(21 days)
No reference devices were used in this submission.
No
The description focuses on image translation and rotation based on instrument movement and does not mention AI/ML terms or concepts like training/test sets for model development.
No
Explanation: The device aids in diagnosis and treatment by providing visual feedback to the physician for instrument repositioning, but it does not directly treat a disease or condition itself.
No
TrackX v.2.0 is designed to aid in the diagnosis and treatment of disease by tracking surgical instruments relative to a fluoroscope, providing real-time visual feedback for repositioning instruments. While it uses diagnostic images, its primary function is not to diagnose disease but to guide a clinician's actions during procedures where diagnosis and treatment are already being undertaken. It provides "real-time feedback," aiding "repositioning" and "respositioning their surgical instruments," which are actions related to treatment or intervention guidance rather than direct diagnosis.
No
The device description explicitly states that TrackX interfaces with an "off-the-shelf tracking system" and captures images via a "video cable," indicating reliance on external hardware components beyond just the software itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to aid in the diagnosis and treatment of disease" by providing real-time feedback on surgical instrument position during fluoroscopic procedures. This is a clinical decision support and guidance tool used during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: TrackX captures images from a fluoroscope and tracks surgical instrument position. It provides visual feedback to the physician. This is directly related to the performance of a medical procedure, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory analysis
The device's function is to enhance the accuracy and efficiency of a surgical procedure by providing real-time positional information relative to imaging. This falls under the category of medical device software used for image processing and surgical guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.
Product codes (comma separated list FDA assigned to the subject device)
OWB, LLZ, JAA
Device Description
TrackX is a software application which captures diagnostic images from a fluoroscope via a video cable. In addition, TrackX interfaces with an off-the-shelf tracking system in order to track the position of surgical instruments relative to the fluoroscope. The user controls and views information via a primary monitor. The viewing monitor is not part of the subject device.
TrackX will track the location of the tip of a surgical instrument. TrackX works by translating and rotating an X-ray image which contains the surgical instrument on the screen based on the surgeon's movement of the instrument. This real-time feedback allows the physician to reposition the instrument with greater accuracy between X-ray images. This aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images.
TrackX is designed per recommendations provided in the following FDA guidance documents:
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Off-The-Shelf Software Use in Medical Devices
- Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices
- Design Considerations and Pre-market Submission Recommendations for ● Interoperable Medical Devices
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Bench Testing
Instrument Tracking with Optical
Purpose: To verify that TrackX with the Polaris optical tracking system is able to provide a measurement off a reference point in the X-ray image.
Key Results: The location of projected markers should be within a 2mm mean of their expected 10mm increment from the detected instrument tip to each consecutive projected marker. The testing demonstrated that TrackX met specifications. The testing used established test methods that were used for the predicate device.
Software Verification
Purpose: To implement the intended changes for both the projection feature and the home base selector.
Key Results: The software testing performed for the modifications that are the subject of this Special 510(k) used established test methods that were used for the predicate device.
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.
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.
No reference devices were used in this submission.
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
§ 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.
0
Image /page/0/Picture/10 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Track X Technology, LLC % Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 ALEXANDRIA VA 22314
March 5, 2020
Re: K200360
Trade/Device Name: TrackX v.2.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, LLZ, JAA Dated: February 12, 2020 Received: February 13, 2020
Dear Calley Herzog:
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 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
1
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 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200360
Device Name TrackX v.2.0
Indications for Use (Describe)
TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.
Type of Use (Select one or both, as applicable)
X 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
K200360 - 510(K) SUMMARY
1. SUBMITTER
| Submitter: | TrackX Technology, LLC
200 Timberhill Place, Suite 223
Chapel Hill, NC 27514
Tel: 888-787-2259 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Skwerer
Tel: 888-787-2259
david.skwerer@trackx.tech |
| Submission Correspondent: | Calley Herzog
Senior Consultant
Biologics Consulting Group, Inc.
1555 King St., Suite 300
Alexandria, VA 22314
(720) 883-3633
cherzog@biologicsconsulting.com |
| Date Prepared: | March 4, 2020 |
DEVICE 2.
| Name of Device: | TrackX v.2.0 |
|---|---|
| Common or Usual Name: | Image processing system |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| 21 CFR § 892.1650 | |
| Regulatory Class: | Class II |
| Classification Product Code: | OWB |
| Subsequent Product Codes: | LLZ, JAA |
PREDICATE DEVICE 3.
| Predicate Device Name: | TrackX |
|---|---|
| Manufacturer: | Track X Technology, LLC |
4
| 510(k) Number: | K173736 |
|---|---|
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| 21 CFR § 892.1650 | |
| Regulatory Class: | Class II |
| Classification Product Code: | |
| Subsequent Product Codes: | OWB |
| LLZ, JAA | |
| Reference Devices: | No reference devices were used in this submission. |
DEVICE DESCRIPTION 4.
TrackX is a software application which captures diagnostic images from a fluoroscope via a video cable. In addition, TrackX interfaces with an off-the-shelf tracking system in order to track the position of surgical instruments relative to the fluoroscope. The user controls and views information via a primary monitor. The viewing monitor is not part of the subject device.
TrackX will track the location of the tip of a surgical instrument. TrackX works by translating and rotating an X-ray image which contains the surgical instrument on the screen based on the surgeon's movement of the instrument. This real-time feedback allows the physician to reposition the instrument with greater accuracy between X-ray images. This aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images.
TrackX is designed per recommendations provided in the following FDA guidance documents:
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Off-The-Shelf Software Use in Medical Devices
- Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices
- Design Considerations and Pre-market Submission Recommendations for ● Interoperable Medical Devices
INDICATION FOR USE న్.
The indications for use statement is identical to that of the predicate device:
TrackX is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6. WITH THE PREDICATE DEVICE
The predicate device is the submitter's own Track X as cleared in K173736. The purpose of this 510(k) is to acquire clearance of two new features, Projection and Home Base Selector.
The markers used with the TrackX software are identical to the snaps used with the predicate device with additional snaps noted in letters to file.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K200360 | K173736 |
| Submitter | TrackX Technology, LLC | TrackX Technology, LLC |
| Classification Regulation | 892.1650 - Image-intensified | |
| fluoroscopic X-ray system | 892.1650 - Image-intensified | |
| fluoroscopic X-ray system | ||
| Classification Product Code | OWB - interventional | |
| fluoroscopic X-ray system | OWB - interventional | |
| fluoroscopic X-ray system | ||
| Subsequent Product Codes | JAA - system, X-ray, | |
| fluoroscopic, image-intensified | ||
| LLZ - system, image processing, | ||
| radiological | JAA - system, X-ray, | |
| fluoroscopic, image-intensified | ||
| LLZ - system, image processing, | ||
| radiological | ||
| Device Class | 2 | 2 |
| Indications | Indicated for use in any | |
| application where a fluoroscope | ||
| is incorporated to aid in diagnosis | ||
| and treatment of disease. | Indicated for use in any | |
| application where a fluoroscope | ||
| is incorporated to aid in diagnosis | ||
| and treatment of disease. | ||
| Compatible Hardware | ||
| Platforms | Any computer that meets the | |
| following minimum | ||
| specifications: | ||
| CPU: Intel i5 | ||
| GPU: NVIDIA 760 | ||
| RAM: 8 GB | ||
| HDD: 256 GB | ||
| Frame Grabber: Aver Media | ||
| H339, Elgato or Accustream | ||
| Operating System: Windows 10 | Any computer that meets the | |
| following minimum | ||
| specifications: | ||
| CPU: Intel i5 | ||
| GPU: NVIDIA 760 | ||
| RAM: 8 GB | ||
| HDD: 256 GB | ||
| Frame Grabber: Aver Media | ||
| H339 or Elgato | ||
| Operating System: Windows 10 | ||
| Software is run on a stand- | ||
| alone computer and monitor | Yes | Yes |
| Device is passive and doesn't | ||
| control the fluoroscope | Yes | Yes |
| For use during procedures that | ||
| involve fluoroscopy | Yes | Yes |
| Proposed Device | Predicate Device | |
| Provides visual cues which help | ||
| guide the user in positioning | ||
| the instrument back to where it | ||
| was when a prior X-ray image | ||
| of it was taken. | Yes | Yes |
| Requires a tracking system | ||
| when tracking is being used. | Yes | Yes |
| Requires a tracker to interface | ||
| with the tracking system. | Yes | Yes |
| Requires a sterile tracker | ||
| attached to the instrument in | ||
| order to track the location of | ||
| the tip of the surgical | ||
| instrument. | Yes | Yes |
| Allows the user to select which | ||
| tracked object is the origin | ||
| relative to which the C-arm | ||
| and Instruments are tracked. | ||
| (Home Base Selector) | Yes | No |
| Provides a measurement off of | ||
| a reference point in the X-ray | ||
| image. (Projection) | Yes | No |
6
The modifications described above do not change the fundamental technology or the intended use of the device. Therefore, based on the identical indications, similar technological characteristics, and results of performance testing, TrackX is substantially equivalent to the submitter's own cleared device K173736.
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Like the predicate device, there are no direct or indirect patient-contacting components of the subject device. Therefore, biocompatibility testing is not needed for this device.
Sterilization
Like the predicate device, the only sterile components are the TrackX Snaps that are attached to the instrument. TrackX Snaps are provided sterile, for single use only, and labeled with a threeyear shelf life. The snaps are sterilized using Gamma sterilization, and the sterilization method has been validated in accordance with AAMI/ISO 11137-1 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices (2006) to demonstrate a Sterility Assurance Level (SAL) of 10 °.
7
Shelf Life
Accelerated aging tests were conducted to support a three-year shelf life on samples having been packaged and sterilized to a single (validated) sterilization cycle. The validated cycle includes a minimum of 25 kGy and a maximum of 40 kGy exposure and is the same process used to sterilize the final device.
Electrical Safety and electromagnetic compatibility (EMC)
Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Bench Testing
Instrument Tracking with Optical
The purpose of this testing was to verify that TrackX with the Polaris optical tracking system is able to provide a measurement off a reference point in the X-ray image. The location of projected markers should be within a 2mm mean of their expected 10mm increment from the detected instrument tip to each consecutive projected marker. The testing demonstrated that TrackX met specifications. The testing used established test methods that were used for the predicate device.
Software Verification
The purpose of this testing is to implement the intended changes for both the projection feature and the home base selector. The software testing performed for the modifications that are the subject of this Special 510(k) used established test methods that were used for the predicate device.
Animal Study
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Study
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSIONS 8.
As described above, based on the Indication for Use identical to the predicate device, similar technological characteristics, and results of performance testing, TrackX v. 2.0 is substantially equivalent to the TrackX as cleared in K173736.