The AMPLATZER® TorqVue® Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

Device Description

The AMPLATZER® TorqVue® Catheter Delivery System is a sterile, single-use device designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 5-12 French (2.5-4.8 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 (optional), Plastic Vise, Hemostasis Valve.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® Delivery System. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Test Data" section.

Here's a breakdown of the requested information:

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Catheter Integrity	Not explicitly detailed, but implied to meet performance standards for a delivery system.	"confirms that the functional characteristics... are substantially equivalent to the predicate device"
Catheter Kink Resistance	Not explicitly detailed, but implied to meet performance standards for a delivery system.	"confirms that the functional characteristics... are substantially equivalent to the predicate device"
Leak Resistance	Not explicitly detailed, but implied to meet performance standards for a delivery system.	"confirms that the functional characteristics... are substantially equivalent to the predicate device"
Hub Strength	Not explicitly detailed, but implied to meet performance standards for a delivery system.	"confirms that the functional characteristics... are substantially equivalent to the predicate device"
Device Delivery Capability	Ability to deliver various implantable devices through the system.	"the ability to deliver various implantable devices" and "substantially equivalent to the predicate device"

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set (i.e., the specific number of devices or trials for each verification and validation test).

The data provenance is from laboratory verification and validation testing. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this was a pre-market submission for a physical medical device, not a data-driven AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes validation for a physical medical device, not an AI or diagnostic imaging device where expert ground truth establishment for a test set would typically be required. The "ground truth" for this device's performance is based on direct physical testing against established functional requirements and comparison to a predicate device.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools assisting human readers, which is not the case for this delivery system.

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

This information is not applicable as the submission is for a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used

The "ground truth" for this device's performance was established through laboratory verification and validation testing against functional requirements and by demonstrating substantial equivalence to a predicate device (Medtronic® SelectSite™ Deflectable Catheter Delivery System). This involves engineering and performance metrics rather than medical pathology, outcomes, or expert consensus in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This information is not applicable for the same reason as point 8.

Summary

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173

510(k) SUMMARY of Safety and Effectiveness

Applicant Information: l.

Date Prepared:	August 16, 2007
Submitter:	AGA Medical Corporation
Address:	5050 Nathan Lane NorthPlymouth, MN 55442
EstablishmentRegistration No.	2135147
Contact Person:	Patricia A. LaForteRegulatory Affairs Associate
Telephone Number:	(763) 531-3062
Fax Number:	(763) 647-5932

II. Device Information:

Trade Name:	AMPLATZER® TorqVue® Delivery System
Common Name:	Delivery System
Classification Name:	Catheter, Percutaneous
Classification:	Class II, 21 CFR 870.1250
Product Code:	DQY
Predicate Device:	Medtronic® SelectSite™ Deflectable Catheter Delivery System510(k) No. K033989, Reg. No. 870.1250; Product Code: DQY
	Predicate Device Intended Use: The deflectable catheter systemis intended to provide a pathway through which diagnostic andtherapeutic transvenous devices are introduced within thechambers and coronary vasculature of the heart, and forintroducing balloon catheters into the coronary sinus or leads intovessels of the left heart via the coronary sinus.
Device Description:	The AMPLATZER® TorqVue® Catheter Delivery System is asterile, single-use device designed to facilitate the introduction oftransvenous devices to chambers and coronary vasculature of theheart and for introducing therapeutic devices to a location withinthe peripheral vasculature.

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The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 5-12 French (2.5-4.8 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: 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 (optional) - 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.] Plastic Vise – a handle that is attached to the Delivery Cable . 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® TorqVue® Delivery System is intended to Intended Use: provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Comparison to The AMPLATZER® Torqvue® Delivery System is substantially Predicate Device: 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.

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Verification and validation testing confirms that the functional Test Data: characteristics of the AMPLATZER® TorqVue® Delivery Systems 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® TorqVue® Delivery System is substantially equivalent to the currently marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

AGA Medical Corporation c/o Ms. Patricia A. LaForte Regulatory Affairs Associates 5050 Nathan Lane North Plymouth, MN 55442-3209

Re: K072313

Trade/Device Name: AMPLATZER® TorqVue® Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2007 Received: August 17, 2007

Dear Ms. LaForte:

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.

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

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Page 2 - Ms. Patricia A. LaForte

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

R. lochner

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

Enclosure

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Statement of Indications for Use

510(k) Number: Ko 723| 3 -----------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: AMPLATZER® TorqVue® Delivery System

Indications for use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter-Use OR (Part 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)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510/k) Number_k 07 2313

AMPLATZER® TorqVue® 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).