(245 days)
No
The description focuses on the mechanical components and intended use for spinal stabilization, with no mention of AI or ML capabilities.
Yes
The device is described as providing immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal conditions, which directly relates to supporting or restoring a patient's health.
No
The device is described as a system of implants (rods, pedicle screws, connectors, and set screws) intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is to physically support and stabilize, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of rods, pedicle screws, connectors, and set screws, all of which are physical hardware components made of Titanium Alloy. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Streamline MIS Cannulated System as a system of implants (rods, screws, connectors) intended for surgical implantation to stabilize the spine. It is used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, based on the provided information, the Streamline MIS Cannulated System is a surgical implant device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Streamline MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
Product codes
MNH, MNI
Device Description
The Streamline MIS Cannulated System consists of rods, pedicle screws, connectors, and set screws 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. The Streamline MIS Cannulated System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lower thoracic and/or lumbar spine during open or percutaneous spinal procedures. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, Rods and Connecting components are comprised of Titanium Alloy per ASTM F 136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; L5-S1 vertebra; L3-S1
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)
Mechanical testing was presented to characterize construct and component performance, including testing static and fatigue compression bending and static torsion per recognized ASTM F1717 as outlined in FDA's "Guidance for Industry and Staff: Spinal Systems 510(k)s" issued May 3, 2004.
Additional testing was performed per internal protocols to characterize component performance and included evaluation of crosslink disassociation, saddle/cap separation, and yoke disassociation from screw head.
The test results of verification testing demonstrate that the mechanical performance of the Pioneer Streamline MIS Cannulated System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080026, K072187, K080518, K080504
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
3.0 510(k) Summary
Sponsor: Pioneer Surgical Technology AUG 10 2010 375 River Park Circle Marquette, MI 49855 (906) 225-5602 Contact: Emily M. Downs Prepared: August 10, 2010 Device Name: Streamline MIS Cannulated System Classification Name: Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System - §888.3070, Class II. Product Codes: Product codes: MNH, MNI; Panel Code 87 Predicate Device: K080026 - Quantum MIS Cannulated System (SE date - 1/28/08) K072187 - LowTop Spinal Rod System (SE date - 10/12/07) K080518 - Quantum Spinal System (SE date -- 3/20/08) K080504 - LowTop Spinal Rod System (SE date - 3/20/08) Description: The Streamline MIS Cannulated System consists of rods, pedicle screws, connectors, and set screws 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. The Streamline MIS Cannulated System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lower thoracic and/or lumbar spine during open or percutaneous spinal procedures. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, Rods and Connecting components are comprised of Titanium Alloy per ASTM F 136. Intended Use: The Streamline MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), spinal tumor, and failed previous fusion /or (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the
treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine
1
| fusion. | |
|---|---|
| Technological | |
| Characteristics | The Streamline MIS Cannulated System consists of a range of |
| polyaxial screw lengths and diameters that match that of predicate | |
| systems. The rods and connecting components are identical to that | |
| of the predicate system. Intended Use and Materials are also | |
| identical to that of the predicate systems. |
Both the Streamline MIS Cannulated and the predicate system use a
component (set screw/ cap) that connects to the screw yoke to lock
down the rod/ screw head. The mechanism by which this
component locks to the screw head is different between the
Streamline MIS Cannulated (threaded) and that of the Pioneer
predicate system (cam lock). |
| Performance Data: | Mechanical testing was presented to characterize construct and
component performance, including testing static and fatigue
compression bending and static torsion per recognized ASTM F1717
as outlined in FDA's "Guidance for Industry and Staff: Spinal
Systems 510(k)s" issued May 3, 2004,
Additional testing was performed per internal protocols to
characterize component performance and included evaluation of
crosslink disassociation, saddle/cap separation, and yoke
disassociation from screw head.
The test results of verification testing demonstrate that the
mechanical performance of the Pioneer Streamline MIS Cannulated
System is substantially equivalent to the predicate devices. |
| Performance and SE
Determination: | Comparisons of device performance data, materials, indications and
design/function to predicate devices were provided in making a
determination of substantial equivalence. |
(L3-S1) with removal of the implants after the attainment of a solid
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or other bird, with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % Ms. Emily M. Downs Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855-0627
Re: K093771
Trade/Device Name: Streamline MIS Cannulated System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: July 30, 2010 Received: August 02, 2010
Dear Ms. Downs:
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
. AUG 10 2010
3
Page 2 - Mr.
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/CDRHOffices/ycm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 Indications for Use Statement
K093771 AUG 1 0 2010
510(k) Number (if known): K093771
Device Name:
Indications for Use:
Streamline MIS Cannulated System
The Streamline MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use -----------
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO43771 510(k) Number_