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.

AI/ML Overview

The Medtronic SelectSite™ C304 Deflectable Catheter System is a medical device designed to provide a pathway for introducing diagnostic and therapeutic transvenous devices into the heart chambers and coronary vasculature.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for substantial equivalence, not a detailed study report with specific acceptance criteria metrics. Instead, it describes a more general approach to demonstrating equivalence.

Acceptance Criteria Category	Reported Device Performance	Comments
Mechanical Testing	Met all specified design and performance requirements.	Implies various mechanical properties (e.g., tensile strength, flexibility, deflection capabilities) were within pre-defined limits, but specific metrics are not detailed.
Functional Testing	Met all specified design and performance requirements.	Suggests the catheter performed its intended functions (e.g., introducibility, steerability, patency) as expected, but specific metrics are not detailed.
Biocompatibility Testing	Verified that the device is biocompatible based on ISO 10993-1.	Confirms the device does not cause adverse biological reactions when in contact with tissues. This is a qualitative assessment based on standardized tests.
Sterilization Validation	Will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.	Assures the device achieves a specified sterility assurance level (SAL).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the "test set" in terms of number of devices or units tested for mechanical and functional performance. It generally refers to "Device integrity testing."

Data Provenance: The testing was likely conducted in a laboratory setting by Medtronic Ireland, the applicant. The document does not specify country of origin for data, but the applicant is Medtronic Ireland. The studies are for a new iteration of an existing device, so it would be considered internal company data.
Retrospective or Prospective: These engineering and biocompatibility tests are prospective in nature, designed and executed to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective assessments, such as image interpretation or clinical outcomes. For mechanical, functional, and biocompatibility testing of a catheter, "ground truth" is defined by established engineering specifications, material standards, and biological safety guidelines. Experts in these fields (e.g., materials scientists, biomedical engineers, toxicologists) would define the acceptance limits and interpret test results, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are usually for clinical trials or studies where there's a need to resolve discrepancies in expert opinions on an outcome. For the types of tests described (mechanical, functional, biocompatibility, sterilization), the "adjudication" is typically through adherence to pre-defined test protocols, objective measurement criteria, and statistical analysis of results against pre-established acceptance limits. There's no mention of a human-based adjudication method for these engineering and biological tests.

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 MRMC comparative effectiveness study was mentioned or conducted, as this is a physical medical device (catheter), not an AI-powered diagnostic or interpretive tool. Therefore, there's no mention of AI assistance or its effect size on human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm-only performance study was done for the same reason as point 5; this is a physical medical device.

7. The Type of Ground Truth Used

For the SelectSite™ C304 Deflectable Catheter System:

Mechanical & Functional Testing: Ground truth is established by engineering specifications, design requirements, and performance standards derived from the intended use and comparison to predicate devices. These are objective, quantifiable criteria (e.g., force required for deflection, maximum torque, flow rates, durability cycles).
Biocompatibility: Ground truth is established by international standards like ISO 10993-1, which define acceptable biological responses and testing methodologies based on the nature and duration of patient contact.
Sterilization: Ground truth is established by validated sterilization cycles that achieve a specified sterility assurance level (SAL), typically 10^-6, in accordance with recognized standards for EtO sterilization.

8. The Sample Size for the Training Set

This concept is primarily relevant for machine learning or AI models. Given that this is a physical medical device and not an AI system, there is no "training set" in the context of data used to train an algorithm. The development of the device would involve materials selection, design iterations, and testing, but not in the sense of a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical medical device. The "ground truth" for the development of the device lies in engineering principles, material science, and clinical needs that guided its design and subsequent validation testing.

Summary

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510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE	K061416
Date Prepared:	May 19, 2006	Page 1 of 2
Applicant:	Medtronic IrelandParkmore Business Park WestGalwayIreland	OCT 2 5
Submission Correspondent:	Michelle NivalaRegulatory Affairs SpecialistMedtronic, Inc.1015 Gramsie Road

Telephone:	(763) 505 7863
Fax:	(763) 505 7877
E-Mail	michelle.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

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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

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 (<24 hours) to circulating blood.

Sterilization Validation

The SelectSite™ C304 Deflectable Catheter System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion

Through the data and information presented, Medtronic Ireland considers the SelectSite™ C304 Deflectable Catheter System to be substantially equivalent to legally marketed predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2006

Medtronic Ireland c/o Ms. Michele Nivala Regulatory Affairs Specialist Medtronic, Inc. 1015 Gramsie Road Shoreview, MN, 55126-3082

Re: K061416

Trade/Device Name: Selectsite C304 Deflectable Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 4, 2006 Received: October 10, 2006

Dear Ms. Nivala:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Michele Nivala

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-_. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bhimmar for

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):_KOG 14 / 14 / 14 / 14 /

Device Name: SelectSite C304 Deflectable Catheter System

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenmo
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number K061416

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).