(84 days)
Not Found
No
The document describes a mechanical spinal fixation system and its associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and MR compatibility.
Yes
The device is described as a 'Spinal Fixation System' intended for various spinal indications such as degenerative disc disease, trauma, and deformities, which directly addresses medical conditions to restore function and alleviate symptoms.
No
Explanation: The device is described as a spinal fixation system intended for surgical implantation to provide stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it is a "multiple component cannulated pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct," listing physical components like rods, screws, crosslinks, and set screws made of titanium alloy. It also mentions "Class I manual instruments." This clearly indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 provided text describes a surgical implant system (pedicle screws, rods, etc.) used for spinal fixation. It is a physical device implanted into the body.
- Intended Use: The intended use is for posterior spinal fixation as an adjunct to fusion, addressing various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant and associated instrumentation, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformites or curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
Streamline MIS Spinal Fixation System is a temporary, multiple component cannulated pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, extended tab cannulated polyaxial pedicle screws, crosslinks, and locking set screws that are fabricated from titanium alloy (ASTM F136) and provided nonsterile. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.
The locking set screw for use with the subject system is the same as that cleared through K 130286, and will continue to be labeled with the Streamline TL trade name.
Similarly, the crosslinks used with the subject system were previously cleared as part of predicate system K130286 and will continue to be labeled with their respective trade names, Streamline TL Crosslinks and Quantum X-Links.
The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Class I manual instruments are also included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical pedicle, T1-S2 or sacral/iliac
Indicated Patient Age Range
skeletally mature patients
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)
Non-standard testing was used to verify the performance characteristics of the instrumentation. Clinical testing was not required to establish substantial equivalence. The subject drivers were tested for torque to failure characterization, characterized the torque required for bone insertion, to show the torque characterization for cannulated driver materials, and to characterize the torque to failure for the breakaway and hexalobe tip redesign features. All testing supports that Streamline MIS Spinal Fixation System is substantially equivalent to the predicate device for safety and efficacy.
Standard testing was used to determine appropriate MR labeling of this device. Clinical testing was not required to establish substantial equivalence. The subject system was tested to ASTM F2503-13, ASTM F2502-15, ASTM F2213-17 and ASTM F2182-11a. Testing concluded Streamline Spinal Fixation System is 'MR Conditional' and will be labelled as such.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2019
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Michael R. Mach Senior Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K192396
Trade/Device Name: Streamline MIS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 30, 2019 Received: September 3, 2019
Dear Mr. Mach:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192396
Device Name Streamline MIS Spinal Fixation System
Indications for Use (Describe)
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformites or curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
| 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
| Date Prepared: | August 30, 2019 |
|---|---|
| Submitter: | Pioneer Surgical Technology, Inc. |
| DBA RTI Surgical, Inc. | |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Registration No. 1833824 | |
| Contact Person: | Michael R. Mach |
| Senior Regulatory Affairs Specialist | |
| Phone: (386) 418-8888 Ext. 7936 | |
| Fax: (386) 418-1627 | |
| Email: mmach@rtix.com | |
| Alternate Contact: | Kristina Hall |
| Senior Regulatory Affairs Manager | |
| Phone: (386) 418-8888 Ext. 4511 | |
| Fax: (386) 418-1627 | |
| Email: khall@rtix.com | |
| Device | |
| Trade Name: | Streamline MIS Spinal Fixation System |
| Common Name: | Pedicle Screw Spinal System |
| Regulation Number: | 21 CFR 888.3070 Thoracolumbosacral pedicle screw system |
| Product Codes: | NKB (thoracolumbosacral pedicle screw system) |
| Product Classification: | Class II |
| Predicate Device | K130286 Streamline MIS Spinal Fixation System |
Additional Predicate Device
K140696 Streamline TL Spinal Fixation System
Device Description
Streamline MIS Spinal Fixation System is a temporary, multiple component cannulated pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, extended tab cannulated polyaxial pedicle screws, crosslinks, and locking set screws that are fabricated from titanium alloy (ASTM F136) and provided nonsterile. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is
4
completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.
The locking set screw for use with the subject system is the same as that cleared through K 130286, and will continue to be labeled with the Streamline TL trade name.
Similarly, the crosslinks used with the subject system were previously cleared as part of predicate system K130286 and will continue to be labeled with their respective trade names, Streamline TL Crosslinks and Quantum X-Links.
The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Class I manual instruments are also included.
This remains unchanged from K130286.
Indications for Use
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
This remains unchanged from K130286 except for addition of "or sacral/iliac screw fixation" in alignment with RTI's K140696 Streamline TL Spinal Fixation System.
Comparison to Predicate
When compared to the predicate and reference devices, the Pioneer Surgical Technology Streamline MIS Spinal Fixation System presented in this submission have the:
- Same Intended Use
- Same Technological characteristics and Operating principle ●
- Same Design Features ●
- Same Performance
- Same Base Materials (stainless steel, titanium)
- Same Shelf Life
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Summary of Mechanical Performance Data
Non-standard testing was used to verify the performance characteristics of the instrumentation. Clinical testing was not required to establish substantial equivalence. The subject drivers were tested for torque to failure characterization, characterized the torque required for bone insertion, to show the torque characterization for cannulated driver materials, and to characterize the torque to failure for the breakaway and hexalobe tip redesign features. All testing supports that Streamline MIS Spinal Fixation System is substantially equivalent to the predicate device for safety and efficacy.
Summary of Magnetic Resonance (MR) Safety Evaluation
Standard testing was used to determine appropriate MR labeling of this device. Clinical testing was not required to establish substantial equivalence. The subject system was tested to ASTM F2503-13, ASTM F2502-15, ASTM F2213-17 and ASTM F2182-11a. Testing concluded Streamline Spinal Fixation System is 'MR Conditional' and will be labelled as such.
Conclusion
The information provided in this submission demonstrates that the subject system is substantially equivalent to legally marketed pedicle screw systems with respect to intended use, technological characteristics and performance.