(190 days)
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, ML, image processing, or data-driven algorithms.
No.
The device facilitates the delivery of other catheters but does not itself provide a therapeutic effect.
No
Explanation: The device is described as a "wire guide" intended for facilitating the delivery of percutaneous catheters, which is an interventional/therapeutic use, not a diagnostic one. There is no mention of it being used to detect or identify medical conditions.
No
The device description clearly outlines a physical wire guide with specific dimensions, materials (coated mandril, coil), and includes a pin vise. The performance studies listed are all related to the physical properties and performance of a hardware device (fracture, tensile, flex, radiopacity, torque strength, etc.). There is no mention of software functionality.
Based on the provided information, the Roadrunner® Extra Support Wire Guide is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "facilitating delivery of percutaneous catheters into the cardiovascular system." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical wire guide used for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Performance Studies: The performance studies listed (Fracture Testing, Tensile Testing, Flex Testing, etc.) are focused on the physical and mechanical properties of the wire guide, which are relevant to its function as a medical device used in a procedure. IVD performance studies would typically involve evaluating the accuracy and reliability of measurements or analyses performed on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Roadrunner® Extra Support Wire Guide does not perform this function.
N/A
Intended Use / Indications for Use
The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Product codes
DOX
Device Description
The Roadrunner® Extra Support Wire Guide is manufactured in an outer diameter of 0.014 inches and lengths of 180 and 300 centimeters. The flexible tip portion of the subject device is formed into an angled configuration. The Roadrunner® Extra Support Wire Guide consists of a coated mandril with a coil covering the tip of the mandril. A pin vise is supplied with the subject device.
The Roadrunner® Extra Support Wire Guide is a packaged, sterile device intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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 following tests were performed to demonstrate that the Roadrunner® Extra Support Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence:
- Fracture Testing – Testing was performed in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Tensile Testing - Testing was performed in accordance with Annex H of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Flex Testing – Testing was performed in accordance with Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Radiopacity Testing - Radiopacity testing was performed in accordance with the qualitative evaluation described in ASTM F640-12.
- Torque Strength Testing – Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Dimensional Analysis Testing - Testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.
- Rotational Response (Torqueability) Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Surface Analysis Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Corrosion Testing - Testing demonstrated, when tested in accordance with Annex B of BS EN ISO 11070:2014, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- Catheter Compatibility Testing - Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Flex Testing on Aged Devices – Flex testing was repeated on aged devices in accordance with Section 8.5 and Annex B of BS EN ISO 11070:2014. The predetermined acceptance criteria were met.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 5, 2018
Cook Incorporated Ms. Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402
Re: K171948
Trade/Device Name: Roadrunner Extra Support Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: December 6, 2017 Received: December 7, 2017
Dear Ms. Allman:
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.
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 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);
1
Page 2 - Ms. Jennifer Allman
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171948
Device Name
Roadrunner® Extra Support Wire Guide
Indications for Use (Describe)
The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
| Submitted By: | Jennifer L. Allman |
|---|---|
| Cook Incorporated | |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone: (812) 335-3575 x104280 | |
| Fax: (812) 332-0281 | |
| Date Prepared: June 28, 2016 |
Device:
| Trade Name: | Roadrunner® Extra Support Wire Guide |
|---|---|
| Common Name: | Wire, Guide, Catheter |
| Classification Name: | Catheter guide wire |
| DQX (21 CFR §870.1330) |
Indications for Use:
The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Predicate Device:
The predicate Roadrunner™ RLTF Wire Guide (K920824) is available in a 180 cm length and outer diameters of 0.014, 0.016, and 0.018 inches and utilizes identical materials as compared to the subject device. The flexible tip portion of the predicate device is formed into an angled configuration. The predicate device is intended for use in directing a percutaneous catheter into the cardiovascular system.
Comparison to Predicate Device:
The Roadrunner® Extra Support Wire Guide is identical in intended use, fundamental technological characteristics, principle of operation, and materials to the predicate device, Roadrunner™ RLTF Wire Guide (K920824). The only difference is an additional length.
4
Device Description:
The Roadrunner® Extra Support Wire Guide is manufactured in an outer diameter of 0.014 inches and lengths of 180 and 300 centimeters. The flexible tip portion of the subject device is formed into an angled configuration. The Roadrunner® Extra Support Wire Guide consists of a coated mandril with a coil covering the tip of the mandril. A pin vise is supplied with the subject device.
The Roadrunner® Extra Support Wire Guide is a packaged, sterile device intended for single use.
There are no prior submissions for the subject device.
Discussion of Risk Mitigation Activities:
The following tests were performed to demonstrate that the Roadrunner® Extra Support Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence:
- . Fracture Testing – Testing was performed in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Tensile Testing - Testing was performed in accordance with Annex H of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Flex Testing – Testing was performed in accordance with Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Radiopacity Testing - Radiopacity testing was performed in accordance with the qualitative evaluation described in ASTM F640-12.
- . Torque Strength Testing – Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- . Dimensional Analysis Testing - Testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.
5
- . Rotational Response (Torqueability) Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- . Surface Analysis Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- . Corrosion Testing - Testing demonstrated, when tested in accordance with Annex B of BS EN ISO 11070:2014, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- . Catheter Compatibility Testing - Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- I Flex Testing on Aged Devices – Flex testing was repeated on aged devices in accordance with Section 8.5 and Annex B of BS EN ISO 11070:2014. The predetermined acceptance criteria were met.
Conclusion:
The results of the risk mitigation activities support a conclusion that the Roadrunner® Extra Support Wire Guide is substantially equivalent to the predicate device.