AMPLATZER VASCULAR PLUG 4

K113658 · Aga Medical Corp. · KRD · Jun 12, 2012 · Cardiovascular

Device Facts

• Record ID: K113658
• Device Name: AMPLATZER VASCULAR PLUG 4
• Applicant: Aga Medical Corp.
• Product Code: KRD · Cardiovascular
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.

Device Story

AMPLATZER Vascular Plug 4 (AVP4) is a self-expanding Nitinol mesh occlusion device designed for peripheral vascular embolization. It features radiopaque marker bands at each end and a micro-screw attachment for connection to a delivery wire. The system includes a loader (two-tube assembly with stainless steel spring) and a delivery wire (PTFE-covered coil with core wire and end screw). The device is delivered through 4 Fr or 5 Fr 0.038" guidewire-compatible diagnostic catheters. Used by physicians in clinical settings to occlude vessels; the device is deployed to block blood flow in target peripheral vessels. The radiopaque markers assist in visualization during placement. The device is an extension of existing AMPLATZER plug technology, modified for smaller catheter compatibility and improved finish.

Clinical Evidence

Evidence includes bench testing (sterilization, fatigue, material characterization, product performance, packaging, corrosion resistance, chemical characterization per ISO 10993-18, toxicology risk assessment per ISO 10993-17, and MRI compatibility) and in-vivo testing (occlusion canine study, acute canine study, and porcine serum analysis). No new safety or performance issues were identified.

Technological Characteristics

Self-expanding Nitinol mesh; radiopaque marker bands; micro-screw attachment. Delivery system: PTFE-covered coil delivery wire, stainless steel spring loader. Dimensions compatible with 4 Fr and 5 Fr 0.038" diagnostic catheters. Finish: chemically etched Nitinol. Sterilization: standard methods. No software or electronic components.

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)
• AMPLATZER® Vascular Plug II Extended Sizes (K071699)

Submission Summary (Full Text)

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## 510(k) Summary per 21 CFR §807.92

| Submitter's<br>Name and<br>Address | AGA Medical Corporation<br>5050 Nathan Lane North<br>Plymouth, MN 55442 | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration No: | 2135147 | |
| Contact Name<br>and Information | Sherry Kollmann<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Trade Name | AMPLATZER® Vascular Plug 4 | |
| Common Name | Vascular Embolization Device | |
| Classification<br>Name: | Device Embolization, Vascular | |
| Classification | Class II, 21 CFR 870.3300 | |
| Product Code | KRD | |
| Predicate<br>Devices | AMPLATZER® Vascular Plug II<br>510(k) K071125, Reg. No.<br>870.3300; Product Code: KRD | Predicate Device Intended Use<br>(K071125 and K071699):<br>The AMPLATZER® Vascular Plug is<br>indicated for arterial and<br>venous embolizations in the<br>peripheral vasculature |
| | AMPLATZER® Vascular Plug II<br>Extended Sizes<br>510(k) K071699, Reg. No.<br>870.3300; Product Code: KRD | |
| Device<br>Description | The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding,<br>Nitinol mesh occlusion device. The device has a<br>radiopaque marker band at each end and a micro screw<br>attachment at one end for attaching to the delivery wire.<br>The device is an extension of the previously approved<br>AMPLATZER Vascular Plugs and has the identical<br>indications for use: arterial and venous embolizations in the<br>peripheral vasculature.<br><br>Included in the AVP4 device package are:<br>• Loader - consisting of two tubes, one inside the other<br>with a stainless steel spring attached to extend the inner<br>retractable tube<br>• Delivery Wire - comprised of a PTFE covered coil with core<br>wire and attached end screw | |
| Intended Use of<br>Device | The AMPLATZER® Vascular Plug 4 is indicated for<br>arterial and venous embolizations in the peripheral vasculature. | |
| | | |
| Comparison of<br>Technological<br>Characteristics | The AMPLATZER® Vascular Plug 4 incorporates substantially equivalent<br>device materials, packaging materials, fundamental technology,<br>manufacturing processes, sterilization process and intended use as those<br>featured in the AGA predicate devices, AMPLATZER® Vascular Plug II<br>(K071125, approved September 9, 2003) and AMPLATZER® Vascular<br>Plug II Extended Sizes (K071699, approved August 15, 2007).<br><br>In comparison to the predicate device, the AVP4 incorporates the following<br>modifications:<br>• A change to the shape of the device<br>• Adaptation of the loader and delivery wire allowing the AVP4 to be<br>delivered through 4 Fr and 5 Fr 0.038" guidewire-compatible<br>diagnostic catheters versus standard off-the-shelf guide catheters<br>• A change to the finish of the device Nitinol base wire, from black oxide | |
| | (BO) to chemically etched (CE) finish<br><br>The modifications noted above have not altered the intended use or the<br>fundamental scientific technology of the predicate device. | |
| Performance<br>Data | The AMPLATZER® Vascular Plug 4 was subjected to bench testing,<br>biocompatibility testing, and materials testing to support a determination of<br>substantial equivalence to the predicate devices cited. The results of these<br>tests provide reasonable assurance that the proposed device has been<br>designed and tested to assure conformance to the requirements for its<br>intended use. No new safety or performance issues were raised during the<br>testing and, therefore, these devices may be considered substantially<br>equivalent to the predicate devices.<br><br>To demonstrate substantial equivalence of the AMPLATZER Vascular Plug 4<br>to the predicate devices, both <i>in-vitro</i> and <i>in-vivo</i> testing was performed and<br>outlined below:<br><br>The following <i>in-vitro</i> performance testing and/or assessment was completed<br>on the AMPLATZER® Vascular Plug 4: | |
| | Sterilization | Fatigue |
| | Material Characterization | Product Performance Qualification |
| | Simulated Device Use (Design<br>Verification) | Packaging Performance |
| | Corrosion Resistance | Biocompatibility (Implant and<br>delivery system, ISO 10993-1) |
| | Chemical Characterization<br>(ISO 10993-18) | Toxicology Risk Assessment (ISO<br>10993-17) |
| | MRI | |
| | The following <i>in-vivo</i> performance tests were completed on the<br>AMPLATZER® Vascular Plug 4: | |
| | Occlusion Canine Study | |
| | Serum Analysis (Porcine Study) | |
| | Acute Canine Study | |

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Traditional 510(k) Submission Amplatzer® Vascular Plug 4

## Conclusion

Based on the intended use, technological characteristics, and safety and performance testing, the AMPLATZER® Vascular Plug 4 has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the AGA currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 2 2012

AGA Medical Corporation c/o Sherry Kollmann, RAC Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, MN 55442

Re: K113658

Trade/Device Name: Amplatzer Vascular Plug 4 Regulation Number: 21 CFR 870.3300 Regulation Name: Device Embolization, Vascular Regulatory Class: Class II Product Code: KRD Dated: May 16, 2012 Received: May 17, 2012

Dear Ms. Kollmann:

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 from of 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. Sherry Kollmann

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/ReportaProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ui.g. Hillel

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): K | 3658

Device Name: AMPLATZER® Vascular Plug 4

Indications for Use: The AMPLATZER® Vascular Plug 4 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CUS. Killebrew

Pa

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K11 36 58

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