Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of a self-expanding Nitinol mesh occlusion device. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.

Therapeutic

Yes.
The device is used for arterial and venous embolization, which is a therapeutic intervention to block blood vessels for medical reasons.

Diagnostic

No

The device is an occlusion device indicated for embolizations, which is a therapeutic procedure to block blood vessels, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including a self-expanding Nitinol mesh occlusion device, a loader, and a delivery wire. The performance studies also detail in-vitro and in-vivo testing on these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the AMPLATZER® Vascular Plug 4 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for "arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
Device Description: The device is a "self expanding, Nitinol mesh occlusion device" used for embolization. This is a physical implantable device.
Lack of IVD Characteristics: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AMPLATZER® Vascular Plug 4 does not interact with or analyze such specimens.
Performance Studies: The performance studies described involve bench testing, biocompatibility testing, and in-vivo studies (canine and porcine studies) to evaluate the device's physical properties, safety, and effectiveness in blocking blood vessels. These are typical studies for implantable medical devices, not IVDs.

Therefore, the AMPLATZER® Vascular Plug 4 is a therapeutic medical device used for embolization, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

KRD

Device Description

The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a micro screw attachment at one end for attaching to the delivery wire. The device is an extension of the previously approved AMPLATZER Vascular Plugs and has the identical indications for use: arterial and venous embolizations in the peripheral vasculature.

Included in the AVP4 device package are:
• Loader - consisting of two tubes, one inside the other with a stainless steel spring attached to extend the inner retractable tube
• Delivery Wire - comprised of a PTFE covered coil with core wire and attached end screw

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The AMPLATZER® Vascular Plug 4 was subjected to bench testing, biocompatibility testing, and materials testing to support a determination of substantial equivalence to the predicate devices cited. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.

To demonstrate substantial equivalence of the AMPLATZER Vascular Plug 4 to the predicate devices, both in-vitro and in-vivo testing was performed and outlined below:

The following in-vitro performance testing and/or assessment was completed on the AMPLATZER® Vascular Plug 4:
Sterilization
Material Characterization
Simulated Device Use (Design Verification)
Corrosion Resistance
Chemical Characterization (ISO 10993-18)
MRI
Fatigue
Product Performance Qualification
Packaging Performance
Biocompatibility (Implant and delivery system, ISO 10993-1)
Toxicology Risk Assessment (ISO 10993-17)

The following in-vivo performance tests were completed on the AMPLATZER® Vascular Plug 4:
Occlusion Canine Study
Serum Analysis (Porcine Study)
Acute Canine Study

Key Metrics

Not Found

Predicate Device(s)

AMPLATZER® Vascular Plug II 510(k) K071125, AMPLATZER® Vascular Plug II Extended Sizes 510(k) K071699

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

:

510(k) Summary per 21 CFR §807.92

| Submitter's
Name and
Address | AGA Medical Corporation
5050 Nathan Lane North
Plymouth, MN 55442 | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration No: | 2135147 | |
| Contact Name
and Information | Sherry Kollmann
Senior Regulatory Affairs Specialist
Phone: 651-756-5463
Fax: 763-647-5932
e-mail: skollmann@sjm.com | |
| Trade Name | AMPLATZER® Vascular Plug 4 | |
| Common Name | Vascular Embolization Device | |
| Classification
Name: | Device Embolization, Vascular | |
| Classification | Class II, 21 CFR 870.3300 | |
| Product Code | KRD | |
| Predicate
Devices | AMPLATZER® Vascular Plug II
510(k) K071125, Reg. No.
870.3300; Product Code: KRD | Predicate Device Intended Use
(K071125 and K071699):
The AMPLATZER® Vascular Plug is
indicated for arterial and
venous embolizations in the
peripheral vasculature |
| | AMPLATZER® Vascular Plug II
Extended Sizes
510(k) K071699, Reg. No.
870.3300; Product Code: KRD | |
| Device
Description | The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding,
Nitinol mesh occlusion device. The device has a
radiopaque marker band at each end and a micro screw
attachment at one end for attaching to the delivery wire.
The device is an extension of the previously approved
AMPLATZER Vascular Plugs and has the identical
indications for use: arterial and venous embolizations in the
peripheral vasculature.

Included in the AVP4 device package are:
• Loader - consisting of two tubes, one inside the other
with a stainless steel spring attached to extend the inner
retractable tube
• Delivery Wire - comprised of a PTFE covered coil with core
wire and attached end screw | |
| Intended Use of
Device | The AMPLATZER® Vascular Plug 4 is indicated for
arterial and venous embolizations in the peripheral vasculature. | |
| | | |
| Comparison of
Technological
Characteristics | The AMPLATZER® Vascular Plug 4 incorporates substantially equivalent
device materials, packaging materials, fundamental technology,
manufacturing processes, sterilization process and intended use as those
featured in the AGA predicate devices, AMPLATZER® Vascular Plug II
(K071125, approved September 9, 2003) and AMPLATZER® Vascular
Plug II Extended Sizes (K071699, approved August 15, 2007).

In comparison to the predicate device, the AVP4 incorporates the following
modifications:
• A change to the shape of the device
• Adaptation of the loader and delivery wire allowing the AVP4 to be
delivered through 4 Fr and 5 Fr 0.038" guidewire-compatible
diagnostic catheters versus standard off-the-shelf guide catheters
• A change to the finish of the device Nitinol base wire, from black oxide | |
| | (BO) to chemically etched (CE) finish

The modifications noted above have not altered the intended use or the
fundamental scientific technology of the predicate device. | |
| Performance
Data | The AMPLATZER® Vascular Plug 4 was subjected to bench testing,
biocompatibility testing, and materials testing to support a determination of
substantial equivalence to the predicate devices cited. The results of these
tests provide reasonable assurance that the proposed device has been
designed and tested to assure conformance to the requirements for its
intended use. No new safety or performance issues were raised during the
testing and, therefore, these devices may be considered substantially
equivalent to the predicate devices.

To demonstrate substantial equivalence of the AMPLATZER Vascular Plug 4
to the predicate devices, both in-vitro and in-vivo testing was performed and
outlined below:

1

2

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.

3

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.

4

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 (800) 638-2041 or (301) 796-7100 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

5

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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