(270 days)
Amedica Valeo PS System (K072022)
No
The document describes a mechanical pedicle screw system made of titanium alloy. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies are mechanical tests, not related to algorithmic performance.
No.
The device is a pedicle screw system intended for spinal fixation, which is a supportive and stabilizing function rather than directly treating a medical condition or restoring a normal function.
No
The device is described as a "posterior pedicle screw system manufactured from titanium alloy (...) designed for fixation of the non-cervical spine." Its intended use is for "immobilization of the posterior, noncervical spine" as an adjunct to various spinal conditions. This indicates it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description explicitly states it is a posterior pedicle screw system manufactured from titanium alloy and comprised of physical components like screws and rods, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization of the posterior, noncervical spine" and is used as an "adjunct" to treat various spinal conditions. This describes a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details a "posterior pedicle screw system manufactured from titanium alloy" comprised of "pedicle screws and curved and straight rods." This is a physical implant, not a diagnostic reagent, instrument, or kit used for testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on laboratory testing.
The device described is a surgical implant used to stabilize the spine.
N/A
Intended Use / Indications for Use
The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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
NKB, MNI, MNH
Device Description
The icotec Pedicle System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for fixation of the non-cervical spine. The icotec Pedicle System is comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. The icotec Pedicle System can be used for single or multiple level fixations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical 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
Preclinical Testing: The non-clinical tests performed by the company include static compression bending, static torsion, and dynamic compression bending testing per ASTM F1717 of the worst case pedicle screw system. The results of the performed tests demonstrate that the icotec Pedicle System is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
CoreLink Tiger Spine System (K113058), Amedica Valeo PS System (K072022)
Reference Device(s)
Amedica Valeo PS System (K072022)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2016
Icotec AG % Mr. Samuel Pollard Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K151977
Trade/Device Name: icotec Pedicle System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 14, 2016 Received: March 15, 2016
Dear Mr. Pollard:
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/Resourcesfor You/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,
Mark N. Melkerson -S
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) K151977
Device Name icotec Pedicle System
Indications for Use (Describe)
The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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) |
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510(k) Summary
| Device Trade Name: | icotec Pedicle System |
|---|---|
| Manufacturer: | Icotec AG |
| Industriestrasse 12 | |
| 9450 Altstätten | |
| Switzerland | |
| Contact: | Mr. Jörg Schneider |
| Manager Regulatory Affairs | |
| icotec ag | |
| Industriestrasse 12 | |
| 9450 Altstaetten, Switzerland | |
| Phone: +41 71 757.0025 | |
| Fax: +41 71 757.0001 | |
| joerg.schneider@icotec.ch | |
| Prepared by: | Samuel Pollard |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| spollard@mcra.com | |
| Date Prepared: | December 17, 2015 |
| Classification: | 21 CFR §888.3070: Pedicle screw spinal system |
| Class: | III |
| Product Code: | NKB, MNI, MNH |
| Primary Predicate: | CoreLink Tiger Spine System (K113058) |
| Additional Predicate: | Amedica Valeo PS System (K072022) |
Indications for Use:
The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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.
4
Device Description:
The icotec Pedicle System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for fixation of the non-cervical spine. The icotec Pedicle System is comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. The icotec Pedicle System can be used for single or multiple level fixations.
Predicate Devices:
The icotec Pedicle System is substantially equivalent to the primary predicate CoreLink Tiger Spine System (K113058) and reference predicate Amedica Valeo PS System (K072022) with respect to intended use, material, geometry, method of fixation, and mechanical properties. Mechanical testing, including static and dynamic compression bending and static torsion testing, has demonstrated substantial equivalence to previously cleared devices.
Preclinical Testing:
The non-clinical tests performed by the company include static compression bending, static torsion, and dynamic compression bending testing per ASTM F1717 of the worst case pedicle screw system. The results of the performed tests demonstrate that the icotec Pedicle System is substantially equivalent to legally marketed predicate devices.
Conclusion:
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the icotec Pedicle System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.