(247 days)
No
The description focuses on computer-controlled permanent magnets for orienting a device tip and does not mention AI or ML.
No
The device is a navigation system used to steer other devices (catheters or guidewires) to target sites. It does not directly treat a medical condition.
No
The device is described as an interventional workstation for navigating magnetic devices (like catheters or guidewires) through tissue, not for identifying a disease or condition. Its purpose is to guide treatment, not to diagnose.
No
The device description explicitly states it is a "system" that uses "computer-controlled permanent magnets" and "magnetic fields" to orient a device. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for navigating a magnetic device through tissue to target sites in the heart and coronary vasculature. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab setting) diagnostic test.
- Device Description: The description reinforces the in vivo nature by describing the system as an "interventional workstation" for navigating devices through tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or performing diagnostic tests on these samples, which are hallmarks of IVD devices.
Therefore, the Niobe MNS is an interventional medical device used for navigation during procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Niobe MNS is intended to navigate a 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.
Product codes
DXX
Device Description
The Niobe Magnetic Navigation System [MNS] 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right and left heart and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing has demonstrated substantial equivalence of the new device to the predicate device.
The Niobe MNS is a modification of the predicate Telstar MNS. Clinical data are not necessary to support the modifications. Clinical application data for magnetic navigation were provided in K013484. Performance of the Niobe MNS was demonstrated in three canine studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 5 2003 K021555
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 Niobe Magnetic Navigation System [MNS] 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. | |
| Intended use | The Niobe MNS is intended to navigate a 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. |
| Substantial equivalence | The Niobe MNS is substantially equivalent to the Telstar Magnetic Navigation System [MNS], K013484. |
| Technological characteristics | The Niobe Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically-adapted device (e.g., catheter or guidewire). |
| Continued on next page |
//}
1
510(k) Summary of Safety and Effectiveness, Continued
Device comparisons steering control The following is a comparison of the key features of the Niobe MNS vs. the predicate device, the Telstar MNS, K013484.
| Device
Characteristics | New Device-
Niobe MNS | Predicate Device-
Telstar MNS |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | To navigate a 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 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 tableside
physician control
of steerable
device distal
orientation | Yes | Yes |
| Computer control
of steerable
device distal
orientation | Yes | Yes |
| Conducted under
fluoroscopic
visualization | Yes | Yes |
Continued on next page
2/3
2
510(k) Summary of Safety and Effectiveness, Continued
| Physical testing | Performance testing has demonstrated substantial equivalence of the new
device to the predicate device. |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preclinical
animal and
clinical
performance
data | The Niobe MNS is a modification of the predicate Telstar MNS. Clinical
data are not necessary to support the modifications. Clinical application data
for magnetic navigation were provided in K013484. Performance of the
Niobe MNS was demonstrated in three canine studies. |
| 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 |
| Date | January 14, 2003 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2003
Stereotaxis, Inc. c/o Peter A. Takes, Ph.D., RAC Director Clinical and Regulatory Affairs 4041 Forest Park Avenue St. Louis, Missouri 63108
Re: K021555
Trade Name: NiobeTM Magnetic Navigation System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: December 6, 2002 Received: December 9, 2002
Dear Dr. Takes:
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
Page 2 - Peter A. Takes, Ph.D., RAC
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 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. 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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html
Sincerely vours.
R. R. Zadeh M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix 2: Indications for Use Statement
Statement
Indications for Use Statement:
510(k) Number: K_O 2 / رك كـ كــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Device Name: Niobe Magnetic Navigation System [MNS]
Indications for Use: The Niobe MNS is intended to navigate a 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.
(Division Sig
Division of
510(k) number K021355
Prescription Use \checkmark