(57 days)
Not Found
No
The summary describes a physical catheter device and its mechanical and biocompatibility testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used to access vasculature and facilitate placement of guidewires, as well as to infuse/deliver diagnostic and therapeutic agents, rather than to provide therapy itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the device "may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents." While it can deliver diagnostic agents, its primary purpose is access and delivery, not the act of diagnosis itself. The performance studies focus on mechanical and biological properties, not diagnostic accuracy.
No
The device description clearly outlines a physical catheter with specific material construction, dimensions, and physical properties, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for accessing and facilitating procedures within the coronary and peripheral vasculature. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab setting) diagnostic test.
- Device Description: The description details a catheter designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Turnpike catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DOY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
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.
4
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.