(148 days)
Not Found
No
The document describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a spinal fixation system intended to promote fusion and provide stabilization for various spinal conditions, which are therapeutic medical purposes.
No
The device is described as a system of components (rods, hooks, screws, plates, etc.) intended for spinal stabilization and promotion of fusion after various conditions, indicating a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, and plates made of titanium and cobalt chromium, which are hardware.
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 surgical implant system designed to promote fusion and provide stabilization in the spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a system of rods, screws, hooks, and plates made of medical-grade materials. These are physical components used in surgery, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) to diagnose a condition. The device is implanted directly into the patient.
Therefore, the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is intended for:
-Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-Spondylolisthesis
-Spinal Stenosis
-Fracture/ Dislocation
-Atlanto/axial fracture with instability
-Occipito-cervical dislocation
-Deformities or Curvature
-Tumors
-Pseudoarthrosis
-Revision of previous cervical and upper thoracic spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.
The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) using connectors.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
The Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to introduce occipital plate and connecting components to the previously cleared Pioneer Posterior CT System to expand the indications for the system as a whole and to build an OCT spinal construct.
The Pioneer Posterior OCT System components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F1537 cobalt chromium. Medical grade titanium alloy and cobalt chromium may be used together.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipito-cervico-thoracic junction (occiput-T3), upper thoracic spine (T1-T3), cervical/ upper thoracic (C1-T3) 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 conducted in accordance with the FDA's Guidance for Performance Data: Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: dynamic axial compression, static axial compression dynamic torsion and torsion static testing. Testing was conducted in accordance with ASTM F2706 and ASTM F1798. The test results, along with cadaver studies, computer modeling and dimensional analysis, demonstrate that the Pioneer Posterior OCT 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): 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.
Pioneer Posterior Cervico-Thoracic System (K112757), Biomet Spine Nextgen Altius OCT System (K113593), DePuy Mountaineer OCT (K042508), Aesculap Spine: S4 Cervical System (K100147)
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
| 510(k) Summary | K121725 | NOV | 7 2012 | ||
|---|---|---|---|---|---|
| Sponsor: | Pioneer Surgical Technology, Inc. | ||||
| 375 River Park Circle | |||||
| Marquette, MI 49855 | |||||
| Contact: Sarah McIntyre or Emily Downs (906) 225-5861 | |||||
| Prepared November 7, 2012 | |||||
| Device Name: | Pioneer Posterior Occipito-Cervico-Thoracic System | ||||
| (Trade name: Streamline OCT Occipito-Cervico-Thoracic System) | |||||
| Classification: | Class II per Regulation Numbers §888.3050 Spinal interlaminal fixation orthosis | ||||
| and §888.3070 Pedicle screw spinal system | |||||
| Product Codes: KWP, MNH, MNI; Panel Code: 87 | |||||
| Predicate Devices: | Pioneer Posterior Cervico-Thoracic System (K112757) | ||||
| Biomet Spine Nextgen Altius OCT System (K113593) | |||||
| DePuy Mountaineer OCT (K042508) | |||||
| Aesculap Spine: S4 Cervical System (K100147) | |||||
| Description: | The Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System consists of a | ||||
| variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking | |||||
| caps, occipital bone screws, occipital plates and connecting components used to | |||||
| build an occipito-cervico-thoracic spinal construct. The purpose of this submission | |||||
| is to introduce occipital plate and connecting components to the previously cleared | |||||
| Pioneer Posterior CT System to expand the indications for the system as a whole | |||||
| and to build an OCT spinal construct. | |||||
| The Pioneer Posterior OCT System components are manufactured from medical | |||||
| grade ASTM F136 titanium alloy and ASTM F1537 cobalt chromium. Medical | |||||
| grade titanium alloy and cobalt chromium may be used together. | |||||
| Indications for Use: | When intended to promote fusion of the cervical spine and occipito-cervico- | ||||
| thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic | |||||
| (OCT) System is intended for: | |||||
| -Degenerative Disc Disease (as defined by neck or back pain of discogenic | |||||
| origin with degeneration of the disc confirmed by history and radiographic | |||||
| studies) | |||||
| -Spondylolisthesis | |||||
| -Spinal Stenosis | |||||
| -Fracture/ Dislocation | |||||
| -Atlanto/axial fracture with instability | |||||
| -Occipito-cervical dislocation | |||||
| -Deformities or Curvature | |||||
| -Tumors | |||||
| -Pseudoarthrosis | |||||
| -Revision of previous cervical and upper thoracic spine surgery | |||||
| The occipital bone screws are limited to occipital fixation only. The use of the | |||||
| pedicle screws (standard and high angle) is limited to placement in the upper | |||||
| thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are | |||||
| not intended for use in the cervical spine. | |||||
| The hooks, connectors, and rods are also intended to provide stabilization to |
The noons, commoners, and 102 and the more/ dislocation or trauma in the
promote fusion following reduction of fracture/ dislocation or trauma in the
cervical/ upper thoracic
ﺮ
,
1
The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw Indications for Use systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) (continued) ... using connectors.
Mechanical testing was conducted in accordance with the FDA's Guidance for Performance Data: Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: dynamic axial compression, static axial compression dynamic torsion and torsion static testing. Testing was conducted in accordance with ASTM F2706 and ASTM F1798. The test results, along with cadaver studies, computer modeling and dimensional analysis, demonstrate that the Pioneer Posterior OCT System functioned as intended and performed in a manner substantially equivalent to that of predicate systems.
Equivalence for the Pioneer Posterior OCT System is based on similarities of Performance and SE intended use, design, and physical characteristics when compared to predicate Determination: devices. Therefore, Pioneer Surgical Technology believes that there is sufficient evidence to conclude that the Pioneer Posterior OCT System is substantially equivalent to existing legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 7, 2012
Pioneeer Surical Technology, Incorporated % Ms. Sarah Molntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855
Re: K121725
Trade/Device Name: Pioneer Posterior Occipito-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI, MNH Dated: September 24, 2012 Received: September 26, 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
3
Page 2 - Ms. Sarah McIntyre
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 N. Melkerson
Mark N. Melkerson Director
Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K121725 510(k) Number (if known):
Device Name:
Pioneer Posterior Occipito-Cervico-Thoracic System
Indications:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System junetion (overperative disc disease (as defined by neck or back pain of 15 menocu for acgeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.
The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.
The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) using connectors.
OR Prescription Use __ ブ (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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121725