The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.

Device Description

The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Dilator, Loader, Delivery Wire, Vise, Hemostasis Valve.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AMPLATZER® Reliant™ Catheter Delivery System. This is a medical device submission, and the "study" referred to here is the set of verification and validation tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical study with human patients and outcomes data in the typical sense for a diagnostic AI device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Reliant™ Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices."

Specific numerical acceptance criteria and performance values are not provided in this summary. The 510(k) summary typically provides a high-level overview, with detailed test reports available to the FDA reviewer.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Catheter integrity	Demonstrated substantial equivalence to predicate device.
Catheter kink resistance	Demonstrated substantial equivalence to predicate device.
Leak resistance	Demonstrated substantial equivalence to predicate device.
Hub strength	Demonstrated substantial equivalence to predicate device.
Ability to deliver various implantable devices	Demonstrated substantial equivalence to predicate device.
Functional characteristics for intended use	Demonstrated substantial equivalence to predicate device.

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

Sample Size: The document does not specify the sample sizes for each of the "verification and validation testing" categories (catheter integrity, kink resistance, etc.). These would typically be detailed in the full test reports.
Data Provenance: The tests are described as in vitro performance information and laboratory verification tests. This indicates the testing was conducted in a controlled lab setting, not on patient data. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense.

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

This concept is not applicable here. Ground truth, in the context of diagnostic AI, refers to the definitive determination of a condition (e.g., presence of disease) that the AI is trying to detect. For a physical medical device like a catheter delivery system, the "ground truth" for its performance is established through standard engineering and materials testing, adhering to recognized industry standards. The performance is measured against established physical and mechanical specifications, not expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among expert interpretations of complex data (e.g., medical images) to establish a consensus ground truth. Since the "test set" here refers to physical products undergoing engineering tests, this methodology is not relevant.

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. MRMC studies are used for evaluating the impact of diagnostic aids (like AI) on human reader performance for tasks such as image interpretation. This device is a catheter delivery system, a physical tool for introducing other devices, not a diagnostic aid that enhances human reading of cases.

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

Not applicable. This device is a physical catheter delivery system, not a software algorithm.

7. The Type of Ground Truth Used:

As explained in point 3, the concept of "ground truth" in the diagnostic AI sense doesn't apply directly here. The "truth" for this device's performance is derived from:

Engineering specifications and standards: The device is tested against predefined physical and mechanical properties and performance criteria (e.g., minimum tensile strength, maximum leak rate, resistance to kinking).
Predicate device performance: The primary goal of a 510(k) is to demonstrate substantial equivalence. Therefore, the "truth" is often relative to the established performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, for the same reasons as point 8.

Summary

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K070238

FEB 2 8 2007

510(k) SUMMARY of Safety and Effectiveness

Applicant Information: l.

Date Prepared:Submitter:	January 19, 2007AGA Medical Corporation
Address:	5050 Nathan Lane NorthPlymouth, MN 55442
EstablishmentRegistration No.	2135147
Contact Person:	David D. Cox, Ph.D.Senior Regulatory Affairs Manager
Telephone Number:Fax Number:	(763) 531-3064(763) 647-5932

II. Device Information:

Trade Name:	AMPLATZER® Reliant™ Catheter Delivery System
Common Name:	Catheter Delivery System

Classification Name:	Catheter, Percutaneous
Classification:	Class II, 21 CFR 870.1250
Product Code:	DQY

Medtronic® SelectSite® Deflectable Catheter Delivery System Predicate Device: 510(k) No. K033989, Reg. No. 870.1250; Product Code: DQY
Predicate Device Intended Use: The deflectable catheter system is intended to provide a pathway through 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.
The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. Device Description: single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart.
The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components:

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Delivery Catheter used to deliver transvenous devices � Dilator - used within the Delivery Catheter to dilate the vessel . and to help direct the Delivery Catheter during placement Loader- used to help introduce the selected implantable . device into the delivery catheter Delivery Wire - attaches to the implantable device and . facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.] Vise – a handle that is attached to the Delivery Wire by means . of a set screw Hemostasis Valve- used on the proximal end of the Loader to . minimize bleeding from the Delivery Catheter and for flushing air from the system The AMPLATZER® Reliant™ Catheter Delivery System is intended Intended Use: to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart. Comparison to The AMPLATZER® Reliant™ Catheter Delivery System is Predicate Device: substantially equivalent to the predicate device cleared by K033989. The two systems are both handheld catheter systems designed to facilitate access and placement of specified implantable devices within the chambers and coronary vasculature of the heart. Both delivery catheters are single lumen design with a hemostasis valve and an included dilator and introducer. Verification and validation testing confirms that the functional Test Data: characteristics of the AMPLATZER® Reliant" Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
- Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided. the AMPLATZER® Reliant™ Catheter Delivery System is substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGA Medical Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

FEB 2 8 2007

Re: K070238

Amplatzer Reliant Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: February 6, 2006 Received: February 7, 2006

Dear Mr. Job:

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 - Mr. Mark Job

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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Statement of Indications for Use

16070238 510(k) Number:

Device Name: AMPLATZER® Reliant® Catheter Delivery System

Indications for use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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ko 70238

AMPLATZER® Reliant™ Catheter Delivery System 510(k) Premarket Notification

Section 4 - Page 1

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).