(15 days)
Not Found
No
The description focuses on the physical construction and materials of a guide wire, with no mention of AI or ML capabilities.
No.
The device description and intended use clearly state that the guide wires "facilitate the placement of balloon dilatation catheters or other therapeutic devices," indicating they are tools for delivering other therapies, not therapeutic themselves.
No
Explanation: The device is a guide wire intended to facilitate the placement of other therapeutic devices, not to diagnose a condition.
No
The device description clearly details physical components like wires, coatings, and coils, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wires are used to facilitate the placement of other devices during intravascular interventional procedures. This is a procedural device used in vivo (within the body).
- Device Description: The description details the physical components of a guide wire designed for navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids or samples.
Therefore, the IQ™ Hydrophilic Guide Wires are a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IQ™ Hydrophilic Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
74DQX, DQX
Device Description
The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coating are steerable, spring-tipped guide wires. The IQ™ Hydrophilic is available in a nominal diameter of 0.014 inches, Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal three centimeters of all models are radiopaque spring coils and available in either a straight shapeable or a pre-formed J-Tip.
The IQ™ Hydrophilic corewire consists of a PTFE coated SS corewire segment joined via a nickel-chromium alloy coupler to a tapered Nitinol corewire segment. The distal segment of this corewire is coated with an adhesive pre-coat that is jacketed with a Tungsten loaded polyurethane sleeve. This polymer sleeve is coated with ICE® Hydrophilic coating. A SS centering sleeve attaches a SS ribbon to the distal end of the corewire. The distal most portion of the corewire, the centering sleeve and the SS ribbon reside within the hollow center of the 3-cm spring-coil.
The 185-centimeter version of the IQ™ Hydrophilic is designed with a proximal extension section that allows connection to the AddWire™ Extension Wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular
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)
Testing and evaluation of the IQ™ Hydrophilic Guide Wires Summary included torque response, tip prolapse, tip shapeability, marker location, coating adherence/presence, tensile, combined load, visual inspection, polymer peel, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements and are adequate for their intended use.
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
AUG - 1 2003
Special 510(k): Device Modification
BSC IQ Hydrophilic Guide Wire
510(k) Summary
per 21 CFR §807.92
| Submitter's Name
and Address | Boston Scientific Corporation (BSC)
One Scimed Place
Maple Grove, MN 55311 | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name and
Information | Anne V. Rossi
Specialist, Regulatory Affairs
Phone: 763-494-2827
Fax: 763-494-2222
e-mail: Anne.Rossi@bsci.com | | |
| Date Prepared | July 16, 2003 | | |
| Proprietary
Name(s) | IQ™ Hydrophilic Guide Wire | | |
| Common Name | Catheter Guide Wire | | |
| Product Code | 74DQX | | |
| Classification of
Device | Class II, 21 CFR Part 870.1330 | | |
| Predicate Devices | PT2™ Guide Wire | K030617 | May 21, 2003 |
| | Luge™ Guide Wire | K973945 | January 12, 1998 |
| Device
Description | The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coating
are steerable, spring-tipped guide wires. The IQ™ Hydrophilic
is available in a nominal diameter of 0.014 inches, Moderate
Support, and nominal lengths of 185 and 300 centimeters with
Brachial and Femoral marks at 90cm and 100cm respectively.
The distal three centimeters of all models are radiopaque spring
coils and available in either a straight shapeable or a pre-
formed J-Tip.
The IQ™ Hydrophilic corewire consists of a PTFE coated SS
corewire segment joined via a nickel-chromium alloy coupler to
a tapered Nitinol corewire segment. The distal segment of this
corewire is coated with an adhesive pre-coat that is jacketed
with a Tungsten loaded polyurethane sleeve. This polymer
sleeve is coated with ICE® Hydrophilic coating. A SS centering
sleeve attaches a SS ribbon to the distal end of the corewire.
The distal most portion of the corewire, the centering sleeve and
the SS ribbon reside within the hollow center of the 3-cm spring-
coil.
The 185-centimeter version of the IQ™ Hydrophilic is designed
with a proximal extension section that allows connection to the
AddWire™ Extension Wire. | | |
1
The IQ™ Hydrophilic Guide Wires are intended to facilitate the Intended Use of placement and exchange of balloon dilatation catheters or other Device therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Technological The IQ™ Hydrophilic Guide Wires utilize similar materials and Characteristics methods of construction as the currently marketed PT2™ Guide Wire family of quide wires. The differences in construction are the addition of a spring-coil to the distal most tip and a SS ring at the ribbon/corewire joint.
Non-Clinical Test Testing and evaluation of the IQ™ Hydrophilic Guide Wires Summary included torque response, tip prolapse, tip shapeability, marker location, coating adherence/presence, tensile, combined load, visual inspection, polymer peel, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements and are adequate for their intended use. The IQ™ Hydrophilic Guide Wires are considered to be substantially equivalent to guide wires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of in vitro testing and evaluation.
KC32183
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Boston Scientific Corporation c/o Anne V. Rossi Specialist, Regulatory Affairs One Scimed Place Maple Grove, MN 55311
Re: K032183
IQ™ Hydrophilic Guide Wire Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: July 16, 2003 Received: July 21, 2003
Dear Ms. Rossi:
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.
3
Page 2 - Ms. Anne V. Rossi
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 forth in the quality systems (OS) 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) 594-4646. 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) you may obtain. 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
4
Indications for Use Statement
| 510(k) Number
| (if known) | K032183 |
|---|---|
| Device Name | IQ™ Hydrophilic Guide Wire |
| Indications For | |
| Use | The IQ™ Hydrophilic Guide Wires are intended to facilitate the |
| placement of balloon dilatation catheters or other therapeutic | |
| devices during PTCA, PTA, or other intravascular interventional | |
| procedures. The IQ™ Hydrophilic Guide Wires are not intended | |
| for use in the cerebral vasculature. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR §801.109)
Over-The-Counter Use OR
N'DeCartha
iovascular Devices
510(k) Number K032183