(112 days)
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control of the Catheterization Lab.
The Odyssey Workstation is an optional (large screen) display and user interface package which 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 Stereotaxis Odyssey™ Workstation, focusing on acceptance criteria and study information:
Stereotaxis Odyssey™ Workstation Acceptance Criteria and Study Information
The 510(k) summary for the Stereotaxis Odyssey™ Workstation does not explicitly define acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" are implied through the comparison of the device's characteristics to a legally marketed predicate device (the Odyssey™ Workstation in Catheter Lab w/Niobe MNS). The study described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a performance study aiming to meet specific numerical thresholds.
The primary "study" is a comparison of the proposed device's characteristics against a predicate device to affirm substantial equivalence regarding safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a display and user interface package, not a diagnostic algorithm), the acceptance criteria are based on functional and technical characteristics, demonstrating equivalence to the predicate device. The "reported device performance" is the proposed device's characteristics.
| Device Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Odyssey Workstation in Catheter Lab w/o Niobe MNS) |
|---|---|---|
| Display (monitor) Size | 46" | Optional displays: 23", 24", 42", 46", and 56" |
| Pixel Resolution | 1920 x 1080 | 23" and 24" displays - 1920 x 120042" and 46" displays - 1920 x 108056" display - 3840 x 2160 |
| Allowable Video Sources | 12 | 12 |
| Allows control of connected video sources. | Yes | Yes |
| Keypad controls only Navigant | Yes | No |
| 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 |
Note: The "Acceptance Criteria" column represents the characteristics of the predicate device that the proposed device aims to be substantially equivalent to or improve upon without raising new questions of safety or effectiveness. The "Reported Device Performance" column shows the characteristics of the proposed Odyssey Workstation. The differences (e.g., expanded display options, removal of "keypad controls only Navigant") are presented as improvements or modifications that do not alter the fundamental safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" with a defined sample size of patient data. The evaluation is based on comparing the technical specifications and functional capabilities of the new Odyssey Workstation to those of the predicate device. Therefore, there is no patient or image data used for a test set. This is a technical comparison, not a performance study on clinical data.
Data Provenance: Not applicable, as there is no clinical data test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission concerns a display and user interface system, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the confirmed functionality and technical specifications of the device itself and its predicate.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or expert adjudication described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a display and user interface package, not a device that assists human readers in interpreting clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Odyssey Workstation is a display and control system for existing diagnostic tools, not an algorithm that performs a standalone diagnostic function. Its purpose is to consolidate existing information for a clinician, implying a human-in-the-loop scenario.
7. The Type of Ground Truth Used
The "ground truth" in this context is the verified technical specifications and functional capabilities of the device, confirmed through engineering design, testing, and comparison to the predicate device's established characteristics. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning algorithm and therefore does not have a "training set" in the conventional sense. Its functionality is based on software and hardware design, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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'sinformation | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Dennis Pozzo, Regulatory Affairs Master SpecialistPhone: 314-678-6136September 25, 2009 | JAN 21 2010 |
|---|---|---|
| Device/classificationname | • Device Name:- Odyssey™ Workstation• Classification/Common name:- Steerable Catheter Control System• The marketed device(s) to which substantial equivalence is claimed:- Odyssey™ Workstation | |
| Devicedescription | The Odyssey Workstation is an optional (large screen) display and userinterface package which 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 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
| Device Characteristic | Odyssey Workstationin Catheter Labw/Niobe MNS(predicate) | Odyssey Workstation inCatheter Lab w/o NiobeMNS |
|---|---|---|
| Display (monitor) Size | 46" | Optional displays: 23", 24",42", 46" and 56" |
| Pixel Resolution | 1920 x 1080 | 23" and 24" displays - 1920 x120042" and 46" displays - 1920 x108056" diplay - 3840 x 2160 |
| Allowable Video Sources | 12 | 12 |
| Allows control ofconnected video sources. | Yes | Yes |
| Keypad controls onlyNavigant | Yes | No |
| 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 |
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 (800) 638-2041 or (301) 796-7100 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
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).