(195 days)
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.
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
The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.
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.
Here's a breakdown of the acceptance criteria and the study details for the Telstar™ Magnetic Navigation System, Telstar™ Bi-plane Imaging System, and Niobe™ EP Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the primary acceptance criterion appears to be the successful navigation of the catheter to target sites and clinical acceptability of electrograms, demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Magnetic Navigation System (MNS) & Niobe EP Catheter: | |
| Ability to steer and reach designated target sites | Successful navigation of the catheter was achieved to 198 of 200 designated targets (99%) in the 20 patients. The Niobe EP Catheter's ability to steer to target sites was equivalent to the predicate Steerocath in preclinical animal studies. |
| Clinically acceptable electrophysiological recording/pacing | Niobe EP Catheter recorded clinically acceptable, comparable, intracardiac electrograms at each site, equivalent to the predicate Steerocath in preclinical animal studies. The clinical study also confirmed safety and effectiveness. |
| Telstar™ Bi-plane Imaging System (TIS): | |
| Compliance with fluoroscopic equipment requirements | The Bi-plane X-ray System is designed and tested in compliance with the requirements of 21 CFR §1020.32 (Fluoroscopic Equipment). This implies it met the safety and performance standards for fluoroscopic imaging. |
| Niobe™ EP Catheter (Physical & Biocompatibility): | |
| Compliance with Electrode Recording Catheter Guidance | 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. This implies it passed all specified physical integrity and biocompatibility tests outlined in the guidance. |
| Overall Safety and Effectiveness (all components) | Demonstrated to be substantially equivalent to their respective predicate devices. Clinical evaluation confirmed safety and effectiveness. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 20 patients in the clinical study.
- Data Provenance: Single site, retrospective/prospective is not explicitly stated, but clinical evaluation often implies prospective data collection. The country of origin is not specified but is implicitly the US given the submission to the FDA.
- An additional preclinical animal study was conducted using canine hearts.
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the 20-patient clinical test set. However, a "clinical evaluation" implies that the assessment of "successful navigation" and "clinically acceptable" electrograms would have been made by qualified medical professionals (e.g., electrophysiologists, cardiologists) involved in the study.
For the preclinical animal study, the assessment of "clinically acceptable, comparable, intracardiac electrograms" would also have been made by experts, likely veterinary cardiologists or researchers with electrophysiology expertise, although not explicitly detailed.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The "clinical evaluation" suggests direct assessment by the treating/researching physicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study assessed the device's performance in navigating and recording electrograms. It did not directly compare human readers with and without AI assistance for interpretation.
6. Standalone Performance (Algorithm Only)
The device is an interventional system with a human-in-the-loop (physician controlling the navigation). Therefore, a standalone (algorithm only) performance study in the context of interpretation or diagnosis is not applicable. The device's "performance" is in its ability to facilitate catheter navigation and data acquisition under physician control.
7. Type of Ground Truth Used
- Clinical Study: The ground truth for successful navigation and clinically acceptable electrograms was established by the performing clinicians based on direct observation during the procedure (e.g., fluoroscopic visualization) and analysis of the recorded electrograms. This is a form of expert assessment/clinical outcome.
- Preclinical Animal Study: Similar to the clinical study, ground truth for steering ability and electrogram quality was established by expert assessment in the animal model.
- Physical Testing: Ground truth was based on pre-defined specifications and guidance documents (e.g., FDA "Electrode Recording Catheter Preliminary Guidance" and 21 CFR §1020.32 for fluoroscopic equipment).
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of machine learning or AI models. This device is a magnetic navigation system, not an AI-driven diagnostic or image analysis tool that typically requires large training datasets. The "training" for the device would have been its design, engineering, and iterative development leading to the final product.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" for an AI model is mentioned or applicable to this device type, this question is not relevant. The device development would have involved engineering specifications, bench testing, and design verification/validation against intended performance characteristics.
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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
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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 CRIElectronic ControlSystem | K924125 |
| Telstar Bi-planeImaging System | OEC Medical SystemsIMDIS | K974355 |
| Niobe Catheter | EP TechnologiesSteerocath | 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.
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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.
| DeviceCharacteristics | MNS | CRI System |
|---|---|---|
| Direct contact with patient tissue | No | No |
| Remote tableside physician control of steerabledevice distal orientation | Yes | Yes |
| Electronic/computer control of steerable devicedistal 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.
| DeviceCharacteristics | Bi-plane ImagingSystem | OEC Medical SystemsIMDIS |
|---|---|---|
| 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
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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.
| DeviceCharacteristics | Niobe EP Catheter | EP TechnologiesSteerocath |
|---|---|---|
| Direct patient contact | Yes | Yes |
| Single use | Yes | Yes |
| Catheter body size/length | 5-8 French/130 cm | 6 French/100, 130 cm |
| Catheter bodycomposition | Poly Ether Block Amide(Pebax) | Nylon |
| Mechanism of catheteradvancement/retraction | Direct physician control viaphysical manipulation | Direct physician controlvia physical manipulation |
| Mechanism of distal tiporientation (steeringcontrol) | Physician-determinedmagnetic vectors via acomputer interface | Physical manipulation viaa thumbwheel lever at theproximal end of thecatheter |
| Distal tip | Contains Neodymium-Iron-Boron magnets | No magnets |
| Articulation wires (stylets)within catheter | No | Yes |
| Mechanism of steeringorientation | Magnetic field-inducedtorque | Physically induced torque |
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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). Thecatheter met or exceeded all requirements for biocompatibility and physicalcharacteristics. |
|---|---|
| The Bi-plane X-ray System is designed and tested in compliance with therequirements of 21 CFR §1020.32 (Fluoroscopic Equipment). | |
| Preclinicalanimalperformancedata | The MNS was used to steer the Niobe EP Catheter to designated sites withinthe canine heart. The ability of the Niobe EP Catheter and the predicateSteerocath to steer to the target sites was equivalent. Both the Niobe EPCatheter and Steerocath recorded clinically acceptable, comparable,intracardiac electrograms at each site. |
| Clinicalperformancedata | Clinical evaluation was carried out in a single site, 20 patient study to confirmthe safety and effectiveness of the MNS, TIS, and Niobe Catheter. |
| Successful navigation of the catheter was achieved to 198 of 200 designatedtargets in the 20 patients. The conventional marketed catheter also employedwas not able to reach the RV apex in one of the two patients. | |
| The Stereotaxis Magnetic Navigation System, Telstar Bi-plane ImagingSystem, and Niobe EP Catheter were demonstrated to be substantiallyequivalent to their respective predicate devices. | |
| Contact | Peter A. Takes, Ph.D., RACDirector, Clinical & Regulatory AffairsStereotaxis, Inc.4041 Forest Park AvenueSt. Louis, Missouri 63108Ph. 314-615-6964Fax 314-615-6912 |
| Date | April 29, 2002 |
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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.
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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
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Indications for Use Statement
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| 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.
:
§ 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).