AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016

K071125 · Aga Medical Corp. · KRD · Jun 18, 2007 · Cardiovascular

Device Facts

• Record ID: K071125
• Device Name: AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
• Applicant: Aga Medical Corp.
• Product Code: KRD · Cardiovascular
• Decision Date: Jun 18, 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, self-expanding Nitinol mesh occlusion device; features triple-lobed design; includes radiopaque marker bands and stainless steel screw attachment for delivery wire. Device is preloaded in a loader for insertion into a delivery catheter. Used by physicians in clinical settings for peripheral vascular embolization. Upon release from the delivery catheter, the device expands to occlude the target vessel. Benefits include effective vessel occlusion via a minimally invasive approach.

Clinical Evidence

Bench testing and animal studies performed. Bench testing included radial force, handoff/advancement forces, device deployment, recapture, detachment verification, and strength determinations. Animal testing validated the product under simulated conditions of use.

Technological Characteristics

Nitinol mesh occlusion device; triple-lobed design; stainless steel screw attachment; radiopaque marker bands; 135 cm Nitinol delivery wire; available in 4mm, 6mm, 10mm, 12mm, 14mm, and 16mm diameters; sterile, single-use; provided with loader device.

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 (K031810)

Submission Summary (Full Text)

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071125

## 510(k) SUMMARY of Safety and Effectiveness

## Applicant Information:

.

| Date Prepared: | 20 April 2007 |
|-----------------------------------|-----------------------------------------------------|
| Submitter: | 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: | [phone] |
| Fax Number: | [phone] |

## II. Device Information:

AMPLATZER® Vascular Plug II Trade Name:

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

AMPLATZER® Vascular Pluq Predicate Device: 510(k): K031810, Reg. No. 870.3300; Product Code: KRD

> The AMPLATZER® Vascular Predicate Device Intended Use: Plug 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 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 is coiled and packaged in a hoop dispenser.

> The AMPLATZER® Vascular Pluq II is available in fully-expanded diameters of: 4mm, 6mm, 10mm, 12mm, 14mm and 16 mm.

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

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Comparison to Predicate Device:

The AMPLATZER® Vascular Plug II is substantially equivalent to the predicate device cleared by K031810. 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 come preloaded in a loader device. The two devices have the same operating principle, where a self-expanding Nitinol mesh device is received 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.

Three minor modifications were made to the AMPLATZER® Vascular Plug II:

- 1. Modification of the shape from a single-lobed to a triple-lobed design.
- 2. Use of multiple, thinner Nitinol wire braid layers (two or three), compared to the single braid layer of thicker wire in the original design.
- 3. Change to material used in outer layer of Loader component.
- Verification and validation testing confirms that the functional Test Data: vennoderistics 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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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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGA Medical Corp. c/o Ms. Jodi Raus 5050 Nathan Lane North Plymouth, MN 55442-3209

JUN 1 8 2007

Re: K071125

Amplatzer Vascular Plug II Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: May 30, 2007 Received: May 31, 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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Page 2 - Ms. Jodi 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

R. lochner

Image /page/3/Picture/6 description: The image shows a stylized drawing of what appears to be a signature or logo. To the left is a symbol that looks like a cursive letter, possibly an 'S' or 'W', with overlapping lines and curves. To the right of the symbol are two capital letters, 'B' and 'D', stacked vertically. The overall impression is that of a monogram or initial mark, possibly representing a person's name or an organization's branding.

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): | K07 1125 |
|---------------------------|-----------------------------|
| Device Name: | AMPLATZER® Vascular Plug II |

Indications for Use:

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

| Prescription Use ✗<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-the-Counter Use<br>(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)

umna R. Vanes

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number: K071125

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

Indications for Use Statement Page 1 of 1

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