CASE 0:19-cv-01760-PJS-TNL Document 189-29 Filed 12/06/19 Page 1 of 4
`Document Number: PS1068
`Vascular Solutions, Inc.
`Rev. 01
`Product Requirements Document:
`Page 1 of 4
`GuideLiner Catheter System
`
`PRODUCT REQUIREMENTS:
`GuideLiner Catheter System
`
`Document Approvals:
`
`J. Kauphusman
`
`J. Kujawa
`
`8/24/05
`
`8/24/05
`
`Reviewer
`
`Documentation
`
`Distribution:
`
`1.
`
`INTRODUCTION
`
`1.1
`
`Scope
`
`This document defines the safety and perfounance requirements for the Vascular Solutions, Inc.
`GuideLiner (OTW) and rapid exchange (RX) guide catheter support system. These safety and
`perfoiniance features are the minimal requirements for the device to be acceptable for its intended
`clinical use. Applicable clinical use is for increase guide catheter back-up support.
`
`1.2
`
`References
`
`• Guidelines for the Submission of Research and Marketing Applications for Interventional
`Cardiology Devices. May 1994
`• BS EN ISO 10555 — 1:1997, Sterile Single-use Intravascular Catheters.
`• Part 1: General Requirements,
`• ISO 10993:2003 Biological Evaluation of Medical Devices
`• European Sterilization Standard BS EN 556: 1995 Sterilization of Medical Devices —
`Requirements for Teiminally Sterilized Devices to be Labeled Sterile
`• ISO 10993-07; 1995 (E) Ethylene Oxide Sterilization Residuals
`• ISO 594-1:1986 Conical Fittings with 6% Luer Taper
`• ISO 594-2:1998 Conical Fittings with 6% Luer Taper
`• ASTM D 4169-01; Transportation Testing (DC13 AL II)
`• ASTM F 2096-02; Bubble Leak Test
`• MDD 13.3: 21 CFR 801
`
`2.
`
`SYSTEM OVERVIEW
`
`2.1.
`
`General Description
`
`During many coronary interventions the back-up support provided by commonly used guide catheters
`are inadequate to deliver guidewires and PTCA treatment catheters through tortuous anatomy or severe
`stenosis. Advancing a PTCA catheter against resistance causes the guide catheter to back out of the
`coronary ostium rather than advancing the PTCA catheter. The GuideLiner will provide a simple means
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`Confidential - Attorneys' Eyes Only
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`EXHIBIT 29
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`Page 1
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`Teleflex Ex. 2024
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`IPR2020-00132
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`CASE 0:19-cv-01760-PJS-TNL Document 189-29 Filed 12/06/19 Page 2 of 4
`Document Number: PS1068
`Vascular Solutions, Inc.
`Rev. 01
`Product Requirements Document:
`Page 2 of 4
`GuideLiner Catheter System
`
`by which the operator can increase the back-up support of a guide catheter by coaxially inserting a
`GuideLiner into the guide catheter.
`
`2.2.
`
`Product Philosophy
`
`Vascular Solutions strives to introduce products which are an improvement over current technology.
`VSI' s new products must be simple to use, meet clinicians' needs, and improve quality of life for the
`patient. These devices must also meet the financial needs of today's healthcare environment
`
`2.3.
`
`User Profiles
`
`2.3.1.
`
`Physician
`
`• Responsible for the health and comfort of patient
`• Require products to be reliable and pose minimal risk to the patient
`• Under cost containment pressure and will evaluate 'value' of product
`• Interventional Cardiologists and Radiologists are trained in this procedure
`
`2.3.2.
`
`Administration/Risk Management
`
`• Look at the full cost of treatment of a disease state including complications
`• Evaluate ways to reduce risk of complications
`
`2.4.
`
`Key Assumptions
`
`2.4.1. During interventional cases where the physician is attempting to reach into tortuous vessels, or
`where the arteries are more difficult to cross, additional back-up of the guide catheter may be
`achieved either through improved engagement of the coronary system, or by providing
`additional stiffness to the guide catheter.
`Treatment catheters have a useable length of —135cm
`Guide catheters have a maximum overall length of 109cm
`
`2.4.2.
`2.4.3.
`
`3.
`
`REQUIREMENTS/SPECIFICATIONS
`
`PRODUCT SPECIFICATIONS
`
`N
`
`TEST METHOD
`N
`,
`
`USER REQUIREMENTS
`3.1 Performance Requirements
`The catheter system must allow for
`advancement of the treatment catheter beyond
`(deeper) than using a guide catheter alone
`The catheter system must be capable of
`withstanding nounal insertion and removal
`forces through commonly used guide catheters
`and through the arterial system.
`The catheter system must slide inside the guide
`catheter and through the anticipated
`vasculature and be able to navigate the blood
`vessels without kinking.
`The catheter system must provide for an
`atraumatic entry into and travel through the
`blood vessel.
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`EXHIBIT 29
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`Teleflex Ex. 2024
`Medtronic v. Teleflex
`IPR2020-00132
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`IPR2020-00126
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`PROTECTIVE ORDER MATERIAL
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`CASE 0:19-cv-01760-PJS-TNL Document 189-29 Filed 12/06/19 Page 3 of 4
`Document Number: PS1068
`Vascular Solutions, Inc.
`Rev. 01
`Product Requirements Document:
`Page 3 of 4
`GuideLiner Catheter System
`
`The most distal position of the catheter system
`must be visible using standard fluoroscopic
`methods.
`Catheter system must be capable of delivering
`standard PTCA treatment catheters.
`
`Catheter and dilator must be able to be flushed
`with liquid prior to introduction into the guide
`catheter.
`
`The catheter surfaces shall be free of
`extraneous matter.
`The catheter system must be sterile
`
`3.2 Dimensional requirements
`The catheter must be capable of being
`deployed over a .014" guidewire.
`
`The catheter must be able to be deployed
`through a standard coronary guide catheter
`used in percutaneous procedures in both
`diameter and length.
`
`The catheter must be able to be locked in
`position relative to the guide catheter
`
`The length of the catheter must not prevent or
`limit the treatment catheter or stent delivery
`system from being fully deployed.
`
`'0,Vhemical & Biologic Properties,W
`All bio-contact materials used must be
`compatible with the biological tissues, cells
`and fluids.
`EO residual levels of blood contact
`components must meet required medical
`device criteria.
`The device must not contain any Latex
`materials
`3.4 Infection & microbial contamination
`The catheter surfaces must be free of sharp
`edges.
`The device must be non-pyrogenic.
`
`All components entering the sterile field and
`intended for contact with human tissue must be
`sterile.
`
`A,r
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`EXHIBIT 29
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`Page 3
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`Teleflex Ex. 2024
`Medtronic v. Teleflex
`IPR2020-00132
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`Teleflex Ex. 2024
`Medtronic v. Teleflex
`IPR2020-00126
`
`PROTECTIVE ORDER MATERIAL
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`

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`CASE 0:19-cv-01760-PJS-TNL Document 189-29 Filed 12/06/19 Page 4 of 4
`Document Number: PS1068
`Vascular Solutions, Inc.
`Rev. 01
`Product Requirements Document:
`Page 4 of 4
`GuideLiner Catheter System
`
`The catheter should be packaged in such a
`manner to protect the catheter and
`components.
`Catheter must have a reasonable shelf life.
`
`Catheter and package configuration must be
`designed for typical laboratory environment
`storage conditions.
`3.6 Ergonomic Requirements
`The catheter system should employ techniques
`and components that are familiar to the
`physician.
`The RX version of the catheter system should
`be capable of being used by one physician.
`3.7 Interfaces with other devices k 1
`The catheter system connections must be able
`to interface with standard connectors.
`The catheter system must be able to pass a
`.014" guidewire.
`The 5 in 6 catheter must be able to interface
`with a .070" guide catheter.
`The 6 in 7 catheter must be able to interface
`with a 0.078" guide catheter
`The 7 in 8 catheter must be able to interface
`with a 0.088" guide catheter.
`
`4.
`
`REVISION HISTORY
`
`Rev.
`01
`
`Effective Date
`8/24/05
`
`DCO #
`4029
`
`Reason
`Pre-release
`
`Confidential - Attorneys' Eyes Only
`
`VSIMDT00030181
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`- - Confidential - -
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`EXHIBIT 29
`
`Page 4
`
`Teleflex Ex. 2024
`Medtronic v. Teleflex
`IPR2020-00132
`
`Page 4
`
`Teleflex Ex. 2024
`Medtronic v. Teleflex
`IPR2020-00126
`
`PROTECTIVE ORDER MATERIAL
`
`