(138 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI/ML components or functionalities.
Yes
The device is intended to promote fusion and provide stabilization for various spinal conditions, which are therapeutic interventions.
No
The Streamline OCT Occipito-Cervico-Thoracic System is described as a system of rods, hooks, screws, and connecting components used to build a spinal construct for promoting fusion and stabilization, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, plates, and connecting components, 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, hooks, screws, plates, and connectors used to build a spinal construct. These are physical components for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
Therefore, the Streamline OCT Occipito-Cervico-Thoracic System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic 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, 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 (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 Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Streamline OCT Occipito-Cervico-Thoracic 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 add components to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and 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)
The subject system was evaluated per ASTM F1717 Static and Dynamic Compression Bending and Torsion Testing and compared to legally marketed predicate systems. Also, ASTM F1798 testing was performed to evaluate the interconnection mechanisms and subassemblies used in the worst-case spinal construct. Testing demonstrated that the device is as safe, as effective and performs as well as or better than 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 Streamline Occipito-Cervico-Thoracic (OCT) System (K121725), Exactech Gibralt Occipital Spine System (K110197/K121877), Synthes Cervifix/Axon (K991089/K023675), Nex-Link Spinal Fixation System (K031985), DePuy Mountaineer OCT Spinal System (K110353), NuVasive Vuepoint OCT System (K093319)
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
.
:
| Sponsor: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bethany Byman
Phone: (906) 226-4803
Fax: (906) 226-4459 |
| Prepared: | March 19, 2014 |
| Trade name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Common name: | Posterior Occipito-Cervico-Thoracic System |
| Classification: | Class II per §888.3050 Spinal Interlaminal fixation orthosis |
| Product Codes/
Panel: | KWP
Panel Code 87 |
| Predicates: | Pioneer Streamline Occipito-Cervico-Thoracic (OCT) System (K121725)
Exactech Gibralt Occipital Spine System (K110197/K121877)
Synthes Cervifix/Axon (K991089/K023675)
Nex-Link Spinal Fixation System (K031985)
DePuy Mountaineer OCT Spinal System (K110353)
NuVasive Vuepoint OCT System (K093319) |
| Description: | The Streamline OCT Occipito-Cervico-Thoracic 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 add components to the system. |
| Materials: | The system components are manufactured from medical grade ASTM F136
titanium alloy and ASTM F71537 cobalt chromium alloy. Medical grade
titanium alloy and cobalt chromium alloy may be used together. |
| Pre-Clinical
Performance Data: | The subject system was evaluated per ASTM F1717 Static and Dynamic
Compression Bending and Torsion Testing and compared to legally marketed
predicate systems. Also, ASTM F1798 testing was performed to evaluate the
interconnection mechanisms and subassemblies used in the worst-case spinal
construct. Testing demonstrated that the device is as safe, as effective and
performs as well as or better than predicate systems. |
| Intended Use: | When intended to promote fusion of the cervical spine and occipito-cervico-
thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-
Thoracic 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, 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 (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 Streamline OCT System can also be linked to FDA cleared pedicle screw
systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal
Fixation System or Streamline TL Spinal System) using connectors. |
| Technological
Characteristics: | The subject and predicate systems are overall similar in:
- Intended use
- Basic design: rod-based with screw/hook/plate anchors and connecting
components - Materials: Titanium alloy and cobalt chromium alloy
- Sizes: dimensions comparable to predicates
- Sterilization and cleaning methods
- Performance: equivalent mechanical test results
The fundamental scientific technology of the subject system is the same as
predicate devices. There are no significant differences between the
Streamline OCT System and the predicate devices which would adversely
affect the use of the product. |
| Substantial
Equivalence: | This submission supports the position that the subject system is
substantially equivalent to previously cleared pedicle screw systems based
on comparison of indications for use, intended use, materials, technological
characteristics, and pre-clinical performance testing. |
510(k) Summary Pursuant to 21 CFR 807.92
1
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2014
Pioneer Surgical Technology, Inc. Ms. Bethany Byman Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855
Re: K133374
Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: February 03, 2013 Received: February 04, 2013
Dear Ms. Byman:
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.
3
Page 2 - Ms. Bethany Byman
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Vincen同)Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K133374
Device Name: Streamline OCT Occipito-Cervico-Thoracic System
When intended to promote fusion of the cervical spine and occipito-cervico Indications: thoracic junction (occiput-T3); the Streamline 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, 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 (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 Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.
V OR 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 Center for Devices and Radiological Health (CDRH)
Colin O'Neill
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133374