(87 days)
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No
The summary describes a passive implant (interbody fusion device) made of PEEK with tantalum markers. There is no mention of software, image processing, AI, ML, or any computational capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an "anterior cervical interbody" for spinal fusion, indicated for treating degenerative disc disease with pain, which is inherently therapeutic.
No
The device is an interbody fusion system used for spinal surgery, not for diagnosing medical conditions. It is used to treat degenerative disc disease, not diagnose it.
No
The device description explicitly states the device is an implant manufactured from PEEK and tantalum, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate bone fusion in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant made of PEEK and tantalum, designed to be placed within the body. IVDs are typically reagents, kits, or instruments used to test samples taken from the body (like blood, urine, or tissue).
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose a condition or analyze a sample. Its purpose is to provide structural support and promote fusion.
The information provided describes a medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RIGEL™ PEEK 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™ Interbody Fusion System consist of implants manufactured from medical implant grade VESTAKEEP®i4R PEEK per ASTM F2026-17 with tantalum markers fabricated from medical implant grade ASTM F560-17. The Interbody Fusion Devices are offered in three footprints, various heights, and lordosis to accommodate different patient anatomy and an anterior surgical approach. The implants will be provided non-sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
C2-T1 (cervical spine)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Static and dynamic compression and static and dynamic shear were performed adhering to ASTM F2077-17. Subsidence testing was performed adhering to ASTM F2267-04. The preclinical testing listed above that was performed on the RIGEL™ PEEK Anterior Cervical Interbody Fusion System indicate that it is substantially equivalent to the predicate devices in mechanical performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue box, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.
June 6, 2019
MiRus™, LLC Mr. Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway Marietta, Georgia 30067
Re: K190618
Trade/Device Name: RIGEL™ PEEK 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: May 31, 2019 Received: June 3, 2019
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.
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
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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 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.
for CAPT Raquel Peat, PhD, MPH, USPHS Director 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
Device Name
RIGEL™ PEEK Anterior Cervical Interbody Fusion System
Indications for Use (Describe)
The RIGEL™ PEEK 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)
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FORM FDA 3881 (7/17)
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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
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL CORRESPONDENT | Jordan Bauman
Director of Regulatory Affairs and Quality
MiRus™, LLC
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | March 8, 2019 |
| IV. DEVICE | |
| Name of Device | RIGEL™ PEEK Anterior Cervical Interbody
Fusion System |
| Common Name | Intervertebral body fusion device |
| Classification Name | 21 CFR 888.3080 |
| Regulatory Class | Class II |
| Product Codes | ODP |
| Submission Type | Traditional 510(k) |
| V. PREDICATE DEVICE | Cervical Interbody Fusion System - Evolution
Spine, LLC - K160324 (primary predicate)
MiRus™ Lumbar Interbody Fusion System -
MiRus, LLC - K182920 (additional predicate) |
VI. DEVICE DESCRIPTION
The RIGEL™ Interbody Fusion System consist of implants manufactured from medical implant grade VESTAKEEP®i4R PEEK per ASTM F2026-17 with tantalum markers fabricated from medical implant grade ASTM F560-17. The Interbody Fusion Devices are offered in three footprints, various heights, and lordosis to accommodate different patient anatomy and an anterior surgical approach. The implants will be provided non-sterile and are intended for single use only.
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VII. INDICATIONS FOR USE
The RIGEL™ PEEK 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 documentation provided shows that the RIGEL™ PEEK Anterior Cervical Interbody Fusion System is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics and labeling.
IX. PERFORMANCE DATA
Static and dynamic compression and static and dynamic shear were performed adhering to ASTM F2077-17. Subsidence testing was performed adhering to ASTM F2267-04. The preclinical testing listed above that was performed on the RIGEL™ PEEK Anterior Cervical Interbody Fusion System indicate that it is substantially equivalent to the predicate devices in mechanical performance.
X. CONCLUSONS
The RIGEL™ PEEK Anterior Cervical Interbody Fusion System does not raise any new questions of safety or efficacy when compared to the predicate device(s). The RIGEL ™ PEEK Anterior Cervical Interbody Fusion System has demonstrated that it is substantially equivalent in mechanically performance, indications for used, intended use, technological characteristics, materials and labeling to legally marketed predicate devices.