The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

Device Description

The Niobe® Magnetic Navigation System [NMNS] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. The system employs magnetic fields to orient or steer the tip of a magnetic device. The Navigant Navigation Workstation 2.1 [NWS2] is a modification to the Niobe® Magnetic Navigation System (K021555). The changes introduce a new software design and mode of operation, but maintain the existing technology for orientation of magnetically-adapted devices and clinical utility. The NWS2 is a subsystem of the MNS, and requires both an MNS and a digital fluoroscopy system to function properly.

AI/ML Overview

The provided text describes a modification to an existing device, the Niobe® Magnetic Navigation System (MNS), introducing the Navigant™ Navigation Workstation 2.1 (NWS2). The submission focuses on demonstrating substantial equivalence to the predicate device, not on presenting novel performance data based on new acceptance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted from this specific document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific acceptance criteria or performance metrics in a quantitative table format for the NWS2 device. Instead, it relies on demonstrating substantial equivalence to a predicate device (Niobe® MNS, K021555). The "performance" described is that the new device performs in a functionally equivalent manner regarding steering control.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Niobe® MNS with NWS2)
Intended use: Navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.	Meets Equivalent Intended Use: To navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.
Direct contact with patient tissue: No.	Meets Equivalent Performance: No direct contact with patient tissue.
Remote physician control of steerable device distal orientation: Yes.	Meets Equivalent Performance: Yes, remote physician control of steerable device distal orientation.
Computer control of steerable device distal orientation: Yes.	Meets Equivalent Performance: Yes, computer control of steerable device distal orientation.
Conducted under fluoroscopic visualization: Yes.	Meets Equivalent Performance: Yes, conducted under fluoroscopic visualization.
Guided magnetic device employed: Specially designed magnetic catheters/guidewires.	Meets Equivalent Performance: Specially designed magnetic catheters/guidewires.
Steering control: Via magnetic fields, from a control room or at patient table side.	Meets Equivalent Performance: Via magnetic fields, from a control room or at patient table side.
System command: Physician-directed computer command.	Meets Equivalent Performance: Physician-directed computer command.
Magnetic field source: Two permanent magnets - positioned mechanically.	Meets Equivalent Performance: Two permanent magnets - positioned mechanically.
Operating field strength: Up to 0.10 T.	Meets Equivalent Performance: Up to 0.10 T.
Overall performance: Performance testing has demonstrated substantial equivalence of the new device to the predicate device.	Demonstrated Substantial Equivalence: "Performance testing has demonstrated substantial equivalence of the new device to the predicate device."

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

This document states that "Animal and clinical data are not necessary to support the modifications." The Navigant™ Navigation Workstation 2.1 (NWS2) is presented as a software/interface modification to an existing system, rather than a new device requiring extensive animal or clinical testing for its own predicate. Therefore, there is no specific test set sample size or data provenance provided for the NWS2 itself in this submission. The historical data from the predicate devices (K013484 & K021555) are referenced but not detailed here.

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

Not applicable. As noted above, animal and clinical data were not deemed necessary for this specific modification submission. Therefore, no ground truth establishment by experts for a new test set is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring expert adjudication is described in this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic AI device or a device involving human "readers" or AI assistance in interpretation. It's a navigation system for interventional procedures controlled by a physician.

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

Not applicable. The Niobe® MNS with NWS2 is an interventional workstation that requires a human physician in the loop to control the magnetic devices for navigation. Its function is to facilitate physician control.

7. The Type of Ground Truth Used

Not applicable for the NWS2 modification. The submission relies on the established safety and effectiveness of the predicate Niobe® MNS (K021555) and the Telstar® Magnetic Navigation System (K013484), which involved previous animal and clinical data. For the modification itself, the "ground truth" seems to be that the updated software provides an "enhanced navigation interface" while maintaining the existing technology and clinical utility of the predicate device, confirmed through "physical testing" (which is not detailed).

8. The Sample Size for the Training Set

Not applicable. This document pertains to a device modification and substantial equivalence. It does not describe an AI/machine learning model that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. As mentioned, this is not an AI/ML submission requiring a training set with established ground truth.

Summary

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510(k) Summary of Safety and Effectiveness, K032937

Statement	Information supporting claims of substantial equivalence, as defined underthe Federal Food, Drug and Cosmetic Act, regarding safety and effectivenessis summarized below. This summary is formatted in accordance with theAgency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFRPart 807) and can be used to provide a substantial equivalence summary toanyone requesting it from the Agency.
Devicedescription	The Niobe® Magnetic Navigation System [NMNS] is an interventionalworkstation for the navigation of appropriately equipped, magneticallyadapted, devices (e.g., catheters or guidewires) through tissue to designatedtarget sites. The system uses computer-controlled permanent magnets fororienting the tip of a magnetic device.
	The system employs magnetic fields to orient or steer the tip of a magneticdevice.
	The Navigant Navigation Workstation 2.1 [NWS2] is a modification to theNiobe® Magnetic Navigation System (K021555). The changes introduce anew software design and mode of operation, but maintain the existingtechnology for orientation of magnetically-adapted devices and clinicalutility.
	The NWS2 is a subsystem of the MNS, and requires both an MNS and adigital fluoroscopy system to function properly.
Intended use	The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of theNiobe® MNS. The Niobe® MNS with NWS2 is intended to navigatecompatible magnetic devices through tissue to designated target sites in theright and left heart and coronary vasculature by orienting the device tip in adesired direction. The Navigant™ feature provides an enhanced navigationinterface for the physician to control the MNS.
Substantialequivalence	The Niobe® MNS with NWS2 is substantially equivalent to the Telstar®Magnetic Navigation System [TMNS] (K013484), and the NMNS(K021555).
	Continued on next page

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510(k) Summary of Safety and Effectiveness, K032937,

Continued

Technological characteristics

The Niobe® Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically-adapted device (e.g., catheter or guidewire).

Device comparisons steering control

The following is a comparison of the key features of the Niobe® MNS with NWS2 vs. the predicate device, the Niobe® MNS, K021555.

DeviceCharacteristics	New Device-Niobe® MNS withNWS2	Predicate Device-Niobe® MNS
Intended use	To navigate compatiblemagnetic devicesthrough tissue todesignated target sitesin the right and leftheart and coronaryvasculature by orientingthe device tip in adesired direction.	To navigate a magneticdevice through tissue todesignated target sitesin the right and leftheart and coronaryvasculature by orientingthe device tip in adesired direction.
Direct contact withpatient tissue	No	No
Remote physiciancontrol of steerabledevice distal orientation	Yes	Yes
Computer control ofsteerable device distalorientation	Yes	Yes
Conducted underfluoroscopicvisualization	Yes	Yes
Guided magnetic deviceemployed	Specially designedmagneticcatheters/guidewires	Specially designedmagneticcatheters/guidewires
Steering control	Via magnetic fields,from a control room orat patient table side	Via magnetic fields,from a control room orat patient table side

Continued on next page

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510(k) Summary of Safety and Effectiveness, K032937, Continued

Device comparisons – steering control (continued)

	DeviceCharacteristics	New Device-Niobe® MNS withNWS2	Predicate Device-Niobe® MNS
	System command	Physician-directed	Physician-directed
		computer command	computer command
	Magnetic field source	Two permanent	Two permanent
		magnets - positioned	magnets - positioned
	Operating field strength	mechanicallyUp to 0.10 T	mechanicallyUp to 0.10 T

Physical testing	Performance testing has demonstrated substantial equivalence of the newdevice to the predicate device.
Preclinicalanimal andclinicalperformancedata	The Navigant™ Navigation Workstation 2.1 [NWS2] is a modification of thepredicate Niobe® MNS. Animal and clinical data are not necessary to supportthe modifications. Application data (animal and clinical) for magneticnavigation were provided in K013484 & K021555.
Contact	Peter A. Takes, Ph.D., RACDirector, Clinical & Regulatory AffairsStereotaxis, Inc.4041 Forest Park AvenueSt. Louis, Missouri 63108Ph. 314-615-6964Fax 314-615-6912takesp@stereotaxis.com
Date	June 28, 2004

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 2004

Stereotaxis, Inc. c/o Peter A. Takes, Ph.D., RAC Director Clinical and Regulatory Affairs 4041 Forest Park Avenue St. Louis, Missouri 63108

Re: K032937

Trade Name: Navigant™ Navigation Workstation 2.1 (NWS2) Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: 74 DXX Dated: May 6, 2004 Received: May 7, 2004

Dear Dr. Takes:

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 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, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that I'DA'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);

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Page 2 - Peter A. Takes, Ph.D., RAC

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. 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 (301) 594-4648. 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 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 vours.

Neil R. O'Brien

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_______K032937

Device Name: Navigant™ Navigation Workstation 2.1 [NWS2]

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
	for BDZ
Division of Cardiovascular Devices
510(k) Number	K032937

Page 1 of _

Regulation Number and Section

§ 870.1290 Steerable catheter control system.

(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).