K Number
K192214
Device Name
CarboClear VBR System
Date Cleared
2019-10-11

(57 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture). The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.
Device Description
The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments. The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.
More Information

No
The summary describes a passive implant (VBR system) and instruments, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical testing of the physical device.

No
The device is a vertebral body replacement system, which is a structural implant used during surgery, not a therapeutic device designed to cure a disease or health problem.

No

This device is a vertebral body replacement system, which is an implant used in surgical procedures to replace a collapsed or unstable vertebral body. It is a therapeutic device, not a diagnostic one.

No

The device description explicitly states that the system comprises implants (spacers) and instruments, which are physical hardware components made of CFR-PEEK and titanium alloy.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description and Intended Use: The CarboClear Vertebral Body Replacement System is an implantable device used in surgical procedures to replace a damaged vertebral body in the spine. It is a physical device used within the body, not a test performed on a sample outside the body.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.

Therefore, the CarboClear Vertebral Body Replacement System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

Product codes

MQP

Device Description

The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments.

The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar spine (T1-L5)

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 axial compression and torsion testing per ASTM F 2077, expulsion testing, and endplate shear strength testing. Performance characteristics are comparable to those of predicate devices (as applicable), thus demonstrating that the device is substantially equivalent to the predicates.

In addition, bacterial endotoxin testing was conducted for the CarboClear System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Giza® Vertebral Body Replacement (Eden Spine, LLC; K112429), I X-MESH™ Cage System (DePuy Spine; K173787), I Ocelot Stackable Cage System (DePuy Spine; K140759), . Bengal Cage System (DePuy Synthes Spine; K073649), . VERTE-STACKTM (Medtronic Sofamor Danek; K070173)

Reference Device(s)

CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, . K182377), FORZA® Spacer System (Orthofix Inc.; K152475)

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.

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October 11, 2019

CarboFix Orthopedics, Ltd. Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St. Herzeliya 4672411 Israel

Re: K192214

Trade/Device Name: CarboClear® VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: August 13, 2019 Received: August 15, 2019

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

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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 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 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,

for Ronald P. Jean. PhD Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192214

Device Name CarboClear® VBR System

Indications for Use (Describe)

The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

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® VBR 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

October 2019

Trade/Proprietary Name

CarboClear® VBR System

Common Name Spinal Vertebral Body Replacement Device

Classification Name

Spinal intervertebral body fixation orthosis (21 CFR §888.3060; Class II; Product Code MQP).

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Predicate Devices

Primary

  • Giza® Vertebral Body Replacement (Eden Spine, LLC; K112429, and more)
    Additional

  • I X-MESH™ Cage System (DePuy Spine; K173787, and more)

  • I Ocelot Stackable Cage System (DePuy Spine; K140759, and more)

  • . Bengal Cage System (DePuy Synthes Spine; K073649, and more)

  • . VERTE-STACKTM (Medtronic Sofamor Danek; K070173, and more)

Reference

  • CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, . K182377)
  • FORZA® Spacer System (Orthofix Inc.; K152475, and more) ■

Indications for Use

The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

System Description

The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments.

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The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

Substantial Equivalence

The CarboClear VBR System intended use, 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 axial compression and torsion testing per ASTM F 2077, expulsion testing, and endplate shear strength testing. Performance characteristics are comparable to those of predicate devices (as applicable), thus demonstrating that the device is substantially equivalent to the predicates.

In addition, bacterial endotoxin testing was conducted for the CarboClear System.