(211 days)
Nothing to extract
No
The description focuses on the physical characteristics and magnetic navigation capabilities of the guide wire, with no mention of AI or ML.
No
The device is used to position other therapeutic devices, not to provide therapy itself.
No
The device is a steerable guide wire used to introduce and position other therapeutic devices within the vasculature. It does not perform any diagnostic function.
No
The device description clearly details a physical guide wire with specific dimensions, materials (embedded magnet, hydrophilic coating), and a sterilization method (ethylene oxide). It is a tangible hardware device.
No, 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 about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Stereotaxis Endovascular Guide Wire is a device used inside the body (in vivo) to navigate within blood vessels and deliver other medical devices. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states its purpose is to "introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature." This is a procedural function, not a diagnostic one.
- Device Description: The description details its physical characteristics and how it's used for navigation within the body. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the Stereotaxis Endovascular Guide Wire is a medical device used for interventional procedures within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stereotaxis Endovascular 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 Endovascular Guide Wire.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Stereotaxis Endovascular Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 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 extends from the base of the distal coil to the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
The Endovascular Guide Wire is a conventional 0.014" hydrophilically 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 length of the Endovascular Guide Wire is 210cm to 300cm. A taper runs 30cm 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 Endovascular Guide Wire is used with an introducer sheath to access the human vasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and preclinical in-vivo testing demonstrate that the Stereotaxis Endovascular Guide Wire performs in an equivalent manner to both the BSC Choice Guide Wire and the ACS BMW 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.
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.
Not Found
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
§ 870.1330 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
NOV 27 2002
Appendix A: 510(k) Summary of Safety and Effectiveness
| 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 Endovascular Guide Wire is a steerable guide wire that has a
nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 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 extends from the base of the distal coil to
the proximal end of the wire. This device is sterilized with 100% ethylene
oxide. |
| Intended use | The Stereotaxis Endovascular 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 Endovascular Guide Wire. |
| Technological
characteristics | The Endovascular Guide Wire is a conventional 0.014" hydrophilically
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 length of the Endovascular Guide Wire is 210cm to 300cm. A
taper runs 30cm 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 Endovascular Guide Wire is used with an
introducer sheath to access the human vasculature. |
1
| Performance
data | Bench testing and preclinical in-vivo testing demonstrate that the Stereotaxis
Endovascular Guide Wire performs in an equivalent manner to both the BSC
Choice Guide Wire and the ACS BMW Guide Wire predicate devices. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Stereotaxis Endovascular Guide Wire is substantially equivalent to the
BSC Choice Guide Wire (K970244) and the ACS BMW Guide Wire
(K971815) predicate devices. |
| Contact | Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products |
| Date | November 22, 2002 |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 27 2002
Mr. Garv M. Rauvola Director, Regulatory Affairs for Disposable Products Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, MO 63108
Re: K021363
Trade/Device Name: Stereotaxis Endovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 29, 2002 Received: August 30, 2002
Dear Mr. Rauvola:
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 application (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 such 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
3
Page 2 - Mr. Gary M. Rauvola
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 (301) 594-4686. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix L: Revised Indications For Use Statement
Indications for Use Statement
Revised Statement Indications for Use Statement:
510(k) Number: K021363
Device Name: Stereotaxis Endovascular Guide Wire
Indications for Use: The Stereotaxis Endovascular 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 Endovascular Guide Wire.
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021363