The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.

Device Description

The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.

AI/ML Overview

This document describes the MONDRIAN™ Lumbar Interbody Fusion Cage System and its substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

However, I can extract information related to the device's performance and the studies conducted to demonstrate its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MONDRIAN™ Lumbar Interbody Fusion Cage System are based on demonstrating equivalent mechanical performance to predicate devices under the same test conditions. The "reported device performance" is that it met these criteria.

Acceptance Criteria (Type of Testing)	Reported Device Performance
Static Axial Compression	Demonstrates equivalent mechanical performance to predicate device
Static Compression Shear	Demonstrates equivalent mechanical performance to predicate device
Dynamic Axial & Compression Shear	Demonstrates equivalent mechanical performance to predicate device
Expulsion	Demonstrates equivalent mechanical performance to predicate device
Subsidence	Demonstrates equivalent mechanical performance to predicate device

Study Details (as applicable to a physical medical device submission):

Sample sized used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of an AI/ML device. The "test set" here refers to the actual physical devices (MONDRIAN™ Lumbar Interbody Fusion Cage System) subjected to mechanical testing. The provenance of these devices would be their manufacturing origin (CTL Medical Corporation). The studies are in vitro mechanical tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurements, not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical testing results are objective measurements against established standards and predicate device performance.
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 a physical interbody fusion cage, not an AI/ML diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering and material standards (e.g., ASTM F2026, ASTM F136, ASTM F560, ASTM F899, ASTM B211, ASTM B221) and the demonstrated performance of the predicate devices.
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary of the Device's Basis for Clearance:

The MONDRIAN™ Lumbar Interbody Fusion Cage System received FDA clearance (K192863) based on substantial equivalence to existing predicate devices (primarily CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems). This means its safety and effectiveness were demonstrated by showing it has:

The same intended uses.
Similar indications, technological characteristics, and principles of operation.
No new issues of safety or effectiveness raised by its technological differences.
Demonstrated equivalent mechanical performance to the cited predicate devices under the same test conditions in the types of tests listed (Static Axial Compression, Static Compression Shear, Dynamic Axial & Compression Shear, Expulsion, Subsidence).

Summary

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August 26, 2020

CTL Medical Corporation % Mr. Barry E. Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K192863

Trade/Device Name: MONDRIAN 114 Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 17, 2020 Received: July 27, 2020

Dear Mr. Sands:

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

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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 (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 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,

Brent L. Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192863

Device Name

MONDRIANTM Lumbar Interbody Fusion Cage System

Indications for Use (Describe)

The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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

CTL Medical Corporation's MONDIRAN™ Lumbar Interbody Fusion Cage System

Submitter:	Sean Suh
	CTL Medical Corporation
	4550 Excel Parkway Suite 300
	Addison, TX 75001
	Phone: 214-545-5820
	Fax: 888-831-4892
Contact Person:	Barry Sands
	RQMIS, Inc.
	110 Haverhill Road, Suite 526
	Amesbury, MA 01913
	Phone: 978-358-7307
Date Prepared:	Thursday, July 16, 2020
Name of Device:	MONDRIAN™ Lumbar Interbody Fusion Cage System
Regulation:	21 CFR 888.3080
Class:	Class II
Name/Address of Sponsor:	Sean Suh
	CTL Medical Corporation
	4550 Excel Parkway Suite 300
	Addison, TX 75001
Common or Usual Name	Intervertebral Body Fusion Device

Intervertebral Body Fusion Device, Lumbar (Product code MAX)

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Predicate Device

Primary Predicate Device
• CEZANNE Lumbar Interbody Fusion Cage System,	K121567
Additional Predicate Devices
• CEZANNE-II Lumbar Interbody Fusion Cage System,	K131981
• PHANTOM PLUS Cage System,	K082801
• VALEO Spacer System	K091278, K142347, K143518
• VALEO-II IBF Device System	K121892, K142347, K143518
• VALEO-II IBF Device System, LL	K161405
• VALEO-II AL System	K143158
• VALEO-II OL/PL System	K143518
• Nuvasive TLX Interbody System	K171633

Intended Use / Indications for Use

Indications for Use:

These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage

Intended Use:

Technological Characteristics

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devices. Material composition profiles are provided below with their associated standards in Table 1.

Material	Standards
Polyetheretherketone (PEEK)	ASTM F2026: Standard Specification for Polyetheretherketone(PEEK) Polymers for Surgical Implant Applications
Titanium alloy (Ti-6Al-4V)	ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)
Tantalum	ASTM F560: Standard Specification for Unalloyed Tantalum forSurgical Implant Applications (UNS R05200, UNS R05400)
Stainless steel(Instrument shafts)	ASTM F899: Standard Specification for Wrought Stainless Steels forSurgical Instruments
Aluminum(Handles)	ASTM B211: Standard Specification for Aluminum and Aluminum-Alloy Rolled or Cold Finished Bar, Rod, and WireASTM B221: Standard Specification for Aluminum and Aluminum-Alloy Extruded Bars, Rods, Wire, Profiles, and Tubes

Table 1 Material Profile with Associated Standard(s)

Performance Data

Table 2 shows the mechanical testing performed on the MONDRIAN™ Lumbar Interbody Fusion Cage System to establish substantial equivalence with predicate devices and demonstrate structural and functional efficacy.

Testing Performed
Static AxialCompression	X
StaticCompression Shear	X
Dynamic Axial &Compression Shear	X
Expulsion	X
Subsidence	X

Table 2 Performance Testing

The subject lumbar devices demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.

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Substantial Equivalence

The MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the predicate CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). The MONDRIAN™ Lumbar Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The technological differences between the MONDRIAN™ Lumbar Interbody Fusion Cage System and its predicate devices raise no new issues of safety or effectiveness. Thus, MONDRIAN™ Lumbar Interbody Fusion Cage System is substantially equivalent.

The MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). The MONDRIAN™ Lumbar Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MONDRIAN™ Lumbar Interbody Fusion Cage System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). Thus, the MONDRIAN™ Lumbar Interbody Fusion Cage System is substantially equivalent.

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.