The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser. The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.

AI/ML Overview

The provided document is a 510(k) summary for the AMPLATZER® Vascular Plug II, which describes a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, such as test sets, ground truth definitions, expert qualifications, and MRMC studies, are not applicable here.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the standard for 510(k) clearances.

However, I can extract the relevant information from the provided text to demonstrate the device's performance against its stated equivalence.

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

The "acceptance criteria" for a medical device in a 510(k) submission are typically related to demonstrating that the modified device performs as intended and is as safe and effective as the predicate device. These are generally not quantitative metrics like precision or recall, but rather tests confirming functional equivalence.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Test Data)
Intended Use Equivalence:	The AMPLATZER® Vascular Plug II has an identical intended use to the predicate device: "arterial and venous embolizations in the peripheral vasculature."
Design/Material Equivalence:	Both devices are sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion devices. Both have a screw attachment for a Delivery Wire and radiopaque marker bands. Both use identical patient-contacting materials and the same Nitinol Delivery Wire. Both come preloaded in a loader device. Both have the same operating principle. The only modification is an extended size range (3mm, 18mm, 20mm, 22mm added to 4-16mm).
Functional Equivalence:	"Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Vascular Plug II are substantially equivalent to the predicate device cited." This included: Radial force testing, Handoff and advancement forces, Device deployment, Recapture and detachment verification, Overall strength determinations.
Performance Equivalence (In Vivo):	"Animal testing was also performed to validate the product under simulated conditions of use."

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

The document does not specify a "test set" in the context of an AI/ML device. For this medical device, the "test data" refers to the studies performed to validate its functional characteristics and in vivo performance.

Sample Size: Not explicitly quantified. For bench testing (radial force, handoff, etc.), it would depend on the specific test protocols. For animal testing, the number of animals or procedures is not disclosed in the summary.
Data Provenance: Not specified within the provided summary. Typical for such a submission, bench testing would be conducted in a laboratory setting, and animal testing would be conducted under appropriate ethical and regulatory guidelines, likely within the US or a country with comparable standards.

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 concept is not applicable as the submission is for a medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for a test set. The validation relies on engineering and biological tests demonstrating physical and functional attributes.

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

Not applicable. There is no "test set" requiring expert adjudication as would be found in an AI/ML study.

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 not an AI-assisted device, and thus no MRMC study would be performed for human reader improvement.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the verification and validation (V&V) of this device, the "ground truth" is established by:

Engineering specifications and standards: For bench tests like radial force, deployment, and strength. The "ground truth" is adherence to predefined engineering requirements.
Physiological and anatomical suitability: For animal testing, the "ground truth" would be successful embolization and lack of adverse events in a simulated biological environment, demonstrating the device performs its intended function in vivo without unforeseen complications.

8. The sample size for the training set

Not applicable. This is a physical medical 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."

Summary

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

K07/699

AUG 1 5 2007

510(k) SUMMARY of Safety and Effectiveness

l. Applicant Information:

Date Prepared:Submitter:	June 19, 2007AGA Medical Corporation
Address:	5050 Nathan Lane NorthPlymouth, MN 55442
EstablishmentRegistration No.	2135147
Contact Person:	Jodi L. Raus, RACDirector of Regulatory Affairs
Telephone Number:Fax Number:	(763) 531-3056(763) 647-5932

ll. Device Information:

Trade Name:	AMPLATZER® Vascular Plug II
Common Name:	Catheter Delivery System

Classification Name:	Device, Embolization, Vascular
Classification:	Class II, 21 CFR 870.3300
Product Code:	KRD

AMPLATZER® Vascular Plug II Predicate Device: 510(k) No. K071125, Reg. No. 870.3300; Product Code: KRD
Predicate Device Intended Use: The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-Device Description: lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a The AMPLATZER® Vascular Plug II is stainless steel screw. provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser
The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.

AMPLATZER® Vascular Plug - II Special 510(k): Device Modification

510(k) Summary Page 1 of 2

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

The AMPLATZER® Vascular Plug II is indicated for arterial and Intended Use: venous embolizations in the peripheral vasculature.

Comparison to Predicate Device:

The AMPLATZER® Vascular Plug II is substantially equivalent to the predicate device cleared by K071125. The two devices are both embolization devices with identical intended uses, Both devices have exactly the same patient-contacting materials, and have the same Nitinol Delivery Wire. Both devices have the same triple-lobed, multiple wire layer design. Both devices come preloaded in a loader device. The two devices have the same operating principle, where a self-expanding Nitinol mesh device is retrieved in a loader, delivered to the desired embolization site through a delivery catheter and, upon release, both devices expand to occlude the vessel or desired embolization site.

One minor modification was made to the AMPLATZER® Vascular Plug II:

Extended size range, with the addition of 3 mm, 18 . О mm, 20 mm and 22 mm devices to the currentlyapproved size range of 4-16 mm devices.
Test Data:

Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Vascular Plug II are substantially equivalent to the predicate device cited. This included radial force testing, handoff and advancement forces, device deployment, recapture and detachment verification and overall strength determinations. Animal testing was also performed to validate the product under simulated conditions of use.

Based on the technical information, intended use, laboratory Summary: verification tests and in vitro and in vivo performance information provided, the AMPLATZER® Vascular Plug II is substantially equivalent to the currently marketed predicate device.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2007

AGA Medical Corporation c/o Ms. Jodi L. Raus 5050 Nathan Lane North Plymouth, MN 55442

Re: K071699

Trade/Device Name: AMPLATZER Vascular Plug II Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: July 19, 2007 Received: July 20, 2007

Dear Ms. Raus:

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.

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

Ms. Jodi L. Raus

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 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,

B. Comminsion for

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

510(k) Number (if known): KO71699

AMPLATZER® Vascular Plug II Device Name:

Indications for Use:

The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.

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

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hummer

ardiovascular 510fk) Numb

AMPLATZER® Vascular Plug – II Special 510(k): Device Modification

Indications for Use Statement Page 1 of 1

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).