The NorthStar™ 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, cervical spine (C1-C7) and upper thoracic spine (T1-T3):

· Traumatic spinal fractures and/or traumatic dislocations;
Instability or deformity;
· Failed previous fusion (e.g. pseudoarthrosis);
· Tumors involving the cervical/thoracic 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 NorthStar OCT System is 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.

The NorthStar OCT System can also be linked to other SeaSpine Screw Systems including Mariner, NewPort, Sierra, Atoll, Daytona, Malibu, Mariner Outrigger, and Mariner Midline Systems with the use of transitional rods and/or transitional rod connectors.

Device Description

The NorthStar™ OCT System is a spinal fixation system intended to improve the stability of the occipital, cervical, and thoracolumbar areas of the spine. The NorthStar™ OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, transition implants, occipital plates and associated instruments. Implant components are available in a variety of sizes and can be constructed into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indication for the use of bone screws in the occipital, cervical spine (C1-C7), and upper thoracic spine (T1-T3). The implants are manufactured from medical grade titanium alloy and cobalt chrome.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the NorthStar™ OCT Spinal System. It details the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.

However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a spinal implant system with mechanical components (screws, rods, etc.). The non-clinical testing mentioned refers to mechanical performance tests against ASTM standards (e.g., static and dynamic axial compression, torsion testing), not the performance of an AI algorithm on a test set.

Therefore, I cannot provide the requested information from the given text because it is a submission for a hardware medical device, not a software/AI medical device. The concepts of "test set," "ground truth," "expert consensus," "MRMC study," and "standalone algorithm performance" are specific to the evaluation of AI/ML-based medical devices, which are not relevant to this 510(k) submission for a spinal implant.

Summary

{0}------------------------------------------------

March 25, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SeaSpine Orthopedics Corporation Alicia McArthur Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K193615

Trade/Device Name: NorthStar™ OCT Spinal System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: December 23, 2019 Received: December 26, 2019

Dear Alicia McArthur:

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

{1}------------------------------------------------

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.

Colin O'Neill, M.B.E. Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K193615

Device Name NorthStar™ OCT Spinal System

Indications for Use (Describe)

The NorthStar 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, cervical spine (C1-C7) and upper thoracic spine (T1-T3):

· Traumatic spinal fractures and/or traumatic dislocations;
Instability or deformity;
· Failed previous fusion (e.g. pseudoarthrosis);
· Tumors involving the cervical/thoracic 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.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Contact Details

Applicant Name:	SeaSpine® Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 216-5117(760) 683-6874
Contact person:	Alicia McArthur, Regulatory Affairs Specialist
Date Prepared:	December 23, 2019
Device Name
Trade Name:	NorthStar™ OCT Spinal System
Common Name:	Posterior Occipital-Cervical-Thoracic System
Classification Name:	Posterior Cervical Screw System (21 CFR 888.3075)
Class:	II
Product Code:	NKG, KWP

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K090565	KWP	ELLIPSE™ Occipito-Cervico-ThoracicSpinal System	Globus Medical Inc.
Additional Predicate Devices
K083863	KWP, MNI,MNH	Atoll™ OCT SpinalSystem	SeaSpine OrthopedicsCorporation (formerlyTheken Spine, LLC)
K080526	KWP	Sierra™ Spinal System	SeaSpine OrthopedicsCorporation

Device Description

The NorthStar™ OCT System is a spinal fixation system intended to improve the stability of the occipital, cervical, and thoracolumbar areas of the spine.

{4}------------------------------------------------

The NorthStar™ OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, transition implants, occipital plates and associated instruments. Implant components are available in a variety of sizes and can be constructed into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indication for the use of bone screws in the occipital, cervical spine (C1-C7), and upper thoracic spine (T1-T3).

The implants are manufactured from medical grade titanium alloy and cobalt chrome.

Indications for Use

The NorthStar™ 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, cervical spine (C1-C7) and upper thoracic spine (T1-T3):

Traumatic spinal fractures and/or traumatic dislocations; ●
Instability or deformity; ●
Failed previous fusion (e.g. pseudoarthrosis); ●
Tumors involving the cervical/thoracic 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.

The NorthStar™ OCT System is 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.

The NorthStar" OCT System can also be linked to other SeaSpine® Screw Systems including Mariner", NewPort™, Sierra", Atoll™, Daytona™, Malibu™, Mariner™ MIS, Mariner Outrigger™, and Mariner Midline™ Systems with the use of transitional rods and/or transitional rod connectors.

Summary of Technological Characteristics

The NorthStar" OCT System was shown to be substantially equivalent and have equivalent technological characteristics to the cited predicate and reference devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).

Non-Clinical Testing

The NorthStar" OCT System demonstrated similar performance to the predicate systems through static and dynamic axial compression, and static and dynamic torsion testing with reference to ASTM F2706.

Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

{5}------------------------------------------------

Conclusions

The submitted data demonstrates that the NorthStar™ OCT System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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.