(62 days)
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.
The Twin-Pass™ Dual Access Catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. The Twin-Pass catheter comes with a stiffening mandrel to provide support and pushability during catheter insertion.
The SKYWAY catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature.
This document is a 510(k) summary for the Twin-Pass and Skyway Catheters, which are intravascular catheters. It presents a "Summary of Non-Clinical Testing" and explicitly states "No clinical evaluations of this product were conducted."
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be provided from the given document, as no such study was conducted or reported. The 510(k) relies on substantial equivalence to predicate devices rather than direct demonstration of performance against specific acceptance criteria through a study.
The document indicates:
- Summary of Non-Clinical Testing: Flow-rate testing was conducted using saline and a 76% contrast medium. This constitutes non-clinical testing, not a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based device.
- Summary of Clinical Testing: "No clinical evaluations of this product were conducted."
Therefore, the sections of your request regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a study are not applicable to the provided document.
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Appendix D: Twin-Pass and Skyway Catheter 510(k) Summary
| Common/Usual Name: | Intravascular Catheter | APR 12 |
|---|---|---|
| Product Trade Name: | Twin-Pass™ Dual Access Catheter andSkyway™ Support Catheter | |
| Classification Name: | Percutaneous CatheterProduct Code: DQY | |
| Manufacturer: | Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369USA |
Establishment Registration: 2134812
| Contact: | Julie Tapper |
|---|---|
| Regulatory Affairs Associate | |
| (763) 656-4228 phone | |
| (763) 656-4253 fax |
Performance Standards:
No performance standards have been developed under section 514 for this device.
Device Description:
The Twin-Pass™ Dual Access Catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. The Twin-Pass catheter comes with a stiffening mandrel to provide support and pushability during catheter insertion.
The SKYWAY catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature.
Intended Use:
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
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The SKYWAY support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.
Summary of Non-Clinical Testing:
Flow-rate testing was conducted using saline and a 76% contrast medium.
Summary of Clinical Testing:
No clinical evaluations of this product were conducted.
Predicate Devices:
The Twin-Pass™ Dual Access Catheter and Skyway™ Support Catheter are substantially equivalent to the Pivot™ Steerable Microcatheter, Twin-Pass™ Dual Access Catheter, Skyway™ Support Catheter, and Langston™ Dual Lumen Pressure Monitoring Catheter.
Conclusions:
The Twin-Pass™ Dual Access Catheter and Skyway Support Catheter are substantially equivalent to the Pivot™ Steerable Microcatheter, Twin-Pass™ Dual Access Catheter, Skyway™ Support Catheter, and Langston™ Dual Lumen Pressure Monitoring Catheter, based on comparisons between the indications for use, construction materials, and device dimensions.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Vascular Solutions, Incorporated c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K060327
Twin-Pass™ Dual Access Catheter and Skyway™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 7, 2006 Received: February 9, 2006
Dear Ms. Tapper:
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 enclosurc) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou and I DIT bisean that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally promated noticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
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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II. Indications For Use Statement Twin-Pass Dual Access Catheter
510(k) Number:
Vascular Solutions Twin-Pass™ Dual Access Catheter Device Name:
Indications for Use:
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division/Sign-Off)
Division of Cardiovascu
-10(k) Number Ko60527
Page 1 of _
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III. Indications For Use Statement Skyway Support Catheter
510(k) Number:
Device Name: Vascular Solutions Skyway™ Support Catheter
Indications for Use:
The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumema
Page 1 of
ascular Devices
§ 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).