The LeadLiner CS lead delivery system (LeadLiner) is used to deliver pacing or defibrillator leads and consists of the LeadLiner delivery catheter and the LeadLiner inner catheter. It is packaged with a loading tool to assist in delivery of the two-catheter system and the lead through the hemostatic valve of the introducer sheath. It also includes a retention clip to hold the delivery and inner catheters together and allow the operator to manipulate the two catheters as a single system.

AI/ML Overview

The provided text describes a medical device, the LeadLiner CS lead delivery system, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out all the categories in your request, particularly regarding specific acceptance criteria values and a comprehensive study report with quantitative results.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Simulated use	Met specified criteria
Bend radius	Met specified criteria
Torque	Met specified criteria
Tensile	Met specified criteria
Delivery catheter perforations	Met specified criteria

Note: The document states that "Results of the verification tests met the specified acceptance criteria" but does not provide the specific numerical acceptance criteria or the quantitative results of the tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench tests" and "verification tests," which implies a test set was used. However, it does not specify the sample size for these tests. The data provenance is not explicitly stated, but bench tests are typically conducted in a controlled laboratory environment. There is no information on country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests described are engineering/bench tests, not clinical studies requiring expert interpretation of results in the way a diagnostic AI might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of bench testing described for a delivery catheter.

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

An MRMC study was not done. This device is a lead delivery system, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its evaluation.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" would be the engineering specifications and performance standards established for the device's physical and functional characteristics. For example, for "bend radius," the ground truth is likely a pre-defined maximum allowable bend before failure. This is based on engineering specifications and performance standards, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable as the device is a physical medical instrument, not an AI or algorithm that requires a training set.

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

This question is not applicable for the same reason as above.

Summary

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

2 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: November 13, 2013

K133501 510(k) Number: _

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Mia Hunt Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	LeadLiner CS lead delivery system
Common / Usual Name	Catheter, Percutaneous
Classification Name	Class II - 870.1250
Predicate Device	K120158 - Lateral Vein Introducer Kit (Pressure Products)

Device Description

Intended Use / Indications

The LeadLiner CS lead delivery system is intended for the introduction and delivery of pacing or defibrillator leads.

Technological Characteristics

LeadLiner has similar physical and technical characteristics to the predicate device. Both devices are sterile, two-catheter systems designed to facilitate lead placement. The delivery or outer catheter components of both devices have a 9 French O.D, braid reinforcement, and are used with smaller inner catheters. The primary technological difference between LeadLiner and the predicate device is the removal mechanism. LeadLiner delivery catheter has a rapid-exchange,

FEB 2 5 2014

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

pre-perforated design which allows it to be easily split from a delivered lead; the predicate device is removed by cracking the outer catheter hub and using a cutting tool to slice the catheter from the lead.

Substantial Equivalence and Summary of Studies

Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of safe and effective use of LeadLiner is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

. Simulated use
. Bend radius
. Torque
Tensile-Delivery catheter perforations .

Results of the verification tests met the specified acceptance criteria and did not raise new safety or performance questions. Therefore, LeadLiner is substantially equivalent to the predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

February 25, 2014

Vascular Solutions, Inc. Mia Hunt Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369

Re: K133501

Trade/Device Name: Leadliner CS Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: January 6, 2014 Received: January 7, 2014

Dear Ms. Hunt:

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.

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

Page 2 - Mia Hunt

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Linda Ricci-S for

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

Enclosure

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

Indications for Use

K133501 510(k) Number (if known):

Device Name: LeadLiner CS lead delivery system

Indications for Use:

The LeadLiner CS lead delivery system is intended for the introduction of pacing or defibrillator leads.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/10 description: The image shows the name "Linda J. Ricci-S" in a stylized font. The name "Linda" is in a bold, sans-serif font, while the "J. Ricci" portion is in a more decorative font with outlines and geometric shapes. The "-S" is in a simple, sans-serif font, similar to "Linda". The overall design gives the impression of a logo or signature.

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).