(99 days)
Not Found
No
The summary describes a physical medical device (an embolization coil system) and its mechanical and material properties. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
Explanation: The device is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature, which is a therapeutic action.
No
This device is designed to reduce or block blood flow in vessels by physically occluding them, which is a therapeutic function, not a diagnostic one. It is used for "management" of conditions like malformations and aneurysms.
No
The device description clearly states it consists of an implantable coil, introducer, and stylet, which are physical hardware components. The performance studies also focus on physical characteristics and testing of these hardware components.
Based on the provided information, the AZUR PURE is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" and is for "interventional radiologic management" of various vascular lesions. This describes a device used within the body for therapeutic purposes.
- Device Description: The description details an "implantable all-polymer coil" that is deployed into the body. This is consistent with an implantable medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on those samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AZUR PURE does not fit this description.
N/A
Intended Use / Indications for Use
The AZUR PURE 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 PURE Peripheral Coil System, Pushable 18 & 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
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)
Test: Simulated Use, Result: Met established criteria
Test: Dimensional Characteristics, Result: Met established criteria
Test: Tensile Strength, Result: Met established criteria
Test: Advancement Force, Result: Met established criteria
Test: FTIR, Result: Met established criteria
Test: HydroStability, Result: Met established criteria
Test: MRI Compatibility, Result: Met established criteria
Test: Electrical Conductivity, Result: Met established criteria
Test: Packaging Validation, Result: Met established criteria
Test: Sterilization validation, Result: Met established criteria
Test: Shelf Life, Result: Met established criteria
Test: Biocompatibility, Result: Met established criteria
Test: Acute & Chronic Animal Testing, Result: 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
K122543 page 1 of 2 15 , MicroVention
510(K) SUMMARY
NOV 2 8 2012
| Trade Name: | AZUR PURE Peripheral Coil System, Pushable 18 & 35 |
|---|---|
| Generic Name: | Vascular Embolization Coil |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California 92780 U.S.A. | |
| Contact: | Laraine Pangelina |
| Predicate Device: | AZUR Peripheral HydroCoil Endovascular Embolization Coil System, |
| Pushable 18 and 35 (K071939, K091882) |
Device Description:
The AZUR PURE Peripheral Coil System, Pushable 18 & 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
Indications for Use:
The AZUR PURE 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.
| Test | Result |
|---|---|
| Simulated Use | Met established criteria |
| Dimensional Characteristics | Met established criteria |
| Tensile Strength | Met established criteria |
| Advancement Force | Met established criteria |
| FTIR | Met established criteria |
| HydroStability | Met established criteria |
| MRI Compatibility | Met established criteria |
| Electrical Conductivity | Met established criteria |
| Packaging Validation | Met established criteria |
| Sterilization validation | Met established criteria |
| Shelf Life | Met established criteria |
| Biocompatibility | Met established criteria |
| Acute & Chronic Animal Testing | Met established criteria |
Verification and Validation Test Summary:
1
MicroVentour
TERUMO
AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)
| Predicate Devices (K071939, K091882 | AZUR PURE, 510(k) Subject Device | |
|---|---|---|
| Coil Shape | Helical | Same |
| Coil OD (mm) | AZUR 18: 2 - 10 | |
| AZUR 35: 3 - 16 | AZUR 18: 3 - 10 | |
| AZUR 35: 4 - 15 | ||
| Coil Length (cm) | AZUR 18: 2 - 14 | |
| AZUR 35: 4 - 14 | AZUR 18: 2 - 20 | |
| AZUR 35: 4 - 14 | ||
| Delivery Method | Coil housed in an introducer with proximal | |
| hub. Pushable delivery using guidewire. | Same | |
| Hydrogel Implant | ||
| Material | Hydrophilic copolymer | Same |
| Packaging | ||
| Configuration | Placed in capped coil introducer, placed on | |
| packaging card, into pouch, into box, 5/box | Same |
Technological comparison, subject and predicate device:
Summary of Substantial Equivalence:
The AZUR PURE Peripheral Coil System, Pushable 18 & 35 is substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 2 8 2012 -
Microvention, Inc. % Laraine Pangelina 1311 Valencia Ave Tustin, CA 92780 US
Re: K122543
Trade/Device Name: AZUR PURE peripheral coil system Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 2, 2012 Received: November 8, 2012
Dear Ms. 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 for ass stated or 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 r ou may a 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 I lease of actived a determination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or any I oderal statuation and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fat 607), fucemig (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Laraine Pangelina .
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 If you desire specific advice for your do riters offices/CDRH/CDRHOffices/ucm115809.htm for go to into://www.ida.gov/rt8odio.org/w/index.php?tice of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CDRH Ball the Center for Devices und Radionogicular by reference to premarket notification" (21CFR Part flore the regulation entined, "Miordinance 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 Tou thay obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Matthew G. Hillebrenner
for Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiològical Health
Enclosure
4
AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)
INDICATIONS FOR USE
510(k) Number (if known):
K122543 · ·
Device Name:
Indications for Use:
AZUR PURE Peripheral Coil System, Pushable 18 & 35
The AZUR PURE 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 (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. of Killeber
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122543