The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter.

The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system.

The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter.

A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the AZUR Vascular Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy through clinical trials with strict acceptance criteria and performance data in the way a new drug or a novel AI diagnostic device might.

Therefore, the typical structure for detailing "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested, particularly regarding "device performance" in terms of accuracy, sensitivity, or specificity, and the involvement of "experts" for "ground truth," "MRMC studies," or "standalone performance" metrics, does not directly apply to this document. This document is about device safety and technological equivalence, not clinical performance analysis of an AI model or diagnostic tool.

However, I can extract and infer information from the provided document to answer as many of the requested points as possible, focusing on what constitutes "acceptance criteria" and "proof" within the context of a 510(k) submission for a vascular plug.

Here's how to interpret the request in the context of the provided document:

"Acceptance criteria" and "reported device performance": For a vascular plug, these relate to its physical and functional characteristics (e.g., ability to obstruct blood flow, detach reliably, biocompatibility, mechanical integrity). The "proof" comes from an array of non-clinical (bench and animal) tests, not typically from human clinical outcomes data as you'd see for an AI diagnostic.
"Ground truth": This is established by the design specifications and the results of the physical and chemical tests, rather than expert labels on medical images.
"Multi-reader multi-case (MRMC) comparative effectiveness study": This is not applicable to a physical device like a vascular plug. This type of study is for evaluating the impact of a diagnostic tool (often AI-assisted) on human reader performance.
"Standalone (i.e., algorithm only without human-in-the-loop performance)": Again, not applicable as this is not an algorithm or AI device.
"Training set": Not applicable as there is no AI model being trained.

Based on the provided K191680 document for the AZUR Vascular Plug, here is an interpretation of the requested information:

This 510(k) submission demonstrates substantial equivalence to a predicate device, the Medtronic Micro Vascular Plug (K150108), rather than proving clinical efficacy or diagnostic performance through human studies with strict acceptance criteria. The "acceptance criteria" and "performance" are framed in terms of the device's physical, chemical, and mechanical properties, and its ability to function as intended in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a vascular plug, "acceptance criteria" are the predefined specifications and thresholds for its physical, mechanical, and biocompatibility properties, and "reported device performance" refers to the results of the tests conducted to demonstrate that these criteria are met.

Acceptance Criterion (Category / Test)	Description / Goal	Reported Device Performance (Summary from document)
Biocompatibility	Device materials must not cause adverse biological reactions when in contact with the body.	Conducted in accordance with ISO 10993-1. All listed tests (Cytotoxicity, Sensitization, Irritation, Acute/Subchronic Toxicity, Genotoxicity, Pyrogenicity, Implantation, Hemocompatibility, Carcinogenicity) were performed for the implant. Pusher and HDPE introducer sheath also evaluated. Conclusion: "materials used for the AZUR Vascular Plug was shown to be biocompatible per ISO 10993 testing."
Mechanical & Functional Performance	Device must meet specified mechanical integrity and functional characteristics (e.g., deployment, detachment, occlusion).	Successfully passed extensive bench testing including: - Visual/Dimensional Inspection - Electrical Resistance - Exhaustive Extraction Study - Simulated Use (Preparation/Flush, Introduction, Tracking, Advancement, Kink Resistance, Flexibility, Catheter Compatibility, Deployment, Retraction, Detachment, Wall Apposition) - Migration Resistance - Overall performance - Radial force - Attachment strength - Implant joint Tensile Strength - Pusher Sleeve Retention - Particulate - Nickel Ion Release - Corrosion - Magnetic Resonance (MR) Testing - Radiopacity - Occlusion Time - Shelf Life
Safety & Effectiveness (In-vivo)	Device must perform safely and effectively in a living system.	Evaluated in "a number of animal studies including multiple animal species and implantation sites," specifically: - Porcine large animal study - Intramuscular implant rabbit study Conclusion: "The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use."
Sterility	Device must be sterile for use.	Same as predicate: EtO (Ethylene Oxide) sterilization process. "No difference. Identical sterilization process."
Radiopacity	Device must be visible under fluoroscopy.	Platinum marker bands at each end of the plug. "Identical marker bands" to predicate.
Delivery System Compatibility	Device must be deliverable through specified microcatheters.	Designed for delivery through a 0.027" ID microcatheter. This is a design difference from the predicate (0.027" to 0.043" ID) but deemed acceptable due to bench and animal testing.
Detachment Mechanism Reliability	The plug must detach reliably.	Thermoelectric detachment system. This is a design difference from the predicate (Mechanical Detachment) but considered acceptable based on "results of bench testing and physician usability study."

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in terms of number of plugs or specific quantities for each test. The document states "a number of animal studies" and lists "Porcine large animal study" and "Intramuscular implant rabbit study." For bench testing, it lists types of tests but not the quantity of devices tested.
Data Provenance: The studies were internal to MicroVention Inc. and likely conducted at contracted labs. The document does not specify a country of origin for the data or whether the studies were retrospective or prospective, but these would inherently be prospective non-clinical (bench and animal) studies for regulatory submission purposes.

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

Not Applicable in the traditional sense. For a physical device, "ground truth" is established by the design specifications, material properties, and objective measurements from bench and animal studies. There isn't a need for multiple human experts to establish "ground truth" through interpretation (e.g., reading images).
However, the document mentions a "physician usability study" in relation to the detachment system. While not an "expert ground truth" for performance metrics like sensitivity/specificity, it implies the involvement of physicians in evaluating a functional aspect of the device. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, typically in diagnostic imaging studies. This is not relevant to the evaluation of a physical medical device like a vascular plug based on bench and animal testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, not done. This type of study is specifically designed for evaluating diagnostic tools (often AI-assisted systems) and their impact on human reader performance. It is not applicable to a physical vascular plug.

6. Standalone (Algorithm Only) Performance Study

No, not done. This concept is only relevant for AI algorithms or diagnostic software. The AZUR Vascular Plug is a physical medical device.

7. Type of Ground Truth Used

For Biocompatibility: Established by adherence to ISO 10993 standards and direct laboratory measurements of biological responses to materials.
For Mechanical/Functional Performance: Established by engineering specifications, direct physical measurements (e.g., tensile strength, radial force), and observation of functional success/failure in controlled bench and simulated use environments.
For In-Vivo Performance: Established by histological analysis, physiological observations, and procedural success/failure in animal models as per pre-defined animal study protocols.

In essence, the "ground truth" is derived from rigorous, objective, and reproducible scientific and engineering test results against pre-defined specifications.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI model requiring a training set.

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

Not Applicable. As there is no training set, there is no ground truth to establish for one.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2020

MicroVention Inc. Ganesh Balachander Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656

Re: K191680

Trade/Device Name: AZUR Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 21, 2019 Received: June 24, 2019

Dear Ganesh Balachander:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191680

Device Name AZUR Vascular Plug

Indications for Use (Describe)

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

SUBMITTER

MicroVention Inc. 35 Enterprise, Aliso Viejo, CA, 92656 Phone:714-847-8000 Contact Person: Ganesh Balachandar Date Prepared: March 19, 2020

DEVICE

Name of the Device: AZUR Vascular Plug Common Name: Vascular Embolization Device Classification Name: Device, Embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD

PREDICATE DEVICE

Medtronic Micro Vascular Plug (K150108)

REFERENCE DEVICE

MicroVention AZUR CX D35 Peripheral Coil System (K151358)

DEVICE DESCRIPTON

The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter.

The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter.

A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

INDICATIONS FOR USE

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

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COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The subject device, AZUR Vascular Plug has the following similarities to the predicate device, Micro Vascular Plug (K150108), same device classification, same indications for use, same principle of operation, same device design, similar materials and same sterility assurance level and method of sterilization and hence the subject device is substantially equivalent to the predicate device (Table 1).

Table 1: Comparison of Technological Characteristics with Predicate Device
DeviceAttributes	MicroVention AZURVascular Plug(Subject Device)	Medtronic MicroVascular Plug(Predicate Device)	Rationale for Difference(If Present)
FDA Medical Device Classification
DeviceClassification	Class II, KRD, 21 CFR870.3300	Class II, KRD, 21 CFR870.3300	No difference. Identical deviceclassification
Indications for Use
Intended UseStatement	Indicated for use to reduceor block the rate of bloodflow in arteries of theperipheral vasculature.	Intended to reduce orblock the rate of bloodflow in vessels of theperipheral vasculature.	No difference. IdenticalIntended use statement.
Principle of Operation/Fundamental Scientific Technology
Function	Allows the device toobstruct or reduce the rateof blood flow	Allows the device toobstruct or reduce the rateof blood flow	No difference. Identicalfunction.
AnatomicalLocation	Peripheral Vasculature	Peripheral Vasculature	No difference. Identicalanatomical vessels.
Device Design
Plug (implantdescription)	Self-expandable nitinolframe with a PTFE andPET cover over theinternal wire frame	Self-expandable nitinolframe with a PTFE coverover the proximal section	Similar device design.The results of comparativebench testing, physicianusability study and animal studyestablish the substantialequivalency of the subjectdevice, AZUR Vascular Plug
Plug Diameter,Unconstrained	Small: 5 mmMedium: 8 mmLarge: 10 mm	MVP-5Q: 6.5 mmMVP-7Q: 9.2 mmMVP-9Q: 13.0 mm
Target VesselDiameter	Small: 2.5-4.5mmMedium:4.5mm-6.5mmLarge: 6.5mm-8.0mm	MVP-5Q: 3-5mmMVP-7Q: 5-7mmMVP-9Q: 7-9mm	and the predicate device, MicroVascular Plug.
RadiopaqueMarkers	Platinum marker bands ateach end of the plug	Platinum marker bands ateach end of the plug	Identical marker bands
Method ofplacement	Delivery wire through a0.027" ID Microcatheter	Delivery wire through a0.027" to 0.043" IDPercutaneous catheter	The AZUR Vascular Plug isdesigned to be deliveredthrough a smaller ID (0.027"inner diameter) microcatheter.
DetachmentSystem	ThermoelectricDetachment	Mechanical Detachment	The results of bench testing.and physician usability studyestablish the substantialequivalency of the subjectdevice, AZUR Vascular Plugand the predicate device, MicroVascular Plug.
Device Material
Materials ofConstruction	Nitinol, ePTFE, PET,Platinum, Dymax 1128and Polyolefin	Nitinol, PTFE, Platinum,SS301, Solder,Polypropylene sheath,Urethane andCyanoacrylate	Similar device material. Thematerials used for the AZURVascular Plug was shown to bebiocompatible per ISO10993 testing.
Other Attributes
SterilizationProcess	EtO (Ethylene Oxide)	EtO (Ethylene Oxide)	No difference. Identicalsterilization process.
Method ofSupply	Sterile, single use	Sterile, single use	No difference. Identical methodof supply.
Accessories	No accessories	Torquer	AZUR Vascular Plug does notuse a torque device.

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K191680

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH REFERENCE DEVICE

The subject device, AZUR Vascular Plug has the following similarities to the reference device AZUR CX D35 Peripheral Coil System (K151358) :same principle of operation, same delivery wire length,

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same delivery wire materials, same detachment mechanism and similar delivery wire catheter compatibility and hence the subject device is substantially equivalent to the reference device. PERFORMANCE DATA

Biocompatibility testing

The biocompatibility evaluation for the AZUR Vascular Plug device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Guidance on Selection of Tests. The implant is considered a permanent implant blood contacting device, and the pusher is considered an external communicating device, limited (<24hour) circulating blood contacting device.

The battery of testing for the device included the following tests:

Implant

. Cytotoxicity
Sensitization
Irritation or Intracutaneous Reactivity
Acute Systemic Toxicity ●
Subacute/Subchronic Toxicity ●
Genotoxicity
. Material Mediated Pyrogenicity
Implantation ●
Hemocompatibility
Carcinogenicity

Pusher

. Cytotoxicity
Hemocompatibility ●
Subacute/Subchronic toxicity ●

HDPE Introducer sheath

. Cytotoxicity

Mechanical, Visual, and Material Characterization testing

Bench testing conducted for the AZUR Vascular Plug device included the following:

. Visual/Dimensional Inspection
. Electrical Resistance
Exhaustive Extraction Study ●
Simulated Use
- Preparation/Flush ●
- Introduction ●
- Tracking
- . Advancement
- . Kink Resistance
- Flexibility ●
- Catheter Compatibility
- Deployment ●
- Retraction ●
- Detachment ●
- Wall Apposition ●

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Migration Resistance ●
Overall performance
Radial force ●
Attachment strength
. Implant joint Tensile Strength
. Pusher Sleeve Retention
. Particulate
Nickel Ion Release
Corrosion
Magnetic Resonance (MR) Testing
Radiopacity
Occlusion Time ●
Shelf Life

Animal Study

The AZUR Vascular Plug was evaluated in a number of animal studies including multiple animal species and implantation sites. This analysis included the following studies:

Porcine large animal study
Intramuscular implant rabbit study

CONCLUSION

The AZUR Vascular Plug is substantially equivalent to the identified predicate device based on the same intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.

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).