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.

AI/ML Overview

The provided text describes a 510(k) summary for the GuideLiner® V2 catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies. Therefore, many of the requested elements for evaluating AI/algorithm performance (e.g., sample size for test set, expert qualifications, MRMC study, training set details) are not applicable to this submission.

Here's an analysis based on the information provided, highlighting the acceptance criteria and the studies conducted:

Acceptance Criteria and Study that Proves the Device Meets the Acceptance Criteria:

The GuideLiner® V2 catheter received 510(k) clearance based on demonstrating substantial equivalence to its predicate device, the GuideLiner catheter (K091750). The studies conducted for this submission are primarily non-clinical, focusing on engineering verification and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a tabled format for each test. Instead, it states that "Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions." This implies that the device performance for each test met pre-defined internal specifications for safety and functionality, generally aligned with the predicate device's performance characteristics or industry standards for similar devices.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Functional / Performance	Simulated anatomy/concomitant device use	Met specified acceptance criteria
	Kink resistance	Met specified acceptance criteria
	Tensile	Met specified acceptance criteria
	Torque	Met specified acceptance criteria
	Dimensional verifications	Met specified acceptance criteria
	Visual inspections	Met specified acceptance criteria
Biocompatibility	Cytotoxicity	Met specified acceptance criteria
	Sensitization	Met specified acceptance criteria
	Irritation/intracutaneous reactivity	Met specified acceptance criteria
	Acute systemic toxicity	Met specified acceptance criteria
	Material-mediated pyrogens	Met specified acceptance criteria
	Hemocompatibility (Hemolysis, Coagulation, Prothrombin time, Hematological parameters, Complement activation, Thrombogenicity)	Met specified acceptance criteria

2. Sample size used for the test set and the data provenance

Not Applicable (N/A) / Not Provided. This type of information (sample size of a test set, data provenance for clinical/image data) is typical for AI/algorithmic device submissions involving real-world data and clinical performance metrics. For this catheter, the "test set" refers to the physical units of the device subjected to various engineering and biocompatibility tests. The document does not specify the number of units tested for each criterion, nor is "data provenance" a relevant concept in the same way as for clinical data. The tests were likely performed in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A / Not Provided. This information is relevant for AI/algorithm performance studies where expert consensus or review establishes the "ground truth" for diagnostic or predictive tasks. For a medical device like a catheter, "ground truth" relates to physical specifications and performance under defined conditions, which are typically assessed through engineering measurements and established lab protocols, not expert clinical interpretation of test results in the same way.

4. Adjudication method for the test set

N/A / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretation when establishing ground truth for clinical cases in AI/algorithm performance studies. Since expert clinical review of a "test set" for ground truth is not applicable here, neither is an adjudication method. Device performance is determined by objective measurements against predefined engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a non-AI medical device; therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted and is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device does not incorporate an algorithm; therefore, a standalone algorithm performance study was not conducted.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering specifications, regulatory standards, and established laboratory testing protocols. For example, tensile strength would have a numerical "ground truth" value that the device must meet, determined by industry standards for such materials and intended use. Biocompatibility tests have "ground truth" endpoints (e.g., cell viability, lack of systemic toxicity) defined by ISO standards and regulatory guidelines.

8. The sample size for the training set

N/A / Not Provided. This device does not use machine learning, so there is no concept of a "training set." The design and manufacturing process are informed by established engineering principles and prior device experience (including the predicate device), not through training on a dataset in the AI sense.

9. How the ground truth for the training set was established

N/A / Not Provided. As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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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: 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

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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

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 (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

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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

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).