(72 days)
The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
The InstaTrak system with Multiple Dataset Navigation provides the same capability as the existing system, with the additional functionality of utilizing two sets of medical images instead of one. By providing information from multiple datasets, the user can locate and visualize anatomical structures using different imaging modalities. The InstaTrak 3500 Plus System allows the user to view the medical images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through the registration process. In all types of surgery the goal is the same, to display to the surgeon based on the medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. With the additional capability of multiple dataset navigation, the surgeon can now view the position of the tracked instrument using two sets of medical images instead of one. The Multiple Dataset Navigation will provide the user with the ability to co-reqister (fuse) images from multiple datasets such as CT and MR. Using the existing InstaTrak 3500 Plus System software, the user will register one of the datasets, referred to as the Reference Dataset, to the patient. Navigation is then possible on the fused images, with secondary (registered) dataset(s) acting as a visualization enhancement for both surgical planning and intra-operative quidance. The sensors and instruments used for navigation are identical to those utilized by the existing InstaTrak system. Navigation will be disabled until the datasets have been successfully co-registered. Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529. The current system provides displays for a single set of medical images. The Multiple Dataset Navigation option will provide displays for multiple sets of medical images. The addition of the Multiple Dataset Navigation operating mode does not change any of the major components of the InstaTrak System. There are no new receivers, transmitters, or instrument attachment configurations associated with this operational mode. Addition of the Multiple Dataset Navigation mode is a software change only.
The provided 510(k) summary for the GE Medical Systems Navigation and Visualization InstaTrak 3500 Plus with Multiple Dataset Navigation does not contain the specific information requested about acceptance criteria, device performance tables, sample sizes, ground truth establishment, or study designs (MRMC, standalone).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical description of performance validation studies.
Here's what can be extracted based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics in the way typically seen for diagnostic or AI algorithms (e.g., sensitivity, specificity, accuracy). Instead, it focuses on the equivalence of its registration process and navigation capabilities to existing systems.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. The document states that the patient registration method and resulting accuracy for the primary (reference) dataset are "identical to that described in K983529." To find any details about testing or sample sizes, one would need to refer to the K983529 submission, which is not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the 510(k) summary. Given the device's function as an image-guided surgical system for localization, ground truth would likely involve physical measurements or intraoperative verification, rather than expert interpretation of images for diagnosis.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This type of study is typically conducted for diagnostic devices where human readers interpret images. For an image-guided surgical navigation system that aids in locating anatomical structures, an MRMC study in the traditional sense would likely not be relevant or performed. The document focuses on the technical capability of fusing multiple datasets and the accuracy of registration as being equivalent to a predicate. It does not assess the diagnostic performance of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes the "Multiple Dataset Navigation" as a software change that provides the "ability to co-register (fuse) images from multiple datasets." The navigation is then "possible on the fused images." The core function described relates to the accuracy of registration. The document states: "Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529." This implies that the accuracy of the underlying registration algorithm (a standalone component) would have been assessed as part of the original K983529 submission. However, specific details of that assessment are not provided in this summary.
7. The Type of Ground Truth Used:
For the core function of image registration, ground truth would typically involve physical phantoms with known fiducial markers, where the true alignment is precisely measurable. For clinical application, ground truth for actual navigation accuracy is often derived from intraoperative verification using physical measurements or comparison to anatomical landmarks during surgery. The document itself does not specify the type of ground truth used for the claim of "identical accuracy" to K983529.
8. The Sample Size for the Training Set:
This information is not provided. As this device predates the widespread use of deep learning, the concept of a "training set" in the modern AI sense might not apply. The software change focuses on a new capability (multiple dataset navigation) building upon an existing, validated system.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
Summary of Device and Evidence Presented in Document:
The 510(k) summary describes the "InstaTrak 3500 Plus with Multiple Dataset Navigation" as an upgrade (software change only) to an existing image-guided surgical system (InstaTrak 3500 Plus, K983529). The primary new functionality is the ability to co-register (fuse) and navigate using two sets of medical images (e.g., CT and MR) instead of one.
The document claims substantial equivalence to predicate devices (BrainLAB's Vectorvision iPlan and Medtronic's StealthStation with StealthMerge) that also offer multiple dataset fusion.
The key statement regarding performance is:
"Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529."
This statement implicitly argues that because the underlying patient registration method and its accuracy are unchanged from the previously cleared device (K983529), and the new multiple dataset navigation builds upon this existing, validated platform, no new safety or effectiveness concerns are raised. The validation for the core accuracy would therefore refer back to the K983529 submission, which is not detailed here.
Therefore, this document does not present a standalone study with new acceptance criteria and performance data for this particular software upgrade, but rather leverages the established performance of the base system and the equivalence to predicate devices for the new functionality.
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K040050
Page 21 of 3
510(k) SUMMARY
GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION INSTATRAK 3500 PLUS WITH MULTIPLE DATASET NAVIGATION
SUBMITTED BY: ﮩ
GE Medical Systems Navigation and Visualization
| Primary Contact: | Jeff Wagner |
|---|---|
| GE OEC Medical Systems | |
| 384 Wright Brothers Drive | |
| Salt Lake City, UT 84116 | |
| Tel (801) 328-9300 |
DEVICE NAME 2.
| Proprietary Name: | InstaTrak with Multiple Dataset Navigation |
|---|---|
| Common/Usual Name: | Interactive Image Guided Surgical System |
| Classification Name: | Image Processing System |
DEVICE CLASSIFICATION 3.
Image Processing Systems (21 CFR 892.2050 Product Code LLZ) and Computed Tomography Systems (21 CFR 892.1750 Product Code JAK) have been classified under Section 513 of the Act as Class II by the Radiology Devices Panel.
PERFORMANCE STANDARDS 4.
No performance standards applicable to this device have been adopted under Section 514 of the Act. The InstaTrak system complies with the following:
CENELEC EN 55011 CENELEC EN 60601-1-2 CENELEC EN 60601-1 UL2601 CSA601
DEVICE DESCRIPTION 5.
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K040050
Page 2 of 3
Intended Use
The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
General Description
The InstaTrak system with Multiple Dataset Navigation provides the same capability as the existing system, with the additional functionality of utilizing two sets of medical images instead of one. By providing information from multiple datasets, the user can locate and visualize anatomical structures using different imaging modalities.
The InstaTrak 3500 Plus System allows the user to view the medical images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through the registration process. In all types of surgery the goal is the same, to display to the surgeon based on the medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. With the additional capability of multiple dataset navigation, the surgeon can now view the position of the tracked instrument using two sets of medical images instead of one.
The Multiple Dataset Navigation will provide the user with the ability to co-reqister (fuse) images from multiple datasets such as CT and MR. Using the existing InstaTrak 3500 Plus System software, the user will register one of the datasets, referred to as the Reference Dataset, to the patient. Navigation is then possible on the fused images, with secondary (registered) dataset(s) acting as a visualization enhancement for both surgical planning and intra-operative quidance. The sensors and instruments used for navigation are identical to those utilized by the existing InstaTrak system. Navigation will be disabled until the datasets have been successfully co-registered.
Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529.
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K040050
page 3 of 3
The current system provides displays for a single set of medical images. The Multiple Dataset Navigation option will provide displays for multiple sets of medical images. The addition of the Multiple Dataset Navigation operating mode does not change any of the major components of the InstaTrak System. There are no new receivers, transmitters, or instrument attachment configurations associated with this operational mode. Addition of the Multiple Dataset Navigation mode is a software change only.
7. SUBSTANTIAL EQUIVALENCE
The GE Medical Systems Navigation and Visualization Multiple Dataset Navigation option on the InstaTrak system is substantially equivalent to the Image Composer application on the Vectorvision iPlan (K020631), manufactured by BrainLAB, and the StealthStation (K954276) with StealthMerge application, manufactured by Medtronic. Each predicate device also offers the capability to fuse multiple data sets from different imaging modalities. The GE Medical Systems Multiple Dataset Navigation application has the same intended use and utilizes images from the same modalities as the predicate devices. There are no new questions of safety and effectiveness when compared to the predicate devices. The technological platform (InstaTrak, K983529) is unchanged, using the same electromagnetic position sensing and registration process as described in K983529, Except for the Multiple Dataset Navigation function, the InstaTrak system specifications and operating parameters will remain unchanged.
8. CONCLUSION
Based on the above discussion, GE Medical Systems Visualization and Navigation believes that the Multiple Dataset Navigation module is substantially equivalent to the predicate devices.
This concludes this 510(k) summary
lac ti
Jackie Magno Vice President, Regulatory and Six Sigma GE OEC Medical Systems
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2004
Mr. Jackie Magno Vice President, Regulatory Affairs and Six Sigma GE OEC Medical Systems, Inc. General Electric Company 384 Write Brothers Drive SALT LAKE CITY UT 84116-2862
Re: K040050 Trade/Device Name: Insta Trak 3500 Plus with Multiple Dataset Navigation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 22, 2003 Received: January 15, 2004
Dear Mr. Magno:
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 intestste 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, Or ug, 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, I isting 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 such 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, TDA 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (if known): K 0 400 50
Device Name: GE Medical Systems Visualization and Navigation InstaTrak System with Multiple Dataset Navigation
Indications For Use:
The system is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
David A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal
Reproductive, Abdominal,
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).