(21 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a system for anterior vertebral screw fixation of the cervical spine, intended for temporary stabilization during the development of cervical spine fusions for various medical conditions like degenerative disc disease, trauma, tumors, and deformity. This describes a medical intervention aimed at treating or alleviating a disease or condition, which is the definition of a therapeutic device.
No
Explanation: The device is described as an anterior vertebral screw fixation system used for temporary stabilization of the anterior spine during cervical spine fusions, indicating it is a therapeutic or surgical device, not a diagnostic one.
No
The device description explicitly states it consists of bone plates, screws, and associated instruments 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 SECULOK™ ACP System is for "anterior vertebral screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) for structural support and stabilization.
- Device Description: The device is described as consisting of "bone plates, screws and associated instruments" made from titanium alloy. These are physical components designed to be implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of biological samples or diagnostic purposes.
Therefore, the SECULOK™ ACP System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies):
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis
- · Pseudoarthrosis
- · Failed previous fusion
WARNING: The device is not approved for screw attachment or the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The width of plates of to the proposed SECULOK™ ACP System was modified compared to the prior devices (K182055).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The SECULOK™ ACP System was evaluated in a non clinical setting (bench testing) to verify that the data of the proposed devices meet the acceptance criteria of the prior devices (K182055) and no new safety and efficiency issues were raised with this device.
The following tests were performed same as test methods and parameters of the prior system (K182055):
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
The mechanical performance of the proposed devices met the acceptance criteria of the predicate devices (K182055).
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2019
U&I Corporation Kwang-Eun Song Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 KOREA
Re: K190053
Trade/Device Name: SECULOK™ ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 8, 2019 Received: January 11, 2019
Dear Kwang-Eun Song:
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
1
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) K190053
111,000
Device Name SECULOK™ ACP System
Indications for Use (Describe)
The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies):
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis
- · Pseudoarthrosis
- · Failed previous fusion
WARNING: The device is not approved for screw attachment or the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.
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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6. 510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
| Sponsor Contact: | Kwang-Eun Song, Regulatory Affairs Specialist
+82 31 860 6837
kesong@youic.com |
| Date Prepared: | January 08, 2019 |
| Device Name: | Trade Name: SECULOKTM ACP System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Anterior Cervical Plate |
| Product Code: | KWQ |
| Predicate Devices: | |
| Primary - SECULOKTM ACP System (K182055)
Secondary - ASPIRONTM ACP System (K131200, K140234) | |
Description of Device:
The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The width of plates of to the proposed SECULOK™ ACP System was modified compared to the prior devices (K182055).
4
Indications For Use:
The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- . Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- Spondylolisthesis O
- Trauma (including fractures, dislocation)
- Spinal stenosis O
- O Tumors
- O Deformity (defined as scoliosis, kyphosis, or lordosis)
- O Pseudoarthrosis
- Failed previous fusion
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Substantial Equivalence:
SECULOK™ ACP System is substantially equivalent to SECULOK™ ACP System (K182055) and ASPIRON™ ACP System (K131200, K140234) in design, material, mechanical performance, function and intended use.
-
- Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;
- Comparison Technological Characteristics
-
The similar indications for use
-
O Similar design features
-
Incorporate the same materials O
-
The equivalent mechanical performance
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2. Performance evaluation
The SECULOK™ ACP System was evaluated in a non clinical setting (bench testing) to verify that the data of the proposed devices meet the acceptance criteria of the prior devices (K182055) and no new safety and efficiency issues were raised with this device.
The following tests were performed same as test methods and parameters of the prior system (K182055):
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
The mechanical performance of the proposed devices met the acceptance criteria of the predicate devices (K182055).
The SECULOK™ ACP System is substantially equivalent to predicate devices.
3. Conclusion
The data and information provided in this submission support the conclusion that the SECULOK™ ACP System is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.