Turnpike catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Device Description

The Turnpike catheter is a single lumen catheter designed for use in the coronary and/or peripheral vasculature. The shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. Turnpike has a radiopaque tip (polymer or gold-plated) and is available in various tip and shaft configurations and one of three working lengths. Turnpike catheter is hydrophilic coated and is compatible with 0.014" guidewires and 5F guide catheters.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Turnpike Catheter). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software as a medical device (SaMD) context.

The document describes mechanical and biocompatibility tests performed for the Turnpike Catheter to demonstrate its safety and effectiveness compared to predicate devices. These are standard tests for physical medical devices, not for AI/SaMD.

Therefore, I cannot populate the requested table and answer the questions related to AI/SaMD performance. The document does not describe:

A table of acceptance criteria and reported device performance for an AI/SaMD.
Sample sizes, data provenance, or ground truth establishment for a test set in the context of AI/SaMD.
Number/qualifications of experts or adjudication methods for AI/SaMD ground truth.
MRMC or standalone studies for AI/SaMD.
Training set details for an AI model.

The document states that "Verification and validation test results met the specified acceptance criteria and did not raise new questions of safety or effectiveness issues." However, it does not list those acceptance criteria or the specific results in a format relevant to AI/SaMD. It broadly mentions mechanical tests (e.g., working length, radiopacity, torque) and biocompatibility tests (e.g., cytotoxicity, hemolysis), which are entirely different from the performance metrics expected for AI algorithms (e.g., sensitivity, specificity, AUC).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Vascular Solutions, Inc. Ellie Gillespie Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369

Re: K142065 Trade/Device Name: Turnpike Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 30, 2014 Received: October 31, 2014

Dear Ms. Ellie Gillespie,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K142065

Device Name: Turnpike catheter

Indications for Use:

Prescription Use X (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)

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510(k) Summary

[As required by 21 CFR 807.92] Date Prepared: August 15, 2014 510(k) Number: K142065

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Ellie Gillespie Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Turnpike catheter
Common / Usual Name	catheter
Classification Name	870.1250, DQY - Percutaneous catheter, Class II
Predicate Device(s)	K091345 - Gopher Gold catheter (Vascular Solutions, Inc.)K051772 - Tornus Support Catheter (Asahi Intecc Co., Ltd.)

Device Description

Intended Use / Indications

Technological Characteristics Comparison

Turnpike catheter is similar in design and intended use to the predicate devices as they are all single lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature and for 0.014" guidewire exchange. The subject and predicate devices are similar in size (approximately 3F) and compatible with 5F guide catheters. Turnpike catheter is available in longer working lengths than the predicate devices. The subject device has an external polymer shaft coil and tip threads that are similar in intended function but smaller in height than comparable features on the predicate devices. Turnpike catheter has a hydrophilic coat for smooth introduction. The types of materials used in the subject device and one of the predicate devices are similar but vary slightly.

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Substantial Equivalence and Summary of Studies

Technological differences between the subject and predicate devices have been evaluated through biocompatibility and mechanical tests to provide evidence that Turnpike catheter is as safe and effective as the predicate devices. Turnpike catheter is substantially equivalent to the specified predicate devices based on comparisons of device functionality, technological characteristics, and indications for use. The subject device design has been verified and validated through the following mechanical tests:

Working length
Tip and shaft thread functionality
Radiopacity
Hydrophilic coating particulate ●
Hydrophilic coating delamination ●
Tortuosity, guide catheter profile, guidewire passage
Torque

The following biocompatibility tests were performed as recommended by ISO 10993-1:

Cytotoxicity ●
Sensitization ●
Irritation/Intracutaneous Reactivity
Acute Systemic Toxicity ●
. Material Mediated Pyrogenicity
Hemolysis
Complement Activation
In Vitro Hemocompatibility
Coagulation ●
Thrombogenicity

Verification and validation test results met the specified acceptance criteria and did not raise new questions of safety or effectiveness issues. Therefore, Turnpike catheter is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).