(59 days)
No
The device description and performance studies focus on the mechanical properties of the plates and screws, with no mention of AI or ML.
Yes
The device is intended to treat specific medical conditions such as spine instability, fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery, which aligns with the definition of a therapeutic device.
No
The device is a system of plates and screws used for stabilizing the spine during surgery, treating conditions like fractures, tumors, and degenerative disc disease. It is an implantable medical device used for treatment, not diagnosis.
No
The device description explicitly states it consists of plates and screws manufactured from titanium alloy, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Pioneer Lateral Plate System is described as an assortment of plates and screws made from titanium alloy. These are implanted devices used to stabilize the spine.
- Intended Use: The intended use clearly states it's for surgical implantation to treat spine instability. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Pioneer Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The Pioneer Lateral Plate System consists of an assortment of plates and screws manufactured from ASTM F136 Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine; lumbar and lumbosacral (L1-S1) 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)
ASTM F1717 Dynamic axial compression, static axial compression and torsional static testing were performed, in addition to ASTM F543 screw pull-out and screw pull-through testing, to establish substantial equivalence. The test results demonstrate that the Pioneer Lateral Plate System functioned as intended and performed in a manner substantially equivalent to that of predicate systems.
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.
0
170724
MAY - 7 2012
510(k) Summary Sponsor:
Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 (906) 225-5861 Contact: Sarah McIntyre, Emily M. Downs Date: May 3, 2012
Device Name:
. Classification Name: Spinal Intervertebral Body Fixation Orthosis
Classification:
Regulation Number: §888.3060 Spinal intervertebral body fixation orthosis
Product Code: K WQ: Panel Code: 87
· NuVasive Lateral Plate System (K070273) Quantum Spinal System (K080518) Pioneer Lumbar Plate System (K090222)
Pioneer Lateral Plate System
Predicate Devices:
Description:
Intended Use:
Performance Data:
Performance and SE Determination:
The Pioneer Lateral Plate System consists of an assortment of plates and screws manufactured from ASTM F136 Titanium Alloy.
The Pioneer Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.
ASTM F1717 Dynamic axial compression, static axial compression and torsional static testing were performed, in addition to ASTM F543 screw pull-out and screw pull-through testing, to establish substantial equivalence. The test results demonstrate that the Pioneer Lateral Plate System functioned as intended and performed in a manner substantially equivalent to that of predicate systems.
Equivalence for the Pioneer Lateral Plate System is based on similarities of intended use, design, and physical characteristics when compared to predicate devices. Therefore. Pioneer Surgical Technology believes that there is sufficient evidence to conclude that the Pioneer Lateral Plate System is substantially equivalent to existing legally marketed devices.
Page 1 of 1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 7 2012
Pioneer Surgical Technology % Ms. Sarah MoIntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855
Re: K120724
Trade/Device Name: Pioneer Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 7, 2012 Received: March 9, 2012
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 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.
2
Page 2 - Ms. Sarah McIntyre
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,
Erin Keith
~ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
K12 0724 510(k) Number (if known):
Device Name:
Pioneer Lateral Plate System
Indications:
The Pioneer Lateral Plate System is indicated for use via the lateral or anterolatera! surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Prescription Use (Per 21 CFR 801.109)
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)
OR
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KI20724 510(k) Number_
Pioneer Lateral Plate System Traditional 510(k)