(197 days)
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.
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.
The provided document is a 510(k) summary for the Stereotaxis Cronus® Endovascular Guidewire and Stereotaxis Telstar® Magnetic Navigation System [MNS]. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the comprehensive study design.
Here's a breakdown of the information that can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions "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 TRANSEND™ EX Platinum Steerable Guide Wire predicate devices."
This statement confirms that performance data was gathered and compared to predicate devices for elements like:
- Navigational capabilities within the vasculature
- Ability to introduce and position over-the-wire catheters and therapeutic devices
- Compatibility with the Magnetic Navigation System
However, the document does not provide specific quantitative acceptance criteria (e.g., "must achieve X successful navigations out of Y attempts," "force to dislodge must be greater than Z Newton") nor detailed reported performance metrics (e.g., "average navigation time," "percentage of successful catheter placements," "specific force measurements"). It only states that the performance was "equivalent" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "pre-clinical and clinical in vivo testing," but does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide any information regarding experts used to establish ground truth or their qualifications. Given this is a medical device for navigation, it's highly likely that medical professionals (e.g., interventional cardiologists, neurologists) would have been involved in assessing performance during in vivo testing, but this is not detailed in the summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes a medical device (guidewire and magnetic navigation system) for physical navigation, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an algorithm for analysis or diagnosis. The Cronus® Guidewire and Telstar® MNS are physical devices used for interventional procedures, where a human operator is always in the loop. Therefore, a standalone algorithm-only performance assessment is not applicable in the context of this device. The "standalone" performance here would refer to the device mechanisms themselves, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a guidewire and navigation system, "ground truth" would likely involve objective measures of successful navigation, target site achievement, absence of damage to vessels, and functional success of the delivered therapeutic device. While clinical in vivo testing is mentioned, the specific type of ground truth used (e.g., confirmed catheter placement by fluoroscopy, absence of complications observed by clinical review, successful therapeutic outcome) is not explicitly detailed in this summary.
8. The sample size for the training set
The document does not mention a training set. This is expected as the device is not an AI/ML diagnostic or predictive algorithm that requires a "training set" in the typical sense. Performance validation for such a physical device usually relies on pre-clinical and clinical testing, not a dataset-based training approach.
9. How the ground truth for the training set was established
Since no training set is mentioned or implied for this type of device, this question is not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is the primary goal of a 510(k) submission. It broadly states that performance testing occurred and showed equivalence. However, it does not delve into the detailed methodological aspects of the studies, such as specific acceptance criteria, sample sizes, expert qualifications, or detailed ground truth determination, which would be expected for a comprehensive study report.
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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
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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
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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)
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1051373
The information hority WIS. Inc. in accordance with the provisions and 1 38 and 21 CTR 88149
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TMNS & Cronus® Modified 510(k) Stereotaxis, Inc.
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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 underthe Federal Food, Drug and Cosmetic Act, respecting safety and effectivenessis summarized below.For the convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and 510(k)Statements..." (21 CFR §807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency. | |
| Devicedescription | The Telstar® Magnetic Navigation System [TMNS] is an interventionalworkstation for the intravascular navigation of a magnetic-tipped devicethrough tissue to designated target sites in the right and left heart, coronary,peripheral, and neurovasculature. It combines a bi-planar fluoroscopy systemwith a computer controlled magnetic field generator, to provide bothvisualization and control of a magnetically actuated guidewire. The systememploys magnetic fields to orient the guidewire.The Stereotaxis Cronus® Modified is a steerable guidewire that has a nominaldiameter 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 StereotaxisTelstar® Magnetic Navigation System [TMNS]. The wire is configured witha tapered distal tip and an embedded magnet, which is used for navigating thewire through the vasculature. This device is sterilized with 100% ethyleneoxide. | |
| Intended use | The Telstar® Magnetic Navigation System [TMNS] is intended to navigate amagnetic-tipped device through tissue to designated target sites in the rightand left heart, coronary, peripheral, and neurovasculature by orienting thedevice tip in a desired direction.The Stereotaxis Endovascular Guide Wire is intended to introduce andposition over-the-wire catheters and other over-the-wire therapeutic deviceswithin the neurovasculature, coronary and peripheral vasculature duringPTCA or other intravascular interventional procedures. | |
| Continued | Page 2 of 2 | |
| Technologicalcharacteristics | The Telstar® Magnetic Navigation System [TMNS] employs application ofmagnetic fields to orient the distal tip of a magnetically actuated guidewire.The Telstar® Digital Imaging System [TIS], previously cleared underK013484 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 actuationand control. It is designed to navigate within the vasculature to deliver asuitable catheter or interventional device to a desired site. The finishedlengths of the Cronus® Modified are between 180 and 300 cm. A taper runs32 cm proximal to the distal tip. The pushable shaft is a continuous wire thatallows axial force, applied at the proximal end, to be transmitted to the tip ofthe guidewire. | |
| Performancedata | Bench testing and pre-clinical and clinical in vivo testing demonstrate that theStereotaxis 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® Predicateand the Boston Scientific TRANSENDTM EX Platinum Steerable Guide Wirepredicate devices. | |
| Conclusion | The Stereotaxis Telstar® Magnetic Navigation System [TMNS] issubstantially equivalent to the Stereotaxis Telstar® Magnetic NavigationSystem [TMNS] (K013484) and the BrainLAB VectorVision2 (VV2)(K983831) predicate devices.The Stereotaxis Cronus® Modified is substantially equivalent to theStereotaxis Cronus® Predicate (K042854) and the Boston ScientificTRANSENDTM EX Platinum Steerable Guide Wire (K971254) predicatedevices. | |
| Contact | Kelly RowlandRegulatory 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.
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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.
§ 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).