(73 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of a physical implant (anterior cervical plate system) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as "Anterior Cervical Plate System" indicated for "stabilization of the cervical spine," which directly implies a therapeutic function to treat spinal instability.
No
Explanation: The device is an Anterior Cervical Plate System, which is an implantable medical device used for stabilization of the cervical spine. Its function is to provide physical support and stability, not to diagnose medical conditions or analyze patient data.
No
The device description clearly details physical components made of titanium alloy, such as plates and screws, intended for surgical implantation. This indicates a hardware-based medical device, not a software-only one.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (an Anterior Cervical Plate System) used to stabilize the cervical spine. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is for surgical stabilization of the cervical spine, not for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
This device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate.
The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths.
All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- Static compression bending test
- Dynamic compression bending test
- Static torsion test
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.
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
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Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K123578
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Date of Submission: Nov 8, 2012
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Sponsor
Weigao Orthopaedic Device Co., Ltd. No 26 Xiangjiang Road, Tourist Resorts, Weihai, Shandong, 264203, China
Establishment Registration Number: 3006639944
Contact Person: Han Wang Position: Quality & Technique Manager Tel: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification
Proposed Device Name: Anterior Cervical Plate System Classification: II Product Code: K WQ Regulation Number: 888.3060
FEB 1 2013
1
K123578 Page 2 of 3
Review Panel: Orthopedic Intended Use Statement:
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
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- Predicate Device Identification
510(k) Number: K103491 Product Name: SKYLINE® Anterior Cervical Plate System Manufacturer: Depuy Spine, Inc.
- Predicate Device Identification
6. Device Description
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate.
The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths.
All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The materials are [[[[-2
2
Project #: M0082012Aa K123578
Page 3 of 3
wildly used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
This system is provided non-sterile.
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- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- . Static compression bending test
- Dynamic compression bending test
- . Static torsion test
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- Summary of Substantially Equivalent Comparison
The technological characteristics of proposed device and predicate device are the same.
Difference in dimension and test results of mechanical specifications between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Anterior Cervical Plate System, is determined to be Substantially Equivalent (SE) to the predicate device, SKYLINE® Anterior Cervical Plate System (K103491), in respect of safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: February 1, 2013
Weigao Orthopaedic Device Co., Ltd % MID-LINK Consulting Co., Ltd Ms. Diana Hong General Manager P.O Box 237-023 Shanghai, 200237 China
Re: K123578
Trade/Device Name: 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: November 16, 2012 Received: November 20, 2012
Dear Ms. Hong:
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. Diana Hong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Section II Indications for Use
K123578 510(k) Number: Device Name: Anterior Cervical Plate System
Indications for Use:
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
XPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephanie Bechtold 2013.02.01.09
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(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123578