(310 days)
Not Found
No
The summary describes a magnetic navigation system for steering devices using computer-controlled magnets. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on hardware and software modifications to improve imaging and range of motion, not on intelligent data processing or learning.
No
The device is intended to navigate a medical device for treatment, not to directly provide therapy itself. It's a tool for intervention, not a therapeutic device.
No
The device is described as an "interventional workstation" intended to "navigate a compatible magnetic device through tissue to designated target sites." Its function is to steer or orient a magnetic device (like a catheter or guidewire) during interventional procedures, not to diagnose a medical condition.
No
The device description explicitly states the system includes "new hardware" and uses "computer-controlled permanent magnets" and "magnetic fields" to orient the device, indicating it is a hardware-software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature." This describes an in vivo procedure (within a living organism), not an in vitro procedure (outside of a living organism, typically involving samples like blood or tissue).
- Device Description: The description reinforces the in vivo nature by mentioning the navigation of devices "through tissue" and the use of magnetic fields to orient the tip of a device within the body.
- Anatomical Site: The specified anatomical site (heart and coronary vasculature) is within the human body.
- Input Imaging Modality: The reliance on a "digital fluoroscopy system" is consistent with real-time imaging used during interventional procedures within the body.
IVD devices are designed to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device's function is to assist in a medical procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.
Product codes
74 DXX
Device Description
The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device.
The system employs magnetic fields to orient or steer the tip of a magnetic device.
The NWS05 is a modification to the Navigant™ Workstation/Niobe® Magnetic Navigation System (K032937). The changes introduce new software design and mode of operation, new hardware, and a new range of motion to improve imaging, but maintain the existing technology for orientation of magnetically-adapted devices and clinical utility.
The NWS05 requires a digital fluoroscopy system to function properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital fluoroscopy
Anatomical Site
right and left heart and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Physical testing: Performance testing has demonstrated substantial equivalence of the new device to the predicate device.
Preclinical animal and clinical performance data: The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] is a modification of the predicate NWS2. Animal and clinical data are not necessary to support the modifications. Application data (animal and clinical) for magnetic navigation were provided and/or referenced in K032937.
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.
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
§ 870.1290 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
Stereotaxis, Inc. Navigant™/Niobe® Magnetic Navigation System
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Appendix 1: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under
the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness
is summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule “...510(k) Summaries
and 510(k) Statements...” (21 CFR §807) and can be used to provide a
substantial equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The Navigant™ Workstation with Niobe® Magnetic Navigation System
[NWS05] is an interventional workstation for the navigation of appropriately
equipped, magnetically adapted, devices (e.g., catheters or guidewires)
through tissue to designated target sites. The system uses computer-
controlled permanent magnets for orienting the tip of a magnetic device. |
| | The system employs magnetic fields to orient or steer the tip of a magnetic
device. |
| | The NWS05 is a modification to the Navigant™ Workstation/Niobe®
Magnetic Navigation System (K032937). The changes introduce new
software design and mode of operation, new hardware, and a new range of
motion to improve imaging, but maintain the existing technology for
orientation of magnetically-adapted devices and clinical utility. |
| | The NWS05 requires a digital fluoroscopy system to function properly. |
| Intended use | The Navigant™ Workstation with Niobe® Magnetic Navigation System is
intended to navigate a compatible magnetic device through tissue to
designated target sites in the right and left heart and coronary vasculature by
orienting the device tip in a desired direction. The Navigant™ feature
provides an enhanced navigation interface for the physician to control the
MNS. |
| Substantial
equivalence | The NWS05 is substantially equivalent to the Navigant™
Workstation/Niobe® Magnetic Navigation System (K032937). |
| | Continued on next page |
| Technological
characteristics | The NWS05 employs magnetic fields to orient the distal tip of a
magnetically-adapted device (e.g., catheter or guidewire). |
:
1
Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued
Device comparisons steering control The following is a comparison of the key features of The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] vs. the predicate device, the Navigant™ Workstation/Niobe® Magnetic Navigation System (NWS2; K032937).
| Device
Characteristics | New Device -
NWS05 | Predicate Device -
NWS2 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | To navigate a
compatible magnetic
device through tissue to
designated target sites
in the right and left
heart and coronary
vasculature by orienting
the device tip in a
desired direction. | To navigate a
compatible magnetic
device through tissue to
designated target sites
in the right and left
heart and coronary
vasculature by orienting
the device tip in a
desired direction. |
| Direct contact with
patient tissue | No | No |
| Remote physician
control of steerable
device distal orientation | Yes | Yes |
| Computer control of
steerable device distal
orientation | Yes | Yes |
| Conducted under
fluoroscopic
visualization | Yes | Yes |
| Guided magnetic device
employed | Specially designed
magnetic
catheters/guidewires | Specially designed
magnetic
catheters/guidewires |
| Steering control | Via magnetic fields,
from a control room or
at patient table side | Via magnetic fields,
from a control room or
at patient table side |
Continued on next page
2
3/3
Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued
Device comparisons - steering control (continued)
| | Device
Characteristics | New Device -
NWS05 | Predicate Device -
NWS2 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| | System command | Physician-directed
computer command | Physician-directed
computer command |
| | Magnetic field source | Two permanent
magnets – positioned
mechanically | Two permanent
magnets – positioned
mechanically |
| | Operating field strength | Up to 0.10 T | Up to 0.10 T |
| Physical testing | Performance testing has demonstrated substantial equivalence of the new
device to the predicate device. | | |
| Preclinical
animal and
clinical
performance
data | The Navigant™ Workstation with Niobe® Magnetic Navigation System
[NWS05] is a modification of the predicate NWS2. Animal and clinical data
are not necessary to support the modifications. Application data (animal and
clinical) for magnetic navigation were provided and/or referenced in
K032937. | | |
| Contact | Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Stereotaxis, Inc.
4041 Forest Park Avenue
St. Louis, Missouri 63108
Ph. 314-615-6964
Fax 314-615-6912
takesp@stereotaxis.com | | |
| Date | March 11, 2005 | | |
and and the commended and and a successful a second for a comments a comments of the comments of the forme of
. . .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement around the caduceus symbol. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
Stereotaxis. Inc. c/o Mr. Uwe Degenhardt TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K051760
Trade Name: Navigant™ Workstation with Niobe® Magnetic Navigation System, Version NWS05. Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: 74 DXX Dated: April 19, 2006 Received: April 20, 2006
Dear Mr. Degenhardt:
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.
4
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); good manufacturing practice requirements 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Blummenhofer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K051760
Device Name: Navigant™ Workstation with Niobe® Magnetic Navigation System
Indications For Use: The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use .(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bbitmuma
sion of Ca Biolk) Numb
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