(30 days)
Not Found
No
The summary describes an image-guided navigation system using electromagnetic tracking and image overlay, with a focus on compensating for respiratory motion. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML, or complex image analysis beyond overlay and tracking.
No
The device is a stereotactic accessory used for displaying instruments and aiding in navigation during interventional procedures, not for treating a condition itself.
No
The device is used for navigation and visualization of instruments during medical procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of hardware components including an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, and a computer system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The ig4™ Image Guided System is a stereotactic accessory used during clinical interventions to guide instruments (like needles) within the patient's body using imaging modalities (CT, 3D fluoroscopic x-ray, Ultrasound). It does not analyze samples outside of the body.
- Intended Use: The intended use clearly states it's for "displaying an interventional instrument... on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s)" and for "overlaying Ultrasound images onto the model of the target organ(s)." This is about real-time guidance within the patient.
The device is a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The ig4TM 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 is additionally indicated for overlaying Ultrasound images onto the 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, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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. The system software allows additional data overlay of real-time Ultrasound images onto the 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/Ultrasound probes or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), 3D fluoroscopic x-ray, Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical interventions
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 accuracy testing was completed to demonstrate navigation accuracy with Ultrasound overlay 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.
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.
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
§ 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.
0
10693995
JAN 2 7 2010
510(k) Summary Veran Medical Technologies Traditional 510(k) ig4™ Image Guided System - Navigation with Ultrasound Overlay Indications for Use Expansion
Date Prepared:
December 23, 2009
510(k) Applicant:
Veran Medical Technologies, Inc. 5743 West Park Avenue St. Louis, MO 63110 Telephone: (314) 659-8500 Fax: (314) 659-8560
Contact: Scott Wrightstone
Device Information:
Trade Name: ig4TM Image Guided System Common Name: CT stereotactic accessory Classification Name: Computed Tomography X-ray System Classification Code: JAK
Equivalent Legally Marketed Devices:
ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ig4TM Image Guided System (K060903) ig4™ Image Guided System - 3D Fluoroscopic X-ray Navigation (K093146)
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. The system software allows additional data overlay of real-time Ultrasound images onto the 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/Ultrasound probes or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.
Intended Use:
The ig4TM 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
1
organ(s). The ig4™ System is additionally indicated for overlaying Ultrasound images onto the 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, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.
Substantial Equivalence:
The ig4™ Image Guided System - Ultrasound Overlay application has been shown to be substantially equivalent in navigating interventional instrumentation as the ig4™ Image Guided System (K060903) navigating instrumentation in CT-based models of the patient anatomy and the ig4TM Image Guided System - 3D Fluoroscopic X-ray (K093146) in navigating instrumentation in 3D Fluoroscopic X-ray-based models of the patient anatomy. This submission demonstrates that the current ig4™ Image Guided System software allows for instrument navigation with images from ultrasound overlay.
Performance Data:
Bench accuracy testing was completed to demonstrate navigation accuracy with Ultrasound overlay 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 - Ultrasound Overlay application was shown to be substantially equivalent to the ig4™ Image Guided System (K060903) and ig4™ Image Guided System - 3D Fluoroscopic X-ray (K093146) in navigating interventional instrumentation.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of what appears to be three abstract shapes, possibly representing human figures or a symbol related to health and well-being. The logo is 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
JAN 2 7 2010
Mr. Scott Wrightstone QA/RA Manager Veran Medical Technologies, Inc. 5743 West Park Avenue ST. LOUIS MO 63110
Re: K093995
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: December 23, 2009 Received: December 28, 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: ig4TM 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 is additionally indicated for overlaying Ultrasound images onto the 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, 3D fluoroscopic x-ray, or ultrasound 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 In Vitro Diagnostics (OIVD)
Daniel Yarbrough
(Division Sign Off) Division of Radiological Devices
510(k) Number_Ko93995
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