The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infusedeliver diagnostic and therapeutic agents.

Device Description

The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter's shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations. The distal 60cm of each catheter has a hydrophilic coating. The Turnpike catheters are available in 135 cm or 150 cm working lengths and are compatible with 0.014" guidewires and 5F guide catheters.

AI/ML Overview

The provided document is a 510(k) summary for the Turnpike Catheter, which is a medical device used to access vascular regions, facilitate guidewire placement, and deliver diagnostic and therapeutic agents. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Study that Proves Device Performance
Deliverability	Passed	Performance tests
Hydrophilic Coating	Passed	Hydrophilic Coating Evaluation
Tensile Strength	Passed	Performance tests
Torque Strength	Passed	Performance tests
Strain Relief Markings	Passed	Performance tests
ISO 10555-1 Verification	Passed	ISO 10555-1 Verification
ISO 594 Hub Verification	Passed	ISO 594 Hub Verification
Biocompatibility: Cytotoxicity	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Sensitization	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Irritation	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Systemic Toxicity	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Material Mediated Pyrogenicity	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Hemolysis	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Complement Activation	Passed	ISO 10993-1 Biocompatibility tests
Biocompatibility: Thrombogenicity	Passed	ISO 10993-1 Biocompatibility tests

Additional Information

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices or tests performed) for the performance and biocompatibility tests.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory compliance tests for a medical device prior to market, they are typically conducted prospectively in a controlled laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The testing described involves engineering performance and biocompatibility, which are measured objectively against defined standards (e.g., ISO standards) and internal specifications. There is no "ground truth" derived from expert interpretation of medical images or clinical outcomes in the way this question implies. Instead, the "ground truth" (or acceptance criteria) is established by regulatory standards (e.g., ISO 10555-1, ISO 10993-1) and internal design specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reasons as above. The tests performed are objective and yield pass/fail results based on predefined criteria, not subjective interpretations requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device (Turnpike Catheter) is a physical medical device (catheter) used for vascular access and delivery of agents, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests (e.g., deliverability, tensile strength), the "ground truth" is defined by engineering specifications and ISO standards (e.g., ISO 10555-1, ISO 594).
- For the biocompatibility tests, the "ground truth" is defined by biological safety standards as outlined in ISO 10993-1.
- There is no "expert consensus," "pathology," or "outcomes data" in the typical clinical sense used to establish ground truth for this type of device validation.
The sample size for the training set:
- This is not applicable. The Turnpike Catheter is a physical device, and the testing described is not related to training an algorithm or AI model.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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August 9, 2019

Vascular Solutions LLC Ms. Beka Vite Principal Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K191560

Trade/Device Name: Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike Gold Catheter; Turnpike LP Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 11, 2019 Received: June 13, 2019

Dear Ms. Vite:

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/cfpmn/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

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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 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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-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-regulatoryassistance/contact-us-division-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 Kenneth J. Cavanaugh, Ph.D. Director (Acting) 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) K191560

Device Name

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter

Indications for Use (Describe)

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

[As required by 21 CFR 807.92]

Date Prepared: June 11, 2019

K191560 510(k) Number:

Submitter's Name / Contact Person

Manufacturer Contact Person Vascular Solutions LLC Beka Vite Principal Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369 USA Tel: 763-656-4300 Establishment Registration # 2134812 Fax: 763-251-0363

General Information

Trade Name	Turnpike Catheter
	Turnpike Spiral Catheter
	Turnpike Gold Catheter
	Turnpike LP Catheter
Common / Usual Name	Catheter
Classification Name	21 CFR 870.1250, DQY, Percutaneous catheter, Class I
Predicate Device	K151981, Turnpike catheter (Vascular Solutions, Inc.)
	K142065. Turnpike catheter (Vascular Solutions. Inc.)

Device Description

Intended Use

Technological Characteristics Comparison

The key technological differences between the Turnpike catheters and the predicate device are a change to the working length and hub configuration and the addition of a low-profile version.

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K191560 Page 2

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the Turnpike catheters.

The device performance was verified through the following tests:

. Deliverability
Hydrophilic Coating Evaluation ●
Tensile Strength
Torque Strength
. Strain Relief Markings
. ISO 10555-1 Verification
ISO 594 Hub Verification ●

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

Cytotoxicity
Sensitization ●
Irritation
. Systemic Toxicity
●
Material Mediated Pyrogenicity
Hemolysis ●
Complement Activation
. Thrombogenicity

The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the Turnpike catheters are substantially equivalent to the predicate device.

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).