(32 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities, as well as to restore the integrity of the spinal column, which are therapeutic indications.
No
Explanation: The device is described as an implantation system (rods, hooks, screws, plates) for spinal immobilization, which is a therapeutic function, not a diagnostic one. Its purpose is to provide support and aid fusion after diagnosis has been made.
No
The device description explicitly states that the system consists of various hardware components such as rods, hooks, screws, plates, and connecting components made from titanium and cobalt chromium alloys. It also mentions surgical instruments and cases/caddies. There is no mention of software as a component of the 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 Streamline OCT Occipito-Cervico-Thoracic System is described as a system of implants (rods, screws, plates, etc.) made of titanium and cobalt chromium molybdenum alloy, intended for surgical implantation to stabilize the spine.
- Intended Use: The intended use is to provide immobilization and restore the integrity of spinal segments through surgical intervention, not through the analysis of bodily specimens.
The information provided clearly indicates this is a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
Product codes (comma separated list FDA assigned to the subject device)
NKG, 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. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1 to C7), thoracic spine (T1 to T3)
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, including ASTM F1798 testing, was presented to confirm that the subject components do not introduce new worst-case components or cause the system to be more susceptible to loosening or failure. Mechanical construct testing (ASTM F1717 and ASTM F2706) demonstrated that the subject and predicate systems are substantially equivalent. No new risks to safety or effectiveness were raised by the non-clinical testing.
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.
K161498, K143471, K151885, K160697
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
August 18, 2017
Re: K172139
Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: July 13, 2017 Received: July 17, 2017
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 (DICE) 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. 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172139
Device Name
Streamline OCT Occipito-Cervico-Thoracic System
Indications for Use (Describe)
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green leaf-like shape above it.
510(k) Summary As required by 21 CFR 807.92
| As required by 21 CFR 807.92 | |
|---|---|
| Company: | Pioneer Surgical Technology, Inc. |
| DBA RTI Surgical, Inc. | |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Phone: (906) 226-9909 | |
| Fax: (906) 225-5868 | |
| Prepared: July 13, 2016 | |
| Contact: | Sarah Pleaugh, Regulatory Affairs Specialist |
| Trade name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Common name: | Posterior Occipito-Cervico-Thoracic System |
| Classification: | Unclassified; Pre-amendment device (Product Code NKG - |
| Orthosis, Cervical Pedicle Screw Spinal Fixation) | |
| Class II; 21 CFR 888.3050 (Product Code KWP - Appliance, | |
| Fixation, Spinal Interlaminal) | |
| Panel: | Panel Code 87 |
| Predicates: | Primary Predicate: Pioneer Surgical Technology, Inc. DBA RTI |
| Surgical, Inc. Streamline OCT System (K161498) | |
| Additional Predicates: | |
| Medtronic VERTEX Reconstruction System (K143471) | |
| DePuy Summit/Mountaineer OCT System (K151885) | |
| Exactech Gibralt® Spine System and Gibralt® Occipital Spine | |
| System (K160697) | |
| 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. System components are | |
| manufactured from ASTM F136 medical grade titanium alloy and | |
| ASTM F1537 medical grade cobalt chromium molybdenum alloy. | |
| Medical grade titanium alloy and medical grade cobalt chromium | |
| molybdenum alloy may be used together. The system should be | |
| implanted using only the surgical instruments designed for the | |
| system. Cases and caddies are supplied for sterilization and | |
| transport of the implants and instruments. | |
| The purpose of this submission is to modify and add components to | |
| the system. | |
| Indications for | |
| Use: | The Streamline OCT Occipito-Cervico-Thoracic System is intended |
| to provide immobilization and stabilization of spinal segments as an | |
| adjunct to fusion when using autograft and/or allograft for the | |
| following acute and chronic instabilities of the craniocervical | |
| junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to | |
| T3): traumatic spinal fractures and/or traumatic dislocations; | |
| instability or deformity; failed previous fusions (e.g., pseudarthrosis); | |
| tumors involving the cervical/thoracic spine; and degenerative | |
| disease, including intractable radiculopathy and/or myelopathy, neck | |
| and/or arm pain of discogenic origin as confirmed by radiographic | |
| studies, and degenerative disease of the facets with instability. |
The system is also intended to restore the integrity of the spinal
column even in the absence of fusion for a limited time period in
patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit
achievement of fusion.
In order to achieve additional levels of fixation, the Streamline OCT
System may be connected to the Quantum Spinal Fixation System,
Streamline MIS Spinal Fixation System or Streamline TL Spinal
System using connectors and/or transition rods. | |
| Summary of
Technological
Characteristics: | The subject system has a similar fundamental scientific
technology as the predicates. The subject system utilizes
equivalent surgical approaches, fundamental technology, designs,
materials, sterilization and packaging as the predicate devices. |
| Discussion of
Supporting
Clinical Evidence
and Non-Clinical
Testing: | Engineering analysis, including ASTM F1798 testing, was presented
to confirm that the subject components do not introduce new worst-
case components or cause the system to be more susceptible to
loosening or failure. Mechanical construct testing (ASTM F1717
and ASTM F2706) demonstrated that the subject and predicate
systems are substantially equivalent. No new risks to safety or
effectiveness were raised by the non-clinical testing. |
| Substantial
Equivalence and
Comparison to
Legally Marketed
Devices: | The design features, materials, indications for use, surgical
approach, mechanical performance and fundamental technology
are substantially equivalent to predicate devices. This submission
demonstrates there are no new risks to safety or efficacy raised
by the subject Streamline OCT System. |
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Image /page/4/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green dot above it.