(55 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended to provide temporary immobilization and stabilization for cervical spinal fusions in patients with various medical conditions, indicating a direct therapeutic purpose.
No
The device is an orthopedic implant for spinal fusion, providing temporary immobilization and stabilization. It is not used to diagnose a medical condition.
No
The device description explicitly states that the device consists of implants manufactured from various metals and instrumentation manufactured from stainless steel. This indicates a physical hardware device, not a software-only device.
No, 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 (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- CYGNUS™ Anterior Cervical Plate System: This device is an implantable medical device used for spinal fixation within the body. It is a surgical implant, not a diagnostic tool that analyzes biological samples.
The provided information clearly describes a surgical implant used to stabilize the spine, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7)Pseudarthrosis; (8) Failed previous fusions.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The CYGNUS™ Anterior Cervical Plate System consist of implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. and instrumentation manufactured from stainless steel per ASTM F899. The Anterior Cervical Plate Devices are offered in four configurations of various sizes to accommodate different patient anatomy. 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
Not Found
Anatomical Site
cervical spinal fusions (C2 to C7)
anterior spine
Indicated Patient Age Range
Not Found
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)
Static and dynamic compression bending and static torsion were performed adhering to ASTM F1717-15. The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes CSLP System (K000742), EBI Anterior Cervical Plate (K001794), Aesculap ABC Plate (K974706)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
MiRus Atlas Plating System (K190415)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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May 9, 2019
MiRus™, LLC Mr. Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway SE, Suite 108 Marietta, Georgia 30067
Re: K190666
Trade/Device Name: CYGNUS™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 13, 2019 Received: March 15, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190666
Device Name CYGNUSTM Anterior Cervical Plate System
Indications for Use (Describe)
The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.
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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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 13, 2019 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | CYGNUS™ Anterior Cervical Plate System
Spinal Intervertebral Body Fixation Orthosis
21 CFR 888.3060
Class II
KWQ
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary:
Synthes CSLP System (K000742)
Additional:
EBI Anterior Cervical Plate (K001794)
Aesculap ABC Plate (K974706)
Reference: |
MiRus Atlas Plating System (K190415)
VI. DEVICE DESCRIPTION
The CYGNUS™ Anterior Cervical Plate System consist of implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. and instrumentation manufactured from stainless steel per ASTM F899. The Anterior Cervical Plate Devices are offered in four configurations of various sizes to accommodate different patient anatomy. The implants will be provided non-sterile and are intended for single use only.
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VII. INDICATIONS FOR USE
The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7)Pseudarthrosis; (8) Failed previous fusions.
VIII. PREDICATE DEVICE COMPARISON
The documentation provided shows that the CYGNUS™ Anterior Cervical Plate 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 bending and static torsion were performed adhering to ASTM F1717-15. The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance.
X. CONCLUSONS
The CYGNUS™ Anterior Cervical Plate System does not raise any new questions of safety or efficacy when compared to the predicate device(s). The CYGNUS™ Anterior Cervical Plate System has demonstrated that it is substantially equivalent in mechanical performance, indications for used, intended use, technological characteristics, materials and labeling to legally marketed predicate devices.