ILL 8 005
`
`K O~z3
`
`Appendix A: Summary of Safety and Effectiveness
`
`Common/Usual Name:
`
`Emnbolectomy Catheter
`
`Product Trade Name:
`
`Pronto V3 Tm Extraction Catheter
`
`Classification Name:
`
`Unclassified
`Product Code, DXE
`
`Manufacturer:
`
`Vascular Solutions, Inc.
`6464 Sycamore Court
`Minneapolis, Minnesota 55369
`
`Establishment Registration: 2134812
`
`Contact:
`
`Sara L. Coon
`Senior Regulatory Affairs Associate
`(763) 656-4300 phone
`(763) 656-4250 fax
`
`Performance Standards:
`
`No performance standards have been developed
`under section 514 for this device.
`
`Device Description:
`The Pronto V3 extraction catheter is a dual lumnen catheter with related accessories.
`The extraction lumen allows for the aspiration and removal of embolic material
`(thrombus/debris) using the included syringe, extension line and stopcock. The
`catheter has a rounded distal tip with a protected, sloped opening of the extraction
`lumen to facilitate atraumatic advancement of the catheter into the blood vessel and
`Incorporated
`maximize extraction of emboli/thrombi through the extraction lumen.
`within the catheter distal tip is a non-blood contacting radiopaque marker for
`fluoroscopic visualization. The catheter is a monorail design with a distal flexible
`region with stiffness along the shaft tapering to a stiff proximal region. The distal
`segment of the catheter is coated with a hydrophilic coating to lubricate the catheter
`for ease of insertion. The catheter has an approximate outer diameter of 0.065
`inches, allowing delivery through standard 6Fr. guide catheters. The smaller wire
`lumen of the catheter is able to accommodate guide wires that are S 0.014" in
`diameter. The catheter will be available in working lengths of 40 to 145 cm with the
`length changes being made in the proximal rail section. The proximal end of the
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1784
`Medtronic v. Teleflex
`
`
`
`K O~z3
`
`Appendix A: Summary of Safety and Effectiveness
`
`Common/Usual Name:
`
`Emnbolectomy Catheter
`
`Product Trade Name:
`
`Pronto V3 Tm Extraction Catheter
`
`Classification Name:
`
`Unclassified
`Product Code, DXE
`
`Manufacturer:
`
`Vascular Solutions, Inc.
`6464 Sycamore Court
`Minneapolis, Minnesota 55369
`
`Establishment Registration: 2134812
`
`Contact:
`
`Sara L. Coon
`Senior Regulatory Affairs Associate
`(763) 656-4300 phone
`(763) 656-4250 fax
`
`Performance Standards:
`
`No performance standards have been developed
`under section 514 for this device.
`
`Device Description:
`The Pronto V3 extraction catheter is a dual lumnen catheter with related accessories.
`The extraction lumen allows for the aspiration and removal of embolic material
`(thrombus/debris) using the included syringe, extension line and stopcock. The
`catheter has a rounded distal tip with a protected, sloped opening of the extraction
`lumen to facilitate atraumatic advancement of the catheter into the blood vessel and
`Incorporated
`maximize extraction of emboli/thrombi through the extraction lumen.
`within the catheter distal tip is a non-blood contacting radiopaque marker for
`fluoroscopic visualization. The catheter is a monorail design with a distal flexible
`region with stiffness along the shaft tapering to a stiff proximal region. The distal
`segment of the catheter is coated with a hydrophilic coating to lubricate the catheter
`for ease of insertion. The catheter has an approximate outer diameter of 0.065
`inches, allowing delivery through standard 6Fr. guide catheters. The smaller wire
`lumen of the catheter is able to accommodate guide wires that are S 0.014" in
`diameter. The catheter will be available in working lengths of 40 to 145 cm with the
`length changes being made in the proximal rail section. The proximal end of the
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1784
`Medtronic v. Teleflex
`
`
`
`catheter incorporates a standard luer adapter to facilitate the attachment of the
`catheter to the included extension line, stopcock, and syringe. A 74 micrometer filter
`basket (not identified in the schematic below) is included for assistance in filtering
`the blood removed during the procedure for laboratory analysis of thrombus.
`
`Intended Use:
`The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli
`and thrombi from vessels of the arterial systems.
`
`Summary of Non-Clinical Testing:
`Testing conducted included assessments of the design verification of the Pronto V3
`Extraction Catheter along with biocompatibility assessments. The results of this
`battery of tests confirmed the suitability of the Pronto V3 Extraction Catheter for its
`intended use.
`
`Summary of Clinical Testing:
`No clinical evaluations of this product have been conducted.
`
`Predicate Devices:
`The Pronto V3 Extraction Catheter is similar in intended use to the Vascular
`Solutions, Inc. Pronto Extraction Catheter and the Medtronic Export TM Aspiration
`Catheter.
`Conclusions:
`The Pronto V3 Extraction Catheter is substantially equivalent to the Pronto
`Extraction Catheter and the Export Aspiration Catheter. The testing performed
`confirms that the Pronto V3 Extraction Catheter will perform as intended.
`
`Page 2
`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`SEP 2 8 2005
`
`Food and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
`
`Vascular Solutions, Inc.
`c/o Ms. Sara L. Coon
`Senior Regulatory Affairs Associate
`6464 Sycamore Court
`Minneapolis, MN 55369
`
`Re:
`
`K052232
`Pronto V3TM Extraction Catheter
`Regulation Number: 21 CFR 870.5150
`Regulation Name: Embolectomy catheter
`Regulatory Class: I1
`Product Code: DXE
`Dated: August 16, 2005
`Received: August 17, 2005
`
`Dear Ms. Coon:
`
`We have reviewed your Section 510(k) prcmarket 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 1I (Special Controls) or class Ill (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 5 10(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" (21 CFR 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://wx'v.fda.gov/cdrh/industry/support/index.html.
`
`Sincerely yours,
`
`1dbV1Vk
`
`V V t'cvxYA
`
`Bram D. Zuckerman, M.D.
`Director
`Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`Page 4
`
`
`
`Indications For Use Statement
`
`510(k) Number:
`
`K052232
`
`Device Name:
`
`Vascular Solutions Pronto V3TM Extraction Catheter
`
`Indications for Use:
`
`The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli
`and thrombi from vessels of the arterial systems.
`
`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 Cardiovascular Devices
`
`510(k) Number V o
`
`) 3p
`
`Page I of
`
`t
`
`Page 5
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`
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