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

K191560 · Vascular Solutions, LLC · DQY · Aug 9, 2019 · Cardiovascular

Device Facts

• Record ID: K191560
• Device Name: Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
• Applicant: Vascular Solutions, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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 infuse/deliver diagnostic and therapeutic agents.

Device Story

Single-lumen catheters for coronary and peripheral vasculature access; facilitate guidewire placement/exchange and subselective infusion of diagnostic/therapeutic agents. Device features polymer shaft with encapsulated braid and dual-layer coil; radiopaque tip (polymer or gold-plated); hydrophilic coating on distal 60cm. Available in 135cm or 150cm lengths; compatible with 0.014" guidewires and 5F guide catheters. Operated by physicians in clinical settings. Output is physical access to vasculature; enables delivery of agents and guidewire navigation. Benefits include improved navigation and access to discrete vascular regions.

Clinical Evidence

Bench testing only. Performance verification included deliverability, hydrophilic coating evaluation, tensile strength, torque strength, strain relief markings, ISO 10555-1, and ISO 594 hub verification. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity, hemolysis, complement activation, and thrombogenicity. All tests met acceptance criteria.

Technological Characteristics

Single-lumen catheter; polymer shaft with encapsulated braid and dual-layer coil; radiopaque tip (polymer or gold-plated); hydrophilic coating. Dimensions: 135cm or 150cm working lengths; 0.014" guidewire compatibility; 5F guide catheter compatibility. Standards: ISO 10555-1 (catheter performance), ISO 594 (hub), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients requiring access to discrete regions of the coronary and/or peripheral vasculature for guidewire placement/exchange and subselective infusion of diagnostic or therapeutic agents.

Regulatory Classification

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.

Predicate Devices

• Turnpike catheter (K151981)
• Turnpike catheter (K142065)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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 infuseddeliver diagnostic and therapeutic agents.

| 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: [phone] Establishment Registration # 2134812 Fax: [phone]

# 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

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.

#### Intended Use

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 infuse/deliver diagnostic and therapeutic agents.

# 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.