(36 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is intended to provide rigid immobilization and stabilization as an adjunct to fusion, not to provide therapy itself.
No
Explanation: The device, the CarboClear® Hybrid Pedicle Screw System, is an implantable system intended for rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion. Its purpose is therapeutic, to provide structural support, rather than to diagnose a condition or disease.
No
The device description explicitly states it is composed of implants and instruments, which are physical hardware components. There is no mention of software as the primary or sole component.
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 surgical implant system used for spinal stabilization and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the system (screws, rods, etc.) made of materials like CFR-PEEK and titanium. These are physical implants, not reagents or instruments used to test biological samples.
- 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 in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a structural issue in the spine.
N/A
Intended Use / Indications for Use
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of nonoperative treatment.
The CarboClear® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Product codes
NKB
Device Description
The CarboClear® Hybrid 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® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy set screw, and with CarboClear CFR-PEEK rods. The implants may include tantalum markers. CarboClear titanium alloy rod is also offered.
The implants are supplied sterile, and are intended for single use.
The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and/or sacral segments from L2 to S1
Indicated Patient Age Range
skeletally mature
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
Previously conducted performance testing of the CarboClear® Hybrid Pedicle Screw System included static and dynamic tests according to ASTM F1717, as well as static flexion-extension moment test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests were shown to be comparable to those of predicate devices. No new performance testing was necessary to support the current submission.
Key Metrics
Not Found
Predicate Device(s)
K233793, K240846, K082236, K130291, K192930
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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November 5, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Carbofix Orthopedics Ltd. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'Hoshlim St. Herzeliya, 4672411 Israel
Re: K243106
Trade/Device Name: CarboClear® Hybrid Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 30, 2024 Received: September 30, 2024
Dear Hila 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 (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
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Sincerely,
Image /page/2/Figure/3 description: The image shows a digital signature. The signature is by Eileen Cadel -S. The date of the signature is 2024.11.05, and the time is 09:27:13 -05'00'. The signature is for something.
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
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
CarboClear® Hybrid Pedicle Screw System
Indications for Use (Describe)
CarboClear® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of nonoperative treatment.
The CarboClear® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
CarboFix Orthopedics Ltd.
CarboClear® Hybrid Pedicle Screw System
APPLICANT NAME
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
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
September 30, 2024
TRADE/PROPRIETARY NAME
CarboClear® Hybrid Pedicle Screw System
COMMON NAME
Pedicle Screw System
REGULATION NUMBER AND DEVICE CLASS
Class II; 21 CFR §888.3070
PRODUCT CODE, REGULATORY DESCRIPTION AND REVIEW PANEL
NKB; Thoracolumbosacral Pedicle Screw System; Orthopedic
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PREDICATE DEVICES
Primary Predicate Device:
CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K233793)
Additional Predicate Devices:
- CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846)
- · CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more)
- · S4® Spinal System (Aesculap Spine; K130291 and more)
- · Dymaxeon Spine System (Back 2 Basics Direct, LCC; K192930)
INTENDED USE/INDICATIONS FOR USE
CarboClear® Hybrid Pedicle Screw System
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
SYSTEM DESCRIPTION
The CarboClear® Hybrid 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® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy set screw, and with CarboClear CFR-PEEK rods. The implants may include tantalum markers. CarboClear titanium alloy rod is also offered.
6
CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR® HYBRID PEDICLE SCREW SYSTEM
The implants are supplied sterile, and are intended for single use.
The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
PURPOSE OF SUBMISSION
Expansion of indications for use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
Compared to the cleared CarboClear® Hybrid Pedicle Screw System (K240846), the subject CarboClear® Hybrid System includes longer rods.
PERFORMANCE DATA
Previously conducted performance testing of the CarboClear® Hybrid Pedicle Screw System included static and dynamic tests according to ASTM F1717, as well as static flexion-extension moment test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests were shown to be comparable to those of predicate devices. No new performance testing was necessary to support the current submission.
SUBSTANTIAL EQUIVALENCE
The intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance of the subject CarboClear® Hybrid Pedicle Screw System are substantially equivalent to those of the predicate devices.
CONCLUSION
Based on the information provided in this 510(k) Premarket Notification, the subject CarboClear® Hybrid Pedicle Screw System is substantially equivalent to its predicate devices.