K Number

Device Name

GUIDELINER V2 CATHETER

Manufacturer

VASCULAR SOLUTIONS, INC.

Date Cleared

2011-12-01

(133 days)

Product Code

DQY

Regulation Number

870.1250

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 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K091750

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical construction and mechanical properties of a catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are also focused on physical and material properties.

Therapeutic

No.
The device description indicates its purpose is to access vasculature and facilitate placement and exchange of other interventional devices and guidewires, not to provide a therapeutic effect itself.

Diagnostic

Explanation: The device is described as assisting with the placement and exchange of guidewires and other interventional devices, rather than detecting or diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical catheter with various material components (PTFE liner, stainless steel coil, Pebax resin, silicone wipe, stainless steel push wire, platinum-iridium marker bands) and includes performance studies related to physical properties (kink resistance, tensile, torque, dimensions, biocompatibility). This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the GuideLiner catheters are 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. This describes a device used within the body for interventional procedures, not a device used to examine specimens outside the body to provide diagnostic information.
Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen, push wire, radiopaque markers, and positioning marks. These are characteristics of an invasive medical device used for procedures, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or providing diagnostic information based on laboratory testing.

In summary, the GuideLiner catheter is an interventional medical device used for facilitating procedures within the circulatory system, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and/or peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091750

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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: 763.656.4317 (direct) Fax: 763.656.4253 Email: mnienstedt@vasc.com Alternate Contact Person Stacv Ouellette Senior Regulatory Operations Associate Tel: 763.656.4217 (direct) Fax: 763.656.4253 Email: souellette@vascularsolutions.com

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

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

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

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.

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

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 (800) 638-2041 or (240) 276-3150 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

Indications for Use

K112082 510(k) Number:

Device Name: GuideLiner V2 catheter

Indications for Use:

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