(220 days)
The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor: g) Pseudoarthrosis; h) Revision of previous surgery
The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) with nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
The provided document describes a 510(k) premarket notification for the Azure Anterior Cervical Plate System. This document is a regulatory submission for a medical device (a spinal implant), not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (K130825 - Azure Anterior Cervical Plate System, SE) by removing constrained screws from the system due to a field failure mode. The performance data presented is related to mechanical testing of the spinal implant, not the performance of an AI/ML algorithm.
Therefore, I cannot populate the requested table and information as it pertains to an AI/ML device.
However, I can extract the relevant information regarding the modification to the device and the reason for the change, which led to a performance test.
Summary of Device Modification and Performance Study:
The purpose of this 510(k) submission is the removal of constrained screws from the Azure Anterior Cervical Plate System. This change was initiated because the constrained screw constructs were experiencing "total fracture of the locking mechanism" in the field.
A modified Dynamic Axial Compression test was conducted in accordance with ASTM F1717 standard to compare the performance of constrained and semi-constrained screws.
Acceptance Criteria and Reported Device Performance (for mechanical testing, not AI):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevention of "total fracture of the locking mechanism" failure mode experienced with constrained screws. | Constrained screw constructs: were able to cause total fracture of the locking mechanism, "similar to the failures experienced in the field." This indicates that the constrained screws failed to meet the implied criteria of preventing this specific failure mode. |
| Semi-constrained screw constructs should not exhibit the same failure modes as constrained screws. | Semi-constrained screw constructs: "did not experience the same failure modes," thereby eliminating the risk of locking mechanism fracture. This indicates that the semi-constrained screws met the implied criteria of preventing the identified failure mode. In addition, simulated testing with semi-constrained screws was performed to validate a new recommended surgical technique, further demonstrating safety and effectiveness. |
| Device with semi-constrained screws should be safe and effective and substantially equivalent to the predicate. | The tests demonstrated that "the Azure system containing semi-constrained screws is safe and effective for use and is substantially equivalent or better than its predicate device Azure Anterior Cervical Plate System K130825." This general statement of equivalence and safety/effectiveness indicates that the system with semi-constrained screws met the overall regulatory acceptance for substantial equivalence after the modification. |
Regarding the specific questions about AI/ML studies:
- Sample size for the test set and data provenance: N/A (Not an AI/ML device)
- Number of experts used to establish the ground truth...: N/A (Not an AI/ML device)
- Adjudication method: N/A (Not an AI/ML device)
- Multi reader multi case (MRMC) comparative effectiveness study: N/A (Not an AI/ML device)
- Standalone (i.e. algorithm only...) performance: N/A (Not an AI/ML device)
- Type of ground truth used: N/A. The "ground truth" here is mechanical failure analysis (ASTM F1717 standard, field failure reports for constrained screws).
- Sample size for the training set: N/A (Not an AI/ML device)
- How the ground truth for the training set was established: N/A (Not an AI/ML device)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Orthofix, Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K143028
Trade/Device Name: Azure Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: April 29, 2015 Received: April 30, 2015
Dear Ms. Volosen:
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. 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); good manufacturing practice requirements as set
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Page 2 - Ms. Natalia Volosen
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K143028
Device Name
Azure Anterior Cervical Plate System
Indications for Use (Describe) The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor: g) Pseudoarthrosis; h) Revision of previous surgery
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
Azure Anterior Cervical Plate System
| 510(k) Owner InformationName:Address: | Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056 |
|---|---|
| Telephone Number:Fax Number:Email: | 214.937.2145214-937-3322nataliavolosen@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia VolosenSenior Regulatory Affairs Specialist |
| Date Prepared: | May 14, 2015 |
| Name of Device | |
| Trade Name / Proprietary Name: | Azure Anterior Cervical Plate System |
| Common Name: | Anterior Cervical Plate System |
| Product Code: | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Regulatory Classification: | Class II per 21 CFR § 888.3060 |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K130825 - Azure Anterior Cervical Plate System, SE5/7/2013No reference devices were used in this submission |
| Reason for 510(k) Submission: | Removal of constrained screws from the Azure |
system
Device Description
The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) with nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
Intended Use / Indications for Use
The AZURE Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:
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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. There is a black line underneath the word "ORTHOFIX".
- a) Degenerative disc disease (as defined as back pain of discogenic origin with
- degenerative disc confirmed by patient history and radiographic studies);
- b) Spondylolisthesis;
- c) Trauma (i.e., fracture or dislocation);
- d) Spinal stenosis:
- e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- f) Tumor;
- q) Pseudoarthrosis:
- h) Revision of previous surgery
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
There are no changes in the intended use, design, specifications and / or materials of Azure Cervical Plate system. The purpose of this 510(k) submission is to remove the constrained screw configuration from the Azure Anterior Cervical Plate system.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
A modified Dynamic Axial Compression test was conducted in accordance to ASTM F1717 standard for Azure constructs containing constrained and semi-constrained screws. The results of the modified ASTM F1717 testing show that constrained screw constructs were able to cause total fracture of the locking mechanism, similar to the failures experienced in the field. The semi-constrained screw constructs did not experience the same failure modes and therefore removing the constrained screws from the system will eliminate the risk of locking mechanism fracture.
In addition, Orthofix performed simulated testing with semi-constrained screws to validate the new recommended surgical technique (fully lagged screws or screws left above the locking mechanism).
These tests demonstrate that the Azure system containing semi-constrained screws is safe and effective for use and is substantially equivalent or better that its predicate device Azure Anterior Cervical Plate system K130825.
Basis of Substantial Equivalence
There are no changes in the intended use, design, specifications and / or materials between the subject Azure system and the Azure Cervical Plate system K130825.
The subject Azure Anterior Cervical Plate System will be as safe and effective as its predicate device Azure Anterior Cervical Plate System (K130825). Usage of constrained or semi-constrained screws is a surgeon preference based on their training and experience.
§ 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.