(83 days)
Not Found
No
The 510(k) summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is used to treat specific medical conditions affecting the cervical spine, indicating a therapeutic purpose.
No
This device is a surgical implant designed for anterior cervical fixation, used to stabilize the spine. It does not perform any diagnostic functions such as imaging, signal analysis, or data interpretation to identify or classify disease or conditions. Its purpose is therapeutic (fixation), not diagnostic.
No
The device description clearly states it consists of physical components (plates and screws) intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for anterior cervical fixation to treat various spinal conditions. This involves surgically implanting a device into the body.
- Device Description: The device is described as a system of plates and screws used to secure to vertebral bodies. This is a physical implantable device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Pioneer Aspect Anterior Cervical Plate System does not involve any such testing or analysis of biological samples.
Therefore, the Pioneer Aspect Anterior Cervical Plate System is a surgical implant used for spinal fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The system consists of static plates in lengths that range from 10-84mm and include one, two, three and four level designs. The plates have an integrated screw retention mechanism. Screws range from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in fixed/variable self-tapping and self-drilling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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 was presented to characterize construct and component performance, including static and fatigue compression bending and static torsion testing per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols to assess screw pull through / retention characteristics. The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K111528 Page 1 of $
3.0 | 510(k) Summary | |
---|---|---|
Sponsor: | Pioneer Surgical Technology | |
AUG 2 4 2011 | ||
375 River Park Circle | ||
Marquette, MI 49855 | ||
(906) 225-5861 | ||
Contact: Sarah McIntyre | ||
Date submitted: June 1, 2011 | ||
Device Name: | Pioneer Aspect Anterior Cervical Plate | |
Classification Name: | The classification of the Pioneer Aspect Anterior Cervical Plate System is Class II, as | |
per the Code of Federal Regulations, Title 21, Section 888.3060: Spinal | ||
intervertebral body fixation orthosis. | ||
Product Codes: | The product code is KWQ. The Panel code is 87. | |
Predicate Device: | K100708 - Pioneer Poise Anterior Cervical Plate System (SE date 06/04/10) | |
Description: | The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of | |
plates and screws. The screws are used to secure the plates to the vertebral bodies of | ||
the cervical spine through an anterior approach. The system consists of static plates | ||
in lengths that range from 10-84mm and include one, two, three and four level | ||
designs. The plates have an integrated screw retention mechanism. Screws range | ||
from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in | ||
fixed/variable self-tapping and self-drilling. | ||
Intended Use: | The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical | |
fixation for the following indications: degenerative disc disease (DDD) (defined as | ||
neck pain of discogenic origin with degeneration of the disc confirmed by history and | ||
radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal | ||
stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, | ||
pseudoarthrosis, and failed previous fusion. | ||
Comparison to Predicate | ||
Devices: | The subject device has indications for use identical to those of the predicate Pioneer | |
Poise system and employs the same principles of operation. Identical materials are | ||
used for both subject and predicate plates and screws. Available screw lengths (10- | ||
20mm), screw diameters (4.0, 4.5mm), overall plate length (10-84mm), and plate | ||
types (one, two, three and four level; static) are identical to predicate. | ||
Material: | The Pioneer Aspect Anterior Cervical Plate System plates and screws are | |
manufactured from titanium alloy (Ti6Al4V ELI, according to ASTM F136). The | ||
plates incorporate a screw-retention mechanism ("spring"), which is manufactured | ||
from Nitinol (ASTM F2063). | ||
Non-Clinical | ||
Performance Data: | Mechanical testing was presented to characterize construct and component | |
performance, including static and fatigue compression bending and static torsion | ||
testing per recognized ASTM F1717, axial pullout screw strength per ASTM F543, | ||
and additional testing performed per internal protocols to assess screw pull through / | ||
retention characteristics. The test results of verification testing demonstrate that the | ||
mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is | ||
substantially equivalent to the predicate device. | ||
Performance and SE | ||
Determination: | Comparisons of device performance data, materials, indications and design/function | |
to predicate devices were provided in making a determination of substantial | ||
equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % Ms. Sarah McIntyre 375 River Park Circle Marquette, Michigan 49855
AUG 24 2011
Re: K111528
Trade/Device Name: Pioneer Aspect Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 22, 2011 Received: July 25, 2011
Dear Ms. McIntyre:
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
2
Page 2 - Ms. Sarah McIntyre
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 2.0
510(k) Number (if known): | K111528 |
---|---|
Device Name: | Pioneer Aspect Anterior Cervical Plate |
Indications for Use: | The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
Prescription Use | |
(Per 21 CFR 801.109) | √ OR |
Over-the-Counter Use _______ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)_
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111528