The InstaTrak 3000 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 rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT, MR, or Xray.

Device Description

The InstaTrak 3000 System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 with FluoroTrak is similar to the InstaTrak 3000 System cleared under K983529. The changes to the system include software enhancements and the addition of a calibration fixture. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures. The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base, cranial, axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user. The original InstaTrak 3000 System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and images is accomplished through the registration process. In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 with FluoroTrak is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the InstaTrak 3000 System with FluoroTrak Module:

Unfortunately, the provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt. The document is a 510(k) summary for premarket notification, which focuses on establishing substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria and detailed statistical results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy: The device performed within the specification while using the new component (FluoroTrak calibration fixture).	The results showed that the device performed within the specification while using the new component. (Specific quantitative specifications are not provided in this document).

Missing Information: The document states "within the specification" but does not explicitly list the quantitative acceptance criteria (e.g., specific accuracy thresholds in millimeters) for location, surgical instrument position, or any other performance metric.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Testing was performed using the new component of the InstaTrak 3000 with FluoroTrak to determine if the new component affected device accuracy."

Missing Information:

Sample Size: The number of tests, cases, or subjects used for this testing is not mentioned.
Data Provenance: There is no information about whether the data was prospective or retrospective, or the country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Missing Information: The document does not describe the methodology for establishing ground truth for the performance testing, nor does it mention the involvement or qualifications of any experts for this purpose.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method (e.g., 2+1, 3+1, none) is mentioned as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or implied in this document. This device is an image-guided surgical system, not an AI diagnostic tool that assists human readers in interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

The performance testing described focuses on the device (InstaTrak 3000 with FluoroTrak module) and its accuracy when using a new component. It is implied to be a standalone performance evaluation of the system, not specifically an algorithm-only study in the context of AI. The core function of the device is image guidance for a surgeon, so human-in-the-loop

Summary

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K942 70

Image /page/0/Picture/2 description: The image contains the words "Visualization" and "Technology" stacked on top of each other. To the left of the words is a square made up of smaller squares. The words are written in a serif font and are black in color.

What You'd Like to See

510(k) Summary VISUALIZATION TECHNOLOGY, INC. INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE

1. SPONSOR

Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887 (978) 933-1000 Telephone:

Primary Contact : Norma LeMay Sr. Requlatory Affairs Coordinator

Secondary Contact : Peter Ohanian Vice President, Quality Assurance & Regulatory Affairs

2. Device Name

Proprietary Name:	InstaTrak 3000 System with FluoroTrak Module
Common/Usual Name:	Interactive Image Guided Surgical System
Classification Name:	Computed Tomography X-Ray System

3. PREDICATE DEVICES

Visualization Technology Inc., InstaTrak 3000 System, K983529, FDA ● concurrence received December 31, 1998
StealthStation System with FluoroNav Module manufactured by Surgical . Navigation Technologies, K990214, FDA concurrence received April 22, 1999

4. Device Description

The InstaTrak 3000 System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak

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3000 with FluoroTrak is similar to the InstaTrak 3000 System cleared under K983529. The changes to the system include software enhancements and the addition of a calibration fixture. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures.

The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base, cranial, axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user.

The original InstaTrak 3000 System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and images is accomplished through the registration process. In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 with FluoroTrak is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor.

5. Intended Use

The InstaTrak 3000 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 rigid anatomical structures such as sinus, skull, cranial, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The InstaTrak 3000 with FluoroTrak, the original InstaTrak 3000 and the Stealth Station with FluoroNav are similar in intended use as they are all indicated for locating rigid anatomical structures during either open or percutaneous procedures. The InstaTrak 3000 with FluoroTrak is identical to both the original InstaTrak 3000 System and the Stealth Station with FluoroNav devices in that they are all intraoperative image-guidance systems intended for cranial, skull base, axial skeletal and sinus surgery.

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The InstaTrak 3000 with FluoroTrak is essentially identical in technological characteristics to the InstaTrak 3000 System cleared under K983529 with the exception of software enhancements and the addition of the calibration fixture. The InstaTrak 3000 with FluoroTrak uses the same electromagnetic position sensing, and registration process as the original InstaTrak 3000 System cleared under K983529.

The InstaTrak 3000 with FluoroTrak, the original InstaTrak 3000 System and the Stealth Station with FluoroNav all use a computer, monitor and hard disk storage system. Both the FluoroTrak and FluoroNav systems offer image guidance using CT, MR or X-Ray images while the original InstaTrak 3000 System only offers CT and MR images.

There is only one new component associated with the InstaTrak 3000 with FluoroTrak, which is the addition of the calibration fixture. This new component will be used with the InstaTrak 3000 System and has been added to accommodate the FluoroTrak Module .

There are no new instruments used other than what was described in the original 510(k) (K983529) for the InstaTrak 3000 System.

7. PERFORMANCE TESTING

Testing was performed using the new component of the InstaTrak 3000 with FluoroTrak to determine if the new component affected device accuracy. The results showed that the device performed within the specification while using the new component.

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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The logo is simple and iconic, representing the department's mission to protect the health of all Americans.

9 2000 MAR

Norma J. LeMay Sr. Regulatory Affairs Coordinator Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887

Re:

K994270 InstaTrak 3000 System with FluoroTrak Module Dated: December 17, 1999 Received: December 20, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA and 90 LLZ

Dear Ms. Lemay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Daniel G. Schultz, M.D.

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

Device Name: Visualization Technology, Inc. InstaTrak 3000 with FluoroTrak™ Module

Indications For Use:

The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or perculaneous 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, cranial, a long bone or vertebra, visible on medical images such as CT, MR, or Xray.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segars

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).