(63 days)
Not Found
No
The document describes a mechanical implant (cervical plate system) and its materials, intended use, and performance testing, with no mention of AI or ML.
No.
The device is intended for "temporary stabilization of the anterior spine during the development of a solid spinal fusion," which is a supportive role in a surgical procedure, not a device used to provide therapy itself.
No.
Explanation: The Athena II Cervical Plate System is described as a system for temporary stabilization and fixation of the anterior spine during the development of a solid spinal fusion. It is a surgical implant system, not a device used to diagnose a medical condition.
No
The device description clearly states the system is composed of physical components manufactured from titanium alloy, including bone plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Athena II Cervical Plate System Function: The Athena II Cervical Plate System is an implantable device used for the mechanical stabilization of the cervical spine during fusion. It is a surgical implant, not a device that analyzes biological samples.
The provided text clearly describes a surgical implant for spinal fixation, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Product codes
KWQ
Device Description
The Athena II Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena II Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena II Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, sub-axial cervical spine from C3 through C7 levels
Indicated Patient Age Range
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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
The pre-clinical testing was performed by an independent laboratory. Testing was conducted per ASTM F1717-13. Testing included:
Test: Static Compression Bending
Result: Substantially equivalent to predicates
Test: Static Torsion
Result: Substantially equivalent to predicates
Test: Static Tension
Result: Substantially equivalent to predicates
Test: Dynamic Compression Bending to 5MM cycles
Result: Substantially equivalent to predicates
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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February 11, 2019
Medyssey USA Inc. % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 3851 Mossy Oak Drive Ft. Myers, Florida 33905
Re: K183409
Trade/Device Name: Athena II Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 6, 2018 Received: December 10, 2018
Dear Dr. Jansen:
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
1
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/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.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known) K183409
Device Name: Athena II Cervical Plate System
Indications for Use (Describe)
The Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
| 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (1/14)
Page 1 of 1
entices (301)-649-6780
3
510(k) Summary
| Date Prepared: | December 3, 2018 |
|---|---|
| Submitter: | Shawn Kim |
| Medyssey USA Inc. | |
| 1550 E. Higgins Road | |
| Suite 123 | |
| Skokie, IL 60077 | |
| 847-427-0200 | |
| 888-518-9070 (fax) | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC. | |
| Product | |
| Trade Names: | Athena II Cervical Plate System |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Cervical Plate System |
| Product Codes: | KWQ |
| Panel Code: | 87 |
Device Descriptions:
The Athena II Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena II Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena II Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
Indications for Use:
The Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Predicate Device(s):
The primary predicate device is the Athena Cervical Plate System (K180022). Additional predicate devices include the Vertebron Cervical Plate (K081567) and the Vectra Cervical Plate System (K050451).
4
The Athena II Cervical Plate System was compared to the predicated devices in regards to:
- Indications for Use
- Materials
- Number of levels covered
- Plate Dimensions
- Screw Dimensions
- . Design features and technological characteristics
The Athena II Cervical Plate System is considered to be substantially equivalent to one or all of the predicate devices in all elements of comparison.
Performance Standards:
The pre-clinical testing was performed by an independent laboratory. Testing was conducted per ASTM F1717-13. Testing included:
| Test | Result |
|---|---|
| Static Compression Bending | Substantially equivalent to predicates |
| Static Torsion | Substantially equivalent to predicates |
| Static Tension | Substantially equivalent to predicates |
| Dynamic Compression Bending to 5MM cycles | Substantially equivalent to predicates |
Conclusion:
Medyssey concludes that the Athena II Cervical Plate system is substantially equivalent to the predicate devices.