(171 days)
The 4CIS SARA Spine System and 4CIS VERTU Spine System is a pedicle screw system indicated for the weathern 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 SARA Spine System and 4CIS VERTU Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis).
The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium alloy that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
The provided document is a 510(k) summary for the "4CIS SARA Spine System" and "4CIS VERTU Spine System." It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to a diagnostic or AI-based function.
Instead, the "Performance Data" section states:
"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) is conducted in accordance with ASTM F1717. Static Tension Test, Static Torsion test, Static Compression test & Dynamic Compression bending test (Fatigue Test) meets performance requirement against predicates."
This indicates that the performance evaluation for this spine system is based on mechanical testing, not on diagnostic accuracy, sensitivity, specificity, or any other metrics typically associated with AI/ML-based medical devices or diagnostic tools. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.
The document primarily focuses on establishing substantial equivalence to predicate devices based on:
- Indications for Use: The devices have the "same or similar indications for use statements."
- Material: Composed of the "same material as the predicate devices" (titanium alloy and cobalt chromium alloy conforming to ASTM F136 and ASTM F1537 respectively).
- Design and Function: "Share similar basic design features and functions as well as their dimensions."
- Mechanical Performance: Demonstrated to meet performance requirements against predicates through mechanical testing according to ASTM F1717.
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February 18, 2021
Solco Biomedical Company India Private Limited Darshak Shah Director Survey No.1540, Beside Torrent Pharma, Village-Rajpur Ahmedabad Mehsana Highway, Ta-Kadi, Dist-Mehsana Gujarat 382715 India
Re: K202498
Trade/Device Name: 4CIS SARA Spine System, 4CIS VERTU Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: December 30, 2020 Received: January 6, 2021
Dear Darshak Shah:
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/cdrl/cfdocs/cfpmr/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
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801); medical device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K202498
Device Name
4CIS SARA Spine System, 4CIS VERTU Spine System
Indications for Use (Describe)
The 4CIS SARA Spine System and 4CIS VERTU Spine System is a pedicle screw system indicated for the weathern 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 SARA Spine System and 4CIS VERTU Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis).
| 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"
This summary of 510(k) substantial equivalence information is being submitted in accordance with requirement of 21 CFR 807.92.
| Submitter | SOLCO Biomedical Company India Private LimitedSurvey No.1540, Beside Torrent Pharma, Village-RajpurAhmedabad Mehsana Highway, Ta-Kadi, Dist-MehsanaGujarat- 382715, INDIA.Tel : +91 851112597, Email: darshak@solco.co.in | ||
|---|---|---|---|
| Contact Person | Darshak Shah- DirectorSOLCO Biomedical Company India Private LimitedPhone : +91 98252 06091, Email: darshak@solco.co.in | ||
| Submission Date | December 21, 2020 | ||
| Trade / Proprietary name | 4CIS SARA Spine System4CIS VERTU Spine Sytem | ||
| Classification Name | Thoracolumbosacral Pedicle screw system | ||
| Classification Code | NKB | ||
| Regulatory Class | Class II | ||
| Regulation Number | 21 CFR 888.3070 | ||
| 510K Number | Trade or Proeprty or model Name | Manufacturer | |
| Predicate Device | K102458 (Primary) | 4CIS® SOLAR SpineSystem | Solco Biomedical Co.,Ltd.-Korea |
| K030383(Reference) | Moss Miami SpinalSystem | DePuy AcroMed | |
| Description of Device | The Spinal Fixation System is a top-loading posterior spinal fixation systemwhich consists of pedicle screws, rods, nuts, transverse (cross) link andassociated instruments. Rigid fixation is provided by pedicle screwsinserted into the vertebral body through pedicle of the lumbar spine viaposterior approach. This system will allow surgeons to build a spinalimplant construct to stabilize and promote spinal fusion through opensurgery. Implant components can be rigidly locked into a variety of differentconfigurations to suit the individual pathology and anatomical conditions of |
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TITLE: 510(k) Summary
| the mature patient. The implant components are supplied non-sterile singleuse and are fabricated from titanium alloy (Ti-6A1-4V ELI) and CobaltChromium alloy that conforms to ASTM F136 and ASTM F1537respectively. Also, Specialized instruments are available for the applicationand removal of the Spinal Fixation System. | |
|---|---|
| The 4CIS SARA Spine System and 4CIS VERTU Spine System is apedicle screw system indicated for the treatment of severeSpondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletallymature patients receiving fusion by autogenous bone graft having implantsattached to the lumbar and sacral spine (L3 to sacrum) with removal of theimplants after the attainment of a solid fusion. | |
| Indications for Use | In addition, the 4CIS SARA Spine System and 4CIS VERTU Spine Systemis intended to provide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of the thoracic,lumbar and sacral spine: degenerative Spondylolisthesis with objectiveevidence of neurological impairment, fracture, dislocation, scoliosis,kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). |
| Comparison ofTechnologicalCharacteristics | The 4CIS SARA Spine System and 4CIS VERTU Spine System and all thepredicates have the same or similar indications for use statements.The system is composed of the same material as the predicatedevices conforming to recognized industry standards for permanentimplants (Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTMF136) and surgical orthopedic instruments. 4CIS SARA Spine System,4CIS VERTU Spine System and cited predicate devices share similarbasic design features and functions as well as their dimensions. Alsothey are provided non-sterile for single use only. |
| Performance Data | Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) is conducted in accordance with ASTM F1717. Static Tension Test, Static Torsion test, Static Compression test & Dynamic Compression bending test (Fatigue Test) meets performance requirement against predicates. |
| Conclusion | The overall technology characteristics, material of construction, design characteristics and performance data lead to the conclusion that our Spine Systems (4CIS SARA Spine System and 4CIS VERTU Spine System) is substantially equivalent to legally marketed predicate devices for intended use, material composition, principles of operation, and design. |
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TITLE: 510(k) Summary
§ 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.