(56 days)
The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-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 provided 510(k) summary for the AMPLATZER® Vascular Plug II does not contain the level of detail regarding acceptance criteria and performance studies typically associated with AI/ML device submissions. This document describes a medical device, an embolization plug, which is a physical device, not a software algorithm. Therefore, many of the requested categories related to software performance, AI/ML models, and clinical study design (like ground truth, expert consensus, MRMC studies, large training/test sets, etc.) are not applicable or detailed in this type of submission for a physical device.
However, I will extract and synthesize the relevant information presented in the document to address as many of your points as possible, adapting the interpretation to fit the context of a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen with software performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" for this physical device are implicitly tied to demonstrating "substantial equivalence" to the predicate device through various verification and validation tests. The "reported device performance" refers to the successful completion of these tests, confirming functional equivalence.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary of Test Data) |
|---|---|
| Functional characteristics substantially equivalent to predicate device (K031810) | - Radial force testing: Confirmed functional equivalence.- Handoff and advancement forces: Confirmed functional equivalence.- Device deployment: Confirmed functional equivalence.- Recapture and detachment verification: Confirmed functional equivalence.- Overall strength determinations: Confirmed functional equivalence. |
| Validation of product under simulated conditions of use | - Animal testing: Validated the product under simulated conditions of use. |
| Maintain identical intended uses as predicate device | - The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature, identical to the predicate device. |
| Maintain same patient-contacting materials | - The AMPLATZER® Vascular Plug II has exactly the same patient-contacting materials as the predicate. |
| Maintain same Nitinol Delivery Wire | - The AMPLATZER® Vascular Plug II has the same Nitinol Delivery Wire as the predicate. |
| Maintain same operating principle | - Both devices operate on the principle of a self-expanding Nitinol mesh delivered through a catheter, expanding to occlude the vessel upon release. |
| Device modifications (shape, braid layers, loader material) do not adversely affect performance and substantial equivalence. | - Verification and validation testing (radial force, deployment, etc.) confirms the functional characteristics are substantially equivalent despite these modifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. The testing described (radial force, handoff, deployment, etc.) likely involved a number of device units or components, and animal testing would have involved a certain number of animals. However, these specific numbers are not provided.
- Data Provenance:
- Country of Origin: Not specified. Standard practice for such tests often involves in-house labs or contract research organizations, but the geographical location is not mentioned.
- Retrospective or Prospective: The testing described (radial force, deployment, animal testing) is inherently prospective. These are laboratory and in-vivo tests conducted specifically for the purpose of demonstrating device performance and safety for the 510(k) submission. They are not analyses of pre-existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is a concept relevant to AI/ML or diagnostic devices where human interpretation is being benchmarked or assisted. For a physical embolization device, the "ground truth" is determined by direct physical measurements (e.g., radial force, deployment success) and direct observation of physiological effects in animal models. No human experts are described as establishing a "ground truth" in the diagnostic sense for these tests.
4. Adjudication Method for the Test Set
This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human interpretations or expert opinions when establishing ground truth for diagnostic accuracy studies. For physical device performance tests (e.g., radial force, deployment), results are typically objective measurements or observations, rather than subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Done?: No, an MRMC comparative effectiveness study was not done or reported.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: This question is not applicable. An MRMC study with AI assistance is specifically designed for AI/ML diagnostic or assistive devices to measure the impact of AI on human reader performance. The AMPLATZER® Vascular Plug II is a therapeutic embolization device, not an AI-powered diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the loop performance) Study
This is not applicable. The AMPLATZER® Vascular Plug II is a physical embolization device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was based on:
- Engineering and Biomechanical Measurements: Objective measurements of physical properties (e.g., radial force, handoff force, deployment success, recapture, detachment, strength).
- In Vivo Observation: Direct observation of the device's performance and physiological interaction in animal models under simulated conditions of use. Essentially, the "truth" was whether the device performed as expected and intended in a controlled physical/biological environment.
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This device is a physical product, not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
{0}------------------------------------------------
071125
510(k) SUMMARY of Safety and Effectiveness
Applicant Information:
.
| Date Prepared: | 20 April 2007 |
|---|---|
| Submitter: | AGA Medical Corporation |
| Address: | 5050 Nathan Lane NorthPlymouth, MN 55442 |
| EstablishmentRegistration No. | 2135147 |
| Contact Person: | Jodi L. Raus, RACDirector of Regulatory Affairs |
| Telephone Number: | (763) 531-3065 |
| Fax Number: | (763) 647-5932 |
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.
{1}------------------------------------------------
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:
-
- Modification of the shape from a single-lobed to a triple-lobed design.
-
- Use of multiple, thinner Nitinol wire braid layers (two or three), compared to the single braid layer of thicker wire in the original design.
-
- 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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (240) 276-0120. 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 (240) 276-3150 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 ✗(Part 21 CFR 801 Subpart D) | AND/OR | Over-the-Counter Use(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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§ 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).