(155 days)
The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
The provided text is a 510(k) summary for the "Fixed, Variable & Corpectomy Cervical Plate System." This document describes a medical device, specifically a spinal implant, and seeks substantial equivalence to a predicate device. It does not present a study with acceptance criteria and reported device performance in the context of an "AI" or "diagnostic" device. Instead, it describes a traditional medical device (a cervical plate system) and its substantial equivalence to a previously cleared device based on design, intended use, indications, anatomic sites, and performance (which likely refers to mechanical and biocompatibility testing, not clinical performance metrics in the way a diagnostic device would have).
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.
The closest information provided is regarding the overall device description and its intended use, which are established for mechanical devices through different types of testing (e.g., biomechanical, material characterization) rather than clinical performance studies with diagnostic metrics.
If this were a diagnostic device, I would expect to see details about sensitivity, specificity, accuracy, or other relevant performance metrics, along with the study design to evaluate these. As that is not the case here, I can only extract information that is present.
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JUN - 3 2008
:
510(k) Summary
Sponsor:
| Sponsor: | Precision Surgery Limited2700 W Ninth Ave, Suite 120Oshkosh WI 54904Phone: 920.223.0547Facsimile: 920.223.0551 |
|---|---|
| Contact Person: | Kamaliit S. Paul, MD |
| Proposed Trade Name: | Fixed, Variable & Corpectomy Cervical Plate System |
| Classification: | Class II |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation: | 888.3060 |
| Device Product Code: | KWQ |
| Device Description: | The Precision Surgery Limited Fixed, Variable & Corpectomy CervicalPlate System comprises plate and screw components in a variety of sizesand lengths. Three styles of plate, including fixed, variable and corpectomy,are available. Primary, self-drilling primary and rescue screws are offered. |
| Intended Use: | The Precision Surgery Limited Fixed, Variable and Corpectomy CervicalPlate System is intended for anterior screw fixation of the cervical spine.These implants have been designed to provide stabilization as an adjunct tocervical fusion. Indications for the use of this implant system includedegenerative disc disease defined as neck pain of discogenic origin with thedegeneration of the disc confirmed by history and radiographic studies,spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosisor failed previous fusion.WARNING: The Precision Surgery Limited Fixed, Variable andCorpectomy Cervical Plate System is not intended for screw attachment orfixation to the posterior elements (pedicles) of the cervical, thoracic orlumbar spine. |
| Materials: | The Precision Surgery Limited Fixed, Variable & Corpectomy CervicalPlate System components are manufactured from titanium alloy (Ti-6A1-4Vper ASTM F136). The screw-retaining central rail is manufactured fromnickel titanium alloy (NiTi per ASTM F2063). |
| SubstantialEquivalence: | Documentation was provided which demonstrated the Precision SurgeryLimited Fixed, Variable & Corpectomy Cervical Plate System to besubstantially equivalent to the previously cleared Fixed & Variable CervicalPlate System. The substantial equivalence is based upon equivalence inbasic design, intended use, indications, anatomic sites and performance. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Precision Surgery Limited % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141
JUN - 3 2008
Re: K073708
Trade/Device Name: Fixed, Variable & Corpectomy Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 05, 2008 Received: May 06, 2008
Dear Dr. Warden:
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.
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); labeling (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 - Karen E. Warden, Ph.D.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K073708
Device Name: Fixed, Variable & Corpectomy Cervical Plate System
Indications for Use:
The Precision Surgery Limited Fixed, Variable and Corpectorny Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use (Per 21 CFR 801.109)
NEEDED)
OR Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for mxn
Division of General, Restorative, and Neurological Devices
510(k) Number K073708
§ 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.