(75 days)
Not Found
No
The document describes a physical guide wire and its use with a magnetic navigation system, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device description states that the guide wire is intended to introduce and position other therapeutic devices, rather than performing a therapeutic function itself.
No
The device is described as a steerable guide wire intended to introduce and position over-the-wire catheters and other therapeutic devices within the vasculature during interventional procedures, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "steerable guide wire" with physical dimensions, coatings, and an embedded magnet, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures." This describes a device used within the body for a therapeutic or interventional purpose, not for examining specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical guide wire designed for navigation within the vasculature, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), providing diagnostic information, or any of the typical components or processes associated with IVD devices.
Therefore, the Stereotaxis Assert™ Guide Wire is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use: The Stereotaxis Assert™ Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with the Stereotaxis Assert™ Guide Wires.
Product codes
DQX
Device Description
The Stereotaxis Assert™ Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and 300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wire, and a PTFE coating covers the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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
Physical testing: The Stereotaxis Assert™ Guide Wire was designed and tested in compliance with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995. The device met design input criteria and was substantially equivalent to the currently marketed predicate device.
Preclinical animal performance data: Testing of the Stereotaxis Assert™ Guide Wire in the swine animal model demonstrated substantial equivalence to the currently marketed predicate device.
Clinical performance data: No clinical studies were needed to support the modifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Appendix 1: 510(k) Summary of Safety and Effectiveness Kod 3457
| 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 Stereotaxis Assert™ Guide Wire is a steerable guide wire that has a
nominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and
300 cm. The guide wire is designed only for use in conjunction with the
Stereotaxis Magnetic Navigation System. The wire is configured with a
tapered distal tip and an embedded magnet, which is used for navigating the
wire through the vasculature. A hydrophilic coating covers the distal portion
of the wire, and a PTFE coating covers the proximal end of the wire. This
device is sterilized with 100% ethylene oxide. |
| Technological
characteristics | The Assert™ Guide Wire is a conventional 0.014" coated endovascular guide
wire 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 guide wire are 180cm and 300cm. A taper runs
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
guide wire. The guide wire is used with an introducer sheath to access the
human vasculature. |
| Intended use | Indications for Use: The Stereotaxis Assert™ Guide Wire is intended to
introduce and position over-the-wire catheters and other over-the-wire
therapeutic devices within the coronary and peripheral vasculature during
PTCA or other intravascular interventional procedures. |
| | Contraindications: This guide wire is not intended for use without the
Stereotaxis Magnetic Navigation System. The device is not intended for use
in the cerebral vasculature. Rotational atherectomy devices, and any
ferromagnetic interventional devices, are contraindicated for use with the
Stereotaxis Assert™ Guide Wires. |
| Device
comparisons | The Stereotaxis Assert™ Guide Wire is a minor design modification of the
currently marketed Stereotaxis Endovascular Guide Wire. The new wire has a
modified taper to the core wire profile, has a different hydrophilic coating on
the distal end, and carries a PTFE coating on the proximal end. |
| Physical testing | The Stereotaxis Assert™ Guide Wire was designed and tested in compliance
with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated
January 1995. The device met design input criteria and was substantially
equivalent to the currently marketed predicate device. |
| Preclinical
animal
performance
data | Testing of the Stereotaxis Assert™ Guide Wire in the swine animal model
demonstrated substantial equivalence to the currently marketed predicate
device. |
| Clinical
performance
data | No clinical studies were needed to support the modifications. |
| Substantial
equivalence | The Assert™ Guide Wire is a substantially equivalent modification of the
Stereotaxis Endovascular Guide Wire originally cleared under K021363. The
modifications described herein do not affect the intended use of the device or
alter the fundamental scientific technology associated with the device. |
| Contact | Gary M. Rauvola, RAC
Director, Compliance & Regulatory Affairs
Stereotaxis, Inc.
4041 Forest Park Avenue
St. Louis, Missouri 63108
Ph. 314-615-6913
Fax 314-615-6912 |
| Date | December 09, 2004 |
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.
1
Appendix 1: 510(k) Summary of Safety and Effectiveness,
Continued
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.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stereotaxis, Inc. c/o Mr. Gary M. Rauvola Director, Regulatory Affairs for Disposable Products 4041 Forest Park Ave. St. Louis, MO 63108
K043457 Re:
Stereotaxis Assert™ Endovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: February 10, 2005 Received: February 11, 2005
Dear Mr. Rauvola:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainted institution morrototed in interstate referenced and nave decemblicating the arrest over is a section of the marketed in interstate for use stated in the enclosure) to regary mancede provice Americal Device Amendments, or to commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval as training of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merelore, market the devree, seeject of the s
general controls provisions of the Act include requirements for annual registration and general controls provisions of the recentered required of childrens against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entier on a consisted in the program and the can
may be subject to such additional controls. Existing major regulations EDA ma may be subject to such additional controller Extisting the 200 to 898. In addition, FDA may be found in the Code of Feact. Inc.g.
publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Gary M. Rauvola
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuates of a build with other requirements of the Act that I DA has made a actor in and regulations administered by other Federal agencies. You must of any it catal statutes and regulations and limited to: registration and listing (21 Comply with an the Aot 8 requirements, and manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro herens (2 seting your device as described in your Section 510(k) This letter will anow you to begin manteeing your antial equivalence of your device to a legally premits that 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 If you desire specific advice 10. your acc)) 276-0120. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misbranding by reference to premaintentibilities under the Act from the Division of Small other general informational 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,
Dina R. Vachner
- A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Appendix 2: Revised Indications for Use Form
Indications for Use Statement
510(k) Number K043457:
Device Name: Assert™ Guide Wires
Indications for Use: Stereotaxis Assert™ Guide Wires are intended to Indications for Osc. 'Stereotains Fisses and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during therapoutie been intravascular interventional procedures.
Contraindications: This guide wire is not intended for use without the Contraincations: "This garos in System. The device is not intended for use Stereotaxis Magnette Navigantes ... Rotational atherectomy devices, and any In the coloral vasodiatere. I Revices, are contraindicated for use with Stereotaxis Assert™ Guide Wires.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page | of __
Duna P. Vachon
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k 04 לאר 49
The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and 15 consideres of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.