(118 days)
Not Found
No
The summary describes a mechanical catheter and its performance is evaluated through mechanical and biocompatibility tests, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
No
The device is a catheter intended to facilitate placement/exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents, it is not a therapeutic device itself.
No
The device is a catheter used to facilitate the placement of guidewires and deliver agents, not to diagnose a condition. While it can deliver "diagnostic agents," its function is delivery, not the diagnostic imaging or analysis itself.
No
The device description clearly details a physical catheter with specific material construction, dimensions, and physical properties, and the performance studies focus on mechanical and biocompatibility testing of this physical device.
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/or peripheral vasculature. This involves direct interaction with the patient's circulatory system.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, analyzers, or test kits used outside the body on patient samples.
This device is a medical device used in vivo (within the living body) for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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
1
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
2
Indications for Use
510(k) Number (if known): K142065
Device Name: Turnpike catheter
Indications for Use:
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.
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)
3
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
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.
Intended Use / Indications
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.
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.
4
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.