AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022

K071699 · Aga Medical Corp. · KRD · Aug 15, 2007 · Cardiovascular

Device Facts

• Record ID: K071699
• Device Name: AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
• Applicant: Aga Medical Corp.
• Product Code: KRD · Cardiovascular
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AMPLATZER Vascular Plug II is a sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion device. It includes a screw attachment for a delivery wire and radiopaque marker bands at both ends. The device is provided preloaded in a loader for insertion into a delivery catheter. It is delivered to the target site in the peripheral vasculature; upon release, the mesh expands to occlude the vessel. The device is available in diameters ranging from 3 mm to 22 mm. It is intended for use by clinicians to achieve vascular embolization, providing a mechanical barrier to blood flow.

Clinical Evidence

No clinical data. Evidence consists of bench testing (radial force, handoff/advancement forces, deployment, recapture, and detachment verification) and animal testing performed under simulated conditions of use.

Technological Characteristics

Triple-lobed, self-expanding Nitinol mesh occlusion device; stainless steel screw attachment; radiopaque marker bands; 135 cm delivery wire; hoop dispenser; loader device. Available in diameters 3-22 mm. Sterile, single-use.

Indications for Use

Indicated for arterial and venous embolizations in the peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• AMPLATZER® Vascular Plug II (K071125)

Submission Summary (Full Text)

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K07/699

AUG 1 5 2007

# 510(k) SUMMARY of Safety and Effectiveness

### l. Applicant Information:

| Date Prepared:<br>Submitter: | June 19, 2007<br>AGA Medical Corporation |
|-----------------------------------|-----------------------------------------------------|
| Address: | 5050 Nathan Lane North<br>Plymouth, MN 55442 |
| Establishment<br>Registration No. | 2135147 |
| Contact Person: | Jodi L. Raus, RAC<br>Director of Regulatory Affairs |
| Telephone Number:<br>Fax Number: | [phone]<br>[phone] |

### 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

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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.

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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## 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