(127 days)
The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.
The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior cervical intervertebral body screw fixation from C2 to T1. Rigid fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. Implant components consist of a variety of shapes and sizes of plates, bone screws and associated instruments. Locking caps are pre- assembled to the plates. They cover the heads of the bone screws to reduce the potential for screw back-out. With this locking mechanism, implant components can be rigidly locked into many different configurations to suit the individual pathology and anatomical conditions of the mature patient. They are made of titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Implants must not be used with the components from any other system or manufacturer in a construct.
This FDA document is a 510(k) clearance letter for a medical device called the "4CIS® Pinehurst Anterior Cervical Plate System". It addresses the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. The "Performance Data" section (page 4) mentions mechanical testing according to ASTM F1717 but does not provide details on specific acceptance criteria or results. It explicitly states that "Above non-clinical performance data in the form of a comprehensive literature review was provided".
Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from this document. The provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance (as it's not an AI/ML study).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about standalone (algorithm-only) performance.
- The type of ground truth used (other than mechanical testing standards).
- Sample size for a training set.
- How ground truth for a training set was established.
This document is for a physical orthopedic implant, not a software device, and thus the requested AI/ML specific information is not relevant or present.
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January 16, 2019
Solco Biomedical Co., Ltd. % Mr. Hwi Joon Park Manager First Gold Corporation 14110 Dallas Parkway, Suite 135 Dallas, Texas 75254
Re: K182489
Trade/Device Name: 4CIS® Pinehurst Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 18, 2018 Received: December 20, 2018
Dear Mr. Park:
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182489
Device Name
4CIS® Pinehurst Anterior Cervical Plate system
Indications for Use (Describe)
The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.
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, Gyeonggi-do, 17704Republic of KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983 |
|---|---|
| Contact Person | HWI JOON, PARK14110 Dallas Pkwy Suite 135, Dallas, Texas 75254 USAPhone: +1-972-247-2486Fax: +1-972-247-2413 |
| Submission Date | Sep 04, 2018 |
| Trade / Proprietary name | 4CIS® Pinehurst Anterior Cervical Plate system |
| Common / Usual Name | Intervertebral body fixation orthosis |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
| Classification Code | KWQ |
| Regulatory Class | Class II |
| Regulation Number | 888.3060 |
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| Description of Device | The 4CIS® Pinehurst Anterior Cervical Plate system is intended foranterior cervical intervertebral body screw fixation from C2 to T1.Rigid fixation is provided by bone screws inserted into the vertebralbody of the cervical spine using an anterior approach.Implant components consist of a variety of shapes and sizes of plates.bone screws and associated instruments. Locking caps are pre-assembled to the plates. They cover the heads of the bone screws toreduce the potential for screw back-out.With this locking mechanism, implant components can be rigidlylocked into many different configurations to suit the individualpathology and anatomical conditions of the mature patient.They are made of titanium alloy (Ti-6AI-4V ELI) per ASTM F136.Implants must not be used with the components from any othersystem or manufacturer in a construct. |
|---|---|
| Indication for Use | The 4CIS® Pinehurst Anterior Cervical Plate system is intended foranterior interbody screw fixation from C2 to T1. The system is indicatedfor use in the temporary stabilization of the anterior spine during thedevelopment of cervical spinal fusions in patients with: 1) degenerativedisc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) SpinalStenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, orscoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions. |
| Comparison ofTechnologicalCharacteristics with thePredicate Devices | Indication for UseThe subject 4CIS® Pinehurst Anterior Cervical Plate system and all thepredicates have the same or similar indications for use statements.MaterialsThe subject device is composed of the same material as the predicatedevices conforming to recognized industry standards for permanentimplants and surgical orthopedic instruments.Design Features/FunctionsThe subject 4CIS® Pinehurst Anterior Cervical Plate system and citedpredicate devices share similar basic design features and functions.DimensionsThe subject 4CIS® Pinehurst Anterior Cervical Plate system isdimensionally similar to cited predicate devices.SterilizationThe subject 4CIS® Pinehurst Anterior Cervical Plate system and citedpredicate devices are provided non-sterile for single use only.Performance SpecificationMechanical testing confirmed 4CIS® Pinehurst Anterior Cervical Platesystem demonstrated equivalent performance to the cited predicatedevice 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. |
| Conclusion | The overall technology characteristics and mechanical performance datalead to the conclusion that 4CIS® Pinehurst Anterior Cervical Platesystem is substantially equivalent to legally marketed predicate devicesfor intended use, material composition, principles of operation, anddesign. |
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.