(67 days)
The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Trinica Select Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter
Plates are offered in one-level, two-level, and four-level fusion configurations (22 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.
The provided document is a 510(k) summary for the Trinica Select Anterior Cervical Plate System. It describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in this document.
The document states:
- Summary of Non-Clinical Tests: "Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria."
- Conclusions Drawn From Testing: "Testing of the Trinica Select Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the devices and that the design modifications do not affect device safety and effectiveness."
However, it does not specify what these established criteria are, what the reported device performance was against these criteria, or provide any details about the study design that would allow me to populate the requested table and answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness.
This document focuses on demonstrating substantial equivalence for a physical medical device (an anterior cervical plate system) based on material, design, and non-clinical performance testing (likely mechanical testing under loads), rather than clinical performance or the performance of an AI/ML algorithm.
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U 22344 p1/3
5. 510(k) Summary
SEP 2 4 2002
Submitter's Information
Date:
Name/Address:
July 24, 2002
Centerpulse Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439
Telephone Number:
Fax Number:
Contact:
Device Information
Trade Name:
Common Name:
Classification:
Predicate Devices:
Minneapolis, Minnesota
(952) 830-6284
(952) 832-5620
Tim Miller Director of Clinical and Regulatory Affairs
Trinica Select™ Anterior Cervical Plate System
Spinal Intervertebral Body Fixation Orthosis
Class II, KWQ
Trinica" Anterior Cervical Plating System K012305, concurrence date August 22, 2001
Michelson Anterior Cervical Plate K974435, concurrence date February 19, 1998
Synthes Anterior Cervical Spine Locking Plate K945700, concurrence date July 20, 1995
Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System K971883, concurrence date October 16, 1997
Medtronic Sofamor-Danek Zephir" Anterior Cervical Plate System K994239, concurrence date June 19, 2000
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Device Description:
The Trinica Select Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter
Plates are offered in one-level, two-level, and four-level fusion configurations (22 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.
Intended Use:
The Trinica Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Comparison of Required Technological Characteristics
The Trinica Select™ Anterior Cervical Plate System is substantially equivalent to the predicate Synthes anterior cervical spine system (K945700, concurrence date July 20, 1995). The table below provides a comparison of equivalency characteristics.
| Characteristics | Equivalency |
|---|---|
| Intended Use | Identical |
| Anatomical Sites | Identical |
| Target Population | Identical |
| Sterilization | Identical |
| Packaging | Identical |
| Operating Principle | Identical |
| Materials | Identical |
| Labeling | Substantially Equivalent |
| Physical Characteristics (Design) | Substantially Equivalent |
| Performance Testing | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent |
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Summary of Non-Clinical Tests
Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria.
Conclusions Drawn From Testing
Testing of the Trinica Select Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the devices and that the design modifications do not affect device safety and effectiveness.
2022344 ply
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
SEP 2 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Timothy Miller Director of Clinical and Regulatory Affairs Centerpulse Spine-Tech, Inc. 7375 Bush Lake Road Minneapolis. Minnesota 55439-2027
Re: K022344
Trade/Device Name: Trinica Select Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 28, 2002 Received: August 29, 2002
Dear Mr. Miller:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); labcling (21 CFR Part 801); good manufacturing practice requirements as set 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.
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Page 2 -- Mr. Timothy Miller
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O. Mark N. Millen
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Indications for Use Statement 2.
510(K) Number: K (222) 44
Device Name: Trinica/Trinica Select™ Anterior Cervical Plate System
Indications for Use:
The Trinica/Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
PLEASE DO NOT WRITE BELOW THIS LINE-------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
MarkRR M. Mckers
al. Restorative
510(k) Number K022344
Over-the-Counter-Use (Per 21 CFR 801.109)
(Pending)
§ 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.