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`510(k) SUMMARY
`
`510(k) Number:
`
`Date Prepared
`
`September 28, 2007
`
`Submitter Information
`Submitter's Name/
`Address:
`
`Vascular Solutions, Inc.
`6464 Sycamore Court
`Minneapolis, MN 55369
`
`Establishment Registration
`
`2134812
`
`Contact Person:
`
`Doralie Poganski
`Director, Regulatory Affairs
`(763) 656-4307 telephone
`(763) 656-4200 fax
`dpoganski(vascularsolutions.com
`
`Device Information
`Trade Name:
`Common Name:
`Classification Name:
`Product Code:
`Regulation:
`
`Pronto TM Low Profile Extraction Catheter
`Embolectomy Catheter
`Embolectomy Catheter
`DXE
`Class 11, 21 CFR 870.5150
`
`Predicate Device(s)
`* Vascular Solutions ProntoTM V3 Extraction Catheter (K052232, K063371)
`* Vascular Solutions QXT Extraction Catheter (K071727)
`* Vascular Solutions ProntoTM Short Extraction Catheter (KO51193)
`
`Device Description
`The Vascular Solutions ProntoTM Low Profile (LP) extraction catheter is a dual
`lumen catheter with related accessories. The Pronto LP will has a lower crossing
`
`Page 1
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`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex.1785
`Medtronic v. Teleflex
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`

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`profile to provide compatibility with small vessels and deliverability through a
`standard 0.066" (6F) guide catheter alongside an additional 0.0 14" guidewire.
`
`The catheter has a rounded distal tip with a protected, sloped opening of the
`extraction lumen to facilitate advancement of the catheter into the blood vessel
`and maximize extraction of thrombus through the extraction lumen. Incorporated
`within the catheter distal tip is a non-blood contacting radiopaque marker for
`fluoroscopic visualization. The catheter has a rapid exchange design with a distal
`flexible region with stiffness along the shaft gradually increasing to the proximal
`region. The distal segment of the catheter that includes the guidewire lumen is
`coated with a hydrophilic coating to lubricate the catheter for ease of insertion.
`
`The catheter also incorporates a Y-adapter with an aspiration port and a self
`sealing port with pre-loaded stylet. The stylet reinforces proximal shaft during
`delivery and is removed to allow aspiration of thrombus through the aspiration
`port.
`
`Intended Use/Indications for Use
`
`The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and
`thrombi from vessels in the coronary and peripheral system.
`
`Summary of Non-Clinical Testing
`Performance Testing: Device Verification Testing (DVT) was performed to
`support the equivalency of the Pronto LP extraction catheter to the predicate
`devices. DVT testing included:
`catheter tortuosity
`*
`catheter curve retention
`*
`catheter bond strength testing: hub, mid-shaft, and distal tip strength
`*
`catheter leakage under pressure
`*
`thrombus extraction
`*
`* blood extraction rate testing
`* aspiration testing (with extension tube)
`• packaging stylet removal force
`* 2nd guidewire placement
`introducer passage
`*
`catheter kink testing
`•
`catheter deformation
`*
`* mandrel/wire removal
`* guide catheter profile testing
`
`The Pronto LP Extraction Catheter performance bench test results confirmed that
`the device performs as intended.
`
`Page 2
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`

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`Biocompatibility: Biocompatibility testing in accordance with ISO 10993,
`"Biological Evaluation of Medical Devices" was provided. The material used in
`the Pronto LP extraction catheter has been demonstrated to be biocompatible.
`
`The results of the testing provide reasonable assurance that the device has been
`designed and tested to assure conformance to the requirements for its indications
`for use.
`
`Summary of Clinical Testing
`No clinical evaluations of this product have been conducted.
`
`Statement of Equivalence
`Through the data and information presented, Vascular Solutions considers the
`Pronto LP extraction catheter to be substantially equivalent to the Vascular
`Solutions ProntoTM Short Extraction Catheter, Vascular Solutions Pronto TM V3
`Extraction Catheter, and the Vascular Solutions ProntoTM QXT Extraction
`Catheter. The testing performed confirms that the Pronto LP extraction catheter
`will perform as intended.
`
`Page 3
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`

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`Public Health Service
`
`Food and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
`
`.f DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`DEC ,9 2007
`
`Vascular Solutions, Inc.
`c/o Ms. Doralie Poganski
`Director Regulatory Affairs
`6464 Sycamore Court
`Minneapolis, MN 55369
`
`Re:
`
`K072810
`Trade/Device Name: ProntoTM LP Extraction Catheter
`Regulation Number: 21 CFR 870.5150
`Regulation Name: Embolectomy Catheter
`Regulatory Class: Class II
`Product Code: DXE
`Dated: November 21, 2007
`Received: November 23, 2007
`
`Dear Ms. Poganski:
`
`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.
`
`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
`
`Page 4
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`Page 2 - Ms. Doralie Poganski
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`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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
`(240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to
`premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance,
`please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket
`Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events
`(Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-
`276-3464. 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 (240) 276-3150 or at its Internet address
`http://www.fda.gov/cdrh/industry/support/index.html.
`
`Sincer
`
`yours,
`
`Brain IZuckerman, M.D.
`Direct
`Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`Page 5
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`

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`Indications for Use Statement
`
`510(k) Number (if known):
`
`Device Name: ProntoTM LP Extraction Catheter
`
`Indications for Use:
`
`The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and
`thrombi from vessels in the coronary and peripheral system.
`
`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)
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`Page 6
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