ODYSSEY WORKSTATION

K093092 · Stereotaxis, Inc. · DQK · Jan 21, 2010 · Cardiovascular

Device Facts

• Record ID: K093092
• Device Name: ODYSSEY WORKSTATION
• Applicant: Stereotaxis, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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

Device Story

Odyssey Workstation is a display and user interface package for catheterization labs; consolidates multiple diagnostic tool screens (e.g., Navigant, X-Ray, ECG, Carto) onto a single large flat-panel monitor. Clinicians use the system to view and interpret various data sources simultaneously; customize display layouts; and control connected video sources via native keypad/mouse. System supports up to 12 video sources; allows saving of display layouts. Used by clinicians in catheter labs to facilitate workflow; improves visualization of diagnostic information; aids clinical decision-making by centralizing point of control.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive comparisons of technological characteristics and intended use.

Technological Characteristics

Display/user interface package; supports multiple flat-panel monitor sizes (23", 24", 42", 46", 56"); resolutions up to 3840 x 2160; supports 12 video sources; allows control of connected video sources via keypad/mouse; customizable display layouts; saves display configurations.

Indications for Use

Indicated for use in the catheterization lab to consolidate display and control of multiple diagnostic tool screens and video sources for clinical visualization and workflow management.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Odyssey™ Workstation (K093092)

Reference Devices

• Navigant NWS

Submission Summary (Full Text)

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K093092 ps lopz

Special Premarket Notification Stereotaxis, OdysseyTM Workstation (Standard Cath Labs) September 29, 2009
Page 19

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

្រះបុ

| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: Dennis Pozzo, Regulatory Affairs Master Specialist<br>Phone: [phone]<br>September 25, 2009 | JAN 21 2010 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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>- Odyssey™ Workstation | |
| Device<br>description | The Odyssey Workstation is an optional (large screen) display and user<br>interface package which 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 of the Catheterization Lab. | |
| | Continued on next page | |

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K093092 pg 2 of 2

Special Premarket Notification Stereotaxis, Odyssey™ Workstation (Standurd Cuth Labs) September 29, 2009 l'age 20

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

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| Device Characteristic | Odyssey Workstation<br>in Catheter Lab<br>w/Niobe MNS<br>(predicate) | Odyssey Workstation in<br>Catheter Lab w/o Niobe<br>MNS |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Display (monitor) Size | 46" | Optional displays: 23", 24",<br>42", 46" and 56" |
| Pixel Resolution | 1920 x 1080 | 23" and 24" displays - 1920 x<br>1200<br>42" and 46" displays - 1920 x<br>1080<br>56" diplay - 3840 x 2160 |
| Allowable Video Sources | 12 | 12 |
| Allows control of<br>connected video sources. | Yes | Yes |
| Keypad controls only<br>Navigant | Yes | No |
| 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 |

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

Performance datu

and and promise for the first of the very of the very of the virus of the many of the many to

Based upon the documentation presented in this 510(k) it has been demonstrated that the Odyssey Workstation is safe and effective when used in standard catheter labs,

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. The symbol on the right resembles a stylized human figure or bird-like shape.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 1 2010

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

Re: K093092

Trade/Device Name: Odyssey Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: December 18, 2009 Received: December 22, 2009

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Dennis Pozzo

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFD'A/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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# September 29, Paz 21

### Appendix 2: Indications for Use Statement

Statement

The indications for Use Statement:

510(k) Number: K093092

Device Name: Odyssey™ Workstation

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

AND/OR Prescription Use __ ইংর (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)

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W.M. West

(Division Sign-Off) Division of Cardiovascular Ur-

**510(k) Number** K093092