The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.

Device Description

The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ("half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TrapLiner Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt.

Therefore, many of the requested elements (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable or not available in this type of regulatory submission. The submission centers on verification testing against engineering specifications and biocompatibility standards to demonstrate that the new device performs similarly and safely to already approved devices.

Here's the information that can be extracted or inferred from the provided text, alongside explanations for the N/A sections:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, specific numerical acceptance criteria (e.g., "Kink Resistance shall be > X Newtons") and precise reported performance values (e.g., "Kink Resistance was Y Newtons") are not detailed in this summary. The document lists the types of tests performed:

Test Name	Acceptance Criteria (General)	Reported Device Performance (General)
Kink Resistance	Met specified criteria	Passed
Distal Shaft Flexibility	Met specified criteria	Passed
Distal Tip Compression Force	Met specified criteria	Passed
Collar Crush Force	Met specified criteria	Passed
Interventional Device Passage Track Force	Met specified criteria	Passed
Guidewire Holding Force	Met specified criteria	Passed
Fluoroscopy Visualization	Met specified criteria	Passed
Guide Catheter Backup Support	Met specified criteria	Passed
TrapLiner Balloon Deflation, Device Passage	Met specified criteria	Passed
TrapLiner Balloon Fatigue	Met specified criteria	Passed
TrapLiner Balloon Burst	Met specified criteria	Passed
Balloon-to-Shaft Tensile Strength	Met specified criteria	Passed
Pushwire-to-Shaft Tensile Strength	Met specified criteria	Passed
Distal Tensile Strength	Met specified criteria	Passed
Friction Force	Met specified criteria	Passed
Hydrophilic Coating Particulate in a Simulated Anatomy	Met specified criteria	Passed
Shaft O.D.	Met specified criteria	Passed
Shaft Length	Met specified criteria	Passed
Effective I.D.	Met specified criteria	Passed
Hub Luer Compatibility	Met specified criteria	Passed
In Vivo Efficacy	Met specified criteria	Passed
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, Hemocompatibility)	Per ISO 10993-1 standards; met specified criteria for each test	Passed all tests

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

Sample Size for Test Set: Not specified in the provided summary. These are typically engineering or lab tests, not clinical studies with patients. Sample sizes would refer to the number of device units tested for each specific verification test.
Data Provenance: Not explicitly stated as "country of origin" for data. The tests are laboratory-based and include an "In Vivo Efficacy" test, which implies animal or cadaveric testing, but the specifics are not provided. The overall submission originates from Vascular Solutions, Inc. in Minneapolis, MN, USA.
Retrospective or Prospective: Not applicable in the context of device verification testing for a 510(k) submission.

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

Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards (e.g., ISO 10993-1), and pre-defined acceptance criteria, not expert clinical consensus on patient data.

4. Adjudication method for the test set

Not applicable. This refers to clinical data review, not engineering test results. Compliance with pre-defined pass/fail criteria is the "adjudication" method.

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

Not applicable. This is a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance metrics are irrelevant.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the engineering and mechanical tests, the "ground truth" is defined by pre-specified engineering specifications and performance standards.
For biocompatibility tests, the "ground truth" is established by adherence to international standards like ISO 10993-1.
The "In Vivo Efficacy" test's ground truth would have been established by its specific protocol, likely measuring device function in a simulated biological environment, but the details are not provided.

8. The sample size for the training set

Not applicable. This is a physical medical device, and the concept of "training set" is relevant to machine learning algorithms, not to the verification and validation of a catheter.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.

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

February 3, 2017

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

Re: K161901

Trade/Device Name: TrapLiner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 4, 2017 Received: January 5, 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 (reporting of medical devicerelated 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.

{1}------------------------------------------------

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando
Aguel-S

Fernando Aguel

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161901

Device Name TrapLiner catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

[As required by 21 CFR 807.92] Date Prepared: December 30, 2016 510(k) Number: K161901

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: 763-656-4300
Establishment Registration # 2134812	Fax: 763-656-4253

General Information

Trade Name	TrapLiner catheter
Common / Usual Name	Catheter
Classification Name	21 CFR 870.1250 – percutaneous catheter
Predicate Device	K112082 - GuideLiner V2 catheter (Vascular Solutions, Inc.);P860019/S040 – SCIMED Trapper exchange device (SCIMED LifeSystems, Inc.)

Device Description

Intended Use

Technological Characteristics Comparison

The TrapLiner catheter is similar in design and intended use to the primary predicate device as it is rapidexchange guide extension catheter intended to access discrete regions of the coronary and peripheral vasculature and to facilitate the placement of guidewires and other interventional devices. Like the secondary predicate device, a trapping balloon is present on the TrapLiner catheter to maintain guidewire

{4}------------------------------------------------

position during interventional device exchange. In addition to similar dimensions and guide catheter compatibility (6F, 7F, and 8F), the subject and predicate devices are made from similar materials and both have a lubricious coating.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and mechanical tests to provide evidence of TrapLiner catheter substantial equivalence. The TrapLiner 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 Resistance .
. Distal Shaft Flexibility
Distal Tip Compression Force .
Collar Crush Force ●
. Interventional Device Passage Track Force
Guidewire Holding Force ●
Fluoroscopy Visualization ●
Guide Catheter Backup Support ●
TrapLiner Balloon Deflation, Device Passage ●
TrapLiner Balloon Fatigue ●
TrapLiner Balloon Burst
. Balloon-to-Shaft Tensile Strength
Pushwire-to-Shaft Tensile Strength
Distal Tensile Strength .
Friction Force ●
Hydrophilic Coating Particulate in a Simulated Anatomy ●
Shaft O.D. ●
Shaft Length .
Effective I.D. ●
Hub Luer Compatibility .
. In Vivo Efficacy

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

. Cytotoxicity
. Sensitization
Irritation/Intracutaneous Reactivity .

{5}------------------------------------------------

Systemic Toxicity .
Pyrogenicity .
Hemocompatibility .

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

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).