(87 days)
Not Found
No
The summary describes a physical implant and associated instrumentation for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion system designed to treat degenerative disc disease and is used in conjunction with bone graft and supplemental fixation to promote spinal fusion, which is a therapeutic intervention.
No.
The device is an anterior cervical interbody fusion system used for treatment, not diagnosis. It is intended for surgical implantation and stabilization of the spine, not for identifying or characterizing a medical condition.
No
The device description explicitly states the system consists of implants manufactured from Titanium and instrumentation manufactured from stainless steel, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health. Examples include blood tests, urine tests, and genetic tests.
- This device is an implant. It is a physical device surgically placed into the body to treat a condition (degenerative disc disease).
The description clearly states it's an "Anterior Cervical Interbody Fusion System" and describes its physical components and intended surgical use. It does not involve the analysis of biological samples.
N/A
Intended Use / 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 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.
Product codes
ODP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, bold blue font.
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)
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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17) Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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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™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL
CORRESPONDENT | Jordan Bauman
VP of Regulatory Affairs
MiRus™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | March 13, 2020 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | RIGEL™ 3DR Anterior Cervical Interbody Fusion
System
Intervertebral body fusion device
21 CFR 888.3080
Class II
ODP
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
RIGEL™ PEEK Anterior Cervical Interbody Fusion System
(K190618)
Additional Predicate
EIT Cellular Titanium® Cervical Cage (K170503) |
VI. 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.
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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
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.
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.