(28 days)
Not Found
No
The summary describes a mechanical coil system for embolization and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to reduce or block blood flow in vessels, which is a direct therapeutic action for managing various vascular lesions.
No
Explanation: The device is intended to reduce or block blood flow in vessels, functioning as a treatment device (embolization system) rather than for diagnosing conditions.
No
The device description explicitly states it consists of an "implantable coil attached to a delivery pusher" and a "detachment controller" which utilizes "battery power". These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The AZUR System is an implantable coil system used to physically block blood flow within blood vessels in the peripheral vasculature. It is a therapeutic device used in interventional radiology procedures.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes. Its function is purely mechanical and interventional.
Therefore, the AZUR System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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
KRD
Device Description
The AZUR Peripheral Coil System - Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The detachment controller is activated by the user and this detached the coil. The detachment controller utilizes battery power to detach the coils from the delivery pusher.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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: Dimensional Measurement (Met established criteria), Simulated Use (Met established criteria), Device Repositioning (Met established criteria), Device Detachment (Met established criteria), Advance / Retract 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
1223110
510(K) Summary
| Trade Name: | AZUR Peripheral Coil System - Detachable 35 | AUG 2 9 2012 |
|---|---|---|
| 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 |
|---|---|---|
| K093002 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System – | ||
| Detachable 35 | October 08, 2009 |
Device Description
The AZUR Peripheral Coil System - Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The detachment controller is activated by the user and this detached the coil. The detachment controller utilizes battery power to detach the coils from the delivery pusher.
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.
1
Image /page/1/Picture/0 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 larger font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder font. The graphic is a series of curved lines that resemble a fingerprint or sound waves.
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Device Repositioning | Met established criteria |
| Device Detachment | Met established criteria |
| Advance / Retract Force | 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 35 line extension coils when compared with the predicate devices, MicroVention AZUR Detachable 35 (K093002).
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 35 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 9 2012
MicroVention, Inc. c/o Ms. Cynthia Valenzuela International Regulatory Affairs 1311 Valencia Avenue Tustin, CA 92780
Re: K122316
Trade/Device Name: AZUR Peripheral Coil System - Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: July 25, 2012 Received: August 1, 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.
3
Page 2 -- Ms. Cynthia Valenzuela
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/CDRH0ffices/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.G. Willen
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
K122316 510(k) Number (if known): __
Device Name: AZUR Peripheral Coil System - Detachable 35
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)
MR. Hillen
(Division Sign-Off) Division of Cardiovascular Devices
K 122316 510(k) Number