(112 days)
Not Found
Not Found
No
The description focuses on consolidating existing diagnostic tool displays and providing customizable layouts, with no mention of AI/ML terms or functionalities.
No.
The device is described as a display and user interface package designed to consolidate the point of control and display multiple diagnostic tool screens in a catheterization lab. It does not directly perform therapy or treatment, but rather assists clinicians in viewing and interpreting diagnostic data.
No
The device is described as a display and user interface that consolidates control and viewing of multiple diagnostic tool screens, rather than performing diagnostic functions itself. It facilitates the clinician's viewing and interpretation but doesn't produce diagnostic information.
No
The device description explicitly states it is a "display and user interface package" and mentions a "large flat panel monitor," indicating hardware components are included.
Based on the provided information, the Odyssey Workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to consolidate the point of control and display multiple diagnostic tool screens in a catheterization lab. This is related to managing and viewing data from various sources during a medical procedure, not analyzing biological samples in vitro.
- Device Description: The description focuses on displaying and organizing information from other diagnostic tools (X-Ray, ECG, etc.) on a single screen. It's a user interface and display system, not a device that performs tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests in vitro.
The device is clearly intended for use in a clinical setting (Catheter Lab) by clinicians to manage and view information from other diagnostic devices. This aligns with the definition of a medical device used in patient care, but not specifically an IVD.
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 of the Catheterization Lab.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
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.
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 / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
information | Stereotaxis, Inc.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: Dennis Pozzo, Regulatory Affairs Master Specialist
Phone: 314-678-6136
September 25, 2009 | JAN 21 2010 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device/
classification
name | • Device Name:
- Odyssey™ Workstation
• Classification/Common name: - Steerable Catheter Control System
• The marketed device(s) to which substantial equivalence is claimed: - Odyssey™ Workstation | |
| Device
description | 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. | |
| Intended use | The Odyssey Workstation is an optional display and user interface package
designed to consolidate the point of control of the Catheterization Lab. | |
| | Continued on next page | |
: 11:11:1
:
...
더 ...
[1] [1] ... [1] ... [1] ... [1] ... [1] ... ] [1] ... [1] ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .
.
,
1
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 Workstation
in Catheter Lab
w/Niobe MNS
(predicate) | 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
1200
42" and 46" displays - 1920 x
1080
56" diplay - 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 |
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,
2
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.
3
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
4
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)
ﺐ ﻓﺎ ﺗﻠﻰ ﻣﺪﻳﺮﺍﺕ ﺍﻟﻜﺒﺮﻯ ﺍﻟﻤﺴﺎﺑﻘﺎﺕ ﺍﻟﻤﺴﻠﻤﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺑﻘﻴﺔ ﺍﻟﻤﺴﺎ Concurrence of CDRH. Office of Device Evaluation (ODE)
Page 1 of 1
W.M. West
(Division Sign-Off) Division of Cardiovascular Ur-
510(k) Number K093092