(24 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a guide wire, with no mention of AI or ML capabilities.
No.
The guide wires facilitate the placement of other therapeutic devices, but are not described as performing a therapeutic function themselves.
No.
The device is intended to facilitate the placement of therapeutic devices during interventional procedures, not for diagnosis.
No
The device description clearly describes a physical guide wire made of silicone-coated spring-coil, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the IQ™ 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 a physical guide wire used for navigation within blood vessels. This is a medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The IQ™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Product codes
DQX
Device Description
The IQ™ Guide Wires are silicone-coated, steerable, spring-coil guide wires available in a nominal diameter of 0.014 inches (0.36 mm) and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The tip has Floppy flexibility, while the rail offers Moderate Support (MS). The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The IQ™ Guide Wires will be available with and without a lesion length marker system. The 185-centimeter version 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
Not Found
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, product shelf life, and biocompatibility test results verified that the IQ™ Guide Wires met all of the specified requirements and are suitable for their intended use.
The IQ™ Guide Wires are considered 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Ko52783
000 2 7 2009
510(k) Summary
per 21 CFR §807.92
| Submitter's Name and Address | Boston Scientific Corporation (BSC)
Two Scimed Place
Maple Grove, MN 55311 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Diane Brinza
Specialist, Regulatory Affairs
Phone: 763-694-3061
Fax: 763-694-6966
e-mail: brinzad@bsci.com |
| Date Prepared | September 30, 2005 |
| Proprietary Name(s) | IQ™ Guide Wire |
| Common Name | Catheter Guide Wire |
| Product Code | DQX |
| Classification of Device | Class II, 21 CFR Part 870.1330 |
| Predicate Device | IQ™ Guide Wire K040140 February 12, 2004 |
| Device Description | The IQ™ Guide Wires are silicone-coated, steerable, spring-coil guide wires available in a nominal diameter of 0.014 inches (0.36 mm) and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The tip has Floppy flexibility, while the rail offers Moderate Support (MS). The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The IQ™ Guide Wires will be available with and without a lesion length marker system. The 185-centimeter version is designed with a proximal extension section that allows connection to the AddWire™ Extension Wire. |
1
| Intended Use of
Device | The IQ™ Guide Wires are intended to facilitate the
placement and exchange of balloon dilatation catheters or
other therapeutic devices during PTCA or PTA or other
intravascular interventional procedures. The IQ™ 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
Characteristics | The IQ™ Guide Wires utilize similar materials and
methods of construction as the IQ™ Guide Wires
(K040140, February 12, 2004). The IQ™ Marker version
also has marker coils. |
| Non-Clinical Test
Summary | Bench, product shelf life, and biocompatibility test results
verified that the IQ™ Guide Wires met all of the specified
requirements and are suitable for their intended use.
The IQ™ Guide Wires are considered 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. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
Boston Scientific Corporation c/o Ms. Diane Brinza Specialist, Regulatory Affairs Two Scimed Place Maple Grove. MN 55311
K052783 રિટ: IO™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: September 30, 2005 Received: October 3, 2005
Dear Ms. Brinza:
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. Diane Brinza
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issualled of a backlines with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmation administered by other Federal agencies. You must or any Federal Statutes and regulations daministered wy not limited to: registration and listing (21 comply with an the Act 3 requirements, moraansy.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing became and setting aloctor CFR Part 807), labeling (21 CFR Part 807), government 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on Eevice as described in your device to Age) I his leter will andw you to begin maneting your as the receivelence of your device to a legally premarket notification: "The PDF miching of eastion 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 darres 10-3 at (240) 276-0120. Also, please note the regulation entitled, contact the Orited of Comphance at (210) =76 art 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral information on your responser Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Bhimmerhofer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number
| (if known) | K052783 |
|---|---|
| Device Name | IQ™ Guide Wire |
| Indications For | |
| Use | The IQ™ 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™ Guide Wires are not intended for use in the | |
| cerebral vasculature. |
Prescription Use
(Per Part 21 CFR §801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. M. Minor
(Division Sign-Off) Division of Cardiovascular Devloes 510(k) Number
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