(30 days)
K091385, K92089
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of AI or ML capabilities.
No
The device is a wire guide used to facilitate the delivery of percutaneous catheters, not to provide therapy itself.
No
The device is a wire guide used to facilitate the delivery of catheters, which is an interventional function, not a diagnostic one. While the torque device supplied with it mentions "complex diagnostic and interventional procedures", the wire guide itself does not perform diagnostics.
No
The device description clearly details a physical wire guide constructed of materials like nitinol and polyurethane, and mentions physical tests like tensile, fracture, and flexing tests. It also includes a torque device. This indicates a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate delivery of percutaneous catheters into the peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical wire guide used for navigation within blood vessels. This aligns with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Roadrunner UniGlide Hydrophilic Wire Guide is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roadrunner UniGlide Hydrophilic Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Product codes
DQX
Device Description
The Roadrunner UniGlide Hydrophilic Wire Guide is constructed of a nitinol mandril with a jacket made of polyurethane with tungsten, and is hydrophilically coated. These wire guides are constructed with a shaft diameter of either 0.018 inch. 0.025 inch. 0.035 inch. They are manufactured in 80 cm, 150 cm, and 180 cm lengths and have a tapered, flexible tip. The 0.025 inch, 0.035 inch, and 0.038 inch versions of the Roadrunner UniGlide Hydrophilic Wire Guide are available in both standard and stiff configurations, while the 0.018 inch Roadrunner UniGlide Hydrophilic Wire Guide is available in the standard configuration only. The standard configurations have a 14 cm long tapered, flexible distal tip portion, whereas the stiff configurations have a 20 cm long tapered, flexible distal tip portion. The tip is manufactured in both straight and angled configurations. A torque device is supplied with the Roadrunner UniGlide Hydrophilic Wire Guide. The torque device is intended for use in complex diagnostic and interventional procedures and is designed for torque control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The Roadrunner UniGlide Hydrophilic Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
-
- Tensile Test
-
- Tip Stiffness
-
- Fracture Test
-
- Flexing Test
-
- Torque Testing
-
- Lubricity Test
-
- Biocompatibility Testing
-
- Bioburden Testing
-
- Endotoxin Testing
-
- EtO Residual Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.
- EtO Residual Testing
Key Metrics
Not Found
Predicate Device(s)
K091385, K92089
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
COOK INCORPORATED Roadrunner UniGlide Hydrophilic Wire Guide Special 510(k) Premarket Notification
510(k) Summary
Submitted By:
FEB - 2 2011
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 December 23, 2010
Device:
| Trade Name: | Roadrunner UniGlide Hydrophilic Wire Guide |
|---|---|
| Classification Name: | Wire, Guide, Catheter |
| 21 CFR §870.1330 | |
| Device Classification: | Class II |
| Product Code: | DQX |
| Classification Panel: | Cardiovascular Panel |
Indications for Use:
The Roadrunner UniGlide Hydrophilic Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Predicate Devices:
The Roadrunner UniGlide Hydrophilic Wire Guide is identical to the Approach Hydro ST Wire Guide (K091385) in terms of intended use and similar to the Roadrunner Wire Guide (K92089) ) in terms of materials of construction and technological characteristics.
Device Description:
The Roadrunner UniGlide Hydrophilic Wire Guide is constructed of a nitinol mandril with a jacket made of polyurethane with tungsten, and is hydrophilically coated. These wire guides are constructed with a shaft diameter of either 0.018 inch. 0.025 inch. 0.035 inch. They are manufactured in 80 cm, 150 cm, and 180 cm lengths and have a tapered, flexible tip. The 0.025 inch, 0.035 inch, and 0.038 inch versions of the Roadrunner UniGlide Hydrophilic Wire Guide are available in both standard and stiff configurations, while the 0.018 inch Roadrunner UniGlide Hydrophilic Wire Guide is available in the standard configuration only. The standard configurations have a 14 cm long tapered, flexible distal tip portion, whereas the stiff configurations have a 20 cm long tapered, flexible distal tip portion. The tip is manufactured in both straight and angled configurations. A torque device is supplied with the Roadrunner UniGlide Hydrophilic Wire Guide. The torque device is intended for use in complex diagnostic and interventional procedures and is designed for torque control.
1
Substantial Equivalence:
The Roadrunner UniGlide Hydrophilic Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the peripheral vascular system. Specifically, the identical indications for use and principles of operation and similar materials of construction and technological characteristics of the wire guide compared to the Approach Hydro ST and Roadrunner Wire Guides support a determination of substantial equivalence.
Test Data:
The Roadrunner UniGlide Hydrophilic Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
-
- Tensile Test
-
- Tip Stiffness
-
- Fracture Test
-
- Flexing Test
-
- Torque Testing
-
- Lubricity Test
-
- Biocompatibility Testing
-
- Bioburden Testing
-
- Endotoxin Testing
-
- EtO Residual Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cook, Inc. c/o Karen Bradburn 750 Daniels Way P.O. Box 489 Bloomington, IN 47402-0489
FEB - 2 201
Re: K110009
Trade/Device Name: Roadrunner UniGlide Hydrophilic Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 23, 2010 Received: January 3, 2011
Dear Ms. Bradburn:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
..
、
and the same of the same of the same of the same of the states of
1000 - 1000
.
・・・ 100 million and
3
Page 2 - Ms. Karen Bradburn
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
COOK INCORPORATED Roadrunner UniGlide Hydrophilic Wire Guide Special 510(k) Premarket Notification
510(k) Number (if known):
Device Name: Roadrunner UniGlide Hydrophilic Wire Guide
Indications for Use: For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use -(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | 16110009 |