(56 days)
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.
The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.
The provided text describes the Veran Medical Technologies ig4™ Image Guided System, an accessory for CT or 3D fluoroscopic x-ray systems. The submission is for an expansion of its indications for use to include navigation with 3D fluoroscopic x-ray-based models.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or a specific table with numerical values for performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (ig4™ Image Guided System, K060903) for the expanded indication.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to previously cleared device (K060903) for navigating interventional instrumentation in 3D fluoroscopic x-ray-based models of patient anatomy. | Bench accuracy testing completed to demonstrate 3D fluoroscopic x-ray navigation accuracy on a static phantom. |
| Safety and effectiveness demonstrated. | All verification and validation activities completed by designated individuals, demonstrating safety and effectiveness. |
| No required changes to the system and software of the predicate device for the new indication. | This was affirmed: "There are no required changes to the system and the software of the ig4™ Image Guided System (K060903) for instrument navigation with 3D fluoroscopic x-ray-based models of the patient anatomy." |
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document mentions "Bench accuracy testing... on a static phantom." It does not specify the number of tests or samples (e.g., number of measurements taken, different phantom configurations).
- Data Provenance: The testing was "bench accuracy testing," implying a controlled laboratory environment. The country of origin of the data is not specified, but the applicant's address is in St. Louis, MO, USA. The study was prospective in nature, as it was conducted specifically to support this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The study involved bench accuracy testing on a static phantom, not a clinical study involving human patients or expert interpretation of diagnostic images. Therefore, the concept of "ground truth established by experts" as typically seen in image analysis studies does not apply here. The "ground truth" would be the known, precise physical dimensions and locations within the static phantom.
4. Adjudication Method for the Test Set:
Not applicable, as there was no expert review or human interpretation that would require adjudication. The bench accuracy testing would likely involve comparing the device's reported positions to the known, physical positions within the static phantom.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, the "Bench accuracy testing" focused on the device's intrinsic 3D fluoroscopic x-ray navigation accuracy with a static phantom. This is a standalone performance evaluation, as it assesses the device's ability to accurately track and display without direct human intervention in the tracking mechanism itself, though a human would ultimately operate the system in a clinical setting.
7. The Type of Ground Truth Used:
For the "bench accuracy testing," the ground truth would be the known, precise physical dimensions and locations within the static phantom. This is a physical, measurable ground truth.
8. The Sample Size for the Training Set:
Not applicable. This device is a navigation system based on electromagnetic tracking and imaging, not a machine learning or AI-driven diagnostic algorithm that typically requires a separate training set. The system leverages existing algorithms and principles for localization and navigation, rather than being "trained" on a dataset in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set in the context of machine learning or AI.
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1093146
NOV 30 2009
510(k) Summarv Veran Medical Technologies Traditional 510(k) ig4TM Image Guided System - 3D Fluoroscopic X-ray Navigation Indications for Use Expansion
Date Prepared:
September 24, 2009
510(k) Applicant:
Veran Medical Technologies, Inc. 5743 West Park Avenue St. Louis, MO 63110 Telephone: (314) 659-8500 (314) 659-8560 Fax:
Scott Wrightstone Contact:
Device Information:
ig4TM Image Guided System Trade Name: CT stereotactic accessory Common Name: Classification Name: Computed Tomography X-ray System Classification Code: JAK
Equivalent Legally-Marketed Devices:
ig4TM Image Guided System (K060903)
Device Description:
The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.
Intended Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4TM System compensates for the patient's respiratory phases.
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The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.
Substantial Equivalence:
The ig4™ Image Guided System - 3D fluoroscopic x-ray navigation has been shown to be substantially equivalent in navigating interventional instrumentation in 3D fluoroscopic x-raybased models of the patient anatomy as the ig4™ Image Guided System (K060903) navigating instrumentation in CT-based models of the patient anatomy. This submission demonstrates that the current ig4™ Image Guided System software allows for instrument navigation with imaging systems that generate volumetric data from 3D fluoroscopic x-ray (i.e. - 3D fluoroscopic c-arm systems).
There are no required changes to the system and the software of the ig4™ Image Guided System (K060903) for instrument navigation with 3D fluoroscopic x-ray-based models of the patient anatomy.
Performance Data:
Bench accuracy testing was completed to demonstrate 3D fluoroscopic x-ray navigation accuracy on a static phantom. As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device.
Clinical Data:
Clinical tests were not required to demonstrate the safety and effectiveness of the device.
Conclusion:
The information provided in this 510(k) notification supports that the ig4™ Image Guided System - 3D fluoroscopic x-ray navigation was shown to be substantially equivalent to the ig4™ Image Guided System (K060903) in navigating interventional instrumentation.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 3 0 2009
Mr. Scott Wrightstone QA/RA Manager Veran Medical Technologies. Inc. 5743 West Park Avenue ST LOUIS MO 63110
Re: K093146
Trade/Device Name: ig4TM Image Guided System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2009 Received: October 5, 2009
Dear Mr. Wrightstone:
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. 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.
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 (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 – Indications for Use
510(k) Number: Κυ93146
Device Name: ig4™ Image Guided System
Indications for Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
Page of
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.