The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Device Description

The RIGEL™ 3DR (3D-printed Randomized-lattice) Anterior Cervical Interbody Fusion System consist of implants manufactured from Titanium 6AL-4V ELI per ASTM F3001-14 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Device is offered in various footprints, heights, and lordosis to accommodate different patient anatomy and the Anterior Cervical Surgical Approach. The implants will be provided sterile and are intended for single use only.

AI/ML Overview

This document describes the RIGEL™ 3DR Anterior Cervical Interbody Fusion System, which is a medical device. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of its clinical performance with acceptance criteria in the typical sense of algorithm evaluation.

Therefore, many of the requested elements for an AI/algorithm-based device study (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable to this submission as it is for a physical medical implant.

However, I can extract information related to the device's mechanical performance data which serves as the "study" for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical interbody fusion system, the "acceptance criteria" are implied by the standards chosen for mechanical testing, and the "reported device performance" is that it successfully met these standards. The specific numerical acceptance criteria (e.g., minimum load before failure) are not explicitly stated in this summary, but the conclusion of the submitted study is that the device meets the relevant performance requirements for substantial equivalence.

Acceptance Criterion (Implied by Standard)	Reported Device Performance (as stated in document)
Compliance with ASTM F2077-18 (Static and dynamic compression)	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems based on mechanical testing (successful testing against ASTM F2077-18).
Compliance with ASTM F2077-18 (Static and dynamic compression shear)	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems based on mechanical testing (successful testing against ASTM F2077-18).
Compliance with ASTM F2077-18 (Static and dynamic torsion)	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems based on mechanical testing (successful testing against ASTM F2077-18).
Compliance with ASTM F2267-04 (Subsidence testing)	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems based on mechanical testing (successful testing against ASTM F2267-04).
Expulsion testing	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems based on mechanical testing (successful expulsion testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size used for the test set: Not explicitly stated in this summary (e.g., number of devices tested). For mechanical testing, this would typically involve a specific number of samples for each test type, determined by statistical considerations for materials testing.
Data provenance: Not applicable in the context of clinical data. This is mechanical engineering test data, likely performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for mechanical testing is established by the physical testing itself and adherence to engineering standards. There are no "experts" in the human diagnostic sense establishing ground truth here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for mechanical testing, not a clinical trial requiring adjudication of patient outcomes or diagnoses.

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 is a physical medical implant, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is its ability to withstand specified mechanical forces and conditions as defined by universally accepted ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. This is a form of engineering standard compliance and physical performance measurement.

8. The sample size for the training set

Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

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

Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

Summary of Conclusions from the Document regarding Performance:

The document states under "IX. PERFORMANCE DATA":
"The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:

Static and dynamic compression testing (ASTM F2077-18)
Static and dynamic compression shear testing (ASTM F2077-18)
Static and dynamic torsion testing (ASTM F2077-18)
Subsidence testing (ASTM F2267-04)
Expulsion testing"

And under "X. CONCLUSIONS":
"Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems."

This indicates that all required mechanical tests were performed and the device successfully met the performance characteristics expected for substantial equivalence, as defined by the referenced ASTM standards and comparison to predicate devices.

Summary

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June 11, 2020

MiRus, LLC Mr. Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta, Georgia 30062

Re: K200685

Trade/Device Name: RIGEL™ 3DR Anterior Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 13, 2020 Received: March 16, 2020

Dear Mr. Bauman:

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.

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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 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 Showalter, Ph.D. 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known) Not Known K200685

Device Name

RIGEL™ 3DR Anterior Cervical Interbody Fusion System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17) Page 1 of 1

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K200685 - 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607
II. OFFICIALCORRESPONDENT	Jordan BaumanVP of Regulatory AffairsMiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607
III. DATE PREPARED	March 13, 2020
IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	RIGEL™ 3DR Anterior Cervical Interbody FusionSystemIntervertebral body fusion device21 CFR 888.3080Class IIODPTraditional 510(k)
V. PREDICATE DEVICE	Primary PredicateRIGEL™ PEEK Anterior Cervical Interbody Fusion System(K190618)Additional PredicateEIT Cellular Titanium® Cervical Cage (K170503)

VI. DEVICE DESCRIPTION

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VII. INDICATIONS FOR USE

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

VIII. PREDICATE DEVICE COMPARISON

IX. PERFORMANCE DATA

The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:

Static and dynamic compression testing (ASTM F2077-18) ●
Static and dynamic compression shear testing (ASTM F2077-18) ●
Static and dynamic torsion testing (ASTM F2077-18) .
. Subsidence testing (ASTM F2267-04)
. Expulsion testing

X. CONCLUSONS

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems.

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.