(63 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "temporary stabilization of the anterior spine during the development of cervical spine fusion," which is a therapeutic intervention for various spinal conditions.
No
Explanation: The CarboClear Cervical Plate System is described as a system for temporary stabilization and fixation of the cervical spine, consisting of implants (plates and screws). Its intended use is to aid in cervical spine fusion for various conditions, which indicates it is a therapeutic or surgical device, not one designed for diagnosis.
No
The device description explicitly states that the system comprises implants (plates and screws) and instruments, 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 states "anterior fixation of the cervical spine" and describes its use in stabilizing the spine during fusion. This is a surgical implant used in the body, not a device used to examine specimens outside the body.
- Device Description: The description details implants (plates and screws) made of materials like CFR-PEEK and titanium alloy. These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The CarboClear Cervical Plate System is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.
The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:
Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.
Product codes
KWQ
Device Description
The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.
The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics, including static and dynamic compression bending, and static torsion, per ASTM F1717, and static screw pushout testing, are comparable to those of predicate devices (as applicable), thus demonstrating substantially equivalent mechanical performance of the subject device.
In addition, bacterial endotoxin evaluation was conducted for the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K173487, K182377, K102597, K120409, K130061, K182015
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
June 4, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CarboFix Orthopedics, Ltd. Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'Hoshlim St. Herzeliya, 4672411 Israel
Re: K200883
Trade/Device Name: CarboClear® Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 30, 2020 Received: April 2, 2020
Dear Ms. Rubin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200883
Device Name CarboClear® Cervical Plate System
Indications for Use (Describe)
CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.
The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:
Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
CarboFix Orthopedics Ltd.
CarboClear® Cervical Plate System
Applicant Name
CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
March 2020
Trade/Proprietary Name
CarboClear® Cervical Plate System
Common Name Appliance, Fixation, Spinal Intervertebral Body
Classification Name
Spinal intervertebral body fixation orthosis (21 CFR §888.3060; Class II; Product Code KWQ).
4
Predicate Devices
Primary
. Spider® Cervical Plating System (X-spine Systems, Inc.; K170224, and more) Additional
- Anterior CSLP System (Synthes; K030866, and more) '
- . Reflex® Hybrid Anterior Cervical Plate System (Stryker; K040261, and more)
Reference
- . CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377)
- Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, I K130061, K182015, and more)
Indications for Use
CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.
The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:
Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.
System Description
The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.
The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.
5
Substantial Equivalence
The CarboClear Cervical Plate System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Performance characteristics, including static and dynamic compression bending, and static torsion, per ASTM F1717, and static screw pushout testing, are comparable to those of predicate devices (as applicable), thus demonstrating substantially equivalent mechanical performance of the subject device.
In addition, bacterial endotoxin evaluation was conducted for the system.