(119 days)
For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
The Roadrunner® UniGlide™ Hydrophilic Wire Guide is a hydrophilically coated device constructed of a nitinol core wire with a polyurethane jacket. It is available in diameters ranging from 0.018 in. to 0.038 in. and lengths from 80 cm to 320 cm. The Roadrunner® UniGlide Hydrophilic Wire Guide is manufactured in both a standard shaft and a stiff shaft version. A torque device is supplied with the Roadrunner® UniGlide™ Hydrophilic Wire Guide. The torque device is designed for torque control and is intended for use in complex diagnostic and interventional procedures.
This submission details a 510(k) premarket notification for a modified medical device, the Roadrunner® UniGlide™ Hydrophilic Wire Guide. Since this is a premarket notification for a modified device seeking substantial equivalence to a predicate device, the acceptance criteria and study focus on demonstrating that the modifications do not alter the safety and effectiveness of the device compared to the previously cleared predicate.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Modified device lengths (260 cm and 320 cm) must maintain equivalent hydrated lubricity to the predicate device. | "This testing confirmed that the hydrated lubricity for the modified 260 cm and 320 cm wire guides is equivalent to the hydrated lubricity demonstrated by the predicate wire guides." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the "Hydrated Lubricity Test." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given that the testing was performed to demonstrate substantial equivalence for a manufactured device, it's highly likely this was a prospective test conducted by the manufacturer, Cook Incorporated, in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of submission for a physical medical device (a guide wire) does not involve "experts" establishing ground truth in the sense of medical diagnosis or image interpretation. The ground truth for device performance is based on direct physical testing against engineering specifications and comparisons to the predicate device's established performance. Therefore, this question is not applicable in the context of this document.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving subjective assessments, such as image interpretation, where disagreements between experts need to be resolved. For objective physical device testing like lubricity, an adjudication method is not applicable. The results are typically numerical measurements compared against predefined thresholds or the predicate's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is used to evaluate the impact of a diagnostic tool or AI on human readers' performance (e.g., radiologists interpreting images). This submission is for a physical medical device (a guide wire) and does not involve human readers interpreting data in this context. Therefore, this question is not applicable.
6. Standalone Performance Study
Yes, in a sense. The "Hydrated Lubricity Test" represents a standalone performance evaluation of the modified device itself against a specific physical property (lubricity). While the primary purpose was to demonstrate equivalence to the predicate, the test assesses the device's intrinsic performance attribute. The performance is reported as "equivalent" rather than absolute values.
7. Type of Ground Truth Used
The ground truth used is based on engineering specifications and comparative performance data derived from the predicate device. For the "Hydrated Lubricity Test," the ground truth for "equivalent" performance is the established hydrated lubricity of the predicate device (K110009). The new lengths of the device must meet or perform similarly to this established benchmark.
8. Sample Size for the Training Set
This submission does not involve a "training set" in the context of machine learning or AI models. This is a physical medical device with a modification, and its performance is evaluated through physical and functional testing, not through training data for an algorithm. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established
As stated above, there is no "training set" in this context. Therefore, this question is not applicable. The ground truth for the performance evaluation (lubricity) was established by the predicate device's known performance.
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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, bold, white letters, with a small registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in smaller, white letters. The background of the logo is black.
JUL 1 7 2013
510(k) Summary Date prepared: June 14, 2013
| Submitted By: | David Lehr, RAC, Regulatory Affairs Specialist |
|---|---|
| Cook Incorporated | |
| 750 Daniels Way, P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone: (812)339-2235 Ex. 2309 Fax: (812)332-0281 |
Device:
| Trade Name: | Roadrunner® UniGlide™ Hydrophilic Wire Guide |
|---|---|
| Common Name: | Guide Wire, Catheter |
| Proposed Classification: | DQX (21 C.F.R. § 870.1330) |
Indications for Use:
For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Predicate Device:
Roadrunner® UniGlide™ Hydrophilic Wire Guide, K110009, February 2, 2011
Device Description:
The Roadrunner® UniGlide™ Hydrophilic Wire Guide is a hydrophilically coated device constructed of a nitinol core wire with a polyurethane jacket. It is available in diameters ranging from 0.018 in. to 0.038 in. and lengths from 80 cm to 320 cm. The Roadrunner® UniGlide Hydrophilic Wire Guide is manufactured in both a standard shaft and a stiff shaft version. A torque device is supplied with the Roadrunner® UniGlide™ Hydrophilic Wire Guide. The torque device is designed for torque control and is intended for use in complex diagnostic and interventional procedures.
Substantial Equivalence:
The Roadrunner® UniGlide™ Hydrophilic Wire Guide proposed in this submission is substantially equivalent to the Roadrunner® UniGlide™ Hydrophilic Wire Guide (K110009), which is currently marketed by Cook Incorporated. The proposed Roadrunner® UniGlide Hydrophilic Wire Guide has indications for use, materials of construction, and technological characteristics identical to those of the predicate Roadrunner® UniGlide™ Hydrophilic Wire Guide.
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Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and professional.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 48"
BLOOMINGTON, IN 47402-0439 U.S.A
ONE 812.339.2235 101FORE: 800.457.4501
K130766 p. 2 of 2
Comparison to Predicate Device:
The Roadrunner® UniGlide™ Hydrophilic Wire Guide has been modified from the predicate Roadrunner® UniGlide " Hydrophilic Wire Guide to include additional device lengths of 260 and 320 cm. The proposed Roadrunner® UniGlide™ Hydrophilic Wire Guide is comparable to the predicate device in design, intended use, materials, and technology.
Test Data:
The Roadrunner® UniGlide™ Hydrophilic Wire Guide was subjected to the following test to assure device performance and to assure that the design modification of the device is reliable under the specified testing parameters.
Hydrated Lubricity Test: This testing confirmed that the hydrated lubricity for the modified 260 cm and 320 cm wire guides is equivalent to the hydrated lubricity demonstrated by the predicate wire guides.
In conclusion, the results of testing provide reasonable assurance that the device is as safe and as effective as the predicate device, and support a determination of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
July 17, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cook, Inc. c/o Mr. David Lehr, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K130766
Trade/Device Name: Roadrunner® UniGlide™ Hydrophilic Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: June 14, 2013 Received: June 18, 2013
Dear Mr. Lehr:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. David Lehr, RAC
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Special 510(k) Premarket Notification
Roadrunner® UniGlide™ Hydrophilic Wire Guide Cook Incorporated June 14, 2013
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)
Bram D. Zuckerman -S 2013.07.17 21:16:02 -04'00'
§ 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.