(175 days)
No
The summary describes a mechanical device (coil and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to reduce or block blood flow in vessels for the management of various peripheral vasculature lesions, which are therapeutic interventions.
No
This device is an implantable coil system used to reduce blood flow in vessels of the peripheral vasculature. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of an implantable coil made of platinum alloy with a hydrogel core and a delivery pusher, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The AZUR Peripheral Coil System is an implantable device used to physically reduce or block blood flow within the peripheral vasculature. It is delivered and deployed inside the body during an interventional radiologic procedure.
The device's function is to physically interact with the patient's anatomy to achieve a therapeutic effect, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The AZUR Peripheral Coil System is intended to reduce or 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 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 CX Detachable 18 Peripheral Coil System consists of an implantable coil attached to a delivery pusher.
The implantable coil is made of platinum alloy with an inner hydrogel core. The implantable coils are designed in 3D spherical structure in various loop sizes and lengths. They are delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR Detachment Controller, which is activated by the user and this detaches the coil. The AZUR Detachment Controller is packaged and sold separately.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was undertaken to demonstrate the substantial equivalence of the subject device to the AZUR CX Detachable 18 Peripheral Coil System when used according to the Instructions for Use. The design verification and validation program included the evaluations listed below:
- . Visual Inspection
- . Simulated Use Testing
- . Advance/Retract force testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
MicroVention, Inc Laraine Pangelina Sr. Regulatory Affairs Manager 1311 Valencia Avenue Tustin, California 92780
Re: K162524
Trade/Device Name: AZUR CX Detachable 18 Peripheral Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 30, 2017 Received: February 1, 2017
Dear Ms. Laraine Pangelina:
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel-S
Fernando Aguel
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162524
Device Name
AZUR CX Detachable 18 Peripheral Coil System
Indications for Use (Describe)
The AZUR Peripheral Coil System is intended to reduce or 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Trade Name: | AZUR CX Detachable 18 Peripheral Coil System |
|---|---|
| Generic Name: | Vascular Embolization Device |
| Classification: | Class II, 21 CFR 870.3300 |
| Date Submitted: | September 1, 2016 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California 92780 U.S.A. | |
| Contact: | Laraine Pangelina |
| Sr. Regulatory Affairs Manager | |
| MicroVention, Inc. | |
| PH: 714-247-8150 | |
| Predicate Device: | AZUR CX Detachable 18 Peripheral Coil System (K123384) |
| Reference Device: | K120630, AZUR Peripheral Coil System - Detachable 18 |
| 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. | |
| Device Description: | The AZUR CX Detachable 18 Peripheral Coil System consists of an |
| implantable coil attached to a delivery pusher. |
The implantable coil is made of platinum alloy with an inner hydrogel core.
The implantable coils are designed in 3D spherical structure in various loop
sizes and lengths. They are delivered to the treatment site through the
microcatheter. The proximal end of the delivery pusher is inserted to the
AZUR Detachment Controller, which is activated by the user and this
detaches the coil. The AZUR Detachment Controller is packaged and sold
separately. |
Predicate / Subject Technological Comparison:
| Design Feature | Cleared Device (K123384) | Line Extension (subject device) |
|---|---|---|
| Coil shape | 3D spherical | Same |
| Coil OD (mm) | 4 – 20 | 2 - 3 |
| Coil Length, restrained (cm) | 13 - 40 | 2 - 8 |
| Method of Coil Delivery | Coil attached to a delivery pusher. The proximal | |
| end of the delivery pusher is inserted to the AZUR | ||
| Detachment Controller, which is activated to detach | ||
| and deliver the coil. The AZUR Detachment | ||
| Controller is packaged and sold separately. | Same | |
| Catheter Compatibility | Compatible with microcatheters having an ID of > | |
| 0.021" | Compatible with microcatheters having | |
| an ID of 0.019" - 0.027" | ||
| Method of Supply | Sterile, single use | Same |
| Package Configuration | Dispenser coil, pouch & shipping carton | Same |
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Pre-Clinical Testing: Microvention developed a design verification and validation program for the AZUR CX Detachable 18 Peripheral Coil System Line Extension with reference to the FDA Guidance for Vascular and Neurovascular Embolization Devices. Bench testing was undertaken to demonstrate the substantial equivalence of the subject device to the AZUR CX Detachable 18 Peripheral Coil System when used according to the Instructions for Use. The design verification and validation program included the evaluations listed below:
- . Visual Inspection
- . Simulated Use Testing
- . Advance/Retract force testing
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the substantial equivalence of the subject device to the predicate device, the AZUR CX Detachable 18 Peripheral Coil System (K123384) with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method. Based on the supportive data provided in this 510(k), it can be concluded that any differences in technological characteristics do not raise new concerns of safety or effectiveness. Therefore it is our conclusion that the subject device is substantially equivalent to the predicate device.