CarboClear Navigated Instruments

K201251 · CarboFix Orthopedics , Ltd. · OLO · Aug 5, 2020 · Neurology

Device Facts

Record IDK201251
Device NameCarboClear Navigated Instruments
ApplicantCarboFix Orthopedics , Ltd.
Product CodeOLO · Neurology
Decision DateAug 5, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 882.4560
Device ClassClass 2
AttributesTherapeutic

Intended Use

CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboCleare Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClears Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Story

CarboClear Navigated Instruments consist of reusable, manually operated surgical tools including probes, bone taps, and a screwdriver. Used in spinal surgery, these instruments interface with the Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures for pedicle screw placement. The instruments feature physical connection points for the NavLock Tracker, allowing the navigation system to track the instrument position relative to patient anatomy (CT/MR models or fluoroscopy). By providing real-time spatial tracking, the system aids the surgeon in accurate instrument positioning, potentially improving surgical precision and patient outcomes. The device is intended for use in an operating room environment by trained surgeons.

Clinical Evidence

Bench testing only. Evidence includes engineering analysis (comparative dimensional measurements), compatibility testing (physical connection with NavLock Tracker), and registration testing to verify accuracy and functionality with the Medtronic StealthStation System.

Technological Characteristics

Reusable, manually operated surgical instruments (probes, bone taps, screwdriver). Designed for mechanical compatibility with Medtronic StealthStation System and NavLock Tracker. Materials and dimensions are consistent with predicate navigated instruments. No electronic components; passive navigation interface.

Indications for Use

Indicated for use during spinal surgery for the preparation and placement of CarboClear Pedicle Screws in patients requiring stereotactic surgical navigation.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. August 5, 2020 CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'hoshlim St. Herzeliya, 4672411 Israel Re: K201251 Trade/Device Name: CarboClear Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 3, 2020 Received: May 11, 2020 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 (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 {1}------------------------------------------------ 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 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 (QS) 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, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K201251 Device Name CarboClear® Lumbar Cage System #### Indications for Use (Describe) CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboCleare Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClears Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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}------------------------------------------------ CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR® NAVIGATED INSTRUMENTS ## 510(k) Summary # CarboFix Orthopedics Ltd. CarboClear® Navigated Instruments ### 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 August 4, 2020 ## Trade/Proprietary Name CarboClear® Navigated Instruments ## Common Name Stereotaxic Instrument; Navigated Probe, Navigated Bone Tap, Navigated Screwdriver ## Regulation Number and Device Class 21 CFR §882.4560; Class II ## Product Code, Regulation Description and Review Panel OLO; Stereotaxic Instrument; Orthopedic {4}------------------------------------------------ ### Predicate Devices #### Primary Predicate: - . Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153442) ### Additional Predicates: - Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) - Globus Navigation Instruments (Globus Medical, Inc.; K153203) - I CarboClear® Pedicle Screw System Instruments (CarboFix Orthopedics, Ltd .; K173487, K182377) ### Indications for Use CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. ### System Description CarboClear® Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear Pedicle Screws during spinal surgery. {5}------------------------------------------------ #### Technological Characteristics and Comparison to Predicates CarboClear® Navigated Instruments, similar to the predicate navigated instruments, are intended to be used with the Medtronic's StealthStation® System to assist the surgeon in locating anatomical structures. Additionally, the CarboClear® Navigated Instruments and their predicate devices have similar technological characteristics, including design, dimensions, materials and technology, and they function in the same manner. Performance testing demonstrates that the CarboClear® Navigated Instruments are substantially equivalent to the predicate devices. #### Performance Data Design validation testing, including engineering analysis, compatibility testing and registration, was conducted to verify that the CarboClear® Navigation Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments. Engineering analysis included comparative dimensional measurements for the subject and predicate instruments. Compatibility testing evaluated the physical compatibility and connection between the NavLock Tracker and CarboClear® Navigated Instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation® System. #### Substantial Equivalence Based on the information provided in this Premarket Notification, CarboClear® Navigated Instruments have been found to be substantially equivalent to the predicate devices with respect to intended use, technological characteristics and performance.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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