The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System [MNS]. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

Device Description

The Cardiodrive® advances or retracts a compatible magnetic electrophysiology [EP] mapping catheter, through a hemostasis introducer, remotely via a User Interface (UI) located either at the patient table or in the control room.

The Stereotaxis Cardiodrive® consists of an electrical controller, motor assembly, and user controls, plus sterile, single-use advancer unit, patient mounting bracket, flexible drive shaft, and hemostasis valve adapter.

AI/ML Overview

The provided document K042850 is a 510(k) summary for the Stereotaxis Cardiodrive® Catheter Advancer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results or extensive performance data against specific acceptance criteria.

Based on the information provided, here's what can be extracted and what is not available in the document:

This 510(k) summary does not include a detailed study that proves the device meets specific acceptance criteria in the format of a clinical trial with human subjects. Instead, it relies on demonstrating equivalence to an existing predicate device through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not provide specific quantitative acceptance criteria or detailed device performance metrics beyond a statement of equivalence. The "acceptance criteria" here are implied by the performance of the predicate device, which the new device is stated to match.

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence to the predicate device (Stereotaxis Catheter Advancer System (CAS)) in advancing and retracting compatible magnetic EP mapping catheters.	"Bench testing demonstrates that the Stereotaxis Cardiodrive® performs in an equivalent manner to the Stereotaxis Catheter Advancer System (CAS) predicate device."
Safety and Effectiveness comparable to the predicate device.	The FDA's substantial equivalence determination implies it meets safety and effectiveness standards comparable to the predicate.

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

Sample Size for Test Set: Not specified. The document only mentions "Bench testing," which implies testing of the device itself rather than a patient-based test set or a dataset for an AI model.
Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable, as no human data or AI training/test data are mentioned for this submission. The testing was bench testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a mechanical system, and its performance was assessed via bench testing, not through expert review of diagnostic outputs or images.

4. Adjudication Method for the Test Set

Not applicable. No expert review or adjudication process is described for bench testing of a mechanical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or reported. This device is a mechanical system for catheter manipulation, not a diagnostic imaging or AI-assisted interpretation device that would typically undergo MRMC studies.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic product.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI algorithm. The device operates as a standalone mechanical system controlled by a user.

7. Type of Ground Truth Used

Bench Testing Performance: The "ground truth" for this submission is the established performance and safety profile of the predicate device, against which the new device demonstrated equivalence through bench testing.

8. Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable. This is not an AI or machine learning device. The "ground truth" for comparison was the predicate device's established performance.

Summary

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K042850

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Appendix 1 – 510(k) Summary of Safety and Effectiveness

Statement	Information supporting claims of substantial equivalence, as defined underthe Federal Food, Drug and Cosmetic Act, respecting safety and effectivenessis summarized below.For the convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and 510(k)Statements..." (21 CFR §807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency.
Devicedescription	The Cardiodrive® advances or retracts a compatible magneticelectrophysiology [EP] mapping catheter, through a hemostasis introducer,remotely via a User Interface (UI) located either at the patient table or in thecontrol room.
Intended use	The Stereotaxis Cardiodrive® is intended for automatically advancing andretracting only compatible magnetic electrophysiology [EP] mappingcatheters. It is not intended to advance the EP mapping catheter through thecoronary vasculature nor the coronary sinus.
Technologicalcharacteristics	The Stereotaxis Cardiodrive® consists of an electrical controller, motorassembly, and user controls, plus sterile, single-use advancer unit, patientmounting bracket, flexible drive shaft, and hemostasis valve adapter.
Performancedata	Bench testing demonstrates that the Stereotaxis Cardiodrive® performs in anequivalent manner to the Stereotaxis Catheter Advancer System (CAS)predicate device.
Conclusion	The Stereotaxis Cardiodrive® is substantially equivalent to the StereotaxisCatheter Advancer System (CAS) (021802) predicate device.
Contact	Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products
Date	September 20, 2004

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

Stereotaxis, Inc. c/o Mr. Gary Rauvola, RAC Director, Regulatory Affairs - Disposable Products 4320 Forest Park Avenue Suite 100 St. Louis, MO 63108

K042850 Re:

Trade/Device Name: Stereotaxis Cardiodrive® Catheter Advancer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 12, 2006 Received: June 13, 2006

Dear Mr. Rauvola:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave review your see determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) it itgans)
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to econiner of the 1125 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees that have been receasing t require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diciere, mailes of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device 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 FDA's issuance of a substantial equivalence determination does not mean 1 Toast of advised that 1197 5 results over device complies with other requirements of the Act that I DA has made a detel regulations administered by other Federal agencies. You must

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Page 2 - Mr. Gary Rauvola, RAC

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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmarfor

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

The indications for Use Statement:

510(k) Number: K042850_______________________________________________________________________________________________________________________________________________________

Device Name: Stereotaxis Cardiodrive®

Stereotaxis Cardiodrive®:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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S.K. McComber

Julsion Sign-Off) Division of Cardlovascular Devloes 510(k) Number

Page I of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).