(41 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the bone plates and screws, with no mention of AI/ML, image processing, or data-driven analysis.
Yes
The device is intended for temporary stabilization of the anterior spine during the development of cervical spine fusions for various medical conditions, indicating a direct role in treating or managing a disease or condition.
No
This device is an anterior vertebral screw fixation system intended for temporary stabilization of the spine during fusion, not for diagnosis.
No
The device description explicitly states that the SECULOK™ ACP System consists of bone plates, screws, and associated instruments, all made from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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.
- Device Description: The device is described as "bone plates, screws and associated instruments" made from titanium alloy, which are typical components of surgical implants.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SECULOK™ ACP System does not perform any such function.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical properties of the implant (static compression bending, static torsion, compression bending fatigue), which are relevant for surgical implants, not IVDs.
In summary, the SECULOK™ ACP System is a surgical implant designed for internal fixation of the cervical spine, not a device used for testing biological samples outside the body.
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:
O 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 (pedicles) of the cervical, thoracic or lumbar spine.
Product codes
KWO
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-6Al-4V ELI) in accordance with ASTM F136. All implants are single use only.
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
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)
The SECULOK™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. All tests met all acceptance criteria and that verifies performance of the SECULOK™ ACP System is substantially equivalent to predicate devices.
The following tests were performed:
- (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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASPIRON™ ACP System (K131200, K140234)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 10, 2018
U&I Corporation Kwang-Eun Song Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 KOREA
Re: K182055
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: KWO Dated: July 27, 2018 Received: August 2, 2018
Dear Mr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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
2
Indications for Use
510(k) Number (if known) K182055
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:
O 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 (pedicles) of the cervical, thoracic or lumbar spine.
| 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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3
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: | July 27, 2018 |
| Device Name: | Trade Name: SECULOK™ ACP System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Anterior Cervical Plate |
| Product Code: | KWQ |
| Predicate Devices: | ASPIRON™ 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-6Al-4V ELI) in accordance with ASTM F136. All implants are single use only.
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 ●
- 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 fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Substantial Equivalence:
SECULOK™ ACP System is substantially equivalent to ASPIRON™ ACP System (K131200, K140234) in design, material, mechanical performance, function and intended use.
The mechanical performance of the SECULOK™ ACP System met the acceptance criteria which have been established from the predicate devices.
-
- 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
-
Similar design features ●
-
Incorporate the same materials
-
The equivalent mechanical performance
5
2. Performance Testing
The SECULOK™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. All tests met all acceptance criteria and that verifies performance of the SECULOK™ ACP System is substantially equivalent to predicate devices.
The following tests were performed:
- (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
-
- 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.