(83 days)
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Odyssey Workstation:
Summary of Acceptance Criteria and Device Performance for the Odyssey Workstation (K072371)
| Acceptance Criteria (Device Characteristic) | Proposed Odyssey Workstation (Reported Performance) | Predicate Niobe MNS w/Navigant NWS (Predicate Performance) |
|---|---|---|
| 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 |
Detailed Study Information:
-
Sample size used for the test set and the data provenance:
The provided document does not contain details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on comparing the technological characteristics of the proposed device to a predicate device. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention any experts or the establishment of ground truth in the context of a performance study with a test set. The submission appears to be based on a comparison of technical specifications rather than a clinical performance study involving expert assessment. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no specific test set or performance study is described, there is no information about an adjudication method. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done as the device is not an AI-assisted diagnostic tool. The Odyssey Workstation is a display and user interface package. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was done. The device is a workstation designed to consolidate display and control in a catheter lab, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As there is no mention of a performance study requiring ground truth, this information is not applicable or provided. The basis for clearance appears to be substantial equivalence based on technological characteristics. -
The sample size for the training set:
The document does not mention a training set. This device is hardware with an interface, not an AI/ML algorithm that would typically require a training set. -
How the ground truth for the training set was established:
Since no training set is discussed, this information is not applicable or provided.
Conclusion on Study Evidence:
The provided 510(k) summary for the Odyssey Workstation (K072371) does not describe a traditional clinical performance study with defined acceptance criteria for accuracy, sensitivity, or specificity, nor does it detail a test set, ground truth, or expert involvement. Instead, the submission demonstrates substantial equivalence by comparing the technological characteristics of the proposed Odyssey Workstation against a legally marketed predicate device (Niobe MNS w/Navigant NWS). The conclusion 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." This indicates that the clearance was based on demonstrating that the new device's features and performance are substantially similar to or improve upon the predicate device without raising new questions of safety or effectiveness. The "performance data" likely refers to the comparison of the technical specifications listed in the table, showing how the Odyssey Workstation meets or exceeds the capabilities of the predicate in key areas relevant to its intended use as a display and user interface.
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Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter'sinformation | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Dennis Pozzo, Regulatory Affairs SpecialistPhone: 314-678-6136August 14, 2007NOV 1 4 2007 |
|---|---|
| Device/classificationname | • 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, VersionNWS05- Navigant Navigation Workstation 2.1- Stereotaxis Niobe Magnetic Navigation System |
| Devicedescription | The Odyssey Workstation is an optional (large screen) display and userinterface package designed to augment the Navigation software system. TheOdyssey Workstation allows the clinician to view multiple diagnostic toolscreens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on onelarge flat panel monitor to view and interpret a variety of sources on a singlescreen. There are multiple view formats available, and the clinician cancustomize layouts to facilitate their specific workflow. |
| Intended use | The Odyssey Workstation is an optional display and user interface packagedesigned 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 OdysseyWorkstation | Predicate Niobe MNSw/Navigant NWS |
|---|---|---|
| Display (monitor) Size | 46" | 23" |
| Pixel Resolution | 1920 x 1080 | 1920 x 1200 |
| Allowable Video Sources | 12 | 2 |
| Allows control ofconnected video sources. | Yes | One video source iscontrollable the other is not. |
| Keypad controls onlyNavigant | Yes | Yes |
| Allows control of videosources' native keypad andmouse. | Yes | Yes |
| Displays graphics &verbiage of connectedvideo sources. | Yes | Yes |
| Allows the user to choosebetween predeterminedlayout/scripts or acustomizable display. | Yes | Yes |
| Allows user interactionbetween video sources onthe 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 (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
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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)
(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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(Division Sign-Off)
Division of Cardlovascular Devices 510(k) Number
§ 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).