(247 days)
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to restore the integrity of the spinal column in patients with advanced-stage tumors, which is a therapeutic purpose.
No
Explanation: The device is a pedicle screw system intended to restore the integrity of the spinal column by building a spinal construct with implants. Its purpose is mechanical support, not diagnosis. The performance studies mentioned are for mechanical characteristics, not diagnostic accuracy.
No
The device description explicitly states the system is composed of implants (pedicle screws, rods, locking elements) and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to restore spinal column integrity in patients with advanced-stage tumors. This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is composed of implants (screws, rods, locking elements) made of materials like CFR-PEEK and titanium. These are physical components designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The CarboClear Pedicle Screw System does not fit this description.
N/A
Intended Use / Indications for Use
The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product codes
NKB
Device Description
The CarboClear Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The CarboClear implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell.
The implants are supplied sterile, and are intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine
Indicated Patient Age Range
Not Found
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
Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use.
Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device.
Key Metrics
Not Found
Predicate Device(s)
K052398, K152604, K170347, K160879, K170543
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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July 18, 2018
CarboFix Orthopedics, Ltd. Ms. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, 4672411 ISRAEL
Re: K173487
Trade/Device Name: CarboClear® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: June 19, 2018 Received: June 21, 2018
Dear Ms. Wachsler-Avrahami:
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 comprehensive regulatory information about medical devices and radiation-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) K173487
Device Name CarboClear® Pedicle Screw System
Indications for Use (Describe)
The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of 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
CarboFix Orthopedics Ltd.
CarboClear® Pedicle Screw System (Oncology)
Applicant Name
CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Hila Wachsler-Avrahami CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
July 18, 2018
Trade/Proprietary Name
CarboClear® Pedicle Screw System
Common Name
Pedicle Screw System
Regulatory Classification Name and Number, and Product Code
Thoracolumbosacral pedicle screw system; 21 CFR §888.3070; Class II; Product Code NKB.
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Predicate Devices
Primary Predicate:
-
그 Mesa Spinal System (K2M, Inc .; K052398 and more)
Additional Predicates: -
CD HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347)
-
VIPER® and EXPEDIUM® Fenestrated Screw Systems (DePuy Spine, Inc.; 트 K160879, K170543)
Indications for Use
The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
System Description
The CarboClear Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The CarboClear implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell.
The implants are supplied sterile, and are intended for single use.
Performance Data and Substantial Equivalence
The CarboClear Pedicle Screw System intended use, design, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable. The material is different but does not raise any different safety and effectiveness questions.
Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device
5
is safe and effective for its intended use.
Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device.
Conclusion
Based on the information provided in this Premarket Notification, including clinical and non-clinical performance data, the subject CarboClear® Pedicle screw System is substantially equivalent to its predicate devices.