(115 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and deployment mechanism of a coil system, with no mention of AI or ML technologies.
Yes
The device is described as an implantable coil system intended to reduce or block blood flow in peripheral vasculature for the management of various lesions, which is a direct treatment of a medical condition.
No
Explanation: The device is intended to block blood flow in vessels, functioning as a treatment for lesions in the peripheral vasculature. It does not gather information to determine a medical condition.
No
The device description clearly states it consists of an implantable all-polymer coil, an introducer, and a stainless steel stylet, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for reducing or blocking blood flow in vessels of the peripheral vasculature and is used in the interventional radiologic management of various vascular lesions. This is a therapeutic and interventional procedure performed in vivo (within the body).
- Device Description: The device is an implantable coil delivered through a catheter. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that 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 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 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)
| Verification & Validation
| Test Summary: | Test | Result |
|---|---|---|
| Simulated Use | ||
| • Prep/Insert | ||
| • Track/Push | ||
| • Deployment | ||
| • Stability | ||
| • Overall Performance | Met same criteria as predicate | |
| Advancement Force | Met same criteria as predicate | |
| Tensile Strength at glue joint | Met same criteria as predicate | |
| Expansion Characteristics | Met same criteria as predicate |
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
AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MicroVention
510(K) SUMMARY
Trade Name: AZUR PURE Peripheral Coil System, Pushable 35 Generic Name: Vascular Embolization Device, accessory Classification: Class II, 21 CFR 870.3300 Submitted By: MicroVention, Inc OCT 2 8 2013 1311 Valencia Avenue Tustin, California 92780 U.S.A. Contact: Laraine Pangelina Predicate Device: AZUR PURE Peripheral Coil System, Pushable 35 (K122543) The AZUR PURE is intended to reduce or block the rate of blood Indications for Use: 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 PURE Peripheral Coil System, Pushable 35, consists of Device Description: 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.
| Verification & Validation
| Test Summary: | Test | Result |
|---|---|---|
| Simulated Use | ||
| • Prep/Insert | ||
| • Track/Push | ||
| • Deployment | ||
| • Stability | ||
| • Overall Performance | Met same criteria as predicate | |
| Advancement Force | Met same criteria as predicate | |
| Tensile Strength at glue joint | Met same criteria as predicate | |
| Expansion Characteristics | Met same criteria as predicate |
1
AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil
| Predicate / Subject
Technological
| Comparison: | Feature | Predicate Device | Subject Device |
|---|---|---|---|
| Coil shape | Helical | Same | |
| Coil OD (mm) | 3 - 16 | Same | |
| Coil Length (cm) | 6 - 14 | Same | |
| Overcoil | None | PEEK | |
| 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 |
Summary of Substantial Equivalence: The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2013
MicroVention, Inc. c/o Laraine Pangelina 1311 Valencia Avenue Tustin, CA 92780
Re: K132083
Trade/Device Name: AZUR PURE Peripheral Coil System, Pushable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: September 10, 2013 Received: September 11, 2013
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 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 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference 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/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 Small Manufacturers, 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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MICH THE MICH CHIP THE MICH
INDICATIONS FOR USE
K132083 510(k) Number (if known): Device Name: AZUR PURE Peripheral Coil System, Pushable 35 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.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (Optional Format 1-2-96).
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