(14 days)
Not Found
No
The summary describes a physical medical device (embolization coil system) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML-enabled devices.
Yes
The device is described as an "Endovascular Embolization Coil System" intended to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" for conditions like "arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions." This directly indicates it is used for medical treatment or therapy.
No
The device is an embolization coil system designed to block blood flow, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it consists of an implantable coil, introducer, and stylet, which are physical hardware components.
No, 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 Function: The Azur Peripheral HydroCoil Endovascular Embolization Coil System is a medical device used within the body to physically block blood flow in vessels. It is an implantable device used in interventional procedures.
- Intended Use: The intended use clearly states it's for "reducing or blocking the rate of blood flow in vessels of the peripheral vasculature" and for "interventional radiologic management." This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided describes a device used for treatment, not for analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The Azur Peripheral HydroCoil Endovascular Embolization 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 HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.
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
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:
- Visual Inspection: Met established criteria
- Dimensional Measurement: Met established criteria
- Simulated Use: Met established criteria
- Advancement force: Met established criteria
- Distal tip tensile test: Met established criteria
- Proximal tip tensile test: Met established criteria
- Body coil tensile 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).
0
K091882 page 1 of 2
510(k) Summary
JUL - 8 2009
| Trade Name: | Azur™ Peripheral HydroCoil® Endovascular Embolization System -
Pushable 18 |
|-----------------|-------------------------------------------------------------------------------|
| Generic Name: | Vascular Embolization Coil |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc
75 Columbia
Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K071939 | Azur™ Peripheral HydroCoil® | |
| Endovascular Embolization System- | ||
| Pushable 18 | January 11, 2008 | |
| K050954 | HydroCoil Embolic System | June 28, 2005 |
Device Description
The Azur™ Peripheral HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.
1
Indication For Use
The intended use as stated in the product labeling is as follows:
The Azur Peripheral HydroCoil Endovascular Embolization 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 |
|---|---|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Advancement force | Met established criteria |
| Distal tip tensile test | Met established criteria |
| Proximal tip tensile test | Met established criteria |
| Body coil tensile test | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18 coils when compared with the predicate devices, MicroVention Azur Pushable 18 coils [K071939] and HydroCoil Embolic System (HES) [K050954].
The devices,
- Have the same intended use, 트
- Use the same operating principle. 트
- Incorporate the same basic design,
- 트 Use similar construction and material,
- 러 Are packaged and sterilized using same material and processes.
In summary, the Azur Pushable 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 seal of the Department of Health & Human Services (HHS). The seal is circular and features an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 8 2009
MicroVention, Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 75 Columbia, Suite A Alison Viejo, CA 92656
Re: K091882
Azur Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II (two) Product Code: KRD Dated: June 22, 2009 Received: June 24, 2009
Dear Ms. Gong:
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 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. Naomi Gong
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/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by (eference 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
una R. bachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k), Azur Pushable 18
MicroVention, Inc.
Indications for Use
6091882 510(k) Number (if known):
Device Name:
Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18
Indications For Use:
The Azur Peripheral HydroCoil Endovascular Embolization 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
sumer R. V.
(Division Sign-Off) (Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices 7 -
510(k) Number K09183
Page 1 of 1
Page 18 of 119