AMPLATZER VASCULAR PLUG

K031810 · Aga Medical Corp. · KRD · Sep 9, 2003 · Cardiovascular

Device Facts

• Record ID: K031810
• Device Name: AMPLATZER VASCULAR PLUG
• Applicant: Aga Medical Corp.
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AMPLATZER Vascular Plug is a self-expandable, cylindrical embolization device composed of Nitinol wire mesh with platinum marker bands at both ends. It is preloaded in a PTFE loader and delivered via standard 5 or 6 French guiding catheters using a stainless steel delivery cable. The device is deployed percutaneously by a physician in a clinical setting to occlude vessels in the peripheral vasculature. The plug is mechanically released from the delivery cable via an unthreading mechanism. By providing a stable, self-expanding structure that conforms to the vessel wall, the device facilitates rapid occlusion and endothelialization, offering a more precise positioning alternative to traditional embolization coils. The healthcare provider uses fluoroscopic guidance to position and deploy the plug, with the output being the physical occlusion of the target vessel to treat conditions requiring embolization.

Clinical Evidence

Animal study (canine model) compared AMPLATZER Vascular Plug to standard coils. Results: Plug showed significantly shorter occlusion time (5.0 ± 3.5 min vs 10.2 ± 9.8 min, P < 0.001) and superior positioning precision. Recanalization rates were lower for plugs at 1 week (15% vs 33%) and 1 month (78% vs 80%). At 2 months, 88% of plug-occluded vessels remained occluded vs 0% for coils. Plugs showed firm attachment and endothelialization. Bench testing confirmed mechanical performance, including pull strength, luer compatibility, and deployment force.

Technological Characteristics

Self-expandable cylindrical plug; Nitinol wire mesh; platinum marker bands; stainless steel delivery cable; PTFE loader. Dimensions: 4-16 mm diameter, 7-8 mm length. Deployment: Mechanical unthreading. Biocompatibility: Cytotoxicity, hemolysis, sensitization, Ames test, intracutaneous injection, systemic toxicity. Standards: ISO 594 (luer testing).

Indications for Use

Indicated for arterial and venous embolizations in the peripheral vasculature for patients requiring vessel occlusion.

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

• Embolization Coil Positioner Set (K940189)
• Flipper Detachable Coil (K993455)
• Fibered Platinum Coil (K955293)
• Guglielmi Detachable Coil (K951256, K960705, K962503)

Submission Summary (Full Text)

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

# 6. 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR 807.92.

| Contact Person: | Patrice Stromberg<br>Regulatory Affairs Associate<br>AGA Medical Corporation<br>682 Mendelssohn Avenue<br>Golden Valley, MN 55427 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 11, 2003 |
| Device Name: | AMPLATZER® Vascular Plug<br>Arterial Embolization Device (79KRD)<br>(21 CFR 870.3300) |

#### Device Description:

The AMPLATZER Vascular Plug is provided sterile and is intended for one-time use. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. The delivery system is comprised of a 135 cm long, stainless steel delivery cable and a PTFE loader. The AMPLATZER Vascular Plug is preloaded in a loader and delivered through currently available standard 5 or 6 French guiding catheters. The device will be available in the following sizes.

| Order No. | Vascular | Device | Catheter Requirements* | | |
|------------|----------|--------|------------------------|----------------|---------|
| | Plug | Length | Minimum | Minimum | Maximum |
| | Diameter | | Size | Inner Diameter | Length |
| 9-PLUG-004 | 4 mm | 7 mm | 5 French | .056" | 100 cm |
| 9-PLUG-006 | 6 mm | 7 mm | 5 French | .056" | 100 cm |
| 9-PLUG-008 | 8 mm | 7 mm | 5 French | .056" | 100 cm |
| 9-PLUG-010 | 10 mm | 7 mm | 6 French | .067" | 100 cm |
| 9-PLUG-012 | 12 mm | 8 mm | 6 French | .067" | 100 cm |
| 9-PLUG-014 | 14 mm | 8 mm | 6 French | .067" | 100 cm |
| 9-PLUG-016 | 16 mm | 8 mm | 6 French | .067" | 100 cm |

* For use with standard guiding catheters meeting minimum internal diameter requirements.

#### Intended Use:

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

## Predicate Devices:

The AMPLATZER Vascular Plug is similar to many devices already in commercial distribution for arterial and venous embolization. These devices include an Embolization Coil Positioner Set (COOK, Incorporated), Flipper Detachable Coil (COOK, Incorporated), Fibered Platinum Coil (Boston Scientific Target), and Guglielmi Detachable Coil (Boston Scientific Target). The devices

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

are introduced percutaneously using a catheter or microcatheter introducer. The following is a comparison of technological characteristics. Also refer to Table 6-1 for summary of Technological Characteristics.

The Embolization Coil Positioner Set was reviewed as substantially equivalent under D.C. K940189 and is indicated for arterial and venous embolization. The device is constructed of stainless steel and synthetic fiber with a coil wire diameter of 0.018 to 0.038 inches. The coils are available in straight or curled shapes with an emboli size range of 2 to 20 mm. A push-button release mechanism is the method of deployment.

The Flipper Detachable Coil was reviewed as substantially equivalent under D.C. K993455 and is indicated for arterial and venous embolization for the peripheral vasculature. The device is constructed of stainless steel and synthetic fiber with a coil wire diameter of 0.035 inches. The coils are available in curled shapes with an emboli diameter range of 3 to 8 mm. Deployment is achieved when interlocking threads between the coils and the delivery wire are unscrewed.

The Fibered Platinum Coil was reviewed as substantially equivalent under D.C. K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is constructed of platinum and synthetic fiber with a coil diameter of 0.010 to 0.035 inches. The coils are available in the following shapes: straight, C-shaped, helical and complex helical. The emboli size range is 2 to 30 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter.

The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and arterial venous embolizations in the peripheral vascular. The device is constructed of platinum with a coil wire diameter of 0.010 to 0.018 inches. The coils are available in a helical shape with an emboli size range of 2 to 20 mm. The coils are deployed by electrolytic detachment from the wire guide.

·

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

| Device | Design | Coil wire<br>diameter | Shape |
|--------------------------------------------------------|----------------------------------------|-----------------------|--------------------------------------------------------|
| COOK, Embolization Coil<br>Positioner Set | Stainless steel and synthetic<br>fiber | 0.018-0.038" | Straight or curled |
| COOK, Flipper Detachable<br>Embolization Coil | Stainless steel and synthetic<br>fiber | 0.035" | Curled |
| Boston Scientific Target,<br>Fibered Platinum Coil | Platinum and synthetic fiber | 0.010 - 0.035" | Straight, C-shaped,<br>helical; and complex<br>helical |
| Boston Scientific Target,<br>Guglielmi Detachable Coil | Platinum | 0.010-0.018" | Helical |
| AMPLATZER Vascular<br>Plug | Nitinol wire | .0015" - .003" | Cylindrical, "plug" |

Table 6-1 Summary of Technological Characteristics Compared to Predicate Device

## Safety and Performance:

Animal Testing was conducted to evaluate the efficacy and recanalization rates of the AMPLATZER Vascular Plug as compared to standard coils. All procedures were performed successfully without misplacement. The following results were obtained:

- . Occlusion time was significant shorter with the AMPLATZER Vascular Plugs as compared to Cook coils (5.0 ± 3.5 minutes vs. 10.2 ± 9.8 minutes, P < 0.001).
- . Technically, positioning of the coils was far less precise than positioning of the AMPLATZER Vascular Plugs. Recanalization occurred with both the plugs and coils, but was more prominently seen in the coil group (33% and 80% at 1 week and 1 month vs. 15% and 78% for plugs) although it is well known from clinical practice that recanalization of coils embolized vessels in human subjects is exceedingly rare. The higher incidence of recanalizations in canines is due to the more active fibernolitic system of this species.
- Occluder stability was assessed immediately following deployment. No . migrations occurred.
- At 2 months, all vessels occluded with coils (100%) had become . recanalized compared to 16 out of 18 (88%) with the AMPLATZER Vascular Plug.
- Gross examination of occluded vessels showed all AMPLATZER . Vascular Plugs to be well endothelialized and firmly attached to the vessel wall, whereas spring coils were easy to shell out.

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

Bench testing was done to evaluate the ability of the AMPLATZER Vascular Plug and Delivery System to perform in accordance with the requirements of the design plan.

# AMPLAZER Vascular Plug Test Results:

- Vascular Plug Elongation Study Linear measurements of the Vascular ● Plug prior to and under a compression restraint.
- Pull Testing Laser Welded Marker Bands on Vascular Plug ●
- Pull Testing Screw Attachment to Marker Band Laser Weld .
- Threaded Connection Pull Testing Pull testing to verify the strength . property of the connection in between the delivery cable screw and the device end screw attachment.
- Vascular Plug detachment (unthreading) from delivery cable. .

## AMPLATZER Delivery System Test Results:

- Pull Test Weld Joint Cable to Cable Screw Verify weld strength ●
- Luer Testing Loader hubs were subjected to ISO 594 luer testing. .
- Loader Hub to PTFE tubing tensile strength -- Pull tested until hub . separation from the loader tubing.
- Loader Hub Luer Fitting Hoop dispenser and loader will allow . flushing with a syringe.
- Passage and Deployment through 5F or 6F Guide Catheters Measure . advancement force in the catheters.

The following Biocompatibility Testing was performed.

- . Cytotoxicity
- Hemolysis .
- Sensitization ●
- Ames Salmonela ●
- Intracutaneous Injection .
- Systemic Toxicity ●

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use for arterial and venous embolization in the peripheral vasculature.

#### Statement of Equivalence:

The AMPLATZER Vascular Plug is substantially equivalent in intended use to currently marketed coils indicated for arterial and venous embolizations in the peripheral vascular. The proposed device is substantially equivalent to the Embolization Coil Positioner Set (COOK, Incorporated), Flipper Detachable Embolization Coil (COOK, Incorporated), the Fibered Platinum Coil (Boston Scientific Target), and the Guglielmi Detachable Coil (Boston Scientific Target).

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGA Medical Corporation c/o Mr. Patrice M. Stromberg 682 Mendelssohn Avenue Golden Valley, MN 55427

Re: K031810

AMPLATZER® Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial embolization device Regulatory Class: Class III (three) Product Code: 79 KRD Dated: June 11, 2003 Received: June 12, 2003

Dear Mr. Stromberg:

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.

{5}------------------------------------------------

Page 2 - Mr. Patrice M. Stromberg

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 (OS) 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Page 1 __of_1

510(k) Number (if known): K031810

Device Name: AMPLATZER Vascular Plug

Indications For Use:

.

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

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

(Optional Format 3-10-98)

N. DeCortin

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K03810