(66 days)
The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® MIS Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
The CapLOX II® / TowerLOX® MIS Pedicle 4.5mm Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to be implanted from the posterior approach. The screws are currently available in diameters from 4.9-9.0mm and in lengths frOm 30-100mm. The line extension will include the addition of 4.5mm screws for the CapLOX II® /TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additional instrumentation will also be added to the system. Overall, the system includes pedicle screws, and the instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.
The provided document is a 510(k) premarket notification letter and summary for a medical device, specifically the CapLOX II® / TowerLOX® MIS Pedicle Screw System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or a standalone study as might be seen for novel devices or AI/software products requiring such validation.
Therefore, the information requested in the prompt, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods for AI performance, is not applicable to this document. This submission pertains to a mechanical implant (pedicle screw system) and its line extension (adding a 4.5mm screw and instrumentation). The "study" referenced in the document is primarily mechanical testing and engineering analysis to demonstrate that the new components perform equivalently to the predicate device and do not introduce new safety concerns.
Here's an attempt to address the prompt based only on the information available in the provided text, highlighting where the requested details are not present due to the nature of the device and submission:
Acceptance Criteria and Device Performance for Captiva Spine, Inc.'s CapLOX II® / TowerLOX® MIS Pedicle Screw System (K193270)
The device in question is a mechanical implant (pedicle screw system), and its 510(k) submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to meet pre-defined acceptance criteria for a diagnostic or AI-driven system. The "acceptance criteria" here relate to demonstrating equivalence in mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Proxy: Demonstration of Equivalence to Predicate) | Reported Device Performance |
|---|---|
| No new "worst case" introduced compared to predicate devices. | Engineering Analysis and Dynamic Compression Bending testing per ASTM F1717 were conducted. Results confirmed that the 4.5mm pedicle screws perform equivalently to the predicate data and do not introduce a new "worst case" implant. |
| Similar Indications for Use. | Identical to predicate device. |
| Similar Materials of manufacture. | Identical to predicate device (titanium alloy Ti-6Al-4V ELI per ASTM F136). |
| Similar Structural support mechanism. | Identical to predicate device. |
| No new safety or effectiveness concerns. | Assessed and concluded that minor differences do not raise any new safety and effectiveness issues. Risk management techniques confirmed no new worst cases. Overall technology characteristics lead to the conclusion of substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in the context of a clinical test set. The evaluation was primarily through mechanical testing (Dynamic Compression Bending testing per ASTM F1717). For such tests, the "sample size" would typically refer to the number of physical devices or components tested, which is not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. The performance data is derived from benchtop mechanical testing. The origin would be the testing facility where the ASTM F1717 tests were performed. This is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of clinical diagnoses or interpretations, is not established for this type of mechanical device submission. The "ground truth" for mechanical testing is adherence to established engineering standards and material properties, evaluated by engineers.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission. Mechanical testing results are typically evaluated against pre-defined engineering specifications.
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
- MRMC Study: No. This device is a pedicle screw system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This device is a physical implant, not an algorithm or software.
7. The type of ground truth used
- Type of Ground Truth: For the mechanical testing, the "ground truth" is defined by established engineering standards and material science properties (e.g., ASTM F1717 for mechanical performance, ASTM F136 for material composition). The objective is to demonstrate that the device meets these standards and performs comparably to the predicate.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that would utilize a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.
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January 31, 2020
Captiva Spine, Inc. George Chaux Systems & Regulatory Compliance Manager 967 N. Alternate A1A Suite 1 Jupiter, Florida 33477
Re: K193270
Trade/Device Name: CapLOX II®/TowerLOX® MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: January 13, 2020 Received: January 15, 2020
Dear George Chaux:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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 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).
Sincerely,
for
Ronald P. Jean, Ph.D. Director (Acting) 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) K193270
Device Name
CapLOX II® / TowerLOX® MIS Pedicle Screw System
Indications for Use (Describe)
The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® MIS Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
| 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: CapLOX II® / TowerLOX® MIS Pedicle Screw SystemLine Extension | |
|---|---|
| Manufacturer /Submitter | Captiva Spine, Inc.967 N. Alternate A1A Ste.1Jupiter, FL 33477-3206 |
| Contact Person | George ChauxSystems & Regulatory Compliance ManagerPhone: (877) 772-5571 x719Fax: (866) 318-3224Email: george.chaux@captivaspine.com and regulatory@captivaspine.com |
| Date Prepared | November 22, 2019 |
| Trade Name | CapLOX II® / TowerLOX® MIS Pedicle Screw System |
| Common Name | Pedicle Screw System |
| Proposed Class | Class II |
| ClassificationName | Thoracolumbosacral pedicle screw system (21 CFR § 888.3070) |
| Product Code | NKB |
| ClassificationPanel | Division of Orthopedic Devices |
| PredicateDevices | Primary Predicate:• CapLOX II® / TowerLOX® Pedicle Screw System (K131538) |
| SubmissionScope | The purpose of this submission is the addition of a line extension of a 4.5mmpedicle screw and instrumentation in order to provide additional deviceofferings under the CapLOX II® / TowerLOX® MIS Pedicle Screw Systemportfolio when performing surgical corrections to the thoracic, lumbar andsacral spine using minimally invasive surgical techniques. |
| DeviceDescription | The CapLOX II® / TowerLOX® MIS Pedicle 4.5mm Screw System is animplant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136.It is to be implanted from the posterior approach. The screws are currentlyavailable in diameters from 4.9-9.0mm and in lengths frOm 30-100mm. Theline extension will include the addition of 4.5mm screws for the CapLOX II®/TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additionalinstrumentation will also be added to the system. Overall, the system includespedicle screws, and the instrumentation in order to complete the procedureand implant construct when performed using minimally invasive surgicaltechniques. |
| Indications forUse | The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior,non-cervical pedicle fixation system intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunct tofusion in the treatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar and sacral spine including degenerativespondylolisthesis with objective evidence of neurologic impairment, fracture,dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failedprevious fusion. |
| In addition, when used as a pedicle screw fixation system, the CapLOX II® /TowerLOX® MIS Pedicle Screw System is intended for skeletally maturepatients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bonegraft only, who are having the device attached to the lumbar and sacral spine(levels may be from L3 to the sacrum/ilium), who are having the deviceremoved after the attainment of a solid fusion. | |
| Summary of theTechnologicalCharacteristics | All CapLOX II® / TowerLOX® MIS Pedicle Screws are made from titaniumalloy that conforms to ASTM F136. The addition of 4.5mm andinstrumentation have been assessed using risk management techniques andwere concluded as not creating a new worst case when compared against thepredicate devices. The subject and predicate devices have the followingcharacteristics that are identical:Indications for Use Materials of manufacture Structural support mechanism The minor differences in the subject and predicate devices were assessed andconcluded as not raising any new issues for safety and effectiveness. |
| PerformanceData | Engineering Analysis and Dynamic Compression Bending testing perASTM F1717 were conducted to confirm that introduction of the 4.5mmpedicle screws perform equivalently to the predicate data and does notintroduce a new "worst case" implant within the current CapLOX II® /TowerLOX® MIS Pedicle Screw System |
| Conclusion | The devices associated with this line extension are the same as the previouslycleared CapLOX II®/TowerLOX® Pedicle Screw System. There are nochanges in the intended use, indications, technological characteristics andprinciples of operation in comparison to the predicate devices. The proposedmodifications raise no new types of safety or effectiveness concerns. Theoverall technology characteristics lead to the conclusion that the devicesunder the line extension are substantially equivalent to the predicate devices. |
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§ 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.