(83 days)
No
The device description focuses on mechanical and electrical components for coil delivery and detachment, with no mention of AI/ML for image analysis, decision support, or other functions.
Yes
The device is intended to reduce or block blood flow in peripheral vasculature vessels for the management of malformations, fistulae, and aneurysms, which are therapeutic interventions.
No
The device is an implantable coil system designed to reduce or block blood flow in vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components including an implantable coil, delivery pusher, and a battery-powered Detachment Controller, indicating it is a hardware device with a software-controlled detachment mechanism.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" for therapeutic purposes (managing arteriovenous malformations, fistulae, aneurysms, etc.). This is a direct intervention on the patient's body.
- Device Description: The device is an implantable coil system delivered through a catheter and detached electrically. This is a physical medical device used for treatment.
- Lack of Diagnostic Activity: 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 specifically designed to perform tests on samples taken from the body, not to directly treat conditions within the body. This device is clearly a therapeutic device used in interventional radiology.
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, atteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Product codes
KRD
Device Description
The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable 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
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
To ensure that the modified device continues to meet the established design and performance specifications, applicable verification and validation testing was repeated on baseline and aged devices, including the following:
- . Visual and Dimensional Inspection
- Advance/Retract Force Testing
- Simulated Use Testing
- Implant/Detachment Zone Tensile ●
Key Metrics
Not Found
Predicate Device(s)
AZUR CX Detachable 18 Peripheral Coil System (K162524, K123384)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2022
MicroVention Inc. Riddhi Pandya Sr. Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656
Re: K223050
Trade/Device Name: AZUR HydroPack 18 Peripheral Coil System (Detachable) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: September 26, 2022 Received: November 29, 2022
Dear Riddhi Pandya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Misti L. Malone -S
Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223050
Device Name
AZUR HydroPack 18 Peripheral Coil System (Detachable)
Indications for Use (Describe)
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, atteriovenous 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. SUBMITTER
MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 Establishment Registration No: 3013556777
Contact Person:
Riddhi Pandya Sr. Regulatory Affairs Specialist Email: Riddhi.Pandya(@microvention.com Telephone: (646)-724-8792 Date Prepared: September 26, 2022
II. DEVICE
Trade Names: AZUR™ HydroPack 18 Peripheral Coil System (Detachable) Classification Name: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: II Product Code: KRD
III.PREDICATE DEVICE
AZUR CX Detachable 18 Peripheral Coil System (K162524, K123384)
IV. DEVICE DESCRIPTION
The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment
4
Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The AZUR Detachment Controller is packaged and sold separately.
V. 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.
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The substantial equivalence of the subject device, AZUR HydroPack 18 Peripheral Coil System (AZUR HydroPack), to the predicate device, AZUR CX 18 Peripheral Coil System (AZUR CX: K123384 cleared November 28, 2012, and K162524 cleared March 3, 2017), was established through an evaluation of the indications for use, principle of operation, materials of construction, method of placement, detachment system, sterilization and method of supply.
| FEATURE | AZUR CX (Predicate) | AZUR HydroPack (Subject) |
|---|---|---|
| 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. | Same | |
| DESIGN FEATURES | ||
| Coil Shape | Spherical (3D) | Wave |
| Coil Restrained | ||
| Length | 2 - 40 cm | 5 - 60 cm |
| Coil Construction | Pt/Tungsten alloy coil & Hydrogel | |
| core | Same | |
| Effective Pusher | ||
| Length | 175 cm | 185 cm |
| Representative | ||
| Illustration | ||
| Image: coil | Image: coil | |
| MATERIALS | ||
| Main Coil | Platinum (92%)/Tungsten (8%) | Same |
| Hydrogel Core | Hydrophilic acrylic polymer (cross | |
| linked copolymer of acrylamide and | ||
| acrylic acid) | Same | |
| Marker Band | Platinum (90%)/Iridium (10%) | Same |
| Detachment | ||
| Element | Polyolefin elastomer filament | Same |
| Stretch Resistant | ||
| Filament | Polyolefin Elastomer | Same |
| Adhesive | UV cure adhesive (DYMAX | |
| 1128A-M-VT) | Same | |
| Delivery Pusher | Core wire: Stainless Steel | |
| Heater coil: Platinum and Stainless | ||
| Steel | ||
| Connector: Gold plated Stainless | ||
| Steel | ||
| Outer jacket: Polyethylene | ||
| Terephthalate (PET) and Polyimide | ||
| Electrical leads: Silver with | ||
| Polyimide insulation | Same | |
| OTHER | ||
| Catheter | ||
| Compatibility | Compatible with microcatheters | |
| having an ID of 0.019" to 0.027" | ||
| (0.48 mm to 0.69 mm) | Compatible with microcatheters | |
| having an ID of 0.021" to 0.027" | ||
| (0.53 mm to 0.69 mm) | ||
| Method of | ||
| Sterilization | E-beam | Same |
| How Supplied | Sterile, for single use | Same |
| Packaging Material | Introducer, dispenser coil, pouch & | |
| shipping carton | Same |
Device Comparison Table:
5
VII. PERFORMANCE DATA
To ensure that the modified device continues to meet the established design and performance specifications, applicable verification and validation testing was repeated on baseline and aged
6
devices, including the following:
- . Visual and Dimensional Inspection
- Advance/Retract Force Testing
- Simulated Use Testing
- Implant/Detachment Zone Tensile ●
VIII. CONCLUSION
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 (K162524, 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.