(58 days)
No
The summary describes a mechanical implant and its testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for vertebral body replacement due to disease, fracture, or tumor, or for reconstruction after corpectomy to decompress the spinal cord, and is intended to provide structural stability and mechanical support to the cervical spine, which directly impacts the patient's health and bodily functions.
No
The device is a vertebral body replacement system intended for structural stability and mechanical support, not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the system consists of implants manufactured from Titanium and instrumentation manufactured from Stainless Steel, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The RIGEL™ 3DR Anterior Cervical Corpectomy System is a physical implant designed to replace a diseased or damaged vertebral body in the cervical spine. It is a surgical device used within the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the RIGEL™ 3DR Anterior Cervical Corpectomy System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.
The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed 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
cervical spine (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 Corpectomy System was assessed through static and dynamic testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-18)
- Static and dynamic torsion testing (ASTM F2077-18)
- Subsidence testing (ASTM F2267-04)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
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October 13, 2023
Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway Suite 100 Marietta, Georgia 30062
Re: K232481
Trade/Device Name: RIGELTM 3DR Anterior Cervical Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: August 16, 2023 Received: August 16, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232481
Device Name
RIGELTM 3DR Anterior Cervical Corpectomy System
Indications for Use (Describe)
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
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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3
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
Vice President, Regulatory Affairs
MiRus™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | September 28, 2023 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | RIGEL™ 3DR Anterior Cervical Corpectomy System
Spinal Intervertebral Body Fixation Orthosis
21 CFR 882.3060
Class II
PLR
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
NEXXT MATRIXX® System - Nexxt Spine LLC (K193412)
Additional Predicate
C-VBR - Cardinal Spine, LLC (K152568)
Reference Devices
RIGEL™ 3DR Anterior Cervical Interbody Fusion System -
MiRus, LLC (K200685)
NGage Surgical Mesh System - Blackstone Medical
(K030744) |
VI. DEVICE DESCRIPTION
The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.
The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR
4
Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.
VII. INDICATIONS FOR USE
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2- T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
VIII. PREDICATE DEVICE COMPARISON
The RIGEL™ 3DR Anterior Cervical Corpectomy System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, and a similar size range of footprints.
IX. PERFORMANCE DATA
The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Corpectomy System was assessed through static and dynamic testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-18)
- Static and dynamic torsion testing (ASTM F2077-18)
- Subsidence testing (ASTM F2267-04) ●
X. CONCLUSIONS
The RIGEL™ 3DR Anterior Cervical Corpectomy System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, and a similar size range of footprints. Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Corpectomy System is substantially equivalent to legally marketed predicate systems.