(69 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is clearly indicated for the treatment of various spinal conditions (e.g., severe Spondylolisthesis, fracture, scoliosis, kyphosis, spinal tumor) as an adjunct to fusion, aiming to immobilize and stabilize spinal segments. These uses align with the definition of a therapeutic device.
No
This device is described as a "pedicle screw system" and "posterior spinal fixation systems" designed to "provide immobilization and stabilization of spinal segments as an adjunct to fusion." It is a physical implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The 4CIS® Spinal System and 4CIS® Low Back System are described as a pedicle screw system and posterior spinal fixation systems. Their intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions.
- Mechanism of Action: This device is a physical implant used to mechanically stabilize the spine. It does not analyze biological samples.
The information provided clearly indicates that this is a surgical implant used directly on the patient's spine, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
The 4CIS® Spinal System and 4CIS® Low Back System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by the 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® Spinal System and 4CIS® Low Back 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 the objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Product codes
MNH, MNI
Device Description
The 4CIS® Spinal System and 4CIS® Low Back System are a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.
The 4CIS® Spinal System and 4CIS® Low Back System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4CIS® Spinal System and 4CIS® Low Back System implant components are supplied in the non-sterile condition for a single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the 4CIS® Spinal System and 4CIS® Low Back System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum), L5-S1 vertebra, thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
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
Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates the substantial equivalence to the above predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 7 - 2005 510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information
| Contact: | Seayoung Ahn, Dr.
7612 Barnum Road, Bethesda, MD 20817 |
|----------------|---------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Solco Biomedical Co., Ltd
34-6 Keumam-ri, Seotan-myeon,
Pyeongtaek, Gyeonggi-do, 451-852
Republic of Korea |
| Date Prepared: | 23 December 2004 |
Device Identification
| Trade Name: | 4CIS® Spinal System and 4CIS® Low Back System |
|---|---|
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Spondylolisthesis Spinal Fixation Device System(MNH) |
| per 21 CFR § 888.3070, | |
| Spinal Pedicle Screw(MNI) per 21 CFR § 888.3070 |
Substantially Equivalent Predicate Legally Marketed Devices
The subject device, 4CIS® Spinal System and 4CIS® Low Back System, is substantially equivalent in the function, design, composition, material and intended use to devices:
Global Spinal Fixation System(K001668), and OPTIMA™ Spinal System(K031585)
Device Description
The 4CIS® Spinal System and 4CIS® Low Back System are a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.
The 4CIS® Spinal System and 4CIS® Low Back System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4CIS® Spinal System and 4CIS® Low Back System implant components are supplied in the non-sterile condition for a single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and
Solco Biomedical Co.,Ltd
4CIS® Spinal System/4CIS® Low Back System 510(k) Submission
1
removal of the 4CIS® Spinal System and 4CIS® Low Back System.
Indications for Use
The 4CIS® Spinal System and 4CIS® Low Back System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by the 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® Spinal System and 4CIS® Low Back 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 the objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Performance Data
Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates the substantial equivalence to the above predicate devices.
Solco Biomedical Co.,Ltd
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.
Public Health Service
MAR 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Solco Biomedical c/o Dr. Saeyoung Ahn 7612 Barnum Road Bethesda, Maryland 20817
K043578 Re:
K043578
Trade/Device Name: 4CIS® Spinal System and 4CIS® Low Back System
Trade/Device Name: 4CIS® Spinal System and 4CIS® Low Back System
1 Regulation Number: 888.3070(b)(1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNH, MNI Dated: December 28, 2004 Received: December 28, 2004
Dear Mr. Ahn:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) prematic is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments. for use stated in the enclosure) to regally manced provided Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug. commerce prior to May 28, 1970, the chacenese with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance was areasted approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses antonions of the Act. and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements for annual misbranding and general controls provisions of the Act mendes requirements
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 If your device is classified (see above) miss existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulates 808 may be subject to such additional controlist Existing major of 99% In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 89% In addion, F be found in the Couc of Federal Regarations, vour device in the Federal Register.
3
Page 2 -- Dr. Saeyoung Ahn
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a substition with other requirements of the Act
that FDA has made a determination that your device onemals . Your must that FDA has made a delemination that your active Federal agencies. You must or any Federal statures and regulations daminities, but not limited to: registration and listing (21 l comply with an the Act 3 requirements, me, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) rogalsment (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section your device as described in your Section 510(k) I his letter will anow you to ocgin mailioning of substantial equivalence of your device to a legally premarket notification. The PDF mining of cassification 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 n you desire specific aarnoliance at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complance an (21 trotification" (21CFR Part 807.97). You may obtain Misoranding of Tereferee to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Mark Millman
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
3578
510(k) Number (if known): 12 p 4
Device Name: 4CIS® Spinal System & 4CIS® Low Back System
Indications for Use:
The 4CIS® Spinal System & 4CIS® Low Back 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 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® Spinal System/4CIS® Low Back 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).
Prescription Use (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043578