(183 days)
The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
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
The provided text describes a 510(k) summary for the AMPLATZER® Vascular Plug 4, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in the same way an AI/ML device would. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies (MRMC) for AI performance is largely not applicable or not present in this type of document for this device.
However, I can extract and restructure the information that is relevant to the performance data and the study performed to demonstrate substantial equivalence for this type of medical device submission.
Acceptance Criteria and Reported Device Performance
For medical devices like the AMPLATZER® Vascular Plug 4, acceptance criteria are typically related to meeting established standards for safety, biocompatibility, and functional performance that demonstrate equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The device performance is reported as successful completion of these tests, indicating conformance to requirements for its intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Successful completion |
| Sterilization | Conforms to requirements |
| Material Characterization | Conforms to requirements |
| Simulated Device Use (Design Verification) | Conforms to requirements |
| Corrosion Resistance | Conforms to requirements |
| Chemical Characterization (ISO 10993-18) | Conforms to requirements |
| MRI Compatibility | Conforms to requirements |
| Fatigue | Conforms to requirements |
| Product Performance Qualification | Conforms to requirements |
| Packaging Performance | Conforms to requirements |
| Biocompatibility (Implant and delivery system, ISO 10993-1) | Conforms to requirements |
| Toxicology Risk Assessment (ISO 10993-17) | Conforms to requirements |
| In-vivo Testing | Successful completion |
| Occlusion Canine Study | Conforms to requirements |
| Serum Analysis (Porcine Study) | Conforms to requirements |
| Acute Canine Study | Conforms to requirements |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comprehensive set of bench testing (in-vitro) and animal studies (in-vivo) designed to demonstrate substantial equivalence to predicate devices (AMPLATZER® Vascular Plug II and AMPLATZER® Vascular Plug II Extended Sizes). The document states: "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."
The following points address the specific questions from your prompt, acknowledging that many are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a vascular plug.
-
A table of acceptance criteria and the reported device performance: Provided above.
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like an AI model. For in-vivo studies, specific numbers of animals (canine and porcine) were used, but the exact count for each study is not provided in this summary document.
- Data Provenance: The in-vivo studies were conducted using canine and porcine models. This is prospective animal study data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image interpretation) is not relevant for this device. The "ground truth" here is the physical and biological performance observed in laboratory and animal studies, assessed by engineers, scientists, and veterinarians against pre-defined safety and performance parameters.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for expert review in clinical trials or AI validation where subjective interpretation is involved. For this device, objective measurements and observations from animal studies and bench tests determine performance.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (vascular plug), not an AI/ML diagnostic or assistive tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For in-vitro tests, the ground truth is based on engineering specifications, material standards, and established physical/chemical properties. For in-vivo animal studies, the "ground truth" is derived from direct biological observations, histological analysis, and physiological measurements in the animal models, assessed against pre-defined safety and performance endpoints for embolization devices.
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and prior knowledge from the predicate devices.
-
How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are validated through the specified bench and animal testing.
{0}------------------------------------------------
:
510(k) Summary per 21 CFR §807.92
| Submitter'sName andAddress | AGA Medical Corporation5050 Nathan Lane NorthPlymouth, MN 55442 | |
|---|---|---|
| EstablishmentRegistration No: | 2135147 | |
| Contact Nameand Information | Sherry KollmannSenior Regulatory Affairs SpecialistPhone: 651-756-5463Fax: 763-647-5932e-mail: skollmann@sjm.com | |
| Trade Name | AMPLATZER® Vascular Plug 4 | |
| Common Name | Vascular Embolization Device | |
| ClassificationName: | Device Embolization, Vascular | |
| Classification | Class II, 21 CFR 870.3300 | |
| Product Code | KRD | |
| PredicateDevices | AMPLATZER® Vascular Plug II510(k) K071125, Reg. No.870.3300; Product Code: KRD | Predicate Device Intended Use(K071125 and K071699):The AMPLATZER® Vascular Plug isindicated for arterial andvenous embolizations in theperipheral vasculature |
| AMPLATZER® Vascular Plug IIExtended Sizes510(k) K071699, Reg. No.870.3300; Product Code: KRD | ||
| DeviceDescription | The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding,Nitinol mesh occlusion device. The device has aradiopaque marker band at each end and a micro screwattachment at one end for attaching to the delivery wire.The device is an extension of the previously approvedAMPLATZER Vascular Plugs and has the identicalindications for use: arterial and venous embolizations in theperipheral vasculature.Included in the AVP4 device package are:• Loader - consisting of two tubes, one inside the otherwith a stainless steel spring attached to extend the innerretractable tube• Delivery Wire - comprised of a PTFE covered coil with corewire and attached end screw | |
| Intended Use ofDevice | The AMPLATZER® Vascular Plug 4 is indicated forarterial and venous embolizations in the peripheral vasculature. | |
| Comparison ofTechnologicalCharacteristics | The AMPLATZER® Vascular Plug 4 incorporates substantially equivalentdevice materials, packaging materials, fundamental technology,manufacturing processes, sterilization process and intended use as thosefeatured in the AGA predicate devices, AMPLATZER® Vascular Plug II(K071125, approved September 9, 2003) and AMPLATZER® VascularPlug II Extended Sizes (K071699, approved August 15, 2007).In comparison to the predicate device, the AVP4 incorporates the followingmodifications:• A change to the shape of the device• Adaptation of the loader and delivery wire allowing the AVP4 to bedelivered through 4 Fr and 5 Fr 0.038" guidewire-compatiblediagnostic 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) finishThe modifications noted above have not altered the intended use or thefundamental scientific technology of the predicate device. | ||
| PerformanceData | The AMPLATZER® Vascular Plug 4 was subjected to bench testing,biocompatibility testing, and materials testing to support a determination ofsubstantial equivalence to the predicate devices cited. The results of thesetests provide reasonable assurance that the proposed device has beendesigned and tested to assure conformance to the requirements for itsintended use. No new safety or performance issues were raised during thetesting and, therefore, these devices may be considered substantiallyequivalent to the predicate devices.To demonstrate substantial equivalence of the AMPLATZER Vascular Plug 4to the predicate devices, both in-vitro and in-vivo testing was performed andoutlined below:The following in-vitro performance testing and/or assessment was completedon the AMPLATZER® Vascular Plug 4: | |
| Sterilization | Fatigue | |
| Material Characterization | Product Performance Qualification | |
| Simulated Device Use (DesignVerification) | Packaging Performance | |
| Corrosion Resistance | Biocompatibility (Implant anddelivery system, ISO 10993-1) | |
| Chemical Characterization(ISO 10993-18) | Toxicology Risk Assessment (ISO10993-17) | |
| MRI | ||
| The following in-vivo performance tests were completed on theAMPLATZER® Vascular Plug 4: | ||
| Occlusion Canine Study | ||
| Serum Analysis (Porcine Study) | ||
| Acute Canine Study |
{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
Page 1 of 1
§ 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).