(84 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is a medical implant designed to promote spinal fusion and treat various spinal conditions, directly addressing health issues and improving patient well-being, which aligns with the definition of a therapeutic device.
No
The Streamline OCT System is a spinal fixation system designed to promote fusion and provide stability in the cervical spine and occipito-cervico-thoracic junction. Its purpose is to treat conditions like degenerative disc disease, spinal stenosis, and fractures by physically stabilizing the spine, not to diagnose these conditions. The document describes its components and intended use for treatment, not for diagnosis.
No
The device description explicitly lists physical components such as rods, hooks, screws, plates, and connecting components, indicating it is a hardware-based medical device.
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 of the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details components like rods, screws, hooks, and plates, which are all physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is used directly on the spine, which is consistent with a surgical implant.
- Performance Studies: The performance studies focus on engineering analysis and comparison to predicate devices for structural integrity and safety in a surgical context.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
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), 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 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
KWP
Device Description
The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the predicate K133374 Streamline OCT 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)
Engineering analysis was sufficient to demonstrate that the subject components do not introduce new worst-case components. Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product and therefore, no new testing was required for the determination of substantial equivalence. The subject product is expected to be as safe, as effective, and perform as well as the predicate.
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
§ 888.3050 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K150254
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 2, 2015 Received: February 3, 2015
Dear Ms. Pleaugh:
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
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Page 2 - Ms. Sarah Pleaugh
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Streamline OCT Occipito-Cervico-Thoracic System
Indications for Use (Describe)
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), 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 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.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary As required by 21 CFR 807.92 K15___________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Pioneer Surgical Technology, Inc.
(DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Pleaugh |
| Phone: | (906) 225-5861 |
| Fax: | (906) 226-4459 |
| Prepared: | February 2, 2015 |
| 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: | K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System
K132332 DePuy Mountaineer OCT Spinal System
K133556 Zimmer Virage OCT Spinal System |
| Description: | The Streamline OCT System consists of a variety of rods, hooks, polyaxial
screws, high-angle screws, locking caps, occipital plates, occipital screws,
and connecting components used to build an occipito-cervico-thoracic
spinal construct. The purpose of this submission is to add components to
the predicate K133374 Streamline OCT System. |
| Materials: | The Streamline OCT System components are manufactured from ASTM
F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt
chromium. Medical grade titanium alloy and medical grade cobalt
chromium may be used together. |
| Technological
Characteristics: | The subject components are overall similar in technological
characteristics as compared to the predicates in terms of:
- Basic technology: polyaxial screws with threaded locking mechanism,
pre-bent OCT spinal rods - Materials: Titanium alloy and cobalt chromium alloy
- Design: sizes and dimensions equivalent or comparable to predicates
There are no significant differences between the subject and predicate
devices which would raise new issues of safety or effectiveness. |
| | Page 1 of 2 |
| 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. |
| Non-Clinical
Performance Data: | Engineering analysis was sufficient to demonstrate that the subject
components do not introduce new worst-case components. Previously
completed Streamline OCT System testing is sufficient to support the
performance of the subject product and therefore, no new testing was
required for the determination of substantial equivalence. The subject
product is expected to be as safe, as effective, and perform as well as the
predicate. |
| Substantial
Equivalence: | The subject system is substantially equivalent to previously cleared
posterior OCT systems based on comparison of intended use, materials,
design, technological characteristics, and performance. |
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