The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.

Device Description

The Niobe Magnetic Navigation System [MNS] 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.

AI/ML Overview

The provided text describes the Niobe Magnetic Navigation System (MNS) and its substantial equivalence to a predicate device, the Telstar MNS. However, it does not contain specific acceptance criteria or a detailed study outlining quantitative performance metrics.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than defining new performance acceptance criteria. It only mentions:

Acceptance Criteria	Reported Device Performance
Not specified	Demonstrated substantial equivalence to the predicate device through physical testing and performance in three canine studies.

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

Test Set Sample Size: "three canine studies" are mentioned as demonstrating performance. No specific number of canines or individual test cases within those studies is provided.
Data Provenance: Prospective animal studies (canine). The country of origin is not specified but implicitly assumed to be the USA given the FDA submission.

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

This information is not provided in the document. The studies were described as "performance" studies, implying measurement of the device's ability to navigate, but the method of establishing ground truth (e.g., target achievement confirmation) and the role of human experts in this process are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable/not provided. The Niobe MNS is a navigation system, not an AI-assisted diagnostic or interpretation tool for human readers. Its purpose is to steer a catheter, not to aid in interpretation of images by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

The device is an "interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices... through tissue to designated target sites." It relies on a "computer-controlled" system but is ultimately used by a physician for "remote tableside physician control." Therefore, it's not a purely standalone algorithm; it's an assistive technology where human-in-the-loop interaction is inherent to its intended use. The performance studies would have evaluated the system's ability to facilitate navigation, which implies its interaction with a user to achieve an outcome.

7. The Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for the performance studies in canines. Given it's a navigation system, potential ground truth elements could include:

Reached Target Site: Verification that the catheter tip reached the designated target in the heart or coronary vasculature. This could be confirmed by imaging (e.g., fluoroscopy) and/or post-mortem examination.
Navigation Accuracy: Measurement of the deviation of the steered device from the intended path.
Procedural Success: Broader outcomes like successful completion of a simulated procedure within acceptable parameters (e.g., time, safety).

However, the specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided in the document. Magnetic navigation systems rely on physical principles and control algorithms, which typically don't involve "training sets" in the same way machine learning models do. Any internal calibration or algorithm development data would not typically be referred to as a "training set" in this context.

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

As no "training set" is described for this type of device, this information is not applicable/not provided. The performance capabilities would be derived from engineering design, physics principles, and iterative testing/refinement rather than a data-driven "ground truth" for training.

Summary of Study Information:

The core of the "study" demonstrating the device meets acceptance criteria (implicitly, substantial equivalence to the predicate device) is described as:

Performance testing: "Performance testing has demonstrated substantial equivalence of the new device to the predicate device."
Canine Studies: "Performance of the Niobe MNS was demonstrated in three canine studies."
Preclinical Data: "Clinical data are not necessary to support the modifications. Clinical application data for magnetic navigation were provided in K013484 (for the predicate device)."

Essentially, the device's performance was evaluated in animal models to show it could achieve its intended purpose (navigating a magnetic device) in a manner comparable to the predicate device. Specific quantitative metrics, sample sizes beyond "three canine studies," and details on ground truth establishment are not disclosed in this 510(k) summary.

Summary

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JAN 1 5 2003 K021555

510(k) Summary of Safety and Effectiveness

Statement	Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device description	The Niobe Magnetic Navigation System [MNS] 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.
Intended use	The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.
Substantial equivalence	The Niobe MNS is substantially equivalent to the Telstar Magnetic Navigation System [MNS], K013484.
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).
	Continued on next page

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510(k) Summary of Safety and Effectiveness, Continued

Device comparisons steering control The following is a comparison of the key features of the Niobe MNS vs. the predicate device, the Telstar MNS, K013484.

DeviceCharacteristics	New Device-Niobe MNS	Predicate Device-Telstar MNS
Intended use	To navigate a magnetic devicethrough tissue to designatedtarget sites in the right and leftheart and coronary vasculatureby orienting the device tip in adesired direction.	To navigate a magneticdevice through tissue todesignated target sites inthe right and left heart andcoronary vasculature byorienting the device tip ina desired direction.
Direct contactwith patienttissue	No	No
Remote tablesidephysician controlof steerabledevice distalorientation	Yes	Yes
Computer controlof steerabledevice distalorientation	Yes	Yes
Conducted underfluoroscopicvisualization	Yes	Yes

Continued on next page

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510(k) Summary of Safety and Effectiveness, Continued

Physical testing	Performance testing has demonstrated substantial equivalence of the newdevice to the predicate device.
Preclinicalanimal andclinicalperformancedata	The Niobe MNS is a modification of the predicate Telstar MNS. Clinicaldata are not necessary to support the modifications. Clinical application datafor magnetic navigation were provided in K013484. Performance of theNiobe MNS was demonstrated in three canine studies.
Contact	Peter A. Takes, Ph.D., RACDirector, Clinical & Regulatory AffairsStereotaxis, Inc.4041 Forest Park AvenueSt. Louis, Missouri 63108Ph. 314-615-6964Fax 314-615-6912
Date	January 14, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

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

Re: K021555

Trade Name: NiobeTM Magnetic Navigation System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: December 6, 2002 Received: December 9, 2002

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.

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

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 (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. 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) 594-4646. 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 vours.

R. R. Zadeh M.D.

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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Appendix 2: Indications for Use Statement

Statement

Indications for Use Statement:

510(k) Number: K_O 2 / رك كـ كــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Device Name: Niobe Magnetic Navigation System [MNS]

Indications for Use: The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.

(Division Sig
Division of
510(k) number K021355

Prescription Use \checkmark

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).