The CapLOX II Spinal 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, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal 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/ilium), who are having the device removed after the attainment of a solid fusion.

Device Description

The Captiva Spine CapLOX II Spinal System is a top-loading spinal fixation system consisting of polyaxial pedicle screws, cannulated polyaxial pedicle screws set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy. The purpose of this submission is to add additional screws to the pedicle screw system.

AI/ML Overview

The provided 510(k) summary for the Captiva Spine CapLOX II Spinal System focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies with acceptance criteria based on metrics like sensitivity or specificity. Therefore, many of the requested data points related to clinical or AI/algorithm performance are not applicable to this submission.

Here's a breakdown of the information that is applicable and a note on what is not:

Acceptance Criteria and Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence in terms of materials	Verified by engineering analysis and comparison to predicates
Substantial equivalence in terms of design	Verified by engineering analysis and comparison to predicates
Substantial equivalence in terms of indications for use	Explicitly stated as substantially equivalent to predicates
Substantial equivalence in terms of operational principles	Verified by engineering analysis and comparison to predicates
Performance of additional screws meets design requirements	Verification activities including FEA and engineering analysis indicates performance is substantially equivalent to predicates.

Study Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This submission relies on engineering analysis (FEA) and comparison to predicate devices, not clinical performance data from a test set of patients or cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No ground truth establishment by experts for a test set of clinical images/data is mentioned. The evaluation is based on engineering principles and comparison to existing devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is mentioned.
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:
- Not applicable. This is not an AI/software device, and no MRMC study or assessment of human reader performance with or without AI assistance was conducted.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a spinal implant system, not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of orthopedic implant, "ground truth" would typically relate to mechanical testing standards and successful clinical history of the predicate devices. The submission points to "Verification activities including FEA and engineering analysis" and "Documentation provided demonstrates that the Captiva Spine CapLOX II Conclusion: Spinal System is substantially equivalent to predicate devices." This implies that the 'truth' for evaluation is adherence to engineering principles and established performance characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.
The sample size for the training set:
- Not applicable. No training set is mentioned as this is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Captiva Spine CapLOX II Spinal System meets acceptance criteria is a technical and engineering analysis comparing the subject device to legally marketed predicate devices. This is characteristic of a 510(k) submission for mechanical devices, where the primary goal is not to prove new clinical efficacy or diagnostic accuracy but to demonstrate "substantial equivalence" to a device already on the market.

The "study" involved:

Verification activities: These included Finite Element Analysis (FEA) and general engineering analysis. These analyses would assess the mechanical properties, stress distribution, and overall design integrity of the new components (additional screws) to ensure they perform equivalently to the existing components and predicate devices.
Comparison to predicate devices: The submission explicitly states the subject device is "substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." This comparison forms the core of the "proof" for a 510(k) submission.

In essence, the "acceptance criteria" were met by demonstrating through engineering data and direct comparison that the CapLOX II Spinal System performs as safely and effectively as the predicate devices for its stated indications.

Summary

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510(k) Summary

SEP 1 3 2011

Submitter:	Captiva Spine967 Alt A1A Suite 1Jupiter, FL 33477Phone: 877-772-5571Fax: 866-318-322
Contact Person:	John SandersQualiReg Resources LLC2361 NW 105th LnSunrise, FL 33322Phone: 954-993-5581Fax: 954-944-1910Email: johnsanders@qualireg.com
Date Prepared:	September 8, 2011
Trade Name:	Captiva Spine CapLOX II Spinal System
Classification	Class II
Classification Name	Pedicle Screw Spinal System
Classification Number	21 CFR 888.3070
Product Code:	MNI, MNH
Predicate Device(s):	The subject device is substantially equivalent to the following devices:K100956 Spondy Spinal Fixation SystemK024096 Optima, Spinal SystemK950099 Synergy VLS SystemK100605 Spine Wave MIS System
Device Description:	The Captiva Spine CapLOX II Spinal System is a top-loading spinalfixation system consisting of polyaxial pedicle screws, cannulated polyaxialpedicle screws set screws, rods, and cross connectors assembled to create arigid spinal construct. It is intended to provide stabilization during thedevelopment of fusion utilizing a bone graft as well as aid in the surgicalcorrection of various spinal deformities and pathologies in thethoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of theimplants (screws and rods) are available to accommodate individual patientanatomy. The purpose of this submission is to add additional screws to thepedicle screw system.

Indications for use/Intended Use

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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, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

Statement of Technological Comparison

The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.

Verification activities including FEA and engineering analysis indicates Performance Data: subject device is substantially equivalent to predicates.

Documentation provided demonstrates that the Captiva Spine CapLOX II Conclusion: Spinal System is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned above a wavy line, possibly representing water or a horizon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

Captiva Spine, Inc. % QualiReg Resources, LLC Mr. John Sanders 2361 NW 105" Lane Sunrise, Florida 33322

SEP 13 2011

Re: K111115

Trade/Device Name: Captiva Spine Capl.OX II Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH Dated: August 12, 2011 Received: August 15, 2011

Dear Mr. Sanders:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hiability 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

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Page 2 - Mr. John Sanders

comply with all the Act's requirements, including, but not limited to: registration and lisung (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric Keith

SrMark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Captiva Spine CapLOX II Spinal System

Indications for Use:

The CapLOX II Spinal 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, dislocation, scollosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number	K111115

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.