(53 days)
No
The summary describes a physical implant and associated hardware for spinal fusion, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an "intervertebral body fusion device" used to "provide structural stability" and "indicated for intervertebral body fusion procedures," which are therapeutic interventions.
No
Explanation: The device is an intervertebral body fusion system, which is an implant used for structural stability, not for diagnosing medical conditions. The "Indications for Use" section mentions "degenerative disc disease (DDD) ... confirmed by history and radiographic studies," but this refers to the patient's existing diagnosis, not a function of the device itself.
No
The device description explicitly states it is an additively manufactured spinal intervertebral body fusion device made from Titanium and Molybdenum-Rhenium alloys, along with associated hardware like plates, screws, and instrumentation. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, addressing degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a spinal intervertebral body fusion device made of materials like Titanium and Molybdenum. This is a physical implant designed to provide structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The device is implanted directly into the patient.
In summary, the MiRus™ 3DR Lumbar Interbody Fusion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.
Product codes
OVD, MAX
Device Description
The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a spinal intervertebral body fusion device used to provide structural stability following lateral lumbar interbody fusion for lumbar degenerative disorders.
The MiRus 3DR LLIF is additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001.
The MiRus MoRe Lateral Lumbar Plating System consists of a lateral plate manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, bone screws, locking cam mechanism, and a connecting screw manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136.
Instrumentation is manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L1-L2 to L5-S1.
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 MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation was assessed through dynamic construct testing and screw dissociation testing in accordance with the following test methods:
- . Dynamic Compression (ASTM F2077-18)
- . Plate/Cage Dissociation Testing
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
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September 11, 2023
MiRus, LLC Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta. Georgia 30062
Re: K232154
Trade/Device Name: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: July 19, 2023 Received: July 20, 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 (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.
1
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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K232154
Device Name
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
Indications for Use (Describe)
The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
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 7, 2023 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | MiRus 3DR Lateral Lumbar Interbody Fusion System
with Integrated Plate Fixation
Intervertebral Body Fusion Device
21 CFR 888.3080
Class II
OVD, MAX
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
CASCADIA Interbody System – K2M (K172941)
Additional Predicate
MiRus 3D Printed Lumbar Interbody Fusion Systems –
MiRus, LLC (K191906)
Reference Device
CYGNUS ™ MoRe Anterior Cervical Plate System – MiRus,
LLC (K220441) |
VI. DEVICE DESCRIPTION
The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a spinal intervertebral body fusion device used to provide structural stability following lateral lumbar interbody fusion for lumbar degenerative disorders.
The MiRus 3DR LLIF is additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001.
4
The MiRus MoRe Lateral Lumbar Plating System consists of a lateral plate manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, bone screws, locking cam mechanism, and a connecting screw manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136.
Instrumentation is manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
VII. INDICATIONS FOR USE
The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.
VIII. PREDICATE DEVICE COMPARISON
The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation 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.
The MiRus™ 3DR LLIF device has been previously cleared (additional predicate - K191906). The MiRus MoRe Lateral Lumbar Plating System device configuration consisting of MoRe alloy plates and titanium alloy locking cams and bone screws is similar to the CYGNUS™ MoRe Anterior Cervical Plate System (reference device - K220441) in terms of materials and design features.
IX. PERFORMANCE DATA
The mechanical performance profile of MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation was assessed through dynamic construct testing and screw dissociation testing in accordance with the following test methods:
- . Dynamic Compression (ASTM F2077-18)
- . Plate/Cage Dissociation Testing
X. CONCLUSIONS
The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation 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 MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is substantially equivalent to legally marketed predicate systems.