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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the AMPLATZER® Vascular Plug:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various tests performed on the AMPLATZER Vascular Plug and its delivery system, primarily focusing on mechanical performance, biocompatibility, and comparing its embolization efficacy to existing coil devices in an animal model. Unlike typical AI/software device submissions, this document focuses on a physical medical device. Therefore, the "acceptance criteria" are more about demonstrating safety and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity, specificity, or AUC as seen in AI/ML applications.

Acceptance Criterion Category	Specific Criterion / Test Performed	Reported Device Performance (Results)
Efficacy (Animal Study)	Shorter occlusion time compared to standard coils	Occlusion time: 5.0 ± 3.5 minutes (AMPLATZER) vs. 10.2 ± 9.8 minutes (Cook coils), P < 0.001 (Significantly shorter for AMPLATZER)
	Positioning precision	AMPLATZER Vascular Plugs were significantly more precise than coils.
	Recanalization rates at 1 week	Plugs: 15% recanalization
	Recanalization rates at 1 month	Plugs: 78% recanalization
	Recanalization rates at 2 months	88% of vessels occluded with AMPLATZER Vascular Plug (16 out of 18) had become recanalized.
	Occluder stability (migration)	No migrations occurred immediately following deployment.
	Endothelialization/Attachment	At 2 months, all AMPLATZER Vascular Plugs were well endothelialized and firmly attached to the vessel wall.
Mechanical Performance (Bench Testing)	Vascular Plug Elongation Study	Linear measurements of the Vascular Plug prior to and under a compression restraint. (Specific numerical results not provided, but implied to meet design plan).
	Pull Testing Laser Welded Marker Bands	(Specific numerical results not provided, but implied to meet design plan).
	Pull Testing Screw Attachment to Marker Band Laser Weld	(Specific numerical results not provided, but implied to meet design plan).
	Threaded Connection Pull Testing	Verified the strength property of the connection between delivery cable screw and device end screw. (Specific numerical results not provided, but implied to meet design plan).
	Vascular Plug detachment (unthreading) from delivery cable	(Implied to demonstrate proper detachment or resistance to unintended unthreading).
	Delivery System: Pull Test Weld Joint Cable to Cable Screw	Verified weld strength. (Specific numerical results not provided, but implied to meet design plan).
	Delivery System: Luer Testing	Loader hubs subjected to ISO 594 luer testing. (Implied to pass).
	Delivery System: Loader Hub to PTFE tubing tensile strength	Pull tested until hub separation. (Specific numerical results not provided, but implied to meet design plan).
	Delivery System: Loader Hub Luer Fitting	Hoop dispenser and loader allow flushing with a syringe. (Functional confirmation).
	Delivery System: Passage and Deployment through 5F or 6F Guide Catheters	Measured advancement force. (Implied to meet specified force limits for smooth passage).
Biocompatibility	Cytotoxicity	(Implied to pass, indicating non-toxic reaction).
	Hemolysis	(Implied to pass, indicating no significant red blood cell destruction).
	Sensitization	(Implied to pass, indicating low potential for allergic reaction).
	Ames Salmonela	(Implied to pass, indicating non-mutagenic).
	Intracutaneous Injection	(Implied to pass, indicating no significant irritation on skin contact).
	Systemic Toxicity	(Implied to pass, indicating no general toxic effects in vivo).

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Animal Study): The document refers to "canines" and "18 vessels" for the 2-month recanalization data, implying a relatively small sample size, likely involving a single study. However, the exact number of animals or vessels used for the initial occlusion time and positioning precision comparisons is not explicitly stated, only "coils" and "plugs" groups.
Data Provenance: The study was an animal study, specifically using canines. No geographical provenance for the animals is provided. It appears to be a prospective study undertaken specifically for device evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information is generally not applicable to a physical device's animal and bench testing. The "ground truth" in this context is the direct physical observation of device performance (e.g., occlusion time, migration, recanalization, mechanical strength, biocompatibility reactions). These assessments are typically performed by trained research staff, veterinarians, and laboratory technicians, not clinical "experts" in the sense of radiologists interpreting images or pathologists reviewing slides.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of clinical adjudication or expert consensus for image interpretation. The measurements (e.g., occlusion time) and observations (e.g., migration, endothelialization) are direct and objective, or based on standard laboratory protocols and analyses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a physical medical device (embolization plug), not an AI-powered diagnostic or assistive tool. Therefore, no human reader studies or AI assistance evaluations were performed or are relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software device. The "standalone" performance here refers to the device's inherent mechanical and biological performance in the animal model and bench tests without human intervention in its function once deployed.

7. The Type of Ground Truth Used:

Efficacy: Direct physiological measurements (occlusion time), gross and microscopic examination of vessel pathology (endothelialization, attachment to vessel wall), and observation for recanalization in the live animal model.
Mechanical & Biocompatibility: Standard engineering tests (pull tests, elongation, luer testing, advancement force) and validated biocompatibility assays.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this physical device.

Summary

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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 StrombergRegulatory Affairs AssociateAGA Medical Corporation682 Mendelssohn AvenueGolden Valley, MN 55427
Date Prepared:	June 11, 2003
Device Name:	AMPLATZER® Vascular PlugArterial Embolization Device (79KRD)(21 CFR 870.3300)

Device Description:

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

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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.

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Device	Design	Coil wirediameter	Shape
COOK, Embolization CoilPositioner Set	Stainless steel and syntheticfiber	0.018-0.038"	Straight or curled
COOK, Flipper DetachableEmbolization Coil	Stainless steel and syntheticfiber	0.035"	Curled
Boston Scientific Target,Fibered Platinum Coil	Platinum and synthetic fiber	0.010 - 0.035"	Straight, C-shaped,helical; and complexhelical
Boston Scientific Target,Guglielmi Detachable Coil	Platinum	0.010-0.018"	Helical
AMPLATZER VascularPlug	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.

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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).

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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.

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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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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

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).