(86 days)
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.
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.
The provided text is a 510(k) summary for the CarboClear® Navigated Instruments. It details the device's intended use, technological characteristics, and comparison to predicate devices, but lacks the specific details about acceptance criteria, numerical performance data, and the study design required to fully answer your request.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The text mentions "Performance testing demonstrates that the CarboClear® Navigated Instruments are substantially equivalent to the predicate devices" and "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."
However, specific metrics for accuracy, functionality, or any other performance aspect, along with their respective acceptance criteria, are not listed.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text mentions "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." These activities imply testing, but the number of samples or the origin of the data (e.g., country, retrospective/prospective) is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. It's likely that "ground truth" in this context would relate to successful navigation, compatibility, and registration, which might involve technical personnel or surgeons, but their number and qualifications are not mentioned.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This type of study is not applicable to this device. The CarboClear® Navigated Instruments are physical surgical instruments used with a navigation system, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance" in the sense of image interpretation. The device's function is to assist surgeons in locating anatomical structures during spinal surgery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. The device is explicitly designed for human use ("manually operated instruments") and in conjunction with the Medtronic StealthStation® System. It is not an autonomous algorithm.
7. The type of ground truth used:
Based on the description of performance testing, the "ground truth" would likely be:
- Physical Compatibility/Functionality: Successful connection and operation with the NavLock Tracker and StealthStation® System.
- Dimensional Accuracy: Comparison of physical dimensions of subject instruments to predicate instruments (mentioned in "Engineering analysis included comparative dimensional measurements").
- Registration Success: The ability of the instruments to be accurately registered with the StealthStation® System.
No mention of pathology, outcomes data, or expert consensus (in the sense of clinical diagnosis) for establishing ground truth is made.
8. The sample size for the training set:
This information is not provided and is not applicable in the context of this device. The CarboClear® Navigated Instruments are physical, reusable surgical tools. They are not an AI/ML algorithm that requires a "training set" in the traditional sense for learning or model development. The performance studies described are for verification and validation of the device's design and functionality.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated above (no training set for this type of device).
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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
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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
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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) |
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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
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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.
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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.
§ 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).