(27 days)
No
The device description and performance studies focus on the mechanical properties of a physical implant and do not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for immobilization of the spine as an adjunct to fusions for conditions like degenerative disc disease, trauma, and tumors, indicating a therapeutic purpose.
No
The device is an anterior cervical plate system designed for immobilization of the spine as an adjunct to fusions, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of plates, screws, and lockers made from titanium alloy, which are physical hardware components.
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 for "anterior screw fixation to the cervical spine (C2-C7)" and is used in the "immobilization of the spine as an adjunct to fusions." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like plates, screws, and lockers made from titanium alloy, designed to be attached to the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudoarthrosis.
- · failed previous fusion,
- · spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System (K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271).
The CastleLoc-P Anterior Cervical Plate System was tested according to ASTM F1717, specifically, Static compression test, Static torsion test, Static tension test and fatigue test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
Not Found
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 21, 2019
L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, #202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA
Re: K190425
Trade/Device Name: CastleLoc-P 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: February 20, 2019 Received: February 22, 2019
Dear Ms. Seo:
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.html; 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 medical devices and radiation-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) K190425
Device Name
CastleLoc-P Anterior Cervical Plate System
Indications for Use (Describe)
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudoarthrosis.
- · failed previous fusion,
- · spinal stenosis.
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
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
- Submitter: 1. L&K BIOMED Co., Ltd. #201, #202 16-25, Dongbaekjungang-ro 16 beon-qil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone: 82-2-6717-1983 e-mail: kate.seo@lnkbiomed.com Contact Person: Jihyeon Seo Date prepared February 20th, 2019
Device Identification 2.
| Trade Name | CastleLoc-P Anterior Cervical Plate System |
|---|---|
| Regulatory Class | Class II |
| Regulation Name/Common Name | Anterior Cervical Plate |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
| (21 CFR888.3060) | |
| Panel | Orthopedic |
| Product Code | KWQ |
Purpose of 510(k) 3.
L&K BIOMED Co. Ltd., is submitting this Special 510(k) to add new components to own 510(k)-cleared device (K143271)
The name of the legally marketed (unmodified) device 4.
■ K143271 CastleLoc-P Anterior Cervical Plate System (primary predicate)
Description of the Device 5.
The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.
4
Indication for Use 6.
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, ●
- 0 trauma (i.e. fractures or dislocations),
- O tumors,
- 0 deformity (defined as kyphosis, lordosis, or scoliosis),
- pseudoarthrosis,
- failed previous fusion, ●
- spinal stenosis.
Comparison of the technological characteristics of the subject and 7. predicate devices
The new components of the CastleLoc-P Anterior Cervical Plate System are considered substantially equivalent to the referenced device (K143271). The systems have the same design, material, scientific technology, and indications for use. The only difference is that there are additional components which use different sterilization method (gamma sterilization).
A rationale was provided as to why gamma sterilization does not affect the performance of the device. They are the same product in all aspect, except sterilization method.
Performance Testing 8.
Mechanical performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System
5
(K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271).
The CastleLoc-P Anterior Cervical Plate System was tested according to ASTM F1717, specifically, Static compression test, Static torsion test, Static tension test and fatigue test.
Conclusion 9.
The additional components of CastleLoc-P Anterior Cervical Plate System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of CastleLoc-P Anterior Cervical Plate System are substantially equivalent to the predicate device (K143271).