(48 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of the coils, with no mention of AI or ML.
Yes
The device is intended for endovascular embolization and vascular occlusion to treat medical conditions like intracranial aneurysms and arteriovenous malformations, which aligns with the definition of a therapeutic device.
No
The device is an embolization coil used for therapeutic purposes (occluding blood vessels) and not for diagnosing a condition.
No
The device description explicitly states the device is comprised of platinum alloy coils, a delivery pusher, and a detachment controller that utilizes battery power. These are all hardware components.
Based on the provided information, the Azur Detachable 18 Coil System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and "vascular occlusion of blood vessels." This describes a therapeutic intervention performed within the body to treat a medical condition.
- Device Description: The description details a physical implant (coils) and a delivery system used to place the implant inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Azur Detachable 18 Coil System does not perform any such analysis of biological samples.
Therefore, the Azur Detachable 18 Coil System is a medical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Azur Detachable 18 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.
The Azur Detachable Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The coils are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
Product codes
HCG
Device Description
The Azur 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, intracranial, neurovascular system
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)
Bench Testing was performed, and the results met established criteria for Visual Inspection, Dimensional Measurement, Tracking, Repositioning-Deployment, Placement - Stability, and Detachment Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).
0
MicroVention Inc.
Special 510(k), Azur Detachable 18
510(k) Summary
| Trade Name: | Azur Detachable 18 | MAR 1 2 2009 |
|---|---|---|
| Generic Name: | Vascular Embolization Device | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc | |
| 75 Columbia | ||
| Aliso Viejo, California U.S.A. | ||
| Contact: | Florin Trusset |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K050954 | MicroVention Inc., HydroCoil Embolic | |
| System (HES) | June 28, 2005 |
Device Description
The Azur 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).
Indication For Use
The Azur Detachable 18 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
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| Tracking | Met established criteria |
| Repositioning- Deployment | Met established criteria |
| Placement - Stability | 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 Detachable 18 line extension coils when compared with the predicate device MicroVention Azur Detachable 18 hydrocoil that was cleared to market under the MicroVention HydroCoil Embolic System (HES) K050954
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 coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
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Public Health Service
MAR 1 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc. % Florin Truuvert, RAC Senior Director, Worldwide Regulatory Affairs 75 Columbia, Suite A Aliso Viejo, California 92656
Re: K090168
Trade/Device Name: Azur Detachable 18 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: February 27, 2009 Received: March 2, 2009
Dear Florin Truuvert:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Florin Truuvert, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Lri Ahmed. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Azur Detachable 18
Indications For Use:
The Azur Detachable Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The coils are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Daniel Kuora for MXKM March 11, 2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K090118