The INFINITY™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

· Traumatic spinal fractures and/or traumatic dislocations.
· Instability or deformity.
· Failed previous fusions (e.g. pseudarthrosis).
· Tumors involving the cervical spine.
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON® Spinal System and VERTEX Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Device Description

The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The INFINITY™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

The sole purpose for this traditional 510(k) is to seek clearance for the INFINTIY OCT System.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the INFINITY™ OCT System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical context with performance metrics like accuracy, sensitivity, or specificity.

Therefore, much of the requested information about acceptance criteria for device performance in terms of diagnostic effectiveness or AI model performance, and the details of such a study, cannot be extracted from this document, as it describes a mechanical spinal implant system, not a diagnostic or AI-driven device.

However, I can extract information related to the non-clinical (mechanical) testing performed to demonstrate substantial equivalence.

Here's the information that can be extracted from the provided text, primarily related to the mechanical performance of the INFINITY™ OCT System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Meet requirements of ASTM F1717 for Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending, Static Torsion Testing, Dynamic Compression Bending, Dynamic Torsion Testing)	"The mechanical testing verifies that the subject components are substantially equivalent to the predicate spinal system currently on the market and has met all mechanical testing requirements based on the worst case construct testing."
Meet requirements of ASTM F2706 for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending, Static Torsion Testing, Dynamic Compression Bending, Dynamic Torsion Testing)	"The mechanical testing verifies that the subject components are substantially equivalent to the predicate spinal system currently on the market and has met all mechanical testing requirements based on the worst case construct testing."
Bacterial endotoxin limit of 20 endotoxin units (EU)/device as per ANSI/AAMI ST72 and USP <161>	"Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted."

2. Sample size used for the test set and the data provenance:

Mechanical Testing: Not explicitly stated beyond "worst case construct testing." The number of constructs tested or the specific types of components within those constructs are not detailed.
Non-Pyrogenicity Endotoxin Testing: "utilizing worst case subject implants." The specific number is not provided.
Data Provenance: The tests were conducted internally by Medtronic, likely in a laboratory setting, to evaluate the mechanical properties and biocompatibility of the device components.

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

This is not applicable as the studies described are non-clinical mechanical and biological compatibility tests, not studies requiring expert interpretation of clinical data or imaging.

4. Adjudication method for the test set:

Not applicable for mechanical and biological compatibility tests. Results are quantitative measurements against established standards.

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 document pertains to a mechanical spinal implant system, not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used:

Mechanical Testing: The "ground truth" is defined by the performance requirements and methodologies outlined in accepted ASTM standards (ASTM F1717 and ASTM F2706) for spinal implant constructs. The device's performance is compared against these engineering specifications and the performance of predicate devices.
Non-Pyrogenicity Endotoxin Testing: The "ground truth" is the established limit of 20 EU/device for bacterial endotoxins in medical devices, as specified by ANSI/AAMI ST72 and USP <161>.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary of what the document does provide regarding "proof":

The document, a 510(k) summary, demonstrates substantial equivalence to existing legally marketed spinal systems. The "study" described is a series of non-clinical, laboratory-based mechanical and biocompatibility tests. These tests were conducted to show that the INFINITY™ OCT System performs comparably to its predicate devices and meets established industry standards for safety and mechanical integrity. The "acceptance criteria" here are compliance with these standards (ASTM and ANSI/AAMI/USP for pyrogenicity).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

August 21, 2017

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

Medtronic Sofamor Danek USA, Inc. Mr. Teias Patel Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K163375

Trade/Device Name: INFINITY™ OCT System Regulatory Class: Unclassified Product Code: NKG. KWP Dated: July 21, 2017 Received: July 24, 2017

Dear Mr. Patel:

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 Part 801); medical device reporting (reporting of medical devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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

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, Katherine D. Kavlock -5

for 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) K163375

Device Name INFINITY™ OCT System

Indications for Use (Describe)

· Traumatic spinal fractures and/or traumatic dislocations.
· Instability or deformity.
· Failed previous fusions (e.g. pseudarthrosis).
· Tumors involving the cervical spine.

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

Note: Segmental fixation is recommended for these constructs.

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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510(k) Summary

July 21, 2017

l. Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Tejas Patel Contact: Sr. Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: tejaskumar.r.patel@medtronic.com

Proprietary Trade Name: INFINITY'™ OCT System II.

Classification: Unclassified

Product Code: NKG, KWP

lll. Predicate Device:

K143471 VERTEX® Reconstruction System (S.E.02/06/2015) – Primary Predicate K003780 VERTEX® Reconstruction System (S.E. 09/28/2001)- Additional Predicates: K052734 VERTEX® Reconstruction System (S.E. 10/21/2005) K070742 VERTEX® Reconstruction System (S.E. 09/14/2007) K071942 VERTEX® Reconstruction System (S.E. 12/11/2007) K082728 VERTEX® Reconstruction System (S.E. 01/16/2009) K090714 VERTEX® Reconstruction System (S.E. 04/17/2009) K091365 VERTEX® Reconstruction System (S.E. 08/06/2009) K123656 VERTEX® Reconstruction System (S.E. 02/25/2013) K123906 VERTEX® Reconstruction System (S.E. 04/01/2013) K152338 VERTEX® Reconstruction System (S.E.10/28/2015) K162379 CD Horizon® Spinal System (S.E. 11/16/2016) These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

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IV. Device Description:

The INFINITY™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

The sole purpose for this traditional 510(k) is to seek clearance for the INFINTIY OCT System.

V. Indications for Use:

The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

Traumatic spinal fractures and/or traumatic dislocations.
Instability or deformity. ●
Failed previous fusions (e.g. pseudarthrosis). ●
Tumors involving the cervical spine. .
. Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

In order to achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY" OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

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Note: Segmental fixation is recommended for these constructs.

VI. Comparison of Technological Characteristics with the Predicate devices:

As established in this submission, the subject INFINITY™ OCT System is substantially equivalent to the identified predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have equivalent technological characteristics to their predicate devices through comparison in areas including design, labeling/intended use, material composition, and function.

VII. Discussion of the Non-clinical Testing/Performance Data:

Mechanical Testing:

In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the identified predicate devices. Design verification testing for the subject implants was completed in accordance with

. ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
. ASTM F2706: Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.

The tests completed were:

Static Compression Bending
Static Torsion Testing
Dynamic Compression Bending
Dynamic Torsion Testing

The mechanical testing verifies that the subject components are substantially equivalent to the predicate spinal system currently on the market and has met all mechanical testing requirements based on the worst case construct testing.

Non-Pyrogenicity Endotoxin Testing:

The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI

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ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests.

VIII. Conclusion:

Based on the design features, the use of established well-known materials, feature comparisons, indications for use, and results of the mechanical testing, the subject INFINITY™ OCT System has been shown to be substantially equivalent to the legally marketed predicate devices cited in this summary.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.