(127 days)
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No
The device description and intended use focus on a mechanical implant for spinal fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "system is intended for anterior interbody screw fixation" and its indications for use include treating medical conditions such as "degenerative disc disease", "Spondylolisthesis", "trauma (including fractures)", "Spinal Stenosis", "tumors", and "deformity". These uses clearly fall under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an anterior cervical plate system for temporary stabilization and fixation of the spine, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical implant components (plates, bone screws, locking caps) made of titanium alloy, which are hardware.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the 4CIS® Pinehurst Anterior Cervical Plate system is an implantable device used for anterior interbody screw fixation in the spine. It is a physical device used in surgery to stabilize the spine.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
Therefore, the 4CIS® Pinehurst Anterior Cervical Plate system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
C2 to T1 (cervical spine)
Indicated Patient Age Range
mature patient
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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. Mechanical testing confirmed 4CIS® Pinehurst Anterior Cervical Plate system demonstrated equivalent performance to the cited predicate device under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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, 17704
Republic of Korea
Phone. +82-31-664-4101
Fax. +82-31-663-8983 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | HWI JOON, PARK
14110 Dallas Pkwy Suite 135, Dallas, Texas 75254 USA
Phone: +1-972-247-2486
Fax: +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 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. |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | 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. |
| Comparison of
Technological
Characteristics with the
Predicate Devices | Indication for Use
The subject 4CIS® Pinehurst Anterior Cervical Plate system and all the
predicates have the same or similar indications for use statements.
Materials
The subject device is composed of the same material as the predicate
devices conforming to recognized industry standards for permanent
implants and surgical orthopedic instruments.
Design Features/Functions
The subject 4CIS® Pinehurst Anterior Cervical Plate system and cited
predicate devices share similar basic design features and functions.
Dimensions
The subject 4CIS® Pinehurst Anterior Cervical Plate system is
dimensionally similar to cited predicate devices.
Sterilization
The subject 4CIS® Pinehurst Anterior Cervical Plate system and cited
predicate devices are provided non-sterile for single use only.
Performance Specification
Mechanical testing confirmed 4CIS® Pinehurst Anterior Cervical Plate
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. |
| Conclusion | The overall technology characteristics and mechanical performance data
lead to the conclusion that 4CIS® Pinehurst Anterior Cervical Plate
system is substantially equivalent to legally marketed predicate devices
for intended use, material composition, principles of operation, and
design. |
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