(310 days)
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.
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.
The provided text does not contain specific acceptance criteria or a study outlining the device's performance against such criteria. Instead, it is a 510(k) summary for the Stereotaxis, Inc. Navigant™/Niobe® Magnetic Navigation System (NWS05), focusing on establishing substantial equivalence to a predicate device (NWS2; K032937).
The document states that "Performance testing has demonstrated substantial equivalence of the new device to the predicate device." However, it does not provide details on what this performance testing entailed, what specific metrics were measured, or what acceptance criteria were used to determine substantial equivalence. It explicitly states that "Animal and clinical data are not necessary to support the modifications" for the NWS05 and refers back to K032937 for "Application data (animal and clinical) for magnetic navigation."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text. The document indicates a reliance on the predicate device's prior approval and the inherent safety and effectiveness of the existing technology as justification for substantial equivalence for the modified device.
{0}------------------------------------------------
Stereotaxis, Inc. Navigant™/Niobe® Magnetic Navigation System
צו
Appendix 1: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined underthe Federal Food, Drug and Cosmetic Act, respecting safety and effectivenessis summarized below. For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule “...510(k) Summariesand 510(k) Statements...” (21 CFR §807) and can be used to provide asubstantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| Devicedescription | The Navigant™ Workstation with Niobe® Magnetic Navigation System[NWS05] is an interventional workstation for the navigation of appropriatelyequipped, 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 magneticdevice. | |
| The NWS05 is a modification to the Navigant™ Workstation/Niobe®Magnetic Navigation System (K032937). The changes introduce newsoftware design and mode of operation, new hardware, and a new range ofmotion to improve imaging, but maintain the existing technology fororientation 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 isintended to navigate a compatible magnetic device through tissue todesignated target sites in the right and left heart and coronary vasculature byorienting the device tip in a desired direction. The Navigant™ featureprovides an enhanced navigation interface for the physician to control theMNS. |
| Substantialequivalence | The NWS05 is substantially equivalent to the Navigant™Workstation/Niobe® Magnetic Navigation System (K032937). |
| Continued on next page | |
| Technologicalcharacteristics | The NWS05 employs magnetic fields to orient the distal tip of amagnetically-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).
| DeviceCharacteristics | New Device -NWS05 | Predicate Device -NWS2 |
|---|---|---|
| Intended use | To navigate acompatible magneticdevice through tissue todesignated target sitesin the right and leftheart and coronaryvasculature by orientingthe device tip in adesired direction. | To navigate acompatible magneticdevice through tissue todesignated target sitesin the right and leftheart and coronaryvasculature by orientingthe device tip in adesired direction. |
| Direct contact withpatient tissue | No | No |
| Remote physiciancontrol of steerabledevice distal orientation | Yes | Yes |
| Computer control ofsteerable device distalorientation | Yes | Yes |
| Conducted underfluoroscopicvisualization | Yes | Yes |
| Guided magnetic deviceemployed | Specially designedmagneticcatheters/guidewires | Specially designedmagneticcatheters/guidewires |
| Steering control | Via magnetic fields,from a control room orat patient table side | Via magnetic fields,from a control room orat 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)
| DeviceCharacteristics | New Device -NWS05 | Predicate Device -NWS2 | |
|---|---|---|---|
| System command | Physician-directedcomputer command | Physician-directedcomputer command | |
| Magnetic field source | Two permanentmagnets – positionedmechanically | Two permanentmagnets – positionedmechanically | |
| Operating field strength | Up to 0.10 T | Up to 0.10 T | |
| Physical testing | Performance testing has demonstrated substantial equivalence of the newdevice to the predicate device. | ||
| Preclinicalanimal andclinicalperformancedata | The Navigant™ Workstation with Niobe® Magnetic Navigation System[NWS05] is a modification of the predicate NWS2. Animal and clinical dataare not necessary to support the modifications. Application data (animal andclinical) for magnetic navigation were provided and/or referenced inK032937. | ||
| Contact | Peter A. Takes, Ph.D., RACDirector, Clinical & Regulatory AffairsStereotaxis, Inc.4041 Forest Park AvenueSt. Louis, Missouri 63108Ph. 314-615-6964Fax 314-615-6912takesp@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
Page 1 of 1
§ 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).