(26 days)
No
The description focuses on the mechanical and material properties of the coils and the detachment mechanism, with no mention of AI or ML for analysis, decision support, or any other function.
Yes
The device is intended to reduce or block blood flow in peripheral vasculature lesions, which directly addresses a medical condition and aims to provide a therapeutic outcome.
No
Explanation: The device is intended to reduce or block blood flow in vessels by embolization with coils to manage conditions like arteriovenous malformations and aneurysms. This is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components like platinum alloy coils with a hydrogel core, a delivery pusher, and a battery-powered detachment controller. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AZUR System is used to "reduce or block the rate of blood flow in vessels of the peripheral vasculature." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (coils) delivered into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The AZUR System is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / 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.
Product codes
KRD
Device Description
The AZUR CX Coil System - Detachable 18 Coils are made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths which have the gel on all the loops. The implant segment is then attached to the delivery 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
Bench Testing: Simulated Use - Met established criteria; Detachment - Met established criteria; Advancement / Retraction Force - Met established criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
K12338
Image /page/0/Picture/1 description: The image shows the logo for MicroVention TERUMO. The logo consists of a stylized graphic to the left of the text "MicroVention" in a sans-serif font. Below "MicroVention" is the word "TERUMO" in a blocky, sans-serif font. The overall design is clean and professional.
· 510(K) Summary
| Trade Name: | AZUR CX Coil System - Detachable 18 | |
|---|---|---|
| Generic Name: | Vascular Embolization Device | NOV 2 8 2012 |
| Classification: | Class II, 21 CFR 870.3300 | |
| Submitted By: | MicroVention, Inc. | |
| 1311 Valencia Avenue | ||
| Tustin, California U.S.A. | ||
| Contact: | Cunthia Valenziela |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K120630 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System - | ||
| Detachable 18 | March 28, 2012 | |
| K071939 | HydroCoil Embolic System (HES) - | |
| HydroFrame | April 22, 2010 |
Device Description
The AZUR CX Coil System - Detachable 18 Coils are made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths which have the gel on all the loops. The implant segment is then attached to the delivery 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
Image /page/1/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo consists of a circular graphic on the left, followed by the text "MicroVention" in a serif font. Below "MicroVention" is the word "TERUMO" in a blocky, sans-serif font. The overall design is simple and professional.
Indication For Use
The intended use as stated in the product labeling is as follows:
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
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Simulated Use | Met established criteria |
| Detachment | Met established criteria |
| Advancement / Retraction Force | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR CX Coil System - Detachable 18 line extension coils when compared with the predicate devices, MicroVention HydroCoil Embolic System -HydroFrame (K100454) and AZUR Detachable 18 (K120630).
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 CX 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Microvention, Inc. c/o Ms. Cynthia Valenzuela International Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
NOV 2 8 2012
Re: K123384
Trade/Device Name: AZUR CX Coil System - Detachable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 31, 2012 Received: November 2, 2012
Dear Ms. Valenzuela:
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 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 801); medical device reporting (reporting of medical
3
Page 2 – [Ms. Cynthia Valenzuela]
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 OF R 809), good maart 820); and if applicable, the electronic forth in the quality systems (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 17 you desire specific acrites to: your Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.fadi.gov/rroungov/ Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may other buner generers, 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,
Matthew G. Hillebrennér
for 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):
AZUR CX Peripheral Coil System (Detachable) Device Name:
Indications For Use:
The AZUR System is intended to reduce or block the rate of blood flow in vessels of the I w HDON byton is intended for use in the interventional radiologic management of perfoneral rasemand or it is a neverysms, and other lesions of the lesions of the peripheral vasculature.
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Prescription Use __ AND/OR X (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)
W.S. Heeler
(Division Sign-O Division of Cardiovascular Devices
510(k) Number