Who is the manufacturer of MODIFICATION TO ENDOVASCULAR GUIDE WIRE?

Stereotaxis, Inc. filed the 510(k) submission for MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457).

What is the FDA product code for MODIFICATION TO ENDOVASCULAR GUIDE WIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MODIFICATION TO ENDOVASCULAR GUIDE WIRE?

510(k) clearance (submission type: Special).

What are the predicate devices for MODIFICATION TO ENDOVASCULAR GUIDE WIRE?

Stereotaxis Endovascular Guide Wire (K021363).

Who can help prepare an FDA 510(k) submission like MODIFICATION TO ENDOVASCULAR GUIDE WIRE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODIFICATION TO ENDOVASCULAR GUIDE WIRE

K043457 · Stereotaxis, Inc. · DQX · Feb 28, 2005 · Cardiovascular

Device Facts

Record ID	K043457
Device Name	MODIFICATION TO ENDOVASCULAR GUIDE WIRE
Applicant	Stereotaxis, Inc.
Product Code	DQX · Cardiovascular
Decision Date	Feb 28, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended 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.

Device Story

Steerable 0.014" guide wire (180cm/300cm) designed for use with Stereotaxis Magnetic Navigation System; features tapered distal tip with embedded magnet for magnetic navigation through vasculature. Hydrophilic coating on distal portion; PTFE coating on proximal end. Used by physicians in clinical settings to navigate vasculature and deliver interventional devices. Magnetic actuation allows precise control; axial force transmitted via pushable shaft. Benefits include enhanced navigation capabilities for complex vascular procedures. Sterilized with 100% ethylene oxide.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by bench testing (compliance with FDA 1995 Coronary and Cerebrovascular Guidewire Guidance) and preclinical swine animal model performance data.

Technological Characteristics

0.014" diameter guide wire; 180cm/300cm lengths. Materials: coated endovascular wire with embedded magnet. Features: tapered distal tip, hydrophilic distal coating, PTFE proximal coating. Actuation: magnetic navigation system. Sterilization: 100% ethylene oxide.

Indications for Use

Indicated for introduction and positioning of over-the-wire catheters and therapeutic devices in coronary and peripheral vasculature during intravascular procedures. Contraindicated for use without Stereotaxis Magnetic Navigation System, use in cerebral vasculature, or use with rotational atherectomy or ferromagnetic interventional devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Stereotaxis Endovascular Guide Wire (K021363)

Related Devices

K042854 — STEREOTAXIS ENDOVASCULAR GUIDE WIRE · Stereotaxis, Inc. · Feb 8, 2005
K021363 — ENDOVASCULAR GUIDE WIRE · Stereotaxis, Inc. · Nov 27, 2002
K032183 — IQ HYDROPHILIC GUIDE WIRE · Boston Scientific Corp · Aug 1, 2003
K060454 — TITAN GUIDEWIRE · Lake Region Mfg., Inc. · Mar 24, 2006
K203533 — VASSALLO GT · Filmecc Co., Ltd. · Apr 21, 2021

Submission Summary (Full Text)

{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.