(183 days)
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl 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.
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are 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 ).
aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).
The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and 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 ally that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
This document details the FDA 510(k) clearance for several spine fusion systems. It primarily describes a comparison of the new devices to a previously cleared predicate device (K202498). The information provided focuses on the physical and mechanical properties of the medical devices, not on an AI/software-based diagnostic or treatment system.
Therefore, many of the requested details related to AI/software performance criteria (such as data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training/test set sample sizes for AI) are not applicable to this submission.
The document discusses "acceptance criteria" in the context of mechanical performance testing for spinal implants.
Here's an extraction of the relevant information regarding acceptance criteria and performance, as can be gleaned from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria Mentioned | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | ASTM F1717 (on worst-case construct) | Not explicitly detailed in criteria column, but implicitly required to "meet performance requirement against predicates." | "Static Compression Bending, Dynamic Compression Bending, Static Torsion, and Static Tension tests results meet performance requirement against predicates." |
| Biocompatibility | FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" | Classified as body contacting devices requiring biological evaluation. | "The subject implants are manufactured from identical materials as the predicate devices, in accordance with the ASTM F136... The materials used for manufacturing the subject device have a long history of safe and effective use identical to predicate devices and biocompatibility testing is not required." (Conclusion that prior successful use of materials negates need for new specific test data) |
| Material Conformance | ASTM F136 (Titanium Alloy), ASTM F1537 (Cobalt Chromium Ally) | Conformance to these standards. | "Implant components are... fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium ally that conforms to ASTM F136 and ASTM F1537 respectively." Also, "system is composed of the same material as the predicate- K202498 devices conforming to recognized industry standards for permanent implants (titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136) and surgical orthopedic instruments." |
| Sterilization | Non-sterile single use | Supplied non-sterile for single use. | "The implant components are supplied non-sterile single use." And "Also they are provided non-sterile for single use only." |
| Intended Use/Indications | Equivalence to predicate's indications. | New devices should have similar indications for use as the predicate. | "The 4CIS WILL PEDICLE SCREW SYSTEM, aBle Xt SPINAL FIXATION SYSTEM & aBle SPINAL FIXATION SYSTEM have similar indications as compare to cleared 4CIS SARA Spine System and 4CIS VERTU Spine System." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as this relates to mechanical testing of physical components rather than a dataset for AI. The text refers to testing "on the worst case construct," implying a representative sample of device configurations.
- Data Provenance: Not applicable in the context of patient data for AI. The "data" pertains to mechanical test results of the physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth for mechanical devices is established through engineering standards and physical testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
- Not applicable as it's not an AI system being evaluated against human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- Not applicable. This is not a human-in-the-loop AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
- For mechanical performance, the "ground truth" is measured physical properties and performance against established ASTM (American Society for Testing and Materials) standards.
- For biocompatibility, the "ground truth" is established through the long history of safe and effective use of the materials conforming to ASTM standards.
- For intended use/indications, the "ground truth" is the regulatory clearance of predicate devices with similar indications.
8. The Sample Size for the Training Set:
- Not applicable, as this is not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as this is not an AI system. Ground truth for the device's design and manufacturing is based on engineering principles, materials science, and regulatory standards.
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February 27, 2024
Solco Biomedical Copany India Private Limited Darshak Shah Director Survey No.1540, Beside Torrent Pharma, Village-Rajpur Ahmedabad Mehsana Highway Kadi, Gujarat/ Mehasana 382715 India
Re: K232607
Trade/Device Name: 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: January 29, 2024 Received: January 29, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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).
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Sincerely,
Colin .. O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232607
Device Name 4CIS SARA Spine System, 4CIS VERTU Spine System 4CIS WILL PEDICLE SCREW SYSTEM aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
Indications for Use (Describe)
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl 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.
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are 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 ).
aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).
| 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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PAGE NO 1 of 4
Image /page/4/Picture/1 description: The image shows the word "SOLCO." in a bold, sans-serif font. The letters are a dark blue color, and there is a red dot to the right of the "O". The logo is simple and modern.
NO : 1.0 TITLE: 510(k) Summary
"510(K) SUMMARY"
This summary of 510(k) substantial equivalence information is being submitted in accordance with requirement of 21 CFR 807.92.
| SOLCO Biomedical Company India Private Limited | ||||
|---|---|---|---|---|
| Survey No.1540, Beside Torrent Pharma, Village-Rajpur | ||||
| Submitter | Ahmedabad Mehsana Highway, Ta-Kadi, Dist-Mehsana | |||
| Gujarat- 382715, INDIA. | ||||
| Tel : +91 851112597, Email: darshak@solco.co.in | ||||
| Darshak Shah- Director | ||||
| Contact Person | SOLCO Biomedical Company India Private Limited | |||
| Phone : +91 98252 06091, Email: darshak@solco.co.in | ||||
| Submission Date | 24 FEB 2024. | |||
| 4CIS SARA Spine System | ||||
| Trade /Proprietary name | 4CIS VERTU Spine System | |||
| 4CIS WILL PEDICLE SCREW SYSTEM | ||||
| aBle SPINAL FIXATION SYSTEM | ||||
| aBle Xt SPINAL FIXATION SYSTEM | ||||
| Classification | Thoracolumbosacral Pedicle screw system | |||
| Name | NKB | |||
| Classification | Class II | |||
| Code | 888.3070 | |||
| Regulatory Class | ||||
| Regulation | ||||
| Number | ||||
| 510K | Trade or Property or | Manufacturer | ||
| Number | model Name | SOLCO Biomedical | ||
| PrimaryPredicate Device | K202498 | 4CIS SARA Spine System4CIS VERTU Spine System | ||
| Company India Private | ||||
| Limited |
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DOC NO: K202498/Summary NO : 1.0
PAGE NO 2 of 4
TITLE: 510(k) Summary
| The Spinal Fixation System is a top-loading posterior spinal fixation system | |
|---|---|
| Description ofDevice | which consists of pedicle screws, rods, and 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 ally that conforms to ASTM F136 and ASTM F1537 respectively. | |
| Also, Specialized instruments are available for the application | |
| and removal of the Spinal Fixation System. | |
| Indication for Use | The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL |
| FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL | |
| PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for | |
| the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI | |
| 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. | |
| The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL | |
| FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL | |
| PEDICLE SCREW 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 | |
| TITLE: 510(k) Summary | |
| deformities of the thoracic, lumbar and sacral spine: degenerativeSpondylolisthesis with objective evidence of neurological impairment,fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previousfusion (pseudarthrosis ).aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREWSYSTEM are intended to used for Minimal Invasive Surgery (MIS). | |
| Comparison ofTechnologicalCharacteristicswith thePredicate Devices | The 4CIS WILL PEDICLE SCREW SYSTEM, aBle Xt SPINAL FIXATIONSYSTEM & aBle SPINAL FIXATION SYSTEM have similar indications ascompare to cleared 4CIS SARA Spine System and 4CIS VERTU SpineSystem. The system is composed of the same material as the predicate-K202498 devices conforming to recognized industry standards forpermanent implants (titanium alloy (Ti-6A1-4V ELI) that conforms to ASTMF136) and surgical orthopedic instruments. aBle SPINAL FIXATIONSYSTEM is modified version of 4CIS SARA Spine System and 4CISVERTU Spine System which does not raise any concern of safety andperformance. 4CIS WILL PEDICLE SCREW SYSTEM is intended to usedfor Minimal Invasive Surgery (MIS). Also they are provided non-sterile forsingle use only. |
| Performance Data | Mechanical testing (static and dynamic compression bending, statictension bending, static torsion) is conducted in accordance with ASTMF1717 on the worst case construct. Static Compression Bending,Dynamic Compression Bending, Static Torsion, and Static Tension testsresults meet performance requirement against predicates. |
| Biocompatibility | The subject implants are permanent implants (> 30 days) and are classifiedas body contacting devices according to FDA's Draft Guidance for Industry |
| and FDA Staff "Use of International Standard ISO-10993, Biological | |
| Evaluation of Medical Devices Part 1: Evaluation and Testing.” The subject | |
| implants are manufactured from identical materials as the predicate | |
| devices, in accordance with the ASTM F136 – Standard Specification for | |
| Wrought Titanium – 6Aluminum – 4Vanadium ELI (Extra-Low-Interstitial) | |
| Alloy for Surgical Implants The materials used for manufacturing the | |
| subject device have a long history of safe and effective use identical | |
| to predicate devices and biocompatibility testing is not required. | |
| 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, 4CIS VERTU Spine System, aBle | |
| SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and | |
| 4CIS WILL PEDICLE SCREW SYSTEM) are substantially equivalent to our | |
| FDA previously cleared devices of K202498 for intended use, material | |
| composition, principles of operation, and overall design. |
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DOC NO: K202498/Summary NO : 1.0
TITLE: 510(k) Summary
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DOC NO: K202498/Summary NO : 1.0
PAGE NO 4 of 4
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.