(209 days)
Not Found
No
The summary describes a mechanical spinal implant system and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, indicating a therapeutic purpose to treat diseases or injuries.
No
The device is described as an implantable system (pedicle screw system, longitudinal rods, polyaxial screws, cross connector) used to provide immobilization and stabilization for spinal fusion, not for diagnosing conditions.
No
The device description explicitly states the system consists of physical components like longitudinal rods, polyaxial screws, and cross connectors, which are hardware. The performance studies also describe mechanical testing of these physical 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 for the immobilization and stabilization of spinal segments within the body as an adjunct to fusion. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details physical components like screws, rods, and connectors, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The SpineFrontier® PedFuse® 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is 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, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
Product codes
MNH, MNI
Device Description
The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Spine Frontier has conducted mechanical testing to demonstrate that the modifications to the PedFuse® Pedicle Screw System provide adequate and substantially equivalent mechanical strength for their intended use. The PedFuse Pedicle Screw System was tested in the following modes:
- . Static Axial Compression Bending (ASTM F1717-13)
- . Static Torsion (ASTM F1717-13)
- Cyclic Axial Compression Bending (ASTM F1717-13) .
- Custom Instrument Testing .
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.
SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420), Medtronic TSRH® Spinal System (K091797), Pioneer Quantum Spinal System (K101790), Globus Transition™ Stabilization System (K073439)
Reference Device(s):
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
MAY 1 4 2014
5.510(K) SUMMARY
| Submitter's Name: | SpineFrontier, Inc. |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915, U.S.A. | |
| Submitter's Telephone: | 978.232.3990 x116 |
| Contact Person: | Paul L. Speidel |
| Regulatory Affairs Manager | |
| Tel: 978.279.9272 | |
| Fax: 978.232.3991 | |
| Prepared by: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | April 16th, 2014 |
| Trade or Proprietary Name: | SpineFrontier® PedFuse® Pedicle Screw System |
| Common or Usual Name: | Orthosis, Spondylolisthesis Spinal Fixation |
| Orthosis, Spinal Pedicle Fixation | |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | MNH, MNI |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | SpineFrontier® PedFuse® Pedicle Screw System |
| (K123164, K092420) | |
| Medtronic TSRH® Spinal System (K091797) | |
| Pioneer Quantum Spinal System (K101790) | |
| Globus Transition™ Stabilization System (K073439) |
Description of the Device
The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector.
CHANGE FROM PREVIOUSLY CLEARED SYSTEM
The purpose of this submission is to make additions to the components of the SpineFrontier® PedFuse® Pedicle Screw System cleared in K123164 and K092420. Hydroxyapatite (HA)-
1
coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.
INDICATIONS FOR USE
The SpineFrontier® PedFuse® 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is 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, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
The indications for use for the SpineFrontier® PedFuse® Pedicle Screw System have not changed relative to the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164. K092420). The indications for use of the SpineFrontier® PedFuse® Pedicle Screw System are similar to that of the predicates Medtronic TSRH® Spinal System (K091797), Pioneer Quantum Spinal System (K101790), and Globus Transition™ Stabilization System (K073439).
TECHNICAL CHARACTERISTICS
The subject screw components are fabricated from medical grade titanium alloy (ASTM F136) with hydroxyapatite coating and the subject rod components are fabricated from cobalt chrome alloy (35N LT or ASTM F1537). Titanium alloys, hydroxyapatite coatings, and cobalt chrome alloys have a successful history of use in the spinal implant industry and use of these materials in these devices does not introduce any previously unaccepted patient risks. The Medtronic TSRH® Spinal System (K091797) and the Pioneer Quantum Spinal System (K101790) include screws that are manufactured from titanium alloy with hydroxyapatite coating. The Medtronic TSRH®
2
Spinal System (K091797) includes components made from medical grade cobalt-chromiummolybdenum alloy, and Pioneer Quantum Spinal System (K101790) includes rods that are manufactured from Cobalt Chrome. The Globus Transition™ Stabilization System includes titanium alloy screws that are hydroxyapatite (HA) coated (ASTM F1185).
PERFORMANCE TESTING SUMMARY
In support of this Special 510(k) Device Modification Premarket Notification, Spine Frontier has conducted mechanical testing to demonstrate that the modifications to the PedFuse® Pedicle Screw System provide adequate and substantially equivalent mechanical strength for their intended use. The PedFuse Pedicle Screw System was tested in the following modes:
- . Static Axial Compression Bending (ASTM F1717-13)
- . Static Torsion (ASTM F1717-13)
- Cyclic Axial Compression Bending (ASTM F1717-13) .
- Custom Instrument Testing .
CONCLUSION
The subject modified PedFuse® Pedicle Screw System is very similar to previously cleared PedFuse® Pedicle Screw System. The subject Pedicle Screw System has similar intended uses, indications, technological characteristics and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the PedFuse® System is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
SpineFrontier, Incorporated Mr. Paul L. Speidel Regulatory Affairs Manager 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915
Re: K133153
Trade/Device Name: SpineFrontier® PedFuse® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: April 17, 2014 Received: April 18, 2014
Dear Mr. Speidel:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Paul L. Speidel
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" (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.
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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
Device Name: SpineFrontier® PedFuse® Pedicle Screw System
The SpineFrontier® 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® Pedicle Screw System is 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, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
| Prescription Use X | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
James P. Bertram -S 2014.05.14 14:48:31 -04'00'
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133153