(102 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to treat acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine as an adjunct to fusion. This aim to treat or alleviate disease, which aligns with the definition of a therapeutic device.
No
This device is described as a "Pedicle Screw System" intended for "immobilization and stabilization of spinal segments" as an "adjunct to fusion." This indicates a therapeutic or supportive role in treatment, rather than a diagnostic one. The "Intended Use" section lists conditions it treats, not conditions it diagnoses.
No
The device description explicitly states it is a "spinal fixation system including polyaxial screws, rods, and connectors," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for the immobilization and stabilization of spinal segments. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a spinal fixation system including screws, rods, and connectors, which are implants. IVDs are typically reagents, instruments, or systems used to perform tests on biological samples.
- Performance Studies: The performance studies described are mechanical tests on the device itself, not studies evaluating the performance of a diagnostic test on biological samples.
Therefore, the STARFIRE™ Pedicle Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Choice Spine STARFIRE™ Pedicle Screw 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerate 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.
Product codes
MNI, MNH, NKB
Device Description
The Choice Spine STARFIRE™ Pedicle Screw System is a top-loading, polyaxial screw spinal fixation system including polyaxial screws, rods, and connectors. The components are provided clean and non-sterile. Various sizes of the implants are provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
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
Mechanical testing was performed according to the guidelines outlined in ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." Static compression bending tests showed that cannulated STARFIRE pedicle screw constructs were equivalent, with respect to bending loads and stiffness, to non-cannulated predicate pedicle fixation systems. Compression bending fatigue tests demonstrated that the cannulated STARFIRE pedicle screw constructs had equivalent or greater endurance strength compared to non-cannulated predicate pedicle fixation systems. In static torsional tests the cannulated STARFIRE pedicle screw constructs, without cross-connectors, were able to resist loads greater than the range of resistance required for the human lumbar spine. Test results indicate that the STARFIRE™ System is equivalent to the predicates in each of the test modes.
Key Metrics
Not Found
Predicate Device(s)
K024096, K031585, K081684, K041592, K062174
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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8. 510(k) Summary
Preparation Date
November 11, 2010
Sponsor
Choice Spine, LP 306 Erin Drive Knoxville, TN 37919 p: 865.246.3333 f: 865.588.4045
Contact
G. Todd Hawkins Director of Regulatory Affairs/Quality Assurance
Trade Name
Choice Spine STARFIRE™ Pedicle Screw System
Common Name
Pedicle Screw Spinal System; Pedicle Screws
Regulatory Classification & Device Product Codes
888.3070
MNI - Orthosis, Spinal Pedicle Fixation MNH - Orthosis, Spondylolisthesis Spinal Fixation NKB - Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Predicate Devices
OPTIMA™ Spinal System (K024096, K031585) Firebird™ Spinal Fixation System (K081684) Coral™ Spinal Fixation System (K041592) Expedium™ 6.35 Spinal Fixation System (K062174)
Device Description
The Choice Spine STARFIRE™ Pedicle Screw System is a top-loading, polyaxial screw spinal fixation system including polyaxial screws, rods, and connectors. The components are provided clean and non-sterile. Various sizes of the implants are provided.
Intended Use
The Choice Spine STARFIRE™ Pedicle Screw 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 and chronic instabilities
NOV 1 5 2010
1
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.
Materials
The Choice Spine STARFIRE™ Pedicle Screw System implants are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, commercially pure titanium (G2) as described by ASTM F67 and stainless steel (316 LVM) as described by ASTM F138.
Technological Characteristics
The Choice Spine STARFIRE™ Pedicle Screw System consists of a range of polyaxial screws, rods, and connectors identical to the identified predicate systems.
The Intended Use of the STARFIRE™ System is identical to the predicate systems. The STARFIRE™ System materials are similar to the predicate systems.
The STARFIRE™ Pedicle Screw System utilizes a set screw mechanism to secure the rod in the same manner as the predicate systems.
Substantial Equivalence
Documentation was provided that demonstrates the Choice Spine STARFIRE™ Pedicle Screw System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, materials, and performance.
Mechanical testing was performed according to the guidelines outlined in ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
Static compression bending tests showed that cannulated STARFIRE pedicle screw constructs were equivalent, with respect to bending loads and stiffness, to noncannulated predicate pedicle fixation systems.
Compression bending fatigue tests demonstrated that the cannulated STARFIRE pedicle screw constructs had equivalent or greater endurance strength compared to non-cannulated predicate pedicle fixation systems.
In static torsional tests the cannulated STARFIRE pedicle screw constructs, without cross-connectors, were able to resist loads greater than the range of resistance required for the human lumbar spine.
Test results indicate that the STARFIRE™ System is equivalent to the predicates in each of the test modes. Documentation of the testing is available in Section 16.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three lines extending from its head, representing growth and development. To the left of the figure, the text "DEPARTMENT OF HEALTH &" is arranged vertically, followed by "HUMAN SERVICES" in a curved formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Choice Spine, LP % Mr. G. Todd Hawkins Director of Regulatory Affairs/Quality Assurance 306 Erin Drive Knoxville, Tennessee 37919
NOV 1 5 2010
Re: K102204
Trade/Device Name: Choice Spine STARFIRE™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: October 21, 2010 Received: October 22, 2010
Dear Mr. Hawkins:
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
3
Page 2 - Mr. G. Todd Hawkins
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); 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Muchup
Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indication for Use Statement
510(k) Number (if known): KLU2204
NOV 1 5 2010
Device Name: Choice Spine STARFIRE" Pedicle Screw System
Indications for Use:
The STARFIRE™ Pedicle Screw 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 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
Prescription Use _ _ _ _ X _ Over-The-Counter Use (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(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
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510(k) Number_________________________________________________________________________________________________________________________________________________________________