(27 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the coil system and its delivery mechanism. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as being used for the 'interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature', which indicates a therapeutic purpose.
No
Explanation: The device is an embolization coil system used to block blood flow, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components made of platinum alloy, a delivery pusher, and a battery-powered detachment controller, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- Device Description and Intended Use: The AZUR Peripheral Coil System is a physical implantable device (coils) used to block blood flow within the peripheral vasculature. It is used in vivo (inside the body) during interventional radiologic procedures.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological specimens, analysis of bodily fluids, or diagnostic information derived from such tests.
The AZUR Peripheral Coil System is a therapeutic device used for embolization (blocking blood vessels).
N/A
Intended Use / Indications for Use
The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The AZUR Peripheral Coil System - Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional radiologic management
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)
Bench Testing:
- Dimensional Measurement: Met established criteria
- Tracking: Met established criteria
- Repositioning / Deployment: Met established criteria
- Detachment Test: Met established criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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K120630 page 1 of 2
MAR 2 8 2012
510(K) Summary of Safety and Effectiveness
| Trade Name: | AZUR Peripheral Coil System - Detachable 18 | |
|---|---|---|
| Generic Name: | Vascular Embolization Device | |
| Classification: | Class II, 21 CFR 870.3300 | |
| Submitted By: | MicroVention, Inc. | |
| 1311 Valencia Avenue | ||
| Tustin, California U.S.A. | ||
| Contact: | Cynthia Valenzuela |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K090168 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System - | ||
| Detachable 18 | March 12, 2009 | |
| K071939 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System - | ||
| Pushable 35 | January 11, 2008 |
Device Description
The AZUR Peripheral Coil System - Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).
1
Indication For Use
The intended use as stated in the product labeling is as follows:
The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Dimensional Measurement | Met established criteria |
| Tracking | Met established criteria |
| Repositioning / Deployment | Met established criteria |
| Detachment Test | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Peripheral Coil System - Detachable 18 line extension coils when compared with the predicate devices, MicroVention AZUR Detachable 18 HydroCoil (K090168) and AZUR Pushable 35 (K071939).
The devices,
- Have the same intended use, .
- Use the same operating principle, ●
- Incorporate the same basic design,
- Use similar construction and material,
- Are packaged and sterilized using same material and processes. .
In summary, the AZUR Peripheral Coil System - Detachable 18 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol, with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Microvention, Inc. c/o Ms. Cynthia Valenzuela International Regulatory Affairs 1311 Valencia Avenue Tustin, CA 92780
MAR 2 8 2012
Re: K120630
Trade/Device Name: AZUR Peripheral Coil System – Detachable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device · Regulatory Class: Class II Product Code: KRD Dated: February 29, 2012 Received: March 1, 2012
Dear Ms. Valenzuela:
We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave reviewed your 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 for assession to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered price to may 20, 1977, 11:5 accordance with the provisions of the Federal Food, Drug, de nees mat have been room 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 r ou may, attreflers, visions 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 I lease of advised that I Driv issualles or our device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must of any I caerar statutes and regirements, including, but not limited to: registration and listing (21 Comply with an the Fee 5 requirements 801); medical device reporting (reporting of medical CI K I all 607), lucemig (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Cynthia Valenzuela
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.
M.S. Whilden
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120630
Device Name: AZUR Peripheral Coil System - Detachable 18
Indications For Use:
The AZUR System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Cuzhilleben
ision of Cardiovascular Devices
K120630 510(k) Number