The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-TI) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone.

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

Device Description

The icotec Cervical Cage is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a Ti-iT® rough CP-titanium coating. The devices are intended to be used with supplemental spinal fixation. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

AI/ML Overview

This document is a 510(k) summary for the icotec Cervical Cage, which is a medical device. The document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format typical of an AI algorithm's performance. Instead, it focuses on demonstrating that the icotec Cervical Cage (subject device) is substantially equivalent to predicate devices. The performance criteria for "substantial equivalence" are based on a comparison of indications for use, design, materials, function, and manufacturing.

The performance testing summarized relates to mechanical properties, not clinical outcomes directly measured against specific numeric criteria for the device itself.

Acceptance Criteria Category (Implied by Substantial Equivalence and Testing)	Reported Device Performance Summary
Mechanical Performance	Demonstrated equivalence and performance through benchtop mechanical testing.
- Static axial compression	Testing performed per ASTM F2077 and ASTM F2267.
- Dynamic axial compression	Testing performed per ASTM F2077 and ASTM F2267.
- Static compression-shear	Testing performed per ASTM F2077 and ASTM F2267.
- Dynamic compression-shear	Testing performed per ASTM F2077 and ASTM F2267.
- Static torsion	Testing performed per ASTM F2077 and ASTM F2267.
- Dynamic torsion	Testing performed per ASTM F2077 and ASTM F2267.
- Expulsion	Testing performed per ASTM F2077 and ASTM F2267 (for the original cage) and additional expulsion testing for the lordotic version.
- Subsidence	Testing performed per ASTM F2077 and ASTM F2267.
Wear Particle Analysis	Testing performed as per ASTM F1877.
Coating Characterization & Performance	Testing performed as per ISO 13179, ASTM F1160, ASTM F1044, ASTM F1147, and ASTM F1978.
Risk Analysis (for new features)	Performed for the inclusion of the lordotic version.
Clinical Performance (for expanded indications)	Comprehensive clinical literature review performed to show clinical performance and success of representative cervical cages in 2 or more levels of the cervical spine. (This refers to prior studies on similar devices, not a new study on the icotec Cervical Cage specifically for multi-level use).
Overall Substantial Equivalence	The subject device was demonstrated to be substantially equivalent to predicates cited with respect to indications, design, materials, function, manufacturing, and performance. This is the primary "acceptance criterion" for 510(k) clearance, and it was met.

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

Mechanical Testing: Not specified in terms of "sample size" for a test set in the way one would for a clinical study. These are benchtop tests. The standards (ASTM, ISO) typically define the number of samples required for each test. The document does not provide the specific number of units tested.
Clinical Literature Review: No specific "test set" was used for the subject device. Instead, a "comprehensive clinical literature review" was conducted on representative cervical cages. The data provenance would be from the published literature, which could include retrospective and prospective studies from various countries. The document does not specify the origin or type of studies included in this review.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this document. The FDA 510(k) clearance process for this medical device (intervertebral body fusion device) relies primarily on demonstrating substantial equivalence through mechanical testing and a review of existing clinical literature for similar devices. There is no mention of human experts establishing a "ground truth" for a test set in the context of an AI device or diagnostic tool.

4. Adjudication Method for the Test Set:

This information is not applicable. Since there is no human-interpreted "test set" in the context of an AI algorithm or diagnostic tool described here, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (an implantable cage), not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of human readers improving with AI assistance.

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

No, a standalone performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used:

For Mechanical Testing: The "ground truth" is established by the specifications and tolerances defined by the relevant ASTM and ISO standards for properties like compression, shear, torsion, expulsion, wear, and coating characteristics.
For Expanded Clinical Indications (multi-level use): The "ground truth" (or supporting evidence) for the clinical performance aspect was based on a "comprehensive clinical literature review" of existing data from representative cervical cages. This relies on published outcomes data from those prior studies.

8. The Sample Size for the Training Set:

This information is not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

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

This information is not applicable. As there is no training set mentioned.

Summary

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March 20, 2020

icotec ag % Mr. Justin Eggleton Vice President, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K192897

Trade/Device Name: icotec Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 13, 2020 Received: February 13, 2020

Dear Mr. Eggleton:

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

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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 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 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,

Brent L. Showalter, Ph.D. Assistant Director (Acting) 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) K192897

Device Name icotec Cervical Cage

Indications for Use (Describe)

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:	icotec Cervical Cage
Manufacturer:	icotec agIndustriestrasse 129450 AltstättenSwitzerland
Contact:	Ms. Marina HessCQO/Management Representativeicotec agIndustriestrasse 129450 Altstaetten, SwitzerlandPhone: +41 71 757.0024Fax: +41 71 757.0001marina.hess@icotec.ch
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com
Date Prepared:	February 4, 2020
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	ODP

Indications for Use:

The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone.

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Device Description:

The purpose of this Traditional 510(k) is to seek marketing clearance for an expansion of the indications for use of the previously cleared icotec Cervical Cage to be used in multiple levels. The subject 510(k) also proposes to add a lordotic version of the previously cleared icotec Cervical Cage.

Primary Predicate Device:

The icotec Cervical Cage is substantially equivalent to the icotec Interbody Cage System in intended use, design, and performance.

Table 1. Primary Predicate Device
Manufacturer	Device Name	K-Number
icotec	icotec Interbody Cage System	K172480

Table 1 Primary Predicate Device

Additional Predicate Device:

The Tyber Medical PT Interbody Spacer System (K182284) is substantially equivalent to the subject device with respect to indications and design.

Performance Testing Summary:

Benchtop mechanical testing of the icotec Cervical Cage was performed in K172480 and applies to the subject device. The benchtop mechanical testing includes the following:

Mechanical testing per ASTM F2077 and ASTM F2267: Static axial compression, dynamic axial compression, static compression-shear, dynamic compression-shear, static torsion, dynamic torsion, expulsion, subsidence.
Wear particle analysis as per ASTM F1877
Coating characterization and performance testing as per ISO 13179, ASTM F1160, ASTM F1044, ASTM F1147, and ASTM F1978

Additionally, to support the inclusion of the lordotic version of the cervical cages, a risk analysis and expulsion testing was performed. To support the expansion of indications for use in multiple levels of the cervical spine, a comprehensive clinical literature review was performed to show the clinical performance and success of representative cervical cages in 2 or more levels of the cervical spine.

Substantial Equivalence:

The subiect device was demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance.

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Conclusion:

The icotec Cervical Cage is substantially equivalent to the cited predicate devices with respect to its indications for use, design, function, materials, and performance.

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.