The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorqVue 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® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 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 single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid 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) summary for the AMPLATZER® TorqVue® 2 Delivery Sheath, a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling typical "acceptance criteria" and "studies" in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested points related to AI software performance (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance, provenance of data) are not applicable to this type of device and submission.

Here's an analysis based on the information provided:

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

For this device, "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm would have sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various functional and safety characteristics. The reported "performance" is that it met these criteria through bench testing.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence to Predicate Device: Satisfy key functional characteristics similar to the AMPLATZER® TorqVue® Delivery System (K072313).	The functional characteristics of the AMPLATZER® TorqVue® 2 Delivery Sheath are substantially equivalent to the predicate device. Bench testing confirmed this.
Visual and Dimensional Integrity: Correct physical appearance and dimensions.	Included in "Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included visual and dimensional inspection."
Resistance to Kinking: Maintain structural integrity and patency when bent.	Included in "Bench testing of the AMPPLATZER® TorqVue® 2 Delivery Sheath included... resistance to kinking due to bending."
Freedom from Leakage (Air and Liquid): Prevent unintended passage of fluids or air.	Included in "Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included... freedom from leakage of air and liquid."
Tensile Strength: Sufficient mechanical strength to withstand operational forces.	Included in "Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included... tensile strength."
Device Interaction: Compatibility and proper interaction with other devices (e.g., devices passed through the sheath).	Included in "Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included... device interaction testing."
Distribution Simulation: Maintain integrity and functionality after simulated shipping/handling.	Included in "Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included... and distribution simulation."
Manufacturing Materials and Processes: Similar to predicate.	"Manufacturing materials and processes are similar" to the predicate.
Sterilization Method: Same as predicate.	"Sterilization method is the same" as the predicate.
Sterile Package Materials: Same as predicate.	"Sterile package materials are the same" as the predicate.
Intended Use: Consistent with the predicate device (or a subset thereof).	"Indications for Use for the TorqVue 2 Delivery Sheath are a subset of the TorqVue Delivery System." The intended use is to "provide a pathway through which devices are introduced within the peripheral vasculature," which is consistent with the general purpose of delivery sheaths.

Study Title: Not explicitly named, but referred to as "Bench testing" and "laboratory verification test."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. Bench testing often involves a statistically determined number of units or replicates for each test, but the exact numbers are not detailed in this summary.
Data Provenance: The testing appears to be internal "bench testing" and "laboratory verification tests" performed by the manufacturer, AGA Medical Corporation, in Plymouth, MN, USA.
Retrospective/Prospective: As this is bench testing of physical properties, these terms are not applicable in the typical clinical study sense. The tests are designed and executed prospectively in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This is a physical medical device (delivery sheath), not an AI algorithm requiring expert interpretation for "ground truth" on images or clinical data. The "ground truth" for its performance is derived from standardized engineering tests measuring physical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: As above, this is bench testing of a physical device. There is no "adjudication method" involving experts for a test set in the context of clinical interpretation or diagnosis. Test results are objective measurements against predetermined specifications.

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: This is a physical medical device, not an AI algorithm. Therefore, MRMC studies are not relevant.

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

Not Applicable: As this is a physical medical device, not an algorithm, the concept of "standalone performance" for an algorithm is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: For a physical device, the "ground truth" is defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "ground truth" for tensile strength would be a defined force threshold, or for kinking, a specific angle of bend without occlusion. These are objective, measurable physical properties.

8. The sample size for the training set

Not Applicable: This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.

Summary

{0}------------------------------------------------

L093476

510(K) Summary (per 21 CFR 807.92)

FEB - 5 2010

1. Applicant Information Date Prepared:
  November 6, 2009

2135147

Submitter:

AGA Medical Corporation 5050 Nathan Lane North Plymouth, MN 55442 USA

Establishment Registration Number:

Contact person:

Diane Carroll Regulatory Affairs Associate Telephone Number: 763.531.3161 Fax Number: 763.647.5932

1. General Device Information Trade Name:
  AMPLATZER® TorqVue® 2 Delivery Sheath

Common Name:

Classification Name: Classification: Product Code:

Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY

Catheter, Delivery Sheath

Predicate Device:

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

3. Device Description

The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal

{1}------------------------------------------------

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

end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy.

The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid 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.

4. Intended Use

The AMPLATZER® TorqVue® 2 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

5. Comparison to Predicate

The AMPLATZER® TorqVue® 2 Delivery Sheath has the following similarities when compared to the predicate device:

· Indications for Use for the TorqVue 2 Delivery Sheath are 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

6. Test Data

The functional characteristics of the AMPLATZER® TorqVue® 2 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation.

7. Summary

Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorgVue® 2 Deliverv Sheath is substantially equivalent to the currently marketed predicate device.

{2}------------------------------------------------

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

FEB - 5 2010

Re: K093476

AMPLATZER® TorqVue® 2 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 06, 2009 Received: November 09, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{3}------------------------------------------------

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/Reporta.Problem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number:	K093476
Device Name:	AMPLATZER TorqVue 2 Delivery Sheath

Indications for Use: The AMPLATZER ToroVue Delivery Sheath is intend

The AMPLATZER TorqVue 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) ് Nivision Sign-Off)

Division of Cardiovascular Devices

510(k) Number K093476

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).