity and equivalence to existing devices, not on the performance of an AI model in interpreting or diagnosing medical images or other data.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided document pertains to a physical medical implant and its mechanical properties.
To answer your request, I would need a document related to the regulatory submission of an AI/ML-driven medical device, which would typically involve clinical performance studies assessing the algorithm's accuracy, sensitivity, specificity, and potentially its impact on human reader performance.
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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
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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.
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 KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983 |
|---|---|
| Contact Person | Hwi-geun YuSolco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do,17704 Republic of KoreaPhone: +82)31-610-4091Fax: +82)31-663-8983 |
| Submission Date | Feb 22, 2019 |
| Trade / Proprietary name | 4CIS® Chiron Spinal Fixation System |
| Common / Usual Name | Spinal Fixation System |
| Classification NameClassification CodeRegulatory ClassRegulation Number | Thoracolumbosacral pedicle screw systemNKBClass II888.3070 |
| Predicate Device | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM(K111136) [DEPUY SPINE, INC.] - Primary PredicateMOSS MIAMI SPINAL SYSTEM (K030383) [DEPUY AcroMed Inc.]- Reference PredicateSYNERGY™ 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 fixationsystem which consists of pedicle screws, rods, nuts, transverse(cross) link and associated instruments. Rigid fixation is provided bypedicle screws inserted into the vertebral body through pedicle of thelumbar spine via posterior approach. This system will allow surgeonsto build a spinal implant construct to stabilize and promote spinalfusion through open surgery or minimally invasive surgery.Implant components can be rigidly locked into a variety of differentconfigurations to suit the individual pathology and anatomicalconditions of the mature patient. The implant components aresupplied non-sterile single use and are fabricated from titanium alloy(Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy perASTM F1537. Also, Specialized instruments are available for theapplication and removal of the Spinal Fixation System. |
| Indication for Use | The 4CIS® Chiron Spinal Fixation System is intended to provideimmobilization and stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of the following acuteand chronic instabilities or deformities of the thoracic, lumbar and sacralspine: degenerative disc disease (defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation); deformities orcurvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis;and failed previous fusion (pseudoarthrosis). |
| Comparison ofTechnologicalCharacteristics with thePredicate Devices | The 4CIS® Chiron Spinal Fixation System and all the predicates havethe same or similar indications for use statements. The system iscomposed of the same material as the predicate devices conforming torecognized industry standards for permanent implants and surgicalorthopedic instruments. The 4CIS® Chiron Spinal Fixation System andcited predicate devices share similar basic design features and functionsas well as their dimensions. Also they are provided non-sterile for singleuse only. Mechanical testing confirmed the 4CIS® Chiron SpinalFixation System demonstrated equivalent performance to the citedpredicate device under the same test conditions. |
| Performance Data | Mechanical testing (static and dynamic compression bending, statictension bending, static torsion) was conducted in accordance withASTM F1717.Above non-clinical performance data in the form of a comprehensiveliterature review was provided in support of substantial equivalence ofthe subject device to the predicate devices. |
| Conclusion | The overall technology characteristics and mechanical performance datalead to the conclusion that Spinal Fixation System is substantiallyequivalent to legally marketed predicate devices for intended use,material composition, principles of operation, and design. |
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§ 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.