(42 days)
No
The device description and performance studies focus on the mechanical properties and materials of a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a temporary implant for anterior fixation to the cervical spine, indicated for various conditions such as degenerative disc disease, trauma, and tumors, all of which aim to treat medical conditions.
No
The device described is an implantable surgical system (plate system and screws) for anterior fixation to the cervical spine, used for treatment (temporary stabilization), not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components made of titanium alloy and Nitinol, including screws, plates, and instrumentation. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- AZURE Anterior Cervical Plate System Description: The provided text clearly describes the AZURE Anterior Cervical Plate System as a temporary implant intended for anterior fixation to the cervical spine. It is a physical device surgically implanted into the body.
- Intended Use: The intended use is to provide structural support and stability to the cervical spine for various conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The description, intended use, and device type all point to this being a surgical implant, not an IVD.
N/A
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:
- Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc a) confirmed by patient history and radiographic studies);
- Spondylolisthesis: b)
- Trauma (i.e., fracture or dislocation); c)
- Spinal stenosis; d)
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- () Tumor;
- Pseudoarthrosis; ള)
- Revision of previous surgery h)
Product codes (comma separated list FDA assigned to the subject device)
KWQ
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) and 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 instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to C7
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)
Mechanical testing for the subject AZURE Anterior Cervical Plate System was conducted in accordance to ASTM F1717-12- Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device the Hallmark Anterior Cervical Plate System (K050892 and K 100614) that have the same intended use, similar indications, technological characteristics, and principles of operation.
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.
Orthofix Anterior Cervical Plate System (K121658), Hallmark Anterior Cervical Plate System (K050892 and K100614)
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.
Not Found
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.
0
K130825 Page 1 of 3
Premarket Notification, Special 510(k) AZURE Anterior Cervical Plate System
510(k) SUMMARY
MAY 0 7 2013
AZURE Anterior Cervical Plate System
Submitter Information
| Name: | Orthofix Inc. |
|---|---|
| Address: | 3451 Plano Parkway |
| Lewisville, TX 75056 | |
| Telephone Number: | 214-937-2000 |
| Fax Number: | 214-937-3322 |
| Email: | alisonbaduel@orthofix.com |
| Registration Number: | 3008524126 |
| Contac Person: | Ally Baduel |
| Regulatory Affairs Specialist | |
| Date Prepared: | March 22, 2012 |
| 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 - 888.3060 - Spinal intervertebral body fixation orthosis |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Orthofix Anterior Cervical Plate System (K121658) & |
| Hallmark Anterior Cervical Plate System (K050892 and K100614) |
Reason for 510(k) Submission: Device modification to cervical plates
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) and 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
1
Premarket Notification, Special 510(k) AZURE Anterior Cervical Plate System
surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.
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:
- Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc a) confirmed by patient history and radiographic studies);
- Spondylolisthesis: b)
- Trauma (i.e., fracture or dislocation); c)
- . Spinal stenosis; d)
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- () Tumor;
- Pseudoarthrosis; ള)
- Revision of previous surgery h)
Summary of Technological Characteristics of the Device Compared to the Selected Predicate Devices
| Characteristic | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| Device Name | AZURE | |||
| Anterior | ||||
| Cervical Plate | ||||
| System | Orthofix Anterior | |||
| Cervical Plate System | ||||
| (K121568) | Hallmark Anterior | |||
| Cervical Plate System | ||||
| (K050892) | Hallmark Anterior | |||
| Cervical Plate System | ||||
| (K100614) | ||||
| Method of | ||||
| Fixation | ACP system | |||
| intended for | ||||
| anterior fixation | ||||
| to the cervical | ||||
| spine from C2 | ||||
| to C7. | ACP system intended | |||
| for anterior fixation to | ||||
| the cervical spine from | ||||
| C2 to C7. | ACP system intended for | |||
| anterior fixation to the | ||||
| cervical spine from C2 to | ||||
| C7. | ACP system intended | |||
| for anterior fixation to | ||||
| the cervical spine from | ||||
| C2 to C7. | ||||
| Implantation | Anterior | |||
| approach | Anterior approach | Anterior approach | Anterior approach | |
| Design | Plates (1-level | |||
| through 5- | ||||
| level) | Plates (1-level through | |||
| 5-level) | Plates | |||
| (1-level through 4-level) | Plates | |||
| (5-level plate only) | ||||
| Material | Ti6Al4V ELI | |||
| per ASTM | ||||
| F136 and | ||||
| Nitinol per | ||||
| ASTM F2063. | Ti6Al4V ELI per | |||
| ASTM F136 and Nitinol | ||||
| per ASTM F2063. | Ti6Al4V ELI per ASTM | |||
| F136. | Ti6Al4V ELI per | |||
| ASTM F136. |
2
PERFORMANCE DATA-Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
| Characteristic | Standard / Test/ FDA Guidance |
|---|---|
| Static Torsion Test | ASTM F1717-12 |
| Static Axial Compression Bending Test | ASTM F1717-12 |
| Dynamic Axial Compression Bending Test | ASTM F1717-12 |
Performance Data Summary
Mechanical testing for the subject AZURE Anterior Cervical Plate System was conducted in accordance to ASTM F1717-12- Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device the Hallmark Anterior Cervical Plate System (K050892 and K 100614) that have the same intended use, similar indications, technological characteristics, and principles of operation.
Basis of Substantial Equivalence
The subject AZURE Anterior Cervical Plate System is substantially equivalent in design, configuration, function, and indications for use to the Orthofix Anterior Cervical Plate System (K121658) and is substantially equivalent in design, configuration, function, performance and indications for use to the Hallmark Anterior Cervical Plate System (K050892 & K100614).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2013
Orthofix, Incorporated % Ms. Ally Baduel Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K130825
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: KWQ Dated: April 09, 2013 Received: April 10, 2013
Dear Ms. Baduel:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Ally Baduel
forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Erin - Weith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
. K130825 510(k) Number (if known):
Device Name: AZURE Anterior Cervical Plate System
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:
- 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);
- Tumor; f)
- g) Pseudoarthrosis;
- Revision of previous surgery h)
Prescription Use: X (Part 21 CFR 801 Subpart D)
And/Or
Over-The-Counter (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices