(81 days)
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) to provide structural stability following discectomy. This falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device is an integrated anterior cervical interbody fusion system designed to provide structural stability after discectomy. Its purpose is treatment, not diagnosis. It treats degenerative disc disease (DDD) but does not diagnose it.
No
The device description explicitly states it consists of physical implants (cages, screws, locking cams) and instrumentation made from materials like Titanium and Stainless Steel. It also describes mechanical performance testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an implantable device used to provide structural stability in the spine after surgery. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes a surgical procedure and the device's role in that procedure, not a diagnostic test.
Therefore, the RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc 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.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.
Product codes
OVE
Device Description
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an integrated anterior cervical interbody fusion device used to provide structural stability following discectomy.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System consists of cages additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking cams manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System implants are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
The interbodies are provided sterile packed and are intended for single use only. The bone screws must be steam sterilized prior to use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The mechanical performance profile of the RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System was assessed through static and dynamic 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
October 27, 2023
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MiRus, LLC Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta. Georgia 30062
Re: K232348
Trade/Device Name: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 29, 2023 Received: August 29, 2023
Dear Jordan 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 QS 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,
Katherine D. Kavlock -S
for
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
Enclosure
2
Indications for Use
510(k) Number (if known) K232348
Device Name
RIGELTM 3DR Standalone Anterior Cervical Interbody Fusion System
Indications for Use (Describe)
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc 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.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.
X 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 - K232348
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 | August 29, 2023 |
| IV. DEVICE
Name of Device | RIGEL™ 3DR Standalone Anterior Cervical Interbody
Fusion System |
| Common Name | Intervertebral Fusion Device With Integrated Fixation,
Cervical |
| Classification Name
Regulatory Class
Product Codes
Submission Type | 21 CFR 888.3080
Class II
OVE
Traditional 510(k) |
| V. PREDICATE DEVICE | Predicate Device
F3D Cervical Stand-Alone Interbody Fusion System –
CoreLink, LLC (K200087) |
| | Reference Device
ANTARES™ 3DR Standalone Anterior Lumbar Interbody
Fusion System – MiRus, LLC (K220115) |
VI. DEVICE DESCRIPTION
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an integrated anterior cervical interbody fusion device used to provide structural stability following discectomy.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System consists of cages additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking cams manufactured from Titanium-6 Vanadium ELI per
4
ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System implants are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
The interbodies are provided sterile packed and are intended for single use only. The bone screws must be steam sterilized prior to use.
VII. INDICATIONS FOR USE
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with deqenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc 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.
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.
VIII. PREDICATE DEVICE COMPARISON
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System has the same technological characteristics as the predicate device including design, intended use, material composition, function, and range of sizes.
IX. PERFORMANCE DATA
The mechanical performance profile of the RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System was assessed through static and dynamic 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)
X. CONCLUSIONS
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate system, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems.