(269 days)
No
The device description and performance studies focus on mechanical properties and traditional surgical implants, with no mention of AI or ML.
Yes
The device is used to stabilize the spine during spinal fusions in patients with various conditions like degenerative disc disease, trauma, and tumors, indicating it is used to treat or alleviate a medical condition.
No
Explanation: The device is an anterior cervical plate system used for temporary stabilization and spinal fusion, not for diagnosing conditions.
No
The device description explicitly states that the system includes screws, plates, and instruments, which are physical hardware components, not software.
No, 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, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is an implantable system consisting of screws, plates, and instruments used for the temporary stabilization of the anterior spine. It is surgically inserted into the body.
- Intended Use: The intended use is for the surgical stabilization of the spine during fusion procedures. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the Met One Czar Anterior Cervical Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Met One Czar Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The Met One Czar Anterior Cervical Plate System includes screws, plates, and a set of instruments to insert the implants. Plates are available in a variety of lengths to accommodate fusion procedures from one to four levels of the cervical spine. Fixation is achieved by inserting the screws through the openings in the plate into vertebral bodies of the cervical spine. Met One Czar plates are manufactured from Titanium 6A1-4V ELI per ASTM F136 and Invibio PEEK-OPTIMA™ LT1 per ASTM F2026.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine from C2 to T1
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)
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression and static torsion per ASTM F1717.
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.
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.
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
December 17, 2018
Met One Technologies % Mr. Daniel Johnson Design Engineer JALEX Medical. LLC 30311 Clemens Road, Suite 5D Westlake, Ohio 44145
Re: K180772
Trade/Device Name: Met One Czar Anterior Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 16, 2018 Received: November 19, 2018
Dear Mr. Johnson:
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
510(k) Number (if known) K180772
Device Name
Met One Czar Anterior Cervical Plate System
Indications for Use (Describe)
The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Met One Technologies. The logo features a blue square on the left side with a large, white "M" inside. To the right of the square, the text "MET ONE" is displayed in a light blue sans-serif font, stacked vertically. Below the square, the word "TECHNOLOGIES" is written in smaller, gray sans-serif letters.
K180772 - 510(k) Summary
| Submitted By: | Met One Technologies
154 N. Festival Dr. Villa F
El Paso, TX 79912 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 03/23/2018 |
| Contact Person: | Daniel Johnson, Design Engineer |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Met One Czar Anterior Cervical Plate System |
| Device Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | KWQ |
| Primary Predicate Device: | Stryker Aviator® Anterior Cervical Plating (ACP) System (K142237)
The primary predicate device has never been subject to a recall. |
| Reference Predicate: | Interpore C-TEK Anterior Cervical Plate System (K041794)
The reference predicate device has never been subject to recall. |
Device Description:
The Met One Czar Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The Met One Czar Anterior Cervical Plate System includes screws, plates, and a set of instruments to insert the implants. Plates are available in a variety of lengths to accommodate fusion procedures from one to four levels of the cervical spine. Fixation is achieved by inserting the screws through the openings in the plate into vertebral bodies of the cervical spine. Met One Czar plates are manufactured from Titanium 6A1-4V ELI per ASTM F136 and Invibio PEEK-OPTIMA™ LT1 per ASTM F2026.
Intended Use:
The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.
Summary of Technological Characteristics:
The Met One Czar Anterior Cervical Plate System and the predicate have the same intended use and fundamental scientific technology. Both devices compare similarly in:
- Design features
- Intended use
- Materials
- Dimensions
- Function ●
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Image /page/4/Picture/0 description: The image shows the logo for MET ONE Technologies. The logo features the letters "M" and "ONE" in a stylized font, with the word "TECHNOLOGIES" written below. Below the logo, the text "Mechanical Testing:" is written in a larger, bold font.
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression and static torsion per ASTM F1717.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.