The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

Device Description

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.

The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.

AI/ML Overview

The provided text describes a 510(k) submission for the Elevation Spine Saber-C System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Static Axial Compression	Device performance should be comparable or superior to predicate devices, demonstrating structural integrity under static axial loading.	Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
	Dynamic Axial Compression	Device performance should be comparable or superior to predicate devices, demonstrating structural integrity and fatigue resistance under dynamic axial loading.	Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
	Compression-Shear	Device performance should be comparable or superior to predicate devices, demonstrating stability under combined compression and shear forces.	Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
	Torsion	Device performance should be comparable or superior to predicate devices, demonstrating resistance to torsional forces.	Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
	Subsidence	Device resistance to subsidence into vertebral bodies should be comparable or superior to predicate devices.	Tested per ASTM F2267-11. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
	Expulsion	Device resistance to expulsion from the intervertebral space should be comparable or superior to predicate devices.	Tested for expulsion (standard not explicitly cited, but likely related to F2077 or F2267). "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
Implantation Compatibility	Cadaver Implantation Study	Successful implantation and stability of the plate and spacer assembly with spiked fixation in cadaveric models.	"Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation." This indicates successful demonstration of implantation.
Material Compliance	Material Standards (PEEK, Titanium, Coating)	Materials used must conform to specified ASTM standards for surgical implant applications.	All listed materials (Implant Grade PEEK, Titanium, Titanium alloy coating) are explicitly stated to conform to their respective ASTM standards (F2026-17, F136-13, F1472-14, F1580-18).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact numerical sample size for individual mechanical tests (e.g., number of devices tested for axial compression). It only states that "Three configurations of the Elevation Spine Saber-C System were tested". For the cadaver implantation study, the sample size is also not specified, only that "a cadaver implantation study was performed".
Data Provenance: The data provenance is not explicitly mentioned (e.g., country of origin, specific testing facility). However, given that it's an FDA submission, the testing would typically be performed in a controlled laboratory setting, likely in the US or a country with comparable regulatory standards. The studies appear to be prospective in nature, as they involve testing the actual device configurations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This type of information is not applicable to the mechanical and cadaveric testing described. These tests rely on objective physical measurements and adherence to engineering standards (ASTM), not on expert human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set:

This is not applicable as the tests performed are objective mechanical and implantation studies, not studies involving human interpretation or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted. The provided text describes mechanical performance testing and a cadaver implantation study, not studies involving human readers and interpretation of medical images.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study of an algorithm was not conducted. This device is a physical intervertebral fusion system, not an AI/algorithm-based diagnostic or therapeutic tool. The testing focuses on its mechanical and physical performance.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing is based on objective engineering standards and physical measurements. For mechanical tests, this means adherence to the specifications and performance envelopes outlined in ASTM F2077-14 and F2267-11, and comparison to predicate device performance. For the cadaver study, successful implantation and observation of stability would serve as the "ground truth" for that aspect.

8. Sample Size for the Training Set:

This information is not applicable. This submission details a physical medical device. There is no AI model or algorithm that requires a "training set" in the context described.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an algorithm.

Summary

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August 7, 2019

Image /page/0/Picture/1 description: The image contains 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.

Elevation Spine % Mr. Steve Brown QA/RA Manager CoorsTek Medical 560 West Golf Course Road Providence. Utah 84332

Re: K190885

Trade/Device Name: Elevation Spine Saber-C System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP, KWO Dated: July 12, 2019 Received: July 15, 2019

Dear Mr. Brown:

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 (QS) 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 mediation-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 Melissa Hall 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

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Indications for Use

510(k) Number (if known) K190885

Device Name Elevation Spine Saber-C System

Indications for Use (Describe)

Indications for Use:

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

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

Device Trade Name:	Elevation Spine Saber-C System
Date:	July 12, 2019
Sponsor:	Elevation Spine2511 Garden Rd. Suite B260Monterey, CA 93940(650) 302-7504
Contact Person:	Steve Brown
Manufacturer:	Elevation Spine
Common Name:	Anterior Cervical Integrated Fixation Spacer System
Device Classification:	Class II
Classification Name:	Intervertebral body fusion device, Spinal intervertebral body fixation orthosis
Regulation:	888.3080888.3060
Device Regulation Panel:	Orthopedic
Device Product Code:	OVE, ODP, KWQ

Purpose:

The purpose of this Traditional 510(k) submission is to gain clearance for the Elevation Spine Saber-C System.

Indications for Use:

The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

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spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

Device Description:

Implant Materials
Material:	Standard:
Implant Grade PEEK	ASTM F2026-17 Standard Specification for Polyetheretherketone(PEEK) Polymers for Surgical Implant Applications.
Titanium	ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4 ELI (Extra Low Interstitial) Alloy for SurgicalImplant Application (UNS R56401)
	ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium Alloy for Surgical Implant Application(UNS R56400)
Titanium alloy coating	ASTM F1580-18 Standard Specification for Titanium andTitanium-6 Aluminum-4 Alloy Powders for Coating of SurgicalImplants

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Legally Marketed Predicate Devices:

Globus Coalition AGX (Primary Predicate) K142218 K173115

Technological Characteristics:

There are no technological characteristics that raise new issues of safety or effectiveness. The Elevation Spine SABER-C is substantially equivalent with respect to its intended use, geometry, materials, and the method of fixation.

Performance Testing:

The SABER-C System Anterior Cervical Integrated Fixation Spacer System was designed and tested as an interbody fusion device for the cervical spine. The objective of this testing was to demonstrate that the subject device is equivalent to predicate devices with respect to testing recommended in ASTM F2077-14 and F2267-11.

Three configurations of the Elevation Spine Saber-C System were tested in static and dynamic axial compression, compression-shear, and torsion per ASTM F2077-14, subsidence per ASTM 2267-11, and expulsion. Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation.

Conclusion

In summary, the results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent with respect to its intended use, geometry, materials, and the method of fixation.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.