GUIDELINER V2 CATHETER

K112082 · Vascular Solutions, Inc. · DQY · Dec 1, 2011 · Cardiovascular

Device Facts

• Record ID: K112082
• Device Name: GUIDELINER V2 CATHETER
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.

Device Story

GuideLiner V2 is a single-lumen, rapid-exchange style catheter used in conjunction with guide catheters to provide support and facilitate interventional device delivery in coronary/peripheral vasculature. Device consists of a distal 25 cm lumen (PTFE liner, stainless steel coil, Pebax resin) reflowed to a stainless steel push wire with a proximal Pebax paddle-style hub. Available in 5.5F, 6F, 7F, and 8F sizes; 150 cm working length. Radiopaque platinum-iridium marker bands and non-radiopaque positioning marks assist in placement. Operated by interventional cardiologists or clinicians in a catheterization lab/OR setting. Device provides a stable platform for guidewire/device exchange, potentially improving procedural success in complex vascular anatomy.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included simulated anatomy/concomitant device use, kink resistance, tensile strength, torque, dimensional verification, and visual inspection. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogens, and hemocompatibility (hemolysis, coagulation, prothrombin time, hematological parameters, complement activation, and thrombogenicity).

Technological Characteristics

Single-lumen catheter; materials: PTFE liner, stainless steel coil, Pebax resin, silicone wipe; platinum-iridium radiopaque marker bands; stainless steel push wire; Pebax paddle-style hub. Sizes: 5.5F, 6F, 7F, 8F; 150 cm working length. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients requiring access to discrete regions of coronary and/or peripheral vasculature to facilitate placement and exchange of guidewires and interventional devices.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• GuideLiner catheter (K091750)

Submission Summary (Full Text)

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# 510(k) Summary

[As required by 21 CFR 807.92] 510(k) Number:_KII 2082

## Date Prepared: November 16, 2011

## Submitter's Information / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person Matt Nienstedt Regulatory Product Specialist Tel: [phone] (direct) Fax: [phone] Email: [e-mail] Alternate Contact Person Stacv Ouellette Senior Regulatory Operations Associate Tel: [phone] (direct) Fax: [phone] Email: [e-mail]

#### General Information

| Trade Name | GuideLiner® V2 catheter |
|---------------------|----------------------------------------------------------|
| Common / Usual Name | catheter |
| Classification Name | 21 CFR 870.1250, percutaneous catheter |
| Predicate Device | GuideLiner catheter (K091750 - Vascular Solutions, Inc.) |

### Device Description

The GuideLiner V2 is a single-lumen catheter offered in four sizes (5.5F, 6F, 7F, and 8F) and is compatible with 6F, 7F, and 8F guide catheters. GuideLiner V2 has a working length of 150 cm and may be placed over either an exchange length or 180 cm guidewire. The larger sizes of GuideLiner catheters are intended to be used within the proximal portions of the coronary vasculature to provide support and/or facilitate use of multiple interventional devices. The distal portion of the device is a 25 cm, single-lumen catheter constructed with a PTFE liner, stainless steel coil, various durometers of Pebax (polyether block amide) resin, and a silicone wipe on the outside diameter of the lumen. The catheter lumen is reflowed to the distal end of a stainless steel push wire. A Pebax paddle-style hub is over molded onto the proximal end of the push wire.

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GuideLiner V2 catheters have two radiopaque platinum-iridium marker bands – one located 2 mm from the distal tip and one located 1 cm distal from the proximal shaft lumen opening. The devices have two non-radiopaque positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip, respectively.

# Intended Use / Indications

GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.

## Technological Characteristics

The GuideLiner V2 and predicate GuideLiner devices have the following characteristics in common:

- . Catheter shaft lumen consists of various durometers of Pebax resin reflowed together.
- Radiopaque marker bands .
- . Positioning marks
- . Silicone wipe
- Identical inner and outer catheter lumen diameters for 6F, 7F, 8F devices .
- . Sterilized by ethylene oxide
- Packaged in identical sterile pouch and retail box .

The GuideLiner 2.0 and predicate GuideLiner devices differ in the following:

- . Shaft materials, construction, and length
- . Dimensional differences

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# Substantial Equivalence and Summary of Studies

GuideLiner V2 catheters are substantially equivalent to the predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design was qualified through the following tests:

- Simulated anatomy/concomitant device use .
- Kink resistance .
- . Tensile
- Torque .
- Dimensional verifications and visual inspections .
- Biocompatibility .
- o Cytotoxicity
- o Sensitization
- Irritation/intracutaneous reactivity o
- Acute systemic toxicity o
- Material-mediated pyrogens o
- o Hemocompatibility
- Hemolysis
- . Coagulation
- . Prothrombin time
- 트 Hemotological parameters
- 트 Complement activation
- Thrombogenicity 트

Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

DEC - 1 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vascular Solutions, Inc. c/o Mr. Matt Nienstedt Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369

Re: K112082

Trade/Device Name: GuideLiner® V2 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY . Dated: November 16, 2011 Received: November 17, 2011

Dear Mr. Nienstedt:

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 includine 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 Foend, on o 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 1 (1 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 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

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Page 2 - Mr. Matt Nienstedt

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.G. Hillebert

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K112082 510(k) Number:

Device Name: GuideLiner V2 catheter

### Indications for Use:

GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Hillebrenner

ision Sign-Off) Division of Čardiovascular Devices

510(k) Number K112082