(128 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of the coil system and detachment controller. There is no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is described as "intended to reduce or blood flow in vessels of the peripheral vasculature" and used for "interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature," which are therapeutic applications.
No
The device is an embolization coil system designed to reduce or block blood flow in vessels of the peripheral vasculature, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components including an implant coil, delivery pusher, and detachment controller, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reducing or blood flow in vessels of the peripheral vasculature" and for "interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details an implantable coil and a delivery system used to place the coil within blood vessels. This is a medical device used for treatment, not for testing samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status.
The AZUR Peripheral Coil System is a therapeutic medical device used for embolization within the peripheral vasculature.
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.
Product codes
KRD
Device Description
The AZUR CX Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing was conducted and passed for: Simulated use, Advance/Retract, Gel Expansion, Appendix Strength, Spring Constant, Pusher Sleeve Retention. Biocompatibility testing was performed on the Coil Implant Segment and the Delivery Pusher Segment, which included tests for Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Systemic Toxicity, Genetic Toxicology, and Intramuscular Implantation, all conforming to relevant ISO standards.
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2015
MicroVention, Inc. Cynthia Valenzuela Project Manager, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K151358
Trade/Device Name: AZUR CX Peripheral Coil System - Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 18, 2015 Received: August 20, 2015
Dear Cynthia 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.
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
1
the quality systems (OS) 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 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 yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151358
Device Name
AZUR CX Peripheral Coil System - Detachable 35
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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3
510(K) Summary of Safety and Effectiveness
Date Prepared: 11SEP2015
510(K) Summary
| Trade Name: | AZUR CX Peripheral Coil System - Detachable 3- |
|---|---|
| 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 |
| Project Manager, Regulatory Affairs | |
| MicroVention, Inc. | |
| Direct: 714-247-8053 | |
| Cell: 949-413-0071 |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K123384 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System - | ||
| Detachable 18 | 28NOV2015 | |
| K130577 | AZUR Peripheral HydroCoil | |
| Endovascular Embolization System - | ||
| Pushable 18 & 35 | 17JUN2013 |
Device Description
The AZUR CX Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is sold separately.
4
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.
Technological Comparison Chart
| Features | Cleared AZUR Pushable 18
& 35 (K130577) | Cleared AZUR CX (D18)
(K123384) | AZUR CX (D35)
Proposed device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Design Attributes | | | |
| Coil Shape | Helical | 3D - Spherical | 3D - Spherical |
| Coil Filar OD (inch) | 0.00275 - 0.0050 | 0.00250 - 0.00400 | 0.0035 - 0.0050 |
| Primary Coil Wind OD
(inch) | 18: 0.0120
35: 0.0220 | 0.0140 - 0.0150 | 0.0290 |
| 3D Coil OD (mm) | 18: 2 – 10mm
35: 4 – 16mm | 4 - 20* | 4 - 20* |
| Restrained Coil Length
(cm) | 18: 2 – 20mm
35: 4 – 20mm | 13 - 40* | 7 - 39 |
| Pusher Length | 18: 2 - 10mm
35: 4 - 16mm | 175cm | 162cm |
| Materials | | | |
| Main Coil Wire | 18: Platinum (92%)/ Tungsten
(8%) | Platinum/Tungsten alloy
(92/8) | 4mm - 8mm:
Platinum/Tungsten alloy (92/8) |
| | 35: Platinum alloy-clad tantalum
[Platinum (90%)/Iridium (10%)] | | 10mm -20mm:
Platinum alloy-clad tantalum
[Platinum (90%)/Iridium (10%)] |
| | 35 (4 mm): Platinum (92%)/
Tungsten (8%) | | |
| Coil-to-Pusher Coupler | - | Platinum / Iridium (90/10) | No coupler |
| Adhesive | UV cure adhesive (DYMAX 1128-AM-VT) | UV cure adhesive (DYMAX
1128-AM-VT) | UV cure adhesive (DYMAX
1128-AM-VT) |
| Implant to the pusher | - | Polyolefin Elastomer | Polyolefin Elastomer |
| Stretch Resistant Filament | - | Polyolefin Elastomer | Polyolefin Elastomer |
| Hydrogel | Hydrophilic acrylic copolymer
(cross-linked copolymer of
polyethylene glycol diacrylamide
and acrylic acid) | Hydrophilic acrylic
copolymer (cross-linked
copolymer of polyethylene
glycol diacrylamide and
acrylic acid) | Hydrophilic acrylic copolymer
(cross-linked copolymer of
polyethylene glycol
diacrylamide and acrylic acid) |
| General | | | |
| Catheter Compatibility | 18: 0.021" - 0.022" ID
35: 0.041" - 0.047" ID | Compatible with
microcatheters having an
ID of > .019" | Compatible with catheters
having an ID of 0.041"-0.047" |
| Method of Supply | Sterile, single use | Sterile, single use | Sterile, single use |
| Package Configuration | Sealed in a poly (ethylene
terephthalate) pouch coated with
silica or aluminum oxide and
placed in a shipping carton | Dispenser coil, pouch &
shipping carton | Dispenser coil, pouch &
shipping carton |
5
Verification of Test Summary
| Bench Testing | Result |
|---|---|
| Simulated use | Passed |
| Advance/Retract | Passed |
| Gel Expansion | Passed |
| Appendix Strength | Passed |
| Spring Constant | Passed |
| Pusher Sleeve Retention | Passed |
Biocompatibility Coil Implant Segment - Biocompatibility Summary
| Test Method | Standard |
|---|---|
| Cytotoxicity | |
| MEM Elution Test | ISO 10993-5 |
| ISO Cell Culture Agar Overlay | ISO 10993-5 |
| Sensitization | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 |
| Irritation | |
| ISO Intracutaneous Reactivity Evaluation Test | ISO 10993-10 |
6
Coil Implant Segment - Biocompatibility Summary
| Test Method | Standard |
|---|---|
| Hemocompatibility | |
| Hemolysis | ISO 10993-4 |
| Prothrombin Time Assay - ISO | ISO 10993-4 |
| Systemic Toxicity | |
| Systemic toxicity (IV injection) | ISO 10993-11 |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 |
| Test Method | Standard |
|---|---|
| Genetic Toxicology | |
| Bacteria Reverse Mutation Assay (Ames Test) | ISO 10993-3 |
| Intramuscular Implantation | |
| 7-day Muscle Implantation | ISO 10993-6 |
| 13-week Intramuscular Implantation Test | ISO 10993-6 |
| 26-week Intramuscular Implantation Test | ISO 10993-6 |
7
Biocompatibility Summary for Delivery Pusher Segment
| Test Method | Standard |
|---|---|
| Cytotoxicity | |
| MEM Elution Test | ISO 10993-5 |
| ISO Cell Culture Agar Overlay | ISO 10993-5 |
| Sensitization | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 |
| Irritation | |
| ISO Intracutaneous Reactivity Evaluation Test | ISO 10993-10 |
| Hemocompatibility | |
| Blood compatibility Evaluation (Hemolysis) | ISO 10993-4 |
| Prothrombin Time Assay - ISO | ISO 10993-4 |
| Systemic Toxicity | |
| Systemic toxicity | |
| (IV injection) | ISO 10993-11 |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 |
8
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Peripheral Coils System - CX Detachable 35 Coils when compared with the predicate devices, MicroVention, Inc. AZUR CX Detachable 18 (K1223384) and AZUR Pushable 18 & 35 (K130577).
- The device, ●
- Has the same intended use, ●
- Uses the same operating principle, ●
- Incorporates the same basic design, ●
- Uses similar construction and material, ●
- Are packaged and sterilized using the same material and processes. .
In summary, the AZUR Peripheral Coil System – CX Detachable 35 Coils described in this submission is, in our opinion equivalent to the predicate devices.