The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Device Description

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion, 4CIS® SOLAR Spine System and 4C1S® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System:

Based on the provided document, the device described is a pedicle screw spinal fixation system, which is a mechanical implant rather than an AI/software device. Therefore, the questions related to AI device performance (MRMC studies, standalone algorithm performance, AI data provenance, number of experts for ground truth, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, especially for additional sizes and shapes of an existing system. The primary method for proving this equivalence for a mechanical device like this is through mechanical testing.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical soundness in accordance with ASTM F1717	Mechanical testing demonstrates equivalence to the predicate device and indicates that the products are as mechanically sound as the predicate device.

Study Information (Relevant to a Mechanical Device Submission)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical trials or data-driven AI. Instead, the "test set" refers to the specific components (additional poly-axial pedicle screw sizes, additional rod sizes, additional insertion set instruments) that were subjected to mechanical testing. The number of these specific components tested is not quantified in this summary.
Data Provenance: The data comes from mechanical testing conducted in accordance with ASTM F1717. The location of the testing is not specified, but the sponsor is Solco Biomedical Co., Ltd. in the Republic of Korea. It is not "retrospective" or "prospective" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For mechanical testing, "ground truth" is typically established by the specifications and standards (e.g., ASTM F1717) themselves, and the results are objectively measured. Expert consensus in the context of clinical interpretation or diagnosis of images is not relevant here.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data, particularly in clinical studies or image interpretation. For mechanical testing, the results are derived from physical measurements and comparisons to predefined thresholds/standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a mechanical device, not an AI or software device. MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is a mechanical device. Standalone algorithm performance is not relevant.

7. The type of ground truth used:

For mechanical devices and equivalence claims based on mechanical testing, the "ground truth" is typically the established limits and performance characteristics of the predicate device and the requirements outlined in the relevant ASTM standards (ASTM F1717). The device's performance is measured against these objective, quantifiable standards.

8. The sample size for the training set:

Not Applicable. This is a mechanical device. There is no concept of a "training set" in the context of an algorithm's development for this type of submission.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI algorithm for this mechanical device, this question is not relevant.

Summary

{0}------------------------------------------------

K082453
pg. 1 of 3

510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

Submission Information

Contact:	Seayoung Ahn155 Gibbs Street, Suite 510, Rockville, MD 20850
Sponsor:	Solco Biomedical Co., Ltd.34-6 Keumam-ri, Seotan-myeon,Pyeongtaek, Gyeonggi-do, 451-852Republic of Korea
Date Prepared:	May 3, 2008

Device Identification

Trade Name:	4CIS® SOLAR Spine System and4CIS® APOLLON Spine System
Common Name:	Pedicle Screw Spinal Fixation System
Classification Name:	Spondylolisthesis Spinal Fixation Device System(MNH) per21 CFR § 888.3070,Spinal Pedicle Screw(MNI) per 21 CFR § 888.3070

Substantially Equivalent Predicate Legally Marketed Devices

The subject devices, 4CIS® VANE Spine System is substantially equivalent in function, design, composition, material and intended use to: 4CIS SOLAR Spine System and 4CIS APOLLON Spine System, K050471, May 22, 2005.

The only reason for this Special 510(k) submission is to introduce additional sizes and There is no change in design, composition, material and intended use. shapes.

Solco Biomedical Co.,Ltd

{1}------------------------------------------------

Substantial Equivalence

The modified devices have the following similarities to those which previously received 510(k) concurrence:

Have the same indicated use, .
. Use the same operating principle,
. Incorporate the same basic design,
� Incorporate the same materials,
. Are packaged and sterilized using the same materials and processes.

In summary, the 4CIS SOLAR and 4CIS APOLLON Spine Systems described in this submission are substantially equivalent to the predicate device.

Device Modification Description

The purpose of this submission is to include the following components in 4CIS SOLAR Spine System and 4CIS APOLLON Spine System:

. Additional poly-axial pedicle screw sizes
Additional rod sizes .
Additional insertion set instruments to be available for use .

Device Description

Solco Biomedical Co.,Ltd

{2}------------------------------------------------

Indications for Use

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Performance Data

Mechanical testing, as listed in APPENDIX 8 that was conducted in accordance with ASTM F1717, demonstrates equivalence to the above predicate device and indicates that the products are as mechanically sound as the predicate device.

Solco Biomedical Co.,Ltd

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written in a circle around the eagle. The seal is black and white.

SEP 2 3 2358

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Solco Biomedical Company, Ltd. % Mr. Saeyoung Ahn 155 Gibbs Street, Suite 510 Rockville, Maryland 20850

Re: K082453

Trade/Device Name: 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system. Regulatory Class: Class II Product Code: MNH, MNI Dated: August 13, 2008 Received: August 25, 2008

Dear Mr. Ahn:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Mr. Saeyoung Ahn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millian

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

្រីប្រ

Indications for Use

510(k) Number (if known):

Device Name: 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System

Indications for Use:

In addition, the 4CIS® SOLAR Spinc System and 4CIS® APOLLON Spine System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal

tumor and failed previous fusion (pseudarthrosis).

Mark M. Millhiser

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Solco Biomedical Co.,Ltd

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.