(100 days)
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as a "screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients" to "restore the integrity of the spinal column," which indicates a therapeutic purpose.
No.
The device is a surgical implant system designed to provide immobilization and stabilization of cervical spinal segments, not to diagnose a condition.
No
The device description clearly states the system is composed of implants (screws, rods, locking elements) and instruments, which are physical hardware components.
Based on the provided information, the CarboClear® Posterior Cervical Screw System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to restore the integrity of the spinal column through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a system of implants (screws, rods, locking elements) made of materials like CFR-PEEK and titanium, designed to be surgically placed in the cervical spine. This is consistent with a medical device used for structural support and stabilization within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the CarboClear® Posterior Cervical Screw System is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CarboClear® Posterior Cervical 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product codes
NKG
Device Description
The CarboClear® Posterior Cervical Screw System ("CarboClear® 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® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients.
The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, cervical spinal segments
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 included static and dynamic tests according to ASTM F1717, ASTM F1798, ASTM F2193, ASTM F1044. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine; K142838), Mesa Mini Spinal System (K2M, Inc.; K153370), CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716)
Reference Device(s)
CarboClear® Cervical Cage and VBR System (CarboFix Orthopedics Ltd.; K222874)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
March 27, 2024
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 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. Batya Cohen Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel
Re: K233989
Trade/Device Name: CarboClear® Posterior Cervical Screw System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG Dated: February 28, 2024 Received: February 28, 2024
Dear Batya Cohen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
CarboClear® Posterior Cervical Screw System
Indications for Use (Describe)
The CarboClear® Posterior Cervical 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 cervical 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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3
510(K) Summary
CarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
Applicant Name
CarboFix Orthopedics, Ltd.
11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Batya Cohen
CarboFix Orthopedics, Ltd.
11 Ha'hoshlim St., Herzeliya 4672411, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
December 2023
Trade/Proprietary Name
CarboClear® Posterior Cervical Screw System
Common Name
Posterior, Cervical Spine Fixation
Classification Name
Orthopedic; Posterior Cervical Screw System (21 CFR §888.3075; Class II; Product Code NKG).
4
Predicate Devices
Primary Predicate:
- . Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine; K142838)
Additional Predicates:
- 트 Mesa Mini Spinal System (K2M, Inc.; K153370)
- I CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716)
Reference:
- I CarboClear® Cervical Cage and VBR System (CarboFix Orthopedics Ltd.; K222874)
Indications for Use
The CarboClear® Posterior Cervical 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
System Description
The CarboClear® Posterior Cervical Screw System ("CarboClear® 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® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients.
The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.
5
Substantial Equivalence
The CarboClear® Posterior Cervical Screw System indications for use are a sub-group of the indications for use of the primary predicate, referring to use of the system 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.
The CarboClear® Posterior Cervical Screw System design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Performance characteristics included static and dynamic tests according to ASTM F1717, ASTM F1798, ASTM F2193, ASTM F1044. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use.
CarboClear® Posterior Cervical Screw System is part of the CarboClear Pedicle Screw Systems family.
Conclusion
Based on the information provided in this Premarket Notification and non-clinical performance data, the subject CarboClear® Posterior Cervical Screw System is substantially equivalent to its predicate devices.