The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.

The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® 3 Delivery Sheath. This document primarily focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical study data involving human performance or specific acceptance criteria for a diagnostic AI device.

Therefore, the requested information, which is typically associated with AI/ML diagnostic device studies, cannot be fully extracted or is not applicable in this context.

Here's an attempt to answer based on the provided text, highlighting where the information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria or specific numerical performance metrics for a diagnostic device. Instead, it states that the functional characteristics were determined to be "substantially equivalent" to predicate devices. The bench tests are described generally.

Acceptance Criteria (Not Explicitly Stated as Numerical Criteria)	Reported Device Performance (Summary from Bench Testing)
Visual and dimensional integrity	Met, as part of substantial equivalence
Resistance to kinking (due to torque and bending)	Met, as part of substantial equivalence
Freedom from leakage of air and liquid	Met, as part of substantial equivalence
Tensile strength	Met, as part of substantial equivalence
Device interaction testing	Met, as part of substantial equivalence
Distribution simulation (at baseline and after 3-year accelerated aging)	Met, as part of substantial equivalence

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

Sample Size: Not specified. The document refers to "bench testing" which typically involves a small, representative sample of devices for engineering tests, not a large clinical test set.
Data Provenance: Not applicable. The data is from laboratory (bench) testing of the device itself, not from clinical data (e.g., patient records, images).

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

Not applicable. This device is a delivery sheath, not a diagnostic device requiring expert review for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or diagnostic decision-making involved in the bench testing described.

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. This is not an AI/ML diagnostic device, and no MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is not an AI/ML algorithm; it is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on engineering specifications, material properties, and functional performance benchmarks (e.g., resistance to kinking, tensile strength, leakage) as determined through bench testing. It's not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and prior regulatory approvals of similar predicate devices.

Summary

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JUL - 9 2009

1091793

510(K) Summary (per 21 CFR 807.92)

1. Applicant Information
  Date Prepared:

June 15, 2009

Submitter:

5050 Nathan Lane North Plymouth, MN 55442 USA

2135147

AGA Medical Corporation

Registration Number:

Contact person:

Establishment

Diane Carroll Regulatory Affairs Associate

Telephone Number: Fax Number:

763.531.3161 763.647.5932

2. General Device Information

Trade Name: Common Name:

Classification Name: Classification: Product Code:

Predicate Device:

AMPLATZER® TorqVue® 3 Delivery Sheath Catheter, Delivery Sheath

Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY

AMPLATZER® TorqVue® Delivery System, K072313, cleared November 2, 2007 Reg. No. 870.1250

AMPLATZER® TorqVue® LP Delivery System, K080757, cleared April 18, 2008 Reg. No. 870.1250

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510(K) Summary (per 21 CFR 807.92) (continued)

3. Device Description

4. Intended Use

The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

5. Comparison to Predicate

The AMPLATZER® TorqVue® 3 Delivery Sheath has the following similarities when compared to the predicate device:

Indications for Use for the TorqVue 3 Delivery Sheath are identical . to the TorqVue LP Delivery System and a subset of the TorqVue Delivery System
. Operating principal is the same
Manufacturing materials and processes are similar .
Sterilization method is the same ●
Sterile package materials are the same

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6. Test Data

The functional characteristics of the AMPLATZER® TorqVue® 3 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 3 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to torque and bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation at baseline (Time=0) and after 3-year accelerated aging.

7. Summary

Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorqVue® 3 Delivery Sheath is substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 9 2009

AGA Medical Corporation c/o Ms. Diane Carroll Regulatory Affairs Associate 5050 Nathan Lane Plymouth, MN 55442

Re: K091793

Trade/Device Name: AMPLATZER TorqVue 3 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: June 15, 2009 Received: June 17, 2009

Dear Ms. Carroll:

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 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. Diane Carroll

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Duna D. Vorhmer

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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Indications for Use Statement

510(k) Number:

K_091793

Device Name:

AMPLATZER® TorqVue® 3 Delivery Sheath

Indications for Use:

The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter-Use (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)

Dura R. LaLonde

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

14091793 510(k) Number

Page 1 of 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).