(74 days)
Not Found
No
The summary describes a mechanical pedicle screw system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an adjunctive treatment for various spinal conditions, indicating its role in managing or alleviating a disease or condition.
No
The provided text describes the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems as devices intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. It lists components like pedicle screws, rods, and hooks, and materials used. This is consistent with a therapeutic or surgical device, not a diagnostic one.
No
The device description explicitly lists hardware components such as pedicle screws, set screws, rods, hooks, instruments, and sterilizer trays, made of various materials. This indicates it is a physical medical device system, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine in skeletally mature patients. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device components are described as implants (screws, rods, hooks) and surgical instruments. These are physical devices used in surgery, not reagents, instruments, or software used to examine specimens.
- No mention of in vitro testing: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: degenerative disc disease (DDD); 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP
Device Description
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems includes components made of implant grade titanium alloy (Ti6Al4V ELI; ASTM F136-02A), cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537, and instrumentation made of PEEK (ASTM F2826) and stainless steel per ASTM F899. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle (polyaxial) screws, set screws, rods, hooks, instruments, and sterilizer trays. Additionally, cross connector components are available with the Lancer™ Open Pedicle system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, non-cervical
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)
Performance Standards: Torsional Grip and Axial Grip per ASTM F1798
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.
Alphatec Zodiac (K033090), Thunderbolt and Lancer™ Pedicle Spinal System (K132049), Globus Revere (K061202)
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
§ 888.3070 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Choice Spine LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K160775
Trade/Device Name: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: March 18, 2016 Received: March 21, 2016
Dear Ms. Finch:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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 yours,
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) K160775
Device Name
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Indications for Use (Describe)
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: degenerative disc disease (DDD); 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (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.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared: | May 27, 2016 |
|---|---|
| Sponsor: | Choice Spine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| Proposed Proprietary | |
| Trade Name: | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems |
| Product Class: | Class III |
| Classification Name: | 888.3060 Spinal Interlaminal Fixation Orthosis |
| 888.3070 - Pedicle Screw Spinal System | |
| Device Product Code: | NKB, MNH, MNI, KWP |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for additional hooks and the |
| additional KWP product code indication to the already cleared Thunderbolt™ and | |
| Lancer™ Pedicle screw System. | |
| Device Description: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems |
| includes components made of implant grade titanium alloy (Ti6Al4V ELI; ASTM | |
| F136-02A), cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537, and | |
| instrumentation made of PEEK (ASTM F2826) and stainless steel per ASTM F899. | |
| These components are available in various designs and sizes that allow the | |
| surgeon to build an implant construct suited to a patient's anatomical and | |
| physiological requirements. | |
| The components include: pedicle (polyaxial) screws, set screws, rods, hooks, | |
| instruments, and sterilizer trays. Additionally, cross connector components are | |
| available with the Lancer™ Open Pedicle system. | |
| Indications: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw |
| Systems are 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: degenerative disc disease | |
| (DDD; 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; deformities or curvatures (i.e., scoliosis, | |
| kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. | |
| When used in a posterior percutaneous approach with MIS instrumentation, the | |
| Thunderbolt™ System is intended for non-cervical pedicle fixation for the | |
| following indications: 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, | |
| pseudoarthrosis; and failed previous fusion in skeletally mature patients. | |
| When used for hook fixation, The Lancer™ Open Pedicle Screw System is | |
| intended for posterior, non-cervical pedicle and non-pedicle fixation for the | |
| following indications: degenerative disc disease(DDD) (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; | |
| pseudoarthrosis; and failed previous fusion. | |
| Predicate Devices: | (Primary) Alphatec Zodiac (K033090) |
| Thunderbolt and Lancer™ Pedicle Spinal System (K132049) | |
| Globus Revere (K061202) | |
| Performance Standards: Torsional Grip and Axial Grip per ASTM F1798 | |
| Conclusion: | Choice Spine concludes that the Thunderbolt™ Minimally Invasive and Lancer™ |
| Open Pedicle Screw System is equivalent to the primary predicate, Alphatec - | |
| Zodiac (K033090) as well as the additional predicates Choice Spine Thunderbolt™ | |
| and Lancer™ (K132049), and Globus Revere (K061202) systems. | |
| Equivalence is based on the similarities in the indications for/intended use, design, | |
| product offering, materials used and levels of attachment when compared to the | |
| predicates. |
4