51 0(k) Premnarket Notification
`Vascular Solutions, Inc.
`
`Twin-Pass"~ Dual Access Catheter
`
`Appendix E: Summary of Safety and Effectiveness
`
`O
`
`.
`
`.L
`
`CommonlUsual Name:
`Prodct Tade ame:
`Classification Name:
`
`Intravascular Catheter
`Twin-PaSSTm Dual Access Catheter
`Unclassified
`Product Code: DOY
`
`Manufacturer:
`
`Vascular Solutions, Inc.
`6464 Sycamore Court
`Minneapolis, Minnesota 55369
`USA
`
`Establishment Registration:
`
`2134812
`
`Contact:
`
`Sara L. Coon
`Senior Regulatory Affairs Associate
`(763) 656-4300 phone
`(763) 656-4200 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 3F 0.0. catheter that has two
`lumens-a short distal lumen and a second full length lumen-each of which are
`compatible with a 0.014" standard guide wire. The Twin-Pass catheter has a
`working length of 135cm and contains positioning markers at 95 and 105cm
`which provide a visual indication of the relative positions of Twin Pass and the
`end of a standard 105cm guide catheter. Two radiopaque marker bands at the
`end of each wire lumen provide for a radiographic means of locating the position
`of each lumen. The softer, distal end of the catheter is coated with a hydrophilic
`coating to assist passage through the guide catheter and vessels while the
`proximal end of the catheter contains a strain relief and a standard luer hub. A
`126cm stiffening mandrel is included which provides support and pushability to
`the Twin-Pass.
`
`CONFIDENTIAL
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1780
`Medtronic v. Teleflex
`
`
`Vascular Solutions, Inc.
`
`Twin-Pass"~ Dual Access Catheter
`
`Appendix E: Summary of Safety and Effectiveness
`
`O
`
`.
`
`.L
`
`CommonlUsual Name:
`Prodct Tade ame:
`Classification Name:
`
`Intravascular Catheter
`Twin-PaSSTm Dual Access Catheter
`Unclassified
`Product Code: DOY
`
`Manufacturer:
`
`Vascular Solutions, Inc.
`6464 Sycamore Court
`Minneapolis, Minnesota 55369
`USA
`
`Establishment Registration:
`
`2134812
`
`Contact:
`
`Sara L. Coon
`Senior Regulatory Affairs Associate
`(763) 656-4300 phone
`(763) 656-4200 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 3F 0.0. catheter that has two
`lumens-a short distal lumen and a second full length lumen-each of which are
`compatible with a 0.014" standard guide wire. The Twin-Pass catheter has a
`working length of 135cm and contains positioning markers at 95 and 105cm
`which provide a visual indication of the relative positions of Twin Pass and the
`end of a standard 105cm guide catheter. Two radiopaque marker bands at the
`end of each wire lumen provide for a radiographic means of locating the position
`of each lumen. The softer, distal end of the catheter is coated with a hydrophilic
`coating to assist passage through the guide catheter and vessels while the
`proximal end of the catheter contains a strain relief and a standard luer hub. A
`126cm stiffening mandrel is included which provides support and pushability to
`the Twin-Pass.
`
`CONFIDENTIAL
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1780
`Medtronic v. Teleflex
`
`
`
`510(k) Premarket Notification
`Vascular Solutions, Inc.
`
`Twin-Pass T Dual Access Catheter
`
`Intended Use:
`The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable
`guidewires in order to access discrete regions of the coronary and peripheral
`arterial vasculature, to facilitate placement of guidewires and other interventional
`devices, and for use during two guidewire procedures.
`
`Summary of Non-Clinical Testing:
`Testing conducted included assessments of the design verification of the Twin-
`Pass Dual Access Catheter along with biocompatibility assessments. The results
`of this battery of tests confirmed the suitability of the Twin-Pass Dual Access
`Catheter for its intended use.
`
`Summary of Clinical Testing:
`No clinical evaluations of this product have been conducted.
`
`Predicate Device:
`The Twin-Pass Dual Access Catheter is similar in intended use and function to
`the Lumend Percutaneous Catheter, the Quick-Cross Catheter, and the Dual
`Lumen Catheter.
`
`Conclusions:
`The Twin-Pass Dual Access Catheter is substantially equivalent to the Lumend
`Percutaneous Catheter, the Quick-Cross Catheter, and the Dual Lumen
`Catheter. The testing performed confirms that the Twin-Pass Dual Access
`Catheter will perform as intended.
`
`CONFIDENTIAL
`
`Page 2
`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
`
`NOV £3 3aa
`
`Vascular Solutions, Inc.
`c/o Ms. Sara L. Coon
`Senior Regulatory Affairs Associate
`6464 Sycamore Court
`Minneapolis, MN 55369
`
`Re:
`
`K052257
`Twin-PassTM Dual Access Catheter
`Regulation Number: 21 CFR 870.1250
`Regulation Name: Percutaneous catheter
`Regulatory Class: II
`Product Code: DQY
`Dated: September 30, 2005
`Received: October 3, 2005
`
`Dear Ms. Coon:
`
`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.
`
`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.
`
`Page 3
`
`
`
`Page 2 - Ms. Sara L. Coon
`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); 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)
`premarket notification. The FDA finding of substantial equivalence of your device to a legally
`marketed predicate 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.aov/cdrh/industrv/support/index.html.
`
`Sincerely yours,
`
`,
`
`Brain D. Zuckerman, M.D.
`Director
`Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`Page 4
`
`
`
`II. Indications-For Use Statement
`
`510(k) Number:
`
`KID0
`
`Device Name:
`
`Vascular Solutions Twin-Pass Dual Access Catheter
`
`Indications for Use:
`
`The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable
`guidewires in order to access discrete regions of the coronary and peripheral
`arterial vasculature, to facilitate placement of guidewires and other interventional
`devices, and for use during two guidewire procedures.
`
`Prescription Use
`(Part 21 CFR 801 Subpart D)
`
`I,
`
`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 Cardiovascular Devices
`l10(1) Number K022$?
`
`Page 1 of
`
`Page 5
`
`
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