ODYSSEY WORKSTATION

K072371 · Stereotaxis, Inc. · DXX · Nov 14, 2007 · Cardiovascular

Device Facts

• Record ID: K072371
• Device Name: ODYSSEY WORKSTATION
• Applicant: Stereotaxis, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Nov 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.

Device Story

Odyssey Workstation is a large-screen display and user interface package for catheter labs; designed to augment existing navigation software systems. Device accepts multiple video inputs (e.g., Navigant, X-Ray, ECG, Carto) from diagnostic tools; consolidates these sources onto a single 46-inch flat panel monitor. Clinicians customize layouts and view formats to facilitate specific workflows; system allows control of connected video sources via native keypad and mouse. Device serves as a centralized point of control for the clinician, improving visualization of disparate diagnostic data streams during procedures. Benefits include streamlined workflow and enhanced information management for the physician.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

46-inch flat panel monitor; 1920 x 1080 resolution; supports up to 12 video sources; allows user-defined layout scripts and customizable display configurations; provides centralized control interface for connected diagnostic equipment.

Indications for Use

Indicated for use in the catheter lab to consolidate display and control of multiple diagnostic tool screens for clinicians.

Regulatory Classification

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.

Predicate Devices

• Stereotaxis, Niobe MNS w/Navigant NWS
• Navigant Workstation w/Niobe Magnetic Navigation System, Version NWS05
• Navigant Navigation Workstation 2.1
• Stereotaxis Niobe Magnetic Navigation System

Submission Summary (Full Text)

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August 22, 2007 Page 35

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# Appendix 1: 510(k) Summary per 21CFR §807.92

| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: Dennis Pozzo, Regulatory Affairs Specialist<br>Phone: [phone]<br>August 14, 2007<br>NOV 1 4 2007 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | • Device Name:<br>Odyssey Workstation<br>• Classification/Common name:<br>Steerable Catheter Control System<br>• The marketed device(s) to which substantial equivalence is claimed:<br>- Stereotaxis, Niobe MNS w/Navigant NWS<br>- Navigant Workstation w/Niobe Magnetic Navigation System, Version<br>NWS05<br>- Navigant Navigation Workstation 2.1<br>- Stereotaxis Niobe Magnetic Navigation System |
| Device<br>description | The Odyssey Workstation is an optional (large screen) display and user<br>interface package designed to augment the Navigation software system. The<br>Odyssey Workstation allows the clinician to view multiple diagnostic tool<br>screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one<br>large flat panel monitor to view and interpret a variety of sources on a single<br>screen. There are multiple view formats available, and the clinician can<br>customize layouts to facilitate their specific workflow. |
| Intended use | The Odyssey Workstation is an optional display and user interface package<br>designed to consolidate the point of control in the Catheter Lab. |

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## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

| Device Characteristic | Proposed Odyssey<br>Workstation | Predicate Niobe MNS<br>w/Navigant NWS |
|----------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------------|
| Display (monitor) Size | 46" | 23" |
| Pixel Resolution | 1920 x 1080 | 1920 x 1200 |
| Allowable Video Sources | 12 | 2 |
| Allows control of<br>connected video sources. | Yes | One video source is<br>controllable the other is not. |
| Keypad controls only<br>Navigant | Yes | Yes |
| Allows control of video<br>sources' native keypad and<br>mouse. | Yes | Yes |
| Displays graphics &<br>verbiage of connected<br>video sources. | Yes | Yes |
| Allows the user to choose<br>between predetermined<br>layout/scripts or a<br>customizable display. | Yes | Yes |
| Allows user interaction<br>between video sources on<br>the display. | Yes | Yes |
| Save display layout | Yes | Yes |
| Print display layout | No | Yes |

### Technological characteristics

The table below lists device characteristics of the proposed Odyssey Workstation vs. the predicate Navigant NWS.

#### Based upon the documentation presented in this 510(k) it has been Performance data demonstrated that the Odyssey Workstation is safe and effective when used with the Niobe MNS w/Navigant NWS.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of multiple curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2007

Stereotaxis, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108

Re: K072371

Trade/Device Name: Odyssey Workstation, Model 00-007000-1 Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: August 22, 2007 Received: August 23, 2007

Dear Mr. Pozzo:

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 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

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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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

B/zimmerman fr

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

The indications for Use Statement: Statement

510(k) Number: K 07237|

Device Name: OdysseyTM Workstation

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Cardlovascular Devices 510(k) Number