(104 days)
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.
The AZUR Pushable 18 & 35 coils are made of platinum alloy (Pt/W: 92/8) with an outer layer of hydrogel polymer with an added over-coil. The over-coil is comprised of a 0.00125" platinum alloy (Pt/W: 92/8) wire which is wound over the hydrogel polymer and two ends are bonded to the main coil with the same DYMAX adhesive used in the existing AZUR Pushable 18 & 35 coils. The over-coil materials and manufacturing processes are also the same as those used in the manufacture of the HES (K0509054) coils. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery ousher
The provided text describes the AZUR Coil System - Pushable 18 & 35 and its acceptance criteria, which are based on bench testing for substantial equivalence to predicate devices. However, the document does not contain information about a study that assesses a device's performance in diagnosing or classifying a condition (e.g., in terms of sensitivity, specificity, accuracy), nor does it mention the use of AI or human readers. Therefore, many of the requested fields cannot be extracted from the given text.
Here is the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | - | Met established criteria |
| Advancement / Retraction Force | - | Met established criteria |
| Note: The specific established criteria are not detailed in the provided text, only that they were met. |
2. Sample size used for the test set and the data provenance
The document describes bench testing, not a clinical study on a patient population. Therefore, there is no information about a test set sample size or data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this was bench testing, not a study requiring expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study is mentioned or implied. The device is a vascular embolization device, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
For the bench testing, the "ground truth" would be the established engineering and performance specifications for the device's physical properties (e.g., advancement/retraction force, performance in simulated use).
8. The sample size for the training set
Not applicable, as this was bench testing for a physical device, and not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image contains the logo for MicroVention TERUMO. The logo consists of a stylized graphic on the left, resembling a series of curved lines or waves. To the right of the graphic is the text "MicroVention" in a clean, sans-serif font, with "TERUMO" appearing in a smaller font size directly below it.
510(K) Summary
JUN 1 7 2013
Trade Name: AZUR Coil System - Pushable 18 & 35 Generic Name: Vascular Embolization Device Class II, 21 CFR 870.3300 Classification:
Submitted By: MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.
Contact: Cynthia Valenzuela
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K071939 | HydroCoil Embolic System (HES) –HydroFrame | 22APR2010 |
| K091882 | AZUR Peripheral HydroCoilEndovascular EmbolizationCoil System - Pushable 18 | 08JUL2009 |
| K050954 | MicroPlex Coil System (MCS) andHydroCoil Embolic System (HES) | 28JUN2005 |
Device Description
The AZUR Pushable 18 & 35 coils are made of platinum alloy (Pt/W: 92/8) with an outer layer of hydrogel polymer with an added over-coil. The over-coil is comprised of a 0.00125" platinum alloy (Pt/W: 92/8) wire which is wound over the hydrogel polymer and two ends are bonded to the main coil with the same DYMAX adhesive used in the existing AZUR Pushable 18 & 35 coils. The over-coil materials and manufacturing processes are also the same as those used in the manufacture of the HES (K0509054) coils.
The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery ousher
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Image /page/1/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo consists of a stylized graphic to the left of the text "MicroVention" in a sans-serif font. Below "MicroVention" is the word "TERUMO" in a bolder, sans-serif font. The overall design is simple and corporate.
Indication For Use
The intended use as stated in the product labeling is as follows:
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
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Simulated Use | Met established criteria |
| Advancement / Retraction Force | Met established criteria |
Summary of Substantial Equivalence . . . . . . . . .
The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Coil System - Pushable 18 & 35 line extension coils when compared with the predicate devices, MicroVention AZUR Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 & 35 (K071939, K091882) and HydroCoil Embolic System (K050954).
The devices,
- . Have the same intended use,
- Use the same operating principle, ●
- Incorporate the same basic design, .
- Use similar construction and material,
- . Are packaged and sterilized using same material and processes.
In summary, the AZUR Coil System - Pushable 18 & 35 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2013
Microvention, Inc. Attention: Cynthia Valenzuela 1311 Valencia Avenue Tustin. CA 92780
Re: K130577
Trade/Device Name: Azur Pushable 18 and 35 System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: May 17, 2013 Received: May 22, 2013
Dear Ms. 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 adülteration." Please note: CDRH döes 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
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Page 2 - [Cynthia Valenzuela]
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D.亿元gKerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: AZUR Peripheral Coil System (Pushable) 18 & 35 System
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brai 2013
§ 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).