(86 days)
Not Found
No
The summary describes manually operated instruments used with a navigation system, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as surgical instruments intended to assist in precisely locating anatomical structures for preparation and placement of pedicle screws, rather than directly treating a medical condition.
No
The device is an instrument used during surgical procedures to assist in locating anatomical structures and placing pedicle screws, not to diagnose a medical condition.
No
The device description explicitly states that the CarboClear® Navigated Instruments are "reusable, manually operated, instruments, including probes, bone taps and a screwdriver," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CarboClear® Navigated Instruments are surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and placing pedicle screws. They are used directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly states they are used "during the preparation and placement of CarboClear® Pedicle Screws during spinal surgery." This is an in-vivo (within the living body) application, not in-vitro (in glass/outside the living body).
- Device Description: The description confirms they are "reusable, manually operated, instruments, including probes, bone taps and a screwdriver." These are surgical tools.
The device is a surgical navigation system component, which falls under the category of medical devices used for surgical procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
Vertebra (spinal surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K153442, K124004, K140454, K143375, K153203, K173487, K182377
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
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)
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) | |
|---|---|
| ☑ 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
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.