(84 days)
The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (TI-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.
The Streamline TL Spinal System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Instrumentation is also available to facilitate implant of device components. The purpose of this submission is to include the Streamline TL Crosslink to the Streamline TL System. The Cross Link is designed to provide added fixation to the spinal construct and is available in fixed (16-45mm) and variable lengths (37 - 85mm).
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Streamline TL Spinal System, structured according to your request:
Based on the provided K111502 510(k) summary for the Streamline TL Spinal System, the device in question is a spinal implant for fixation, not an AI/ML-driven device or an imaging device. Therefore, the questions related to AI performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth for training sets are not applicable to this submission. This 510(k) pertains to a hardware medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result and comparison) |
|---|---|
| Mechanical Testing: | |
| Compression Bending Fatigue (per ASTM F1717) | Functioned as intended; substantially equivalent to the predicate system (K110692). |
| Torsional Static Mechanical Testing (per ASTM F1717) | Functioned as intended; substantially equivalent to the predicate system (K110692). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of test samples (e.g., number of constructs or specific components) used for the mechanical tests. ASTM F1717 would define the minimum number of specimens for such tests, but this detail is not present in the summary.
- Data Provenance: The data is generated from retrospective mechanical testing conducted by the manufacturer, Pioneer Surgical Technology, Inc., likely at their facilities or a contracted lab. The country of origin for the data generation is implicitly the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For a spinal implant, "ground truth" is defined by established engineering standards for mechanical performance (e.g., ASTM F1717) rather than expert radiographic or clinical interpretation. Performance is assessed against these quantifiable engineering benchmarks.
4. Adjudication Method for the Test Set
This question is not applicable. Mechanical testing results are objective measurements and do not typically involve an adjudication process in the way clinical or imaging studies do. The results are compared directly against the performance of the predicate device under the same test conditions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This question is not applicable. The device is a spinal implant, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a spinal implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of this device is based on established mechanical engineering standards (specifically ASTM F1717 for compression bending fatigue and torsional static mechanical testing) and comparison to the performance of a legally marketed predicate device (K110692 - Streamline TL Spinal System). The goal is to demonstrate "substantial equivalence" in mechanical performance.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI model, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, there is no training set for this type of device.
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AUG 2 3 2011
3.0 510(k) Summary
| Sponsor: | Pioneer Surgical Technology, Inc.375 River Park CircleMarquette, MI 49855(906) 225-5602Contact: Sarah McIntyreDate prepared: August 18, 2011 |
|---|---|
| Device Name: | Streamline TL Spinal System |
| Classification Name: | 888.3060, Spondylolisthesis Spinal Fixation Device System and 888.3070 PedicleScrew Spinal System, Class III |
| Product Codes: | NKB, KWQ, MNH, MNI, Panel Code 87 |
| Predicate Device: | K110692 - Streamline TL Spinal System (SE date -- May 12, 2011) |
| Description: | The Streamline TL Spinal System consists of a variety of rods, pedicle screws,connectors, set screws and other connection components used to build a spinalconstruct. The implant components can be rigidly locked into a variety ofconfigurations, with each construct being tailor-made for the individual case.Instrumentation is also available to facilitate implant of device components. |
| The purpose of this submission is to include the Streamline TL Crosslink to theStreamline TL System. The Cross Link is designed to provide added fixation to thespinal construct and is available in fixed (16-45mm) and variable lengths (37 -85mm). | |
| Intended Use: | The Streamline TL Spinal System components are non-cervical spinal fixationdevices intended as an adjunct to fusion for use as a pedicle screw (TI-S2),sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pediclescrew fixation is limited to skeletally mature patients. These devices are indicatedfor all of the following indications: degenerative disc disease (defined as discogenicback pain with degeneration of the disc confirmed by history and radiographicstudies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities orcurvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor,stenosis, pseudoarthosis, and failed previous fusion. |
| Material: | Screws, Set Screws, and Connecting components (including the Streamline TLCrosslink) are comprised of Titanium Alloy per ASTM F136. Rods are comprisedof Titanium Alloy per ASTM F136 or Cobalt Chromium Molybdenum Alloy perASTM F1537. |
| Performance Data: | Compression bending fatigue and torsional static mechanical testing per ASTMF1717 was presented to characterize the performance of the Streamline TL constructwith the Streamline TL Crosslink. |
| The results of verification testing demonstrate that the Streamline TL Crosslinkfunctioned as intended and performed in a manner substantially equivalent to that ofthe predicate system. | |
| Performance and SEDetermination: | Comparisons of device performance data, materials, indications and design/functionto predicate devices were provided in making a determination of substantialequivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology, Inc. % Ms. Sarah MeIntyre 375 River Park Circle Marquette, Michigan 49855
AUG 2 3 2011
Re: K111502
Trade/Device Name: Streamline TL Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, MNH, MNI Dated: May 27. 2011 Received: May 31, 2011
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
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Page 2 - Ms. Sarah McIntyre
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.
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/CDRHQffices/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
f. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K111502
Indications for Use Statement 2.0
KII | 502 510(k) Number (if known):
Streamline TL Spinal System Device Name:
The Streamline TL Spinal System components are non-cervical spinal fixation devices Indications for Use: intended as an adjunct to fusion for use as a pedicle screw (TI-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, pseudoarthosis, and failed previous fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K))1502 510(k) Number_
§ 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.