The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

Device Description

The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the AMPLATZER TorqVue Exchange System. This is a submission for substantial equivalence to a predicate device, not a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission.

The study described is a device verification study to demonstrate that the AMPLATZER TorqVue Exchange System meets established performance criteria and supports equivalency to a predicate device.

Here's the information that can be extracted or deduced from the provided text:

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

Acceptance Criteria	Reported Device Performance
Visual requirements	Met
Performance requirements	Met
Compatibility requirements	Met
Biocompatibility testing (consistent with ISO 10993-1)	Presented (implied as met, as substantial equivalence was concluded)
Sterilization (validated ETO process)	Will continue to be sterilized (implied as met existing standards)

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

Sample Size: Not specified in the document.
Data Provenance: Not specified, but typical for device verification is in-house testing by the manufacturer (AGA Medical Corporation, Plymouth, MN, USA). The study is prospective in nature, as it involves testing the device against specific criteria.

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)

This is not applicable as the study described is a device verification study for a delivery system, not a diagnostic or AI device requiring expert-established ground truth. The "ground truth" here is the established performance criteria for the device itself.

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

Not applicable. The verification testing would involve standardized test methods and measurement, not expert adjudication in the context of diagnostic interpretation.

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. An MRMC study is not relevant for this type of medical device (catheter delivery system). This device does not involve "human readers" or "AI assistance."

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

Not applicable. This device is not an algorithm. The "standalone" performance refers to the device's ability to meet its functional and safety requirements independently. The listed "visual, performance and compatibility testing" assesses this.

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

Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is the established performance criteria and specifications for a catheter delivery system, derived from engineering standards, regulatory requirements, and comparison to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm and does not have a "training set."

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

Not applicable.

Summary

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K080994

510(k) Summary

MAY 1 6 2008

Date Prepared	April 4, 2008
Submitter	AGA Medical Corporation5050 Nathan LanePlymouth, MN 55442
Contact	Michelle NivalaSr. Regulatory Affairs Specialist
Telephone	763.531.3061
Fax	763.647.5932
E-mail	mnivala@amplatzer.com
Trade Name	AMPLATZER TorqVue ExchangeSystem
Common Name	Catheter Delivery System
Device Classification	Class II, 21 CFR 870.1250Catheter, Percutaneous
Product Code	DQY

Summary of Substantial Equivalence

The design, materials and performance of the AMPLATZER TorqVue Exchange System are substantially equivalent to the following predicate device:

AMPLATZER TorqVue Delivery System K072313 cleared November 2, 2007. -

Device Description

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Indications for Use

The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

Technological Characteristics

The design, materials, performance and packaging materials are substantially equivalent or identical to the predicate device referenced.

Summary of Testing

Device verification testing is presented to demonstrate the AMPLATZER TorqVue Exchange System meets established performance criteria and to support equivalency to the predicate device. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.

Biocompatibility testing consistent with ISO 10993-1: "Biological Evaluation of Medical devices -- Part 1: Evaluation and Testing" is also presented.

The AMPLATZER TorqVue Exchange System will continue to be sterilized using a validated ETO sterilization process.

Conclusion

AGA Medical Corporation considers the AMPLATZER TorqVue Exchange System to be substantially equivalent to legally marketed predicate devices through the data and information presented.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol composed of three curved lines that resemble a human figure or a stylized representation of a person.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2008

AGA Medical Corporation c/o Ms. Michelle Nivala Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, MN 55442-3209

Re: K080994

Trade Name: Amplatzer Torqvue Exchange System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, Dated: April 8, 2008 Received: April 7, 2008

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. Michelle 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 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 Biometrics' (OSB) 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,

$\qquad$

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:	K080994
Device Name:	AMPLATZER TorqVue Exchange System
Indications for Use:	The AMPLATZER TorqVue Exchange System is intended forremoval of an AMPLATZER Delivery Sheath and subsequentexchange for an AMPLATZER Delivery Sheath of equal or largerdiameter.

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K080994

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રવે

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).