(138 days)
No
The device description focuses on mechanical components and surgical approaches, with no mention of AI or ML. The modifications described are related to physical features and manufacturing efficiency.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion, treating conditions like degenerative disc disease, spondylolisthesis, and trauma, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The SEURAT™ Universal Pedicle Screw System is a surgical implant designed for stabilization and promotion of spinal fusion; it is not used to diagnose a medical condition.
No
The device description clearly states it is a "multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism," which are all physical hardware components.
Based on the provided information, 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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SEURAT™ Universal Pedicle Screw System is a surgical implant used to stabilize the spine. It is physically implanted into the patient's body during surgery.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is mechanical stabilization, not diagnostic testing of samples.
Therefore, the SEURAT™ Universal Pedicle Screw System falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8 - L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.
The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.
Product codes
NKB, KWP, KWO
Device Description
The SEURAT™ Universal Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism. Various sizes of these implants are available. SEURAT™ Universal Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
SEURAT™ Universal Pedicle Screw System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. The rods, screws utilized as part of the proposed system are identical to devices cleared previously via K120714, K132365, and K140219. The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously via K120714, K121568, K132365, and K140219. The modifications include additional hexalobe screw-head driver feature; screw thread profiles, sizes, and lengths; and/or Minimally Invasive Spine (MIS) screw housing tower ring enhancement which will accommodate wider range of surgeons' usage preference, anatomically bigger patients, and/or consolidation of similar sub-components throughout all CTL Medical's pedicle screw systems for manufacturing efficiency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 - S2/ilium, T8 - L5
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: static compression bending, static tension bending, static torsional and fatigue (dynamic) compression bending testing.
Sample size: Not Specified
Key results: The results met all acceptance criteria and demonstrate that the SEURAT™ Universal Pedicle Screw System does not raise concerns regarding safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K132365, K120714, K121568, K140219
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.
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Image /page/0/Picture/0 description: The image contains 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.
February 14, 2018
CTL Medical Corporation % Mr. Barry E. Sands President ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K173185
Trade/Device Name: SEURAT™ Universal Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 5, 2018 Received: February 8, 2018
Dear Mr. Sands:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -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) K173185
Device Name SEURATTM Universal Pedicle Screw System
Indications for Use (Describe)
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8 - L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.
The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.
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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510(k) SUMMARY
CTL Medical Corporation's SEURAT™ Pedicle Screw System
| Submitter | CTL Medical Corporation
Tosan Onosode
4550 Excel Parkway Suite 300 Addison, TX
75001
Phone: 214-545-5820
Fax: 888-831-4892 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barry E. Sands
RQMIS, Inc.
110 Haverhill Road, Suite 526
Amesbury, MA 01913
Phone: 978-358-7307 |
| Date Prepared: | February 5, 2018 |
| Name of Device | SEURAT™ Universal Pedicle Screw System |
| Name/Address of Sponsor: | CTL Medical Corporation
Sean Suh
4550 Excel Parkway Suite 300 Addison, TX 75001 |
| Common or Usual Name | Pedicle Screw Spinal System, Non-cervical |
| Classification Name: | Per 21 CFR as follows:
§888.3050 Appliance, Fixation, Spinal Interlaminal
§888.3060 Spinal Intervertebral Body Fixation Orthosis
§888.3070 Thoracolumbar pedicle screw system
Product Codes: NKB, KWP, KWQ |
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Predicate Devices
Primary Predicate: K132365, Raphael Pedicle Screw System
Additional Predicates:
K120714, PICASSO MIS Spinal System K121568, DALI Spinal Fixation System K140219, PICASSO II MIS Spinal System
Device Description
Indications for Use:
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8-L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation
Technological Characteristics
The SEURAT™ Universal Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism. Various sizes of these implants are available. SEURAT™ Universal Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
SEURAT™ Universal Pedicle Screw System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. The rods, screws utilized as part of the proposed system are identical to devices cleared previously via K120714, K132365, and K140219. The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously via K120714, K121568, K132365, and K140219.
The fundamental scientific technology and intended use are unchanged from the legally marketed predicate pedicle screw systems. The proposed system will use a modified version of DALI Spinal Fixation System previously cleared via K121568, a modified version of RAPHAEL Pedicle Screw System previously cleared via K132365 and additional lengths for anatomically bigger patients, and a modified version of PICASSO-II MIS Spinal System previously cleared via K140219 predicate based on the K120714, PICASSO MIS Spinal System) and additional size and lengths for anatomically bigger patients. The modifications include additional hexalobe screw-head driver feature; screw thread profiles, sizes, and lengths; and/or Minimally Invasive Spine (MIS) screw housing tower ring enhancement which will accommodate wider range of surgeons' usage preference, anatomically bigger patients, and/or consolidation of similar sub-components throughout all CTL Medical's pedicle screw systems for manufacturing efficiency.
Performance Data
The SEURAT™ Universal Pedicle Screw System device underwent static compression bending, static
5
tension bending, static torsional and fatigue (dynamic) compression bending testing according to ASTM F1717. The results met all acceptance criteria and demonstrate that the SEURAT™ Universal Pedicle Screw System does not raise concerns regarding safety and effectiveness.
Conclusion
The SEURAT™ Universal Pedicle Screw System is as safe and effective as the predicate systems i.e. the primary predicate Raphael Pedicle Screw System (K132365) and the additional predicates: PICASSO MIS Spinal System (K120714), and DALI Spinal Fixation System (K121568).
The SEURAT™ Universal Pedicle Screw System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SEURAT™ Universal Pedicle Screw System and its predicate devices raise no new issues of safety or effectiveness. Thus, the SEURAT™ Universal Pedicle Screw System is substantially equivalent.