(266 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a wire guide used for catheter positioning and exchange. It is an accessory to diagnostic and interventional procedures, not a therapeutic device itself.
No
The device is described as being used for "catheter positioning and exchange in diagnostic and interventional procedures," indicating it is an accessory tool for such procedures, not a diagnostic device itself. Its purpose is mechanical guidance, not analysis or diagnosis.
No
The device description clearly details physical components like a nitinol mandril, platinum coils, polyurethane jacket, and hydrophilic coating, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "catheter positioning and exchange in diagnostic and interventional procedures." This describes a device used within the body during medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details the physical construction of a wire guide designed to be inserted into the body (nitinol mandril, platinum coils, polyurethane jacket, hydrophilic coating). This further supports its use as an interventional/diagnostic tool within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the Roadrunner® PC Wire Guide is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.
Product codes
DQX
Device Description
The Roadrunner® PC Wire Guide is constructed with a nitinol mandril secured with a solder connection to platinum coils at the distal tip. The device has an outer polyurethane jacket that spans the entire device. The length of the device is coated with a hydrophilic coating except the proximal 6 centimeters of the device. The device is available with an angled or straight distal tip. The wire guide is available in a 0.035 inch or 0.038 inch diameter and lengths of 80, 145, 180, and 260 centimeters. The subject device will be provided sterile and intended for single patient use. An Olcott Torque Device and a Wire Guide Inserter are provided with each subject device configuration.
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)
The following tests were performed to demonstrate that the Roadrunner® PC Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.
- Biocompatibility Testing
- Corrosion Testing
- Resistance to Damage by Flex Testing
- Surface Examination Testing
- Simulated Use Testing
- Fracture Testing after Simulated Use Testing
- Tensile Testing after Simulated Use Testing
- Rotational Response (Torqueability) Testing
- Torque Strength Testing
- Catheter Compatibility Testing
- Radio-detectability Testing
- Distal Tip Deflection Testing
- Dimensional Analysis Testing
- Lubricity Testing
- Particulate Testing
All pre-determined acceptance criteria were met. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cook Incorporated Daniel Corbin Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K182985
Trade/Device Name: Roadrunner PC Wire Guide, Olcott Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 24, 2019 Received: June 25, 2019
Dear Daniel Corbin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Lydia Glaw, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182985
Device Name Roadrunner® PC Wire Guide
Indications for Use (Describe)
The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitted By:
Daniel J. Corbin, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Phone: (812) 335-3575 x104018 Fax: (812) 332-0281 Date Prepared: July 22, 2019
Device:
| Trade Name: | Roadrunner® PC Wire Guide |
|---|---|
| Common Name: | Catheter Wire Guide |
| Classification Name: | Wire, Guide, Catheter |
| DQX (21 CFR §870.1330) |
Indications for Use:
The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.
Predicate Device:
The predicate device, the Roadrunner Wire Guide, was cleared for commercial distribution under 510(k) number K920891, on December 21, 1992.
Comparison to Predicate Device:
It has been demonstrated that the subject device, Roadrunner® PC Wire Guide is identical to the predicate device (K920891) in terms of intended use, principles of operation, basic technological characteristics, and similar in materials of construction. Additional wire guide lengths and mandril taper lengths have been included for the subject device as compared to the predicate device. A detailed comparison table of the predicate device and the device subject to this submission can be found in the following table.
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| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| Roadrunner Wire Guide | |||
| (K920891) | Roadrunner® PC Wire Guide | ||
| (Subject of this Submission) | |||
| Device Manufacturer | Cook Inc. | Cook Inc. | |
| Regulation Number | 21 CFR §870.1330 | 21 CFR §870.1330 | |
| Product Code | DQX | DQX | |
| Classification | II | II | |
| Intended Use | The Roadrunner wire guide is used | ||
| for catheter positioning and | |||
| exchange in diagnostic and | |||
| interventional procedures, exclusive | |||
| of the coronary arteries. | The Roadrunner® PC Wire Guide is | ||
| used for catheter positioning and | |||
| exchange in diagnostic and | |||
| interventional procedures, exclusive | |||
| of the coronary arteries. | |||
| Device Diameter (in) | 0.025, 0.028, 0.032, 0.035, 0.038 | 0.035 and 0.038 | |
| Mandril | Nitinol | Identical | |
| Coils | Platinum | Identical | |
| Materials of | Connections | Solder | Identical |
| Construction | Outer | ||
| Jacket | Polyurethane | Identical | |
| Surface | |||
| Coating | Hydrophilic | Identical | |
| Tip Shape | Straight, Angled | Identical | |
| Wire Guide Length (cm) | 30 - 240 | 80, 145, 180, and 260 | |
| Mandril Taper Length (cm) | Not discussed in detail | 9, 10.5, 11.5, 18.5 | |
| Sterilization | EtO | Identical |
Comparison Table of Predicate Device and Subject Device
Reference Device:
The reference devices used for the subject of this submission. The Roadrunner® PC Wire Guide, are K171997 - Mandril Wire Guide (cleared on March 30, 2018) and K130766 - Roadrunner Uniglide Hydrophilic Wire Guide (cleared on July 17, 2013).
Device Description:
The Roadrunner® PC Wire Guides, subject of this submission, have been modified from the predicate device, Roadrunner Wire Guide (K920891), to include additional lengths ranging from 80, 145, 180, and 260 centimeters. The modifications to the Roadrunner® PC Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures. The Roadrunner® PC Wire Guides are packaged, sterile devices intended for single patient use. There are no prior submissions for the subject device.
The Roadrunner® PC Wire Guide is constructed with a nitinol mandril secured with a solder connection to platinum coils at the distal tip. The device has an outer polyurethane jacket that
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spans the entire device. The length of the device is coated with a hydrophilic coating except the proximal 6 centimeters of the device. The device is available with an angled or straight distal tip. The wire guide is available in a 0.035 inch or 0.038 inch diameter and lengths of 80, 145, 180, and 260 centimeters. The subject device will be provided sterile and intended for single patient use. An Olcott Torque Device and a Wire Guide Inserter are provided with each subject device configuration.
Test Data:
The following tests were performed to demonstrate that the Roadrunner® PC Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.
- . Biocompatibility Testing
- Corrosion Testing
- Resistance to Damage by Flex Testing .
- Surface Examination Testing ●
- Simulated Use Testing
- Fracture Testing after Simulated Use Testing ●
- Tensile Testing after Simulated Use Testing ●
- Rotational Response (Torqueability) Testing ●
- Torque Strength Testing
- Catheter Compatibility Testing
- Radio-detectability Testing ●
- . Distal Tip Deflection Testing
- Dimensional Analysis Testing
- Lubricity Testing ●
- Particulate Testing .
All pre-determined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.