(270 days)
No
The description focuses on the physical components and mechanical function of a vascular plug and its delivery system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for use to reduce or block blood flow in arteries, which directly treats a physiological condition (e.g., stopping bleeding or restricting blood supply to a tumor).
No
Explanation: The device is an embolization device designed to block or reduce blood flow, which is a therapeutic function, not a diagnostic one. It is used to treat a condition, not to identify or monitor one.
No
The device description clearly outlines a physical implant (AZUR Vascular Plug) and a delivery system (delivery wire, detachment controller), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the AZUR Vascular Plug is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "reduce or block the rate of blood flow in arteries of the peripheral vasculature." This is a therapeutic intervention performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is an implantable embolization device delivered through a catheter. This is a medical device used for a surgical or interventional procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AZUR Vascular Plug does not interact with or analyze such specimens.
Therefore, the AZUR Vascular Plug is a medical device used for an interventional procedure, not an IVD.
N/A
Intended Use / 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.
Product codes
KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 (
§ 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).
0
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
1
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
2
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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3
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 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.
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.
4
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 | ||||
|---|---|---|---|---|
| Device | ||||
| Attributes | MicroVention AZUR | |||
| Vascular Plug | ||||
| (Subject Device) | Medtronic Micro | |||
| Vascular Plug | ||||
| (Predicate Device) | Rationale for Difference | |||
| (If Present) | ||||
| FDA Medical Device Classification | ||||
| Device | ||||
| Classification | Class II, KRD, 21 CFR | |||
| 870.3300 | Class II, KRD, 21 CFR | |||
| 870.3300 | No difference. Identical device | |||
| classification | ||||
| Indications for Use | ||||
| Intended Use | ||||
| Statement | Indicated for use to reduce | |||
| or block the rate of blood | ||||
| flow in arteries of the | ||||
| peripheral vasculature. | Intended to reduce or | |||
| block the rate of blood | ||||
| flow in vessels of the | ||||
| peripheral vasculature. | No difference. Identical | |||
| Intended use statement. | ||||
| Principle of Operation/Fundamental Scientific Technology | ||||
| Function | Allows the device to | |||
| obstruct or reduce the rate | ||||
| of blood flow | Allows the device to | |||
| obstruct or reduce the rate | ||||
| of blood flow | No difference. Identical | |||
| function. | ||||
| Anatomical | ||||
| Location | Peripheral Vasculature | Peripheral Vasculature | No difference. Identical | |
| anatomical vessels. | ||||
| Device Design | ||||
| Plug (implant | ||||
| description) | Self-expandable nitinol | |||
| frame with a PTFE and | ||||
| PET cover over the | ||||
| internal wire frame | Self-expandable nitinol | |||
| frame with a PTFE cover | ||||
| over the proximal section | Similar device design. | |||
| The results of comparative | ||||
| bench testing, physician | ||||
| usability study and animal study | ||||
| establish the substantial | ||||
| equivalency of the subject | ||||
| device, AZUR Vascular Plug | ||||
| Plug Diameter, | ||||
| Unconstrained | Small: 5 mm | |||
| Medium: 8 mm | ||||
| Large: 10 mm | MVP-5Q: 6.5 mm | |||
| MVP-7Q: 9.2 mm | ||||
| MVP-9Q: 13.0 mm | ||||
| Target Vessel | ||||
| Diameter | Small: 2.5-4.5mm | |||
| Medium:4.5mm-6.5mm | ||||
| Large: 6.5mm-8.0mm | MVP-5Q: 3-5mm | |||
| MVP-7Q: 5-7mm | ||||
| MVP-9Q: 7-9mm | and the predicate device, Micro | |||
| Vascular Plug. | ||||
| Radiopaque | ||||
| Markers | Platinum marker bands at | |||
| each end of the plug | Platinum marker bands at | |||
| each end of the plug | Identical marker bands | |||
| Method of | ||||
| placement | Delivery wire through a | |||
| 0.027" ID Microcatheter | Delivery wire through a | |||
| 0.027" to 0.043" ID | ||||
| Percutaneous catheter | The AZUR Vascular Plug is | |||
| designed to be delivered | ||||
| through a smaller ID (0.027" | ||||
| inner diameter) microcatheter. | ||||
| Detachment | ||||
| System | Thermoelectric | |||
| Detachment | Mechanical Detachment | The results of bench testing. | ||
| and physician usability study | ||||
| establish the substantial | ||||
| equivalency of the subject | ||||
| device, AZUR Vascular Plug | ||||
| and the predicate device, Micro | ||||
| Vascular Plug. | ||||
| Device Material | ||||
| Materials of | ||||
| Construction | Nitinol, ePTFE, PET, | |||
| Platinum, Dymax 1128 | ||||
| and Polyolefin | Nitinol, PTFE, Platinum, | |||
| SS301, Solder, | ||||
| Polypropylene sheath, | ||||
| Urethane and | ||||
| Cyanoacrylate | Similar device material. The | |||
| materials used for the AZUR | ||||
| Vascular Plug was shown to be | ||||
| biocompatible per ISO | ||||
| 10993 testing. | ||||
| Other Attributes | ||||
| Sterilization | ||||
| Process | EtO (Ethylene Oxide) | EtO (Ethylene Oxide) | No difference. Identical | |
| sterilization process. | ||||
| Method of | ||||
| Supply | Sterile, single use | Sterile, single use | No difference. Identical method | |
| of supply. | ||||
| Accessories | No accessories | Torquer | AZUR Vascular Plug does not | |
| use a torque device. |
5
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,
6
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 (