The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Device Description

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purpose of this Special 510(k) is to obtain clearance for the minor print changes to the dimensioning scheme for Percutaneous Rod Inserter, which was originally cleared in CD HORIZON® Spinal System K132639 (S.E. 11/25/2013). The minor print changes include modifications to hard dimensions/tolerances and Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, as well as the addition of a laser mark for visual purposes to the end user.

AI/ML Overview

This document is a 510(k) premarket notification for a modification to an existing medical device, the CD HORIZON® Spinal System, specifically for a Percutaneous Rod Inserter. It's a submission to the FDA, arguing for substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed acceptance criteria and study data typically found in an original device approval or a clinical trial report for AI/software devices.

Here's an analysis based on the provided text, highlighting why most of your requested information is not present:

Key Takeaway: This submission is for minor print changes to an existing Percutaneous Rod Inserter (a physical surgical tool), not for an AI/software device or a new medical device requiring extensive performance studies. The "performance data" section focuses on demonstrating that these minor changes do not negatively impact the device's safety or effectiveness compared to the predicate, rather than establishing new performance metrics.

1. A table of acceptance criteria and the reported device performance:

Not Applicable in the traditional sense for this document. This document is for a mechanical device modification, not a software or AI device with performance metrics like sensitivity, specificity, accuracy, etc.
The "acceptance criteria" here implicitly revolve around ensuring the modified design of the Percutaneous Rod Inserter (minor print changes, hard dimensions/tolerances, GD&T, laser mark) does not compromise the device's safety and effectiveness compared to the predicate device.
Reported device performance: The document states that a "risk analysis," "print review," "mechanical strength rationale," and "tolerance stack analysis" were completed. These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness." This is the reported performance in the context of this submission – that the changes are benign.

2. 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 is a design/engineering assessment of manufacturing changes, not a clinical study on a test set of data. There isn't a "test set" in the sense of patient data or clinical images. The "sample" implicitly refers to the device design itself and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. There is no "ground truth" establishment in this document as it's not a diagnostic or AI device being evaluated against a clinical gold standard. The "experts" would likely be Medtronic's internal engineers and quality assurance personnel conducting the risk analysis and design reviews, but their number and specific qualifications are not detailed here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No test set or clinical judgment/adjudication involved in this type of submission.

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:

Not Applicable. This is explicitly not an AI device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. Not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable. No clinical ground truth is established or used for this submission. The "ground truth" for the assessment is the predicate device's established safety and effectiveness, and the current submission aims to show the modified device is equally safe and effective through engineering analysis.

8. The sample size for the training set:

Not Applicable. No training set, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not Applicable. No training set or ground truth in this context.

Summary of Relevant Information from the Document:

Device: CD HORIZON® Spinal System (specifically, modifications to a Percutaneous Rod Inserter component).
Purpose of Submission: Obtain clearance for minor print changes a mechanical component (Percutaneous Rod Inserter), including modifications to hard dimensions/tolerances, Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, and the addition of a laser mark for visual purposes.
Predicate Device: CD HORIZON® Spinal System (K132639, S.E. 11/25/2013).
Basis for Substantial Equivalence:
- Technological Characteristics: The modified Percutaneous Rod Inserter has the "same fundamental scientific technology and material" as the predicate. It retains the same locking mechanism, arc orientation, rod orientation, and clamping mechanism.
- Materials: Manufactured from the same Medical Grade Stainless Steel (MGSS) and silicone as the predicate device, which have "a long history of safe and effective use; therefore, biocompatibility testing is not required."
- Performance Data (for the modification): A "risk analysis of the print changes was completed in accordance with Medtronic design control procedures." This included a "print review, mechanical strength rationale, and tolerance stack analysis." These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness; therefore, no additional testing is required."
Conclusion: The subject Percutaneous Rod Inserter is considered "as safe and effective as the following predicate" based on the risk analysis and supporting documentation.

Summary

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

October 4, 2016

Medtronic Sofamor Danek USA, Inc. Mr. Justin E. O'Connor Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K162494

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI, OSH Dated: September 6, 2016 Received: September 7, 2016

Dear Mr. O'Connor:

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, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a bold, sans-serif font. The text is black and appears to be centered on a white background. The name is written in a clear and legible manner.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162494

Device Name CD HORIZON® Spinal System

Indications for Use (Describe)

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) SUMMARY

MEDTRONIC Sofamor Danek CD HORIZON® Spinal System September 06, 2016

I.	Submitter	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
	Contact:	Justin O'ConnorRegulatory Affairs SpecialistDirect Telephone: (901)399-2480
	Date Prepared:	September 06, 2016
II.	Subject Device
	Name of Device:	CD HORIZON® Spinal System(Percutaneous Rod Inserter)
	Common Name:	Pedicle Screw Spinal System
	Classification Names:	21 CFR 888.3070 - Pedicle Screw Spinal System,888.3050 - Spinal Interlaminal Fixation Orthosis, and888.3060 - Intervertebral Body Fixation Orthosis
	Class:	Class III (Pre-Amendment)
	Product Code:	NKB, OSH, MNH, MNI, KWP, KWQ
III.	Predicate Device:	CD HORIZON® Spinal System (Primary Predicate)K132639 (S.E. 11/25/2013)

The predicate has not been subject to a design related recall.

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IV. Description:

V. Indications for Use:

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

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Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

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VI. Comparison of Technological Characteristics with the Predicate Devices:

The subject Percutaneous Rod Inserter has the same fundamental scientific technology and material as the predicate device, which was originally cleared in CD HORIZON® Spinal System K132639 (S.E. 11/25/2013). Like the predicate device. the subject device has the same locking mechanism, arc orientation, rod orientation, and clamping mechanism. The subject device is also manufactured from Medical Grade Stainless Steel (MGSS) and silicone as the predicate device.

VII. Performance Data:

The following information is provided in support of substantial equivalence.

Biocompatibility

The subject Percutaneous Rod Inserter is manufactured from the same MGSS and silicone as the predicate device. The materials identified have a long history of safe and effective use; therefore, biocompatibility testing is not required.

Mechanical Testing

A risk analysis of the print changes was completed in accordance with Medtronic design control procedures. The risk analysis, which includes a print review, mechanical strength rationale, and tolerance stack analysis, demonstrated that the minor print changes to the dimensioning scheme and laser marking for the subject Percutaneous Rod Inserter do not introduce new issues of safety or effectiveness; therefore, no additional testing is required.

VIII. Conclusion:

Based on the risk analysis and other supporting documentation provided in this premarket notification, the subject Percutaneous Rod Inserter is considered to be as safe and effective as the following predicate:

o CD HORIZON® Spinal System
- K132639 (S.E. 11/25/2013)

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.