K Number
K061416
Device Name
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
Manufacturer
Date Cleared
2006-10-25

(156 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The deflectable catheter system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Device Description
The SelectSite™ C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 guidewire, 1 needle and 1 syringe. The SelectSite™ C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite™ C304 Deflectable Catheter System is available in four models which are the C304-S59, C304-L69, C304-XS59 and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.
More Information

K#033989, K#032312

Not Found

No
The description focuses on the mechanical components and function of a deflectable catheter system for delivering other devices. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

No
The device is described as providing a "pathway through which diagnostic and therapeutic transvenous devices are introduced," indicating it is an accessory or delivery system for therapeutic devices, not a therapeutic device itself. Its components are for accessing and guiding other devices, not for direct treatment.

No

The device is indicated to "provide a pathway though which diagnostic and therapeutic transvenous devices are introduced," meaning it facilitates the introduction of diagnostic devices, but is not itself a diagnostic device.

No

The device description explicitly lists multiple physical components (catheter, dilator, slitter, guidewire, needle, syringe) and describes their physical functions and testing, 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:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description clearly states that this is a catheter system used to introduce other devices into the body (specifically the heart and its vasculature). It's a tool for accessing internal anatomical sites, not for analyzing samples taken from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.

This device is an invasive medical device used for procedural access and delivery of other devices within the body.

N/A

Intended Use / Indications for Use

The deflectable catheter system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Product codes

DQY

Device Description

The SelectSite™ C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 guidewire, 1 needle and 1 syringe. The SelectSite™ C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite™ C304 Deflectable Catheter System is available in four models which are the C304-S59, C304-L69, C304-XS59 and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

chambers and coronary vasculature of the heart, coronary sinus, vessels of the left heart

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)

Device integrity testing was performed to support the equivalency of the SelectSite™ C304 Deflectable Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The SelectSite met all specified design and performance requirements.

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

Not Found

Predicate Device(s)

K#033989, K#032312

Reference Device(s)

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

Image /page/0/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo, there is a circular graphic with three figures in different positions, suggesting movement or rotation. To the right of the graphic, the word "Medtronic" is written in a bold, sans-serif font. The overall design is simple and professional, conveying a sense of innovation and reliability.

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCEK061416
Date Prepared:May 19, 2006Page 1 of 2
Applicant:Medtronic Ireland
Parkmore Business Park West
Galway
IrelandOCT 2 5
Submission Correspondent:Michelle Nivala
Regulatory Affairs Specialist
Medtronic, Inc.
1015 Gramsie Road
Telephone:(763) 505 7863
Fax:(763) 505 7877
E-Mailmichelle.d.nivala@medtronic.com
Proprietary Name:SelectSite™ C304 Deflectable Catheter System
Common Name:Catheter, Percutaneous
Device Classification:Class II, 21 CFR 870.1250
Product Code:DQY

Shoreview MN 55126-3082

USA

Device Description

The SelectSite™ C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 guidewire, 1 needle and 1 syringe. The SelectSite™ C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite™ C304 Deflectable Catheter System is available in four models which are the 2006

1

Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol contains three stylized figures arranged in a circular pattern.

K06 1416
page 2 of 2

C304-S59, C304-L69, C304-XS59 and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.

Indications for Use

The deflectable catheter system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Substantially Equivalent Devices:

The SelectSite™ C304 Deflectable Catheter System uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:

  • SelectSite™ C304-S5901 and C304-L6901 Deflectable Catheter Systems . (K#033989, cleared January 22, 2004)
  • Medtronic Attain® 6226DEF Deflectable Catheter Delivery System (K#032312, . cleared November 3, 2003)

Summary of Studies:

Device integrity testing was performed to support the equivalency of the SelectSite™ C304 Deflectable Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The SelectSite met all specified design and performance requirements.

Biocompatibility Information

The biocompatibility evaluation completed for the SelectSite™ C304 Deflectable Catheter Delivery System verifies that the SelectSite™ C304 Deflectable Catheter System is biocompatible. The testing which supports the biocompatibility of the SelectSite™ C304 Deflectable Catheter System is consistent with International Standard ISO 10993-1:, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the SelectSite™ C304 Deflectable Catheter System are external communicating devices with limited exposure (