(197 days)
No
The description focuses on magnetic field control and fluoroscopy for navigation, with no mention of AI or ML algorithms for image analysis, decision-making, or control.
No.
The device is a navigation system and a guidewire, intended to guide other therapeutic devices or for diagnostic purposes within the vasculature. It is not described as directly treating a condition itself.
No
The device is described as an interventional workstation for navigation and control of a guidewire, indicating a therapeutic or interventional purpose rather than diagnosis.
No
The device description explicitly states that the system combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator and a steerable guidewire with an embedded magnet. These are significant hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Telstar® Magnetic Navigation System and the Stereotaxis Endovascular Guide Wire are used within the body to navigate and position devices during interventional procedures. They are tools for guiding and manipulating devices inside the vasculature, not for analyzing biological samples.
- Intended Use: The intended use clearly states navigation of a device through tissue to target sites in the body.
- Device Description: The description details a system for controlling a guidewire within the vasculature using magnetic fields and fluoroscopy for visualization.
Therefore, this device falls under the category of an interventional or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stereotaxis Cronus® Endovascular Guidewire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Cronus® Endovascular Guidewire is not intended for use without a Stereotaxis Magnetic Navigation System [MNS]. Rotational atherectomy devices and any ferromagnetic interventional devices are contraindicated for use with the Stercotaxis Endovascular Guidewire.
Stereotaxis Telstar" Magnetic Navigation System [MNS]: The TMNS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction.
Product codes (comma separated list FDA assigned to the subject device)
NDQ
Device Description
The Telstar® Magnetic Navigation System [TMNS] is an interventional workstation for the intravascular navigation of a magnetic-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated guidewire. The system employs magnetic fields to orient the guidewire.
The Stereotaxis Cronus® Modified is a steerable guidewire that has a nominal diameter of 0.014 in/0.36 mm and a nominal length of 210 cm or 300 cm. The guidewire is designed only for use in conjunction with a Stereotaxis Telstar® Magnetic Navigation System [TMNS]. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. This device is sterilized with 100% ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
bi-planar fluoroscopy system, standard fluoroscopy
Anatomical Site
right and left heart, coronary, peripheral, and neurovasculature
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)
Bench testing and pre-clinical and clinical in vivo testing demonstrate that the Stereotaxis Telstar® Magnetic Navigation System [TMNS] and the Cronus® Modified perform in an equivalent manner to the Stereotaxis Telstar® Magnetic Navigation System [TMNS], and the Stereotaxis Cronus® Predicate and the Boston Scientific TRANSENDTM EX Platinum Steerable Guide Wire 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.
K013484, K983831, K042854, K971254
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.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2006
Ms. Kelly Rowland, MA Regulatory Affairs Specialist Ouality and Regulatory Affairs STEREOTAXIS, INC. 4041 Forest Park Avenue St. Louis, MO 63108
Re: K051373
Trade/Device Name: Cronus Guidewire, Model 001-001470-1 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: NDQ Dated: November 29, 2005 Received: December 1, 2005
Dear Ms. Rowland:
This letter corrects our substantially equivalent letter of December 9, 2005
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 (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 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
1
Page 2 - Ms. Rowland
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) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Barbara Muelund
to:
Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
051373
Appendix 2: Indications for Use Statement
Statement
The indications for Use Statement:
510(k) Number: K
Device Name: Stereotaxis Guidewire and Stereotaxis Telstar® Magnetic Navigation System [MNS]
Stereotaxis Guidwire:
The Stereotaxis Cronus® Endovascular Guidewire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Cronus® Endovascular Guidewire is not intended for use without a Stereotaxis Magnetic Navigation System [MNS]. Rotational atherectomy devices and any ferromagnetic interventional devices are contraindicated for use with the Stercotaxis Endovascular Guidewire.
Stereotaxis Telstar" Magnetic Navigation System [MNS]: The TMNS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpari D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Alba EDE MADRY
Conference
DRU, Office of Device Evaluation (ODE)
XM
(Division Sign-Off)
and Neurological
Page い!
1051373
The information hority WIS. Inc. in accordance with the provisions and 1 38 and 21 CTR 88149
3
TMNS & Cronus® Modified 510(k) Stereotaxis, Inc.
, ****
:
.
: : : ・
DEC 9 2005
K051373
May 20, 2005 Page 45
| Appendix 1: 510(k) Summary of Safety and Effectiveness | Page | |
|---|---|---|
| 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 Telstar® Magnetic Navigation System [TMNS] is an interventional
workstation for the intravascular navigation of a magnetic-tipped device
through tissue to designated target sites in the right and left heart, coronary,
peripheral, and neurovasculature. It combines a bi-planar fluoroscopy system
with a computer controlled magnetic field generator, to provide both
visualization and control of a magnetically actuated guidewire. The system
employs magnetic fields to orient the guidewire.
The Stereotaxis Cronus® Modified is a steerable guidewire that has a nominal
diameter of 0.014 in/0.36 mm and a nominal length of 210 cm or 300 cm.
The guidewire is designed only for use in conjunction with a Stereotaxis
Telstar® Magnetic Navigation System [TMNS]. The wire is configured with
a tapered distal tip and an embedded magnet, which is used for navigating the
wire through the vasculature. This device is sterilized with 100% ethylene
oxide. | |
| Intended use | The Telstar® Magnetic Navigation System [TMNS] is intended to navigate a
magnetic-tipped device through tissue to designated target sites in the right
and left heart, coronary, peripheral, and neurovasculature by orienting the
device tip in a desired direction.
The Stereotaxis Endovascular Guide Wire is intended to introduce and
position over-the-wire catheters and other over-the-wire therapeutic devices
within the neurovasculature, coronary and peripheral vasculature during
PTCA or other intravascular interventional procedures. | |
| Continued | Page 2 of 2 | |
| Technological
characteristics | The Telstar® Magnetic Navigation System [TMNS] employs application of
magnetic fields to orient the distal tip of a magnetically actuated guidewire.
The Telstar® Digital Imaging System [TIS], previously cleared under
K013484 and K022565, provides visualization through standard fluoroscopy.
The Cronus® Modified is a conventional 0.014" (0.36 mm) hydrophilic-
coated endovascular guidewire modified to accommodate magnetic actuation
and control. It is designed to navigate within the vasculature to deliver a
suitable catheter or interventional device to a desired site. The finished
lengths of the Cronus® Modified are between 180 and 300 cm. A taper runs
32 cm proximal to the distal tip. The pushable shaft is a continuous wire that
allows axial force, applied at the proximal end, to be transmitted to the tip of
the guidewire. | |
| Performance
data | Bench testing and pre-clinical and clinical in vivo testing demonstrate that the
Stereotaxis Telstar® Magnetic Navigation System [TMNS] and the Cronus®
Modified perform in an equivalent manner to the Stereotaxis Telstar®
Magnetic Navigation System [TMNS], and the Stereotaxis Cronus® Predicate
and the Boston Scientific TRANSENDTM EX Platinum Steerable Guide Wire
predicate devices. | |
| Conclusion | The Stereotaxis Telstar® Magnetic Navigation System [TMNS] is
substantially equivalent to the Stereotaxis Telstar® Magnetic Navigation
System [TMNS] (K013484) and the BrainLAB VectorVision2 (VV2)
(K983831) predicate devices.
The Stereotaxis Cronus® Modified is substantially equivalent to the
Stereotaxis Cronus® Predicate (K042854) and the Boston Scientific
TRANSENDTM EX Platinum Steerable Guide Wire (K971254) predicate
devices. | |
| Contact | Kelly Rowland
Regulatory Specialist | |
| Date | May 20, 2005 | |
The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and 13 considered CONFIDENTIAN (21 CFR §812.38, and 21 CFR §814.9.
4
: 24
Appendix 1: 510(k) Summary of Safety and Effectiveness,
The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.