(365 days)
No
The description focuses on image fusion, navigation based on fixed points and gravity, and angular orientation relative to instruments and gravity. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on accuracy metrics related to angular placement, not on the performance of an AI/ML algorithm.
No.
The device is a surgical navigation system intended to assist in the accurate placement of pedicle screws, providing guidance during spine surgery, not directly treating or curing a medical condition.
No
The device is a surgical navigation system designed to assist in the accurate placement of pedicle screws during spine surgery. It provides navigational guidance and communicates angular position data to the surgeon, rather than diagnosing a condition or disease.
No
The device description explicitly states it is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. While software is a key component, it includes hardware (iPod touch, case, drape) as part of the system.
Based on the provided information, the Bolt Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Bolt Navigation System's Function: The Bolt Navigation System is a surgical navigation system. It uses imaging data (fluoroscopic, MRI, CT) and gravity to guide the placement of pedicle screws during spine surgery. It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states it "assists in the accurate placement of pedicle screws" and provides "surgical planning and navigational telemetry." This is a surgical guidance function, not an in vitro diagnostic function.
Therefore, the Bolt Navigation System falls under the category of surgical navigation or guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.
Product codes (comma separated list FDA assigned to the subject device)
OWB
Device Description
The BNS is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. The BNS is intended to provide navigational guidance during spine surgery. The system uses preand perioperative imaging data, and input from the surgeon via the BNU touchscreen to construct the proper angular position of the instrumentation and implants relative to gravity, and communicates this information to the surgeon via the BNU screen attached to the instrument allowing the surgeon to look at both the surgical site and the navigation data at the same time, thus attenuating the risk of attention shift.
The BNS provides guidance data by displaying the angular orientation of a surgical instrument (such as a pedicle probe or awl) relative to a surgeon selected entry point on the patient and gravity. Angular orientation of the instruments is linked to the imaging data via the BNS.
The system is intended to be used for both image fusion and navigation for spine surgery applications where reference to relevant rigid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative fluoroscopic and pre- operative MRI or CT axial images
Anatomical Site
thoracolumbar and sacral spine (T-9 to S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spine surgery
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)
Nonclinical Testing:
- Sterilization, Cleaning, and Shelf-life Validation
- Biocompatibility Evaluation
- Non-Clinical Software Documentation and Verification
- Non-Clinical Cybersecurity Evaluation
- Electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2)
- Usability Validation testing per IEC 62366-1: 2015, IEC 62366-2ANSI/AAMA HE75 and FDA Guidance for Industry and FDA Staff, including a Surgeon- Performed Cadaveric Study
- Non-Clinical Accuracy Testing per ASTM F2554-10
- Cadaveric Trajectory Accuracy Study, based on a protocol that was discussed and reviewed by FDA via Submission Issue Request on July 12, 2022(Q220500/S001)
Clinical phantom accuracy results:
Mean: 0.35°, Std. Deviation: 0.20°, 95% CI of Mean: 0.39°, 95% CI of Individuals: 0.69°, 99% CI of Mean: 0.41°, 99% CI of Individuals: 0.82°
Cadaveric accuracy results:
Planned trajectory vs actual placement accuracy (
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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December 1, 2022
Circinus Medical Technology, LLC % Alex Cadotte Associate Director, Software & Digital Health MCRA, LLC 803 7th St., NW, 3rd Floor WASHINGTON DC 20001
Re: K213768
Trade/Device Name: Bolt Navigation System ("BNS") Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: October 18, 2022 Received: October 27, 2022
Dear Alex Cadotte:
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,
2022.12.01
11:54:38
-05'00'
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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) K213768
Device Name Bolt Navigation System ("BNS")
Indications for Use (Describe)
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.
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 | K213768 | |||
|---|---|---|---|---|
| Device Trade Name: | Bolt Navigation System (“BNS”) | |||
| Common Name: | Image-intensified fluoroscopic X-ray system | |||
| Manufacturer: | Circinus Medical Technology, LLC | |||
| 4450 Arapahoe Avenue | ||||
| Suite 1000 | ||||
| Boulder, CO 80303 | ||||
| Contact: | Mr. Patrick West | |||
| Circinus Medical Technology, LLC | ||||
| Phone: (207) 651-1334 | ||||
| Email: patrick@boltnav.com | ||||
| Prepared by: | MCRA, LLC | |||
| 1050 K Street NW, Suite 1000 | ||||
| Washington, DC 20001 | ||||
| Phone: (202) 552-5800 | ||||
| Date Prepared: | Oct 25, 2021 | |||
| Classification: | 21 CFR §892.1650 | |||
| Class: | II | |||
| Product Codes: | OWB |
Indications for Use:
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and preoperative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.
Device Description:
The BNS is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. The
4
BNS is intended to provide navigational guidance during spine surgery. The system uses preand perioperative imaging data, and input from the surgeon via the BNU touchscreen to construct the proper angular position of the instrumentation and implants relative to gravity, and communicates this information to the surgeon via the BNU screen attached to the instrument allowing the surgeon to look at both the surgical site and the navigation data at the same time, thus attenuating the risk of attention shift.
The BNS provides guidance data by displaying the angular orientation of a surgical instrument (such as a pedicle probe or awl) relative to a surgeon selected entry point on the patient and gravity. Angular orientation of the instruments is linked to the imaging data via the BNS.
The system is intended to be used for both image fusion and navigation for spine surgery applications where reference to relevant rigid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector.
Predicate Device:
The Track X Technology, TrackX Device (K200360) serves as the primary predicate device. The Augmedics xvision Spine System (K190929) and the Medtronic StealthStation (K133444, K170011) serve as reference devices.
Technological Characteristics Comparison:
The BNS and its primary predicate technology are designed to aid the physician in positioning surgical instruments and placing implants by providing visual feedback on the movement of instruments relative to imaging data. Both systems use software platforms that allow for the surgeon to track the surgical instruments relative to the perioperative fluoroscopic images.
Both systems enable the surgeon to view the orientation of surgical instruments relative to that planned by the surgeon on preoperative image data while performing the surgical procedure with the aid of a fluoroscope. The systems provide guidance data by tracking and displaying orientation of the Spinal Instruments relative to a surgeon identified entry point and the gravity vector. Tracking data is linked to the preoperative imaging data.
Both systems are designed to work effectively with a range of 3rd party surgical instruments.
The BNS and the reference devices are designed to provide trajectory orientation guidance to the surgeon relative to relevant rigid anatomical structure with a performance goal of