CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 1 of 7
`
`(cid:48)(cid:68)(cid:85)(cid:70)(cid:75)(cid:3)(cid:21)(cid:21)(cid:15)(cid:3)(cid:21)(cid:19)(cid:20)(cid:28)
`
`Medtronic Inc.
`Elaine Gullane
`Principal Regulatory Affairs Specialist
`Parkmore Business Park West
`Galway, Ireland
`
`Re: K183353
`Trade/Device Name: Telescope™ Guide Extension Catheter
`Regulation Number: 21 CFR 870.1250
`Regulation Name: Percutaneous Catheter
`Regulatory Class: Class II
`Product Code: DQY
`Dated: February 20, 2019
`Received: February 22, 2019
`
`Dear Elaine Gullane:
`
`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. Although this letter refers to your product as a device, please be aware that
`some cleared products may instead be combination products. The 510(k) Premarket Notification Database
`located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
`product submissions. 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
`
`EXHIBIT E
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`Page 1
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`Teleflex Ex. 2069
`Medtronic v. Teleflex
`IPR2020-00126
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`

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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 2 of 7
`
`K183353 - Elaine Gullane
`
`Page 2
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`requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
`801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
`devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
`https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
`manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
`for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
`applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
`1050.
`
`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 comprehensive regulatory information about medical devices and radiation-emitting products, including
`information about labeling regulations, please see Device Advice
`(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
`(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
`Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
`(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
`(1-800-638-2041 or 301-796-7100).
`
`Sincerely,
`
`Lydia S.
`Glaw -S
`
`Digitally signed by
`Lydia S. Glaw -S
`Date: 2019.03.22
`12:09:56 -04'00'
`
`(cid:73)(cid:82)(cid:85)
`
`Bram D. Zuckerman, M.D.
`Director
`Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`EXHIBIT E
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`Page 2
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`Teleflex Ex. 2069
`Medtronic v. Teleflex
`IPR2020-00126
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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 3 of 7
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`88
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`EXHIBIT E
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`Page 3
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`Teleflex Ex. 2069
`Medtronic v. Teleflex
`IPR2020-00126
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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 4 of 7
`K183353
`
`510(k) Summary per 21 CRF 807.92
`
`Date Prepared:
`
`30th November 2018
`
`Applicant:
`
`Medtronic Ireland
`Parkmore Business Park West
`Galway
`Ireland
`
`Official
`Correspondent:
`
`Proprietary
`Name:
`
`Common
`Name:
`
`Elaine Gullane
`Principal Regulatory Affairs Specialist
`Medtronic Ireland
`Parkmore Business Park West
`Galway
`Ireland
`Phone: (353) 91 708682
`Fax: (353) 91 708672
`Email: elaine.gullane@medtronic.com
`
`Telescope™ Guide Extension Catheter
`
`Guide Catheter
`
`Device
`Classification:
`
`Class II
`
`Regulation
`Number:
`
`Classification
`Name:
`
`21 CFR 870.1250
`
`Percutaneous catheter
`
`Product Code:
`
`DQY
`
`EXHIBIT E
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`Page 4
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`Teleflex Ex. 2069
`Medtronic v. Teleflex
`IPR2020-00126
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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 5 of 7
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`Device
`Description:
`
`The Telescope guide extension catheter is a single-lumen rapid exchange
`catheter. The guide extension catheter is designed to act as an extension to
`a traditional guide catheter and to facilitate the delivery of interventional
`devices into the vasculature. The guide extension catheter is intended to be
`used within the coronary and/or peripheral vasculature to provide support.
`
`The Telescope™ Guide Extension Catheter is offered in sizes compatible
`with 6F and 7F guide catheters as indicated by the product model numbers
`below.
`
`Size
`6F
`7F
`
`Product Model Number
`TELE6F
`TELE7F
`
`
`
`Indications For
`Use:
`
`Telescope™ Guide Extension Catheter is intended to be used in conjunction
`with guide catheters to access discrete regions of the coronary and/or
`peripheral vasculature, and to facilitate placement of interventional devices.
`
`Substantially
`Equivalent
`Device:
`
`Summary of
`Technological
`Differences to the
`Predicate Device:
`
`
`
`Summary of Non-
`Clinical Data:
`
`GuideLiner V3 Catheter (K172090, cleared October 20, 2017).
`
`The following outlines the differences and similarities between the subject
`device - Telescope™ Guide Extension Catheter and the predicate device -
`GuideLiner V3 Catheter:
`• Similar Intended Use
`• Similar Device Design Component/Construction
`• Different device materials
`• Similar Packaging
`• Similar Sterilization Method
`Medtronic’s Telescope™ Guide Extension Catheter is substantially
`equivalent to the predicate device based on similarities in intended use and
`technological characteristics. The testing performed demonstrates that the
`technological differences in the new device do not raise new questions of
`safety and effectiveness.
`
`The technological differences between the subject and predicate devices
`have been evaluated through biocompatibility and design verification tests
`to provide evidence of substantial equivalence for the Telescope™ Guide
`Extension Catheter. The Telescope™ Guide Extension Catheter is
`substantially equivalent to the specified predicate devices based on
`comparisons of the device functionality, technological characteristics, and
`indications for use. The device design has been verified through the
`following:
`
`EXHIBIT E
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`Page 5
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`IPR2020-00126
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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 6 of 7
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`Design Verification/In-Vitro Bench Testing
`The Design Verification Testing included in-vitro bench testing and
`included:
`
`
`• Simulated Use
`• Deliverability
`• Tip compression
`• Pushwire Integrity
`• Torque
`• Lumen Patency
`• Maximum outer diameter
`• Catheter effective length
`• Kink resistance
`• Tensile Strength
`• Coating Integrity
`• Coating Particulate
`
`
`Biocompatibility Testing
`The following Biocompatibility Testing was completed on the Telescope™
`device in compliance with the requirements of ISO 10993-1: 2009/ Cor 1:
`2010- Biological evaluation of medical devices - Part 1: Evaluation and
`testing within a risk management process.
`• Cytotoxicity
`• Acute Systemic Toxicity
`• Material Mediated Pyrogenicity
`• ASTM Hemolysis
`• Complement Activation
`• Partial thromboplastin time
`•
`•
`Irritation / Intracutaneous Reactivity
`• Sensitization
`
`In-vivo Thromboresistance
`
`
`No new safety or effectiveness issues were raised during the testing.
`Therefore, the Telescope™ Guide Extension Catheter is substantially
`equivalent to the predicate device.
`
`
`Summary of
`Clinical Data:
`
`No clinical investigation has been performed for this device.
`
`
`
`EXHIBIT E
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`Page 6
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`CASE 0:19-cv-01760 Document 1-5 Filed 07/02/19 Page 7 of 7
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`The Telescope™ Guide Extension Catheter will be sterilized and validated
`for EtO sterilization in accordance with ISO11135 and EN556 to achieve a
`minimum Sterility Assurance Level (SAL) of 10-6.
`
`The data provided in this 510(k) premarket notification demonstrated that
`the subject device Telescope™ Guide Extension Catheter is substantially
`equivalent to the predicate device.
`
`Sterilization
`Validation:
`
`Conclusion:
`
`
`
`
`
`EXHIBIT E
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`Page 7
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`Teleflex Ex. 2069
`Medtronic v. Teleflex
`IPR2020-00126
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