(83 days)
Not Found
Not Found
No
The description focuses on display and user interface functionality for consolidating existing diagnostic tools, with no mention of AI/ML terms or capabilities.
No
The device is described as a display and user interface package for viewing diagnostic tools, not for providing therapy directly.
No
The device is a display and user interface package, not a medical device that performs a diagnostic function on its own. It allows clinicians to view and interpret information from various diagnostic tools, but it does not generate a diagnosis.
No
The device is described as a "display and user interface package" and mentions a "large flat panel monitor," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to consolidate the point of control and display multiple diagnostic tool screens in a Catheter Lab. This is a system for displaying and interacting with data from other diagnostic tools, not a device that performs tests on biological samples.
- Device Description: The description reinforces that it's a display and user interface package for viewing and interpreting data from various sources. It doesn't mention any analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device is a workstation designed to improve workflow and visualization in a clinical setting by integrating information from other diagnostic devices. This falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.
Product codes
DXX
Device Description
The Odyssey Workstation is an optional (large screen) display and user interface package designed to augment the Navigation software system. The Odyssey Workstation allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician in the Catheter Lab.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The document states: "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." No specific study type, sample size, AUC, MRMC, or standalone performance results are provided.
Key Metrics
Not Found
Predicate Device(s)
Stereotaxis, Niobe MNS w/Navigant NWS
Reference Device(s)
Navigant Workstation w/Niobe Magnetic Navigation System, Version NWS05, Navigant Navigation Workstation 2.1, Stereotaxis Niobe Magnetic Navigation System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
August 22, 2007 Page 35
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Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Stereotaxis, Inc.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: Dennis Pozzo, Regulatory Affairs Specialist
Phone: 314-678-6136
August 14, 2007
NOV 1 4 2007 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | • Device Name:
Odyssey Workstation
• Classification/Common name:
Steerable Catheter Control System
• The marketed device(s) to which substantial equivalence is claimed:
- 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 |
| Device
description | The Odyssey Workstation is an optional (large screen) display and user
interface package designed to augment the Navigation software system. The
Odyssey Workstation allows the clinician to view multiple diagnostic tool
screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one
large flat panel monitor to view and interpret a variety of sources on a single
screen. There are multiple view formats available, and the clinician can
customize layouts to facilitate their specific workflow. |
| Intended use | The Odyssey Workstation is an optional display and user interface package
designed to consolidate the point of control in the Catheter Lab. |
1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Proposed Odyssey
Workstation | Predicate Niobe MNS
w/Navigant NWS |
|----------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------------|
| Display (monitor) Size | 46" | 23" |
| Pixel Resolution | 1920 x 1080 | 1920 x 1200 |
| Allowable Video Sources | 12 | 2 |
| Allows control of
connected video sources. | Yes | One video source is
controllable the other is not. |
| Keypad controls only
Navigant | Yes | Yes |
| Allows control of video
sources' native keypad and
mouse. | Yes | Yes |
| Displays graphics &
verbiage of connected
video sources. | Yes | Yes |
| Allows the user to choose
between predetermined
layout/scripts or a
customizable display. | Yes | Yes |
| Allows user interaction
between video sources on
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.
2
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
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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)
(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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Blymmumo
(Division Sign-Off)
Division of Cardlovascular Devices 510(k) Number