GuideLiner V3 Catheter

K172090 · Vascular Solutions, Inc. · DQY · Oct 20, 2017 · Cardiovascular

Device Facts

• Record ID: K172090
• Device Name: GuideLiner V3 Catheter
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• 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 of interventional devices.

Device Story

GuideLiner V3 is a rapid-exchange guide extension catheter; used in coronary and peripheral vasculature. Device consists of 125 cm stainless steel pushwire shaft and 25 cm full-round, silicone-wiped guide extension segment. Features semi-circular polymer transition, platinum-iridium marker bands, and positioning marks. Operated by physicians in clinical settings to facilitate interventional device placement through existing guide catheters. Provides mechanical support and extension for device delivery; benefits patient by enabling access to challenging vascular anatomy.

Clinical Evidence

Bench testing only. Verification tests included kink radius, bend diameter, extension into anatomy, silicone coating, radiopacity, contrast delivery, interventional device delivery, shaft/hub tensile strength, torque strength, and guide catheter compatibility. Biocompatibility testing performed per ISO 10993-1 included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, ASTM hemolysis, complement activation, and thrombogenicity. All tests met acceptance criteria.

Technological Characteristics

Rapid-exchange guide extension catheter. Materials: stainless steel pushwire, silicone-wiped guide extension, platinum-iridium marker bands, polymer transition. Dimensions: 150 cm working length (125 cm shaft, 25 cm extension). Sizes: 5F, 5.5F, 7F, 8F. Biocompatibility per ISO 10993-1; Hemolysis per ASTM.

Indications for Use

Indicated for patients requiring access to discrete regions of the coronary and/or peripheral vasculature to facilitate placement of 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 V2 Catheter (K112082)

Reference Devices

• TrapLiner Catheter (K161901)

Submission Summary (Full Text)

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October 20, 2017

Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K172090

Trade/Device Name: GuideLiner V3 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 21, 2017 Received: September 22, 2017

Dear Beka Vite:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Kenneth J. Cavanaugh -S

for

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

510(k) Number (if known)

K172090

Device Name GuideLiner V3 Catheter

Indications for Use (Describe)

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 of interventional devices.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------|
| <input type="checkbox"/> Registration (ID: 01-077-001-0-0000) |
| <input type="checkbox"/> One-Time Event (ID: 01-077-001-1-0000) |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

[As required by 21 CFR 807.92] Date Prepared: September 19, 2017 510(k) Number: K172090

## Submitter's Name / Contact Person

| Manufacturer | Contact Person |
|--------------------------------------|-----------------------------------|
| Vascular Solutions, Inc. | Beka Vite |
| 6464 Sycamore Court North | Sr. Regulatory Product Specialist |
| Minneapolis, MN 55369 USA | Tel: [phone] |
| Establishment Registration # 2134812 | Fax: [phone] |

## General Information

| Trade Name | GuideLiner V3 Catheter |
|---------------------|----------------------------------|
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 820.1250 |
| Predicate Device | GuideLiner V2 Catheter - K112082 |
| Reference Device | TrapLiner Catheter – K161901 |

## Device Description

The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes – 5F, 5.5F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semi-circular polymer that meets the proximal end of the full-round guide extension segment. The GuideLiner V3 catheter has two platinumiridium marker bands; the distal marker band is located at the distal tip and the proximal marker band is located near the collar. The GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm (double mark) from the distal tip.

#### 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 of interventional devices.

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## Technological Characteristics Comparison

The key technological difference between the GuideLiner V3 catheter and the predicate device is the addition of the semi-circular polymer transition from the pushrod to the full-round guide extension segment. An additional 5F configuration is also included.

# Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and performance tests to provide evidence of substantial equivalence for the GuideLiner V3 catheter. The GuideLiner V3 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 tests:

- Kink Radius
- . Bend Diameter
- . Extension into Anatomy
- Silicone Coating
- Radiopacity
- Contrast Delivery
- . Interventional Device Delivery
- Shaft Tensile
- Hub Tensile
- Torque Strength
- Distal Shaft Length
- Half-Pipe Length
- Working Length
- Guide Catheter Compatibility

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

- Cytotoxicity
- . Sensitization
- . Irritation
- Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- Thrombogenicity

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the GuideLiner V3 catheter is substantially equivalent to the predicate device.