(103 days)
Not Found
No
The summary describes a mechanical lead delivery system and does not mention any AI or ML components or functionalities.
No
The device is described as a delivery system for pacing or defibrillator leads, which are therapeutic devices, but the LeadLiner itself is not directly therapeutic; it's a tool for introducing other devices.
No
The device is described as a lead delivery system intended for the introduction and delivery of pacing or defibrillator leads, not for diagnosing medical conditions.
No
The device description explicitly details physical components like catheters, a loading tool, and a retention clip, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction and delivery of pacing or defibrillator leads." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "lead delivery system" consisting of catheters and accessories used to physically deliver leads into the body. This is a surgical/interventional tool, not a diagnostic test kit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating the placement of medical leads.
N/A
Intended Use / Indications for Use
The LeadLiner CS lead delivery system is intended for the introduction and delivery of pacing or defibrillator leads.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
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
§ 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).
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
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.
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.