(195 days)
Not Found
No
The document describes a magnetic navigation system and associated imaging and catheter components. It focuses on the mechanical and electrical control of the catheter using magnetic fields and fluoroscopic imaging for visualization. There is no mention of AI, ML, or any form of automated decision-making or image analysis that would typically involve these technologies. The control is described as "computer controlled magnetic field generator," which implies traditional programming rather than AI/ML.
Yes
This device, specifically the Niobe EP Catheter used with the Telstar Magnetic Navigation System, is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart, which are therapeutic interventions.
No
The MNS, TIS, and Niobe EP Catheter are primarily for navigation, imaging, and recording/stimulation to facilitate procedures rather than for diagnosing a condition or disease. While the EP Catheter records electrical activity, this is part of electrophysiology studies, which can be diagnostic, but the device's main function is data acquisition for these studies and pacing, not interpretation or diagnosis itself.
No
The device description clearly outlines hardware components including a bi-planar fluoroscopy system, a computer controlled magnetic field generator, and a modified catheter. It is an interventional workstation, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for navigating a magnetic device (a catheter) within the body (in vivo) to target sites in the heart and coronary vasculature. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system involving a magnetic field generator, a fluoroscopy system for visualization, and a catheter designed for navigation and recording electrical activity within the heart. These are all components of an in-vivo medical device system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on these samples to diagnose a condition. The system's function is to facilitate a procedure within the patient's body.
Therefore, the MNS, TIS, and Niobe EP Catheter system is an interventional medical device system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Magnetic Navigation System: The 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.
Telstar Bi-plane Imaging System: Provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used standalone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.
Niobe EP Catheter: The EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.
Product codes (comma separated list FDA assigned to the subject device)
DXX, MQB, DRF
Device Description
The Telstar™ Magnetic Navigation System [MNS] is an interventional workstation for the intravascular navigation of a magnetic device through tissue to designated target sites in the heart and coronary vasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated catheter. The system employs magnetic fields to orient the catheter.
The Telstar" 14 Bi-plane Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.
The Niobe™ EP Catheter is a conventional 5-8F mapping catheter modified to accommodate magnetic actuation and control. It is designed to navigate into the right heart in order to measure and record electrical activity, and to pace the heart. A separate two-conductor junction box cord is supplied to allow electrical signals to be transmitted from the sterile catheter to a nonsterile signal recorder junction box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, X-ray
Anatomical Site
Heart and coronary vasculature, vascular systems, right heart.
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)
Physical testing: Testing of the EP Catheter was performed in accordance with the FDA "Electrode Recording Catheter Preliminary Guidance" (March, 1995). The catheter met or exceeded all requirements for biocompatibility and physical characteristics.
The Bi-plane X-ray System is designed and tested in compliance with the requirements of 21 CFR §1020.32 (Fluoroscopic Equipment).
Preclinical animal performance data: The MNS was used to steer the Niobe EP Catheter to designated sites within the canine heart. The ability of the Niobe EP Catheter and the predicate Steerocath to steer to the target sites was equivalent. Both the Niobe EP Catheter and Steerocath recorded clinically acceptable, comparable, intracardiac electrograms at each site.
Clinical performance data: Clinical evaluation was carried out in a single site, 20 patient study to confirm the safety and effectiveness of the MNS, TIS, and Niobe Catheter. Successful navigation of the catheter was achieved to 198 of 200 designated targets in the 20 patients. The conventional marketed catheter also employed was not able to reach the RV apex in one of the two patients.
The Stereotaxis Magnetic Navigation System, Telstar Bi-plane Imaging System, and Niobe EP Catheter were demonstrated to be substantially equivalent to their respective predicate devices.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
VC
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under Statement 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 Telstar™ Magnetic Navigation System [MNS] is an interventional workstation for the intravascular navigation of a magnetic device through tissue to designated target sites in the heart and coronary vasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated catheter. The system employs magnetic fields to orient the catheter.
The Telstar" 14 Bi-plane Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.
The Niobe™ EP Catheter is a conventional 5-8F mapping catheter modified to accommodate magnetic actuation and control. It is designed to navigate into the right heart in order to measure and record electrical activity, and to pace the heart. A separate two-conductor junction box cord is supplied to allow electrical signals to be transmitted from the sterile catheter to a nonsterile signal recorder junction box.
Continued on next page
1
510(k) Summary of Safety and Effectiveness, Continued
Magnetic Navigation System: The MNS is intended to navigate a magnetic Intended use 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.
Telstar Bi-plane Imaging System: Provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used standalone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.
Niobe EP Catheter: The EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.
The MNS, TIS, and Niobe Catheter are substantially equivalent to the Substantial equivalence following cleared medical devices:
| Stereotaxis Device | Predicate Device | Predicate 510(k) No. |
|---|---|---|
| MNS | Catheter Research CRI | |
| Electronic Control | ||
| System | K924125 | |
| Telstar Bi-plane | ||
| Imaging System | OEC Medical Systems | |
| IMDIS | K974355 | |
| Niobe Catheter | EP Technologies | |
| Steerocath | K900765 |
Technological characteristics
The Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically actuated catheter. The TIS provides visualization through standard fluoroscopy. The Niobe Catheter is an electrophysiology mapping catheter designed to accommodate magnetic actuation and control.
Continued on next page
2/5-
·
2
3/5
510(k) Summary of Safety and Effectiveness, Continued
Device comparisons steering control The following is a comparison of the key features of the MNS vs. the predicate device, the CRI Electronic Control System, K924125.
| Device
| Characteristics | MNS | CRI System |
|---|---|---|
| Direct contact with patient tissue | No | No |
| Remote tableside physician control of steerable | ||
| device distal orientation | Yes | Yes |
| Electronic/computer control of steerable device | ||
| distal orientation | Yes | Yes |
| Conducted under fluoroscopic visualization | Yes | Yes |
| Automated advancement of the steerable device | No | Yes |
Device comparisons -Imaging
The following is a comparison of the key features of the Telstar Bi-plane Imaging System vs. the predicate device, the OEC Medical Systems IMDIS, K974355.
| Device
Characteristics | Bi-plane Imaging
System | OEC Medical Systems
IMDIS |
|---------------------------|----------------------------|------------------------------|
| Imaging | Fluoroscopic | Fluoroscopic & spot-film |
| Mobility | No | Yes |
| Pulsed fluoro | 7.5, 15, 30 pulses/sec | 2, 4, 8, 15 pulses/sec |
| Pulsed cardiac | 15, 30 pulses/sec | 8, 15, 30 pulses/sec |
| X-ray tube assembly | Rotating anode | Rotating anode |
| Image intensifier | Yes | Yes |
| Monitor | Quad 15" | Dual 16" |
Continued on next page
3
510(k) Summary of Safety and Effectiveness, Continued
Device comparisons — Catheters
The following is a comparison of the key features of the Niobe Catheter vs. the predicate device, the EP Technologies Steerocath, K900765.
| Device
Characteristics | Niobe EP Catheter | EP Technologies
Steerocath |
|--------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Direct patient contact | Yes | Yes |
| Single use | Yes | Yes |
| Catheter body size/length | 5-8 French/130 cm | 6 French/100, 130 cm |
| Catheter body
composition | Poly Ether Block Amide
(Pebax) | Nylon |
| Mechanism of catheter
advancement/retraction | Direct physician control via
physical manipulation | Direct physician control
via physical manipulation |
| Mechanism of distal tip
orientation (steering
control) | Physician-determined
magnetic vectors via a
computer interface | Physical manipulation via
a thumbwheel lever at the
proximal end of the
catheter |
| Distal tip | Contains Neodymium-Iron-
Boron magnets | No magnets |
| Articulation wires (stylets)
within catheter | No | Yes |
| Mechanism of steering
orientation | Magnetic field-induced
torque | Physically induced torque |
Continued on next page
4
9.5
510(k) Summary of Safety and Effectiveness, Continued
| Physical testing | Testing of the EP Catheter was performed in accordance with the FDA
"Electrode Recording Catheter Preliminary Guidance" (March, 1995). The
catheter met or exceeded all requirements for biocompatibility and physical
characteristics. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Bi-plane X-ray System is designed and tested in compliance with the
requirements of 21 CFR §1020.32 (Fluoroscopic Equipment). |
| Preclinical
animal
performance
data | The MNS was used to steer the Niobe EP Catheter to designated sites within
the canine heart. The ability of the Niobe EP Catheter and the predicate
Steerocath to steer to the target sites was equivalent. Both the Niobe EP
Catheter and Steerocath recorded clinically acceptable, comparable,
intracardiac electrograms at each site. |
| Clinical
performance
data | Clinical evaluation was carried out in a single site, 20 patient study to confirm
the safety and effectiveness of the MNS, TIS, and Niobe Catheter. |
| | Successful navigation of the catheter was achieved to 198 of 200 designated
targets in the 20 patients. The conventional marketed catheter also employed
was not able to reach the RV apex in one of the two patients. |
| | The Stereotaxis Magnetic Navigation System, Telstar Bi-plane Imaging
System, and Niobe EP Catheter were demonstrated to be substantially
equivalent to their respective predicate devices. |
| 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 | April 29, 2002 |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Y 1 5 2002
Peter A. Takes, Ph.D., RAC Director Clinical and Regulatory Affairs Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, Missouri 63108
Re: K013484
Trade Name: Telstar™ Magnetic Navigating System, Telstar™ Bi-plane Imaging System and Niobe™ EP Catheter Regulation Number: 21 CFR 870.1290, 892.1650, and 870.1220
Regulation Name: Steerable Catheter Control System, Image-Intensified Fluoroscopic X-ray System, and Electrode Recording Catheter
Regulatory Class: Class II (two) Product Code: DXX, MQB, and DRF Dated: February 1, 2002 Received: February 4, 2002
Dear Dr. Takes:
This letter corrects our substantially equivalent letter of May 2, 2002, regarding the 510(k) number written in the Indications for Use Statement. That number was erroneously written as K01384 although it should have been K013484. Additionally, a newer product code, MQB instead of JAA, has been chosen for the Telstar™ Bi-plane Imaging System to reflect the use of solid state imagers in the device.
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). 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.
6
Page 2 - Peter A. Takes, Ph.D., RAC
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.
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 Errt 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
a marka masa mana masa mara mara mara mar
!
| Statement - MNS | Indications for Use Statement: |
|---|---|
| 510(k) Number: K013484 | |
| Device Name: Telstar™ Magnetic Navigation System [MNS] | |
| Indications for Use: The 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. | |
| Statement - Bi-plane Imaging System | Indications for Use Statement: |
| 510(k) Number: K013484 | |
| Device Name: Telstar™ Bi-plane Imaging System [TIS] | |
| Indications for Use: The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System | |
| Statement - Niobe Catheter | Indications for Use Statement: |
| 510(k) Number: K013484 | |
| Device Name: Niobe™ EP Catheter | |
| Indications for Use: The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart. | |
| Prescription Use: | X |
Division of Cardiovascular & Respiratory Devices
510(k) Number K013484.
: