(152 days)
MicroPlex Coil System and HydroCoil Embolic System:
The MicroPlex Coil System and HydroCoil Embolic System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
AZUR Peripheral Coil System:
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.
The V-Grip Detachment Controller is an accessory for use with the MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR).
The MCS and AZUR devices consist of an implantable coil made of a platinum alloy (Platinum/Tunqsten). The HES and AZUR metal/gel devices consist of an implantable coil made of the same platinum alloy with a hydrogel inner core.
The implantable coil is attached to a delivery pusher via a polyolefin elastomer material. The proximal end of the delivery pusher is inserted into a hand held, battery powered Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The Detachment Controller is packaged and sold separately.
The primary purpose of the subject submission is a modification to the V-Grip/AZUR Detachment Controller to facilitate battery removal and disposal after use of the device.
This document is a 510(k) premarket notification for MicroVention, Inc.'s MicroPlex Coil System, HydroCoil Embolic System, and AZUR Peripheral Coil System, specifically focusing on modifications to the V-Grip Detachment Controller and the AZUR Detachment Controller. The acceptance criteria and supporting study are related to the performance of these detachment controllers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance are presented in the "Bench Test Summary" table. All tests resulted in "PASS," indicating the device met the specified criteria.
| Test | Acceptance Criteria Summary (based on Test Method Summary) | Reported Device Performance |
|---|---|---|
| Output Voltage and Time | All 22+ samples (minimum) before and after sterilization shall have a measurement rating of $9.0 \pm 0.5V$ and $0.75 \pm 0.10$ seconds for a minimum of 20 cycles, to meet 90% confidence of 90% reliability for the voltage, time, and number of cycles. | PASS |
| Detachment | All 22+ samples (minimum) before and after sterilization shall detach the implants at the 11th and 20th cycles in under three detachment attempts. | PASS |
| Battery Voltage Measurement | All 22+ samples (minimum) before and after sterilization shall meet the acceptance criteria of > 7V. | PASS |
| LED and Buzzer Sequence | All 22+ samples (minimum) before and after sterilization shall pass the conditional LED and buzzer sequence tests for standard operation, detachment testing, and functional testing beyond 20 cycles. | PASS |
| EMC Compatibility | Test samples were subjected to five EMC tests in accordance with IEC 60601-1-2:2014. | PASS |
| Software Validation | Software validation testing was performed to demonstrate that the modified V-Grip/Azur Detachment Controller met the requirements of Design Specifications and the Software Requirements Specification. | PASS |
| Electrical Safety | The modified V-Grip/AZUR Detachment Controller was evaluated in accordance with IEC 60601-1:2012 Edition 3.1 and other related standards, including risk management file review and safety testing. | PASS |
| Shelf Life, Accelerated Aging 1 year | Shelf life testing was performed on 22 samples subjected to the equivalent of 1-year accelerated aging, sterilization, and simulated shipping hazard. Visual inspection and output performance were tested. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For "Output Voltage and Time," "Detachment," "Battery Voltage Measurement," "LED and Buzzer Sequence," and "Shelf Life, Accelerated Aging 1 year" tests, the sample size used was 22 samples (minimum), both before and after sterilization.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket notification for a medical device modification, the testing described (bench tests, software validation, electrical safety, etc.) is typically prospective and conducted by the manufacturer or accredited labs (e.g., TUV America for EMC and Electrical Safety) to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a premarket notification for a modification to an accessory for neurovascular embolization devices. The studies conducted are bench tests and engineering validations, not clinical studies involving patient data or expert interpretation of diagnostic images. Therefore, the concept of "ground truth established by experts" (like radiologists for imaging studies) does not apply in this context. The "ground truth" here is determined by engineering specifications, physical measurements, and compliance with recognized standards.
4. Adjudication Method for the Test Set
As this involves bench testing and engineering validation, there is no "adjudication method" in the sense of multiple human readers or experts resolving discrepancies. The results are based on objective measurements against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the safety and performance of a device modification (detachment controller) through bench testing and engineering validation, not on the diagnostic accuracy or effectiveness of an AI system with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is not an AI/algorithm-based diagnostic device. The device itself performs a function (detachment of coils). The tests described are standalone performance tests of the modified mechanical and electrical properties of the detachment controller.
7. The Type of Ground Truth Used
The ground truth for these tests is based on engineering specifications and recognized industry standards. For example:
- Output Voltage and Time: Ground truth is the specified voltage, time, and number of cycles.
- Detachment: Ground truth is successful detachment within a specified number of attempts.
- Battery Voltage Measurement: Ground truth is the specified minimum voltage.
- EMC Compatibility: Ground truth is compliance with IEC 60601-1-2:2014.
- Software Validation: Ground truth is meeting Design Specifications and Software Requirements Specification.
- Electrical Safety: Ground truth is compliance with IEC 60601-1:2012 Edition 3.1 and related standards.
8. The Sample Size for the Training Set
This submission does not discuss a "training set" in the context of machine learning or AI. The tests are for design verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model in this submission. The "ground truth" for the device's design (e.g., target output voltage, detachment time) is established during the device's design and development phase based on performance requirements for its intended use.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2017
MicroVention, Inc. Laraine Pangelina Senior Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780
Re: K162999
Trade/Device Name: MicroPlex Coil System, HydroCoil Embolic System, AZUR Peripheral Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: February 21, 2017 Received: February 22, 2017
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162999
Device Name
MicroPlex Coil System, HydroCoil Embolic System, AZUR Peripheral Coil System
Indications for Use (Describe)
MicroPlex Coil System and HydroCoil Embolic System:
The MicroPlex Coil System and HydroCoil Embolic System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
AZUR Peripheral Coil System:
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.
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for MicroVention. The logo features a stylized, abstract graphic to the left of the company name. Below the company name is the word "TERUMO" in a smaller, sans-serif font.
510(K) SUMMARY
(Prepared October 24, 2016)
The primary purpose of the subject 50(k) is a modification to the V-Grip Detachment Controller and the AZUR Detachment Controller. The V-Grip Detachment Controller is an accessory for use with the MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR)
| Trade Name: | 1. MicroPlex Coil System and HydroCoil Embolic System2. AZUR Peripheral Coil System |
|---|---|
| Generic Name: | 1. Neurovascular Embolization Device (MicroPlex Coil System andHydroCoil Embolic System)2. Vascular Embolization Device (AZUR Peripheral Coil System) |
| CFR Classification: | Class II, 21 CFR 882.5950 (MicroPlex Coil System andHydroCoil Embolic System)Class II, 21 CFR 870.3300 (AZUR Peripheral Coil System) |
| Product Code: | HCG (MicroPlex Coil System andHydroCoil Embolic System)KRD (AZUR Peripheral Coil System) |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780U.S.A. |
| Contact: | Laraine PangelinaSr. Regulatory Affairs ManagerMicroVention, Inc. |
| Predicate Device: | 1. V-Grip Detachment Controller (for use with MicroPlex Coil System andHydroCoil Embolic System), K0509542. AZUR Detachment Controller (for use with AZUR Peripheral CoilSystem), K050954 |
| Indications for Use: | NOTE: The V-Grip Detachment Controller is an accessory for use with theMicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System(HES). The AZUR Detachment Controller is for use with the MicroVentionAZUR Peripheral Coil System (AZUR). As an accessory to the coil systems,the indications for use for the Detachment Controller are the same as that forthe coil systems with which they are used: |
| MicroPlex Coil System and HydroCoil Embolic System: | |
| The MicroPlex Coil System and HydroCoil Embolic System are intended for theendovascular embolization of intracranial aneurysms and other neurovascularabnormalities such as arteriovenous |
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malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
AZUR Peripheral Coil System:
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.
The V-Grip Detachment Controller is an accessory for use with the Device Description: MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR).
The MCS and AZUR devices consist of an implantable coil made of a platinum alloy (Platinum/Tunqsten). The HES and AZUR metal/gel devices consist of an implantable coil made of the same platinum alloy with a hydrogel inner core.
The implantable coil is attached to a delivery pusher via a polyolefin elastomer material. The proximal end of the delivery pusher is inserted into a hand held, battery powered Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The Detachment Controller is packaged and sold separately.
The primary purpose of the subject submission is a modification to the V-Grip/AZUR Detachment Controller to facilitate battery removal and disposal after use of the device. The table below provides a summary of the differences between the current and modified Detachment Controller.
| Characteristic | Current V-Grip/AZURDetachment Controller(K050954) | Modified V-Grip/AZURDetachment Controller(Subject Device) |
|---|---|---|
| Power Source | Three - 12 V alkalinebatteries, not removable orreplaceable | One - 9 V alkalinebattery, removable, notreplaceable |
| Output Voltage | 8 VDC ± 1V | 9.00 VDC ± 0.50V |
| Output Current | 170 mA nominal, 246 mAmaximum | 170 mA nominal, 256 mAmaximum |
| Housing/Funnel | ABS 633 PlasticABS Polyac 747Funnel:Color Science #CS4B627A(V-Grip) and #CS3W768A-2 (AZUR)Housing:Color Science #CS2Y457A(V-Grip) and # CS3G257A(AZUR) | Same materials. Modifieddimensions andconfiguration to allowbattery removal |
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Image /page/5/Picture/0 description: The image shows the logo for MicroVention, a company that specializes in neurovascular products. The logo features the company name in a stylized font, with the word "MicroVention" in a larger font size than the word "TERUMO" which is located underneath. The logo is primarily blue in color, with a gradient effect that gives it a modern and professional look. There is also a graphic to the left of the company name.
Bench Test Summary:
| Test | Test Method Summary | Result |
|---|---|---|
| Output Voltageand Time | All 22 samples (minimum) before and aftersterilization shall have a measurement rating of$9.0 \pm 0.5V$ and $0.75 \pm 0.10$ seconds for aminimum of 20 cycles, to meet 90% confidenceof 90% reliability for the voltage, time, andnumber of cycles. | PASS |
| Detachment | All 22 samples (minimum) before and aftersterilization shall detach the implants at the 11thand 20th cycles in under three detachmentattempts. | PASS |
| Battery VoltageMeasurement | All 22 samples (minimum) before and aftersterilization shall meet the acceptance criteria of> 7V. | PASS |
| LED and BuzzerSequence | All 22 samples (minimum) before and aftersterilization shall pass the conditional LED andbuzzer sequence tests for standard operation,detachment testing, and functional testingbeyond 20 cycles. | PASS |
| EMCCompatibility | Test samples were subjected to five EMC testsin accordance with IEC 60601-1-2:2014. Testingwas conducted for MicroVention by TUVAmerica in San Diego, CA. | PASS |
| SoftwareValidation | Software validation testing was performed todemonstrate that the modified V-Grip/AzurDetachment Controller met the requirements ofDesign Specifications and the SoftwareRequirements Specification. | PASS |
| Electrical Safety | The modified V-Grip/AZUR DetachmentController was evaluated by TUV SUD Americain accordance with IEC 60601-1:2012 Edition 3.1and other related standards. The evaluationincluded the risk management file review andsafety testing, which concluded that the subjectdevice meets the selected requirements of thetest specifications. | PASS |
| Shelf Life,AcceleratedAging 1 year | Shelf life testing was performed on 22 samplesthat had been subjected to the equivalent of 1-year accelerated aging. The test samples weresterilized according to the sterilization cycle thatwill be utilized for commercialized product, andsubjected to simulated shipping hazard per ISTA3A. Visual inspection and output performancewere tested. | PASS |
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Image /page/6/Picture/0 description: The image contains the logo for MicroVention, a company specializing in neurovascular products. The logo features the company name in a stylized font, with the word "MicroVention" in a larger, bolder font and the word "TERUMO" underneath in a smaller font. The logo also includes a graphic element to the left of the company name, consisting of a series of curved lines that create a sense of movement and flow.
| Predicate / SubjectTechnologicalComparison: | Characteristic | Current V-Grip/AZURDetachment Controller(K050954) | Modified V-Grip/AZURDetachment Controller |
|---|---|---|---|
| V-Grip Device GeneralDescription | A self-contained,disposable, hand held,battery powereddetachment controllerprovides the controlledelectrical energy for thedetachment of the coilfrom the deliverypusher. | Same | |
| Power Source | Three - 12 V alkaline batteries,not removable or replaceable | One - 9 V alkaline battery,removable, not replaceable | |
| Output Voltage | $8 VDC \pm 1V$ | $9.00 VDC \pm 0.50V$ | |
| Output Current | 170 mA nominal, 246 mAmaximum | 170 mA nominal, 256 mAmaximum | |
| Printed Circuit Board | Qty. 1: PD00285 - PrintedCircuit Board | Qty. 1: PD110285 - PrintedCircuit Board | |
| Housing/Funnel | ABS 633 PlasticABS Polyac 747Funnel: Color Science#CS4B627A (V-Grip) and#CS3W768A-2 (AZUR)Housing: Color Science #CS2Y457A (V-Grip) and #CS3G257A (AZUR) | Same materials. Modifieddimensions and configurationto allow battery removal | |
| Detachment cycle time | 0.75 seconds | Same | |
| Detachments per unit | 20 | Same | |
| Method of Supply | Sterile and single patientuse | Same | |
| Package Configuration | Placed in sealed pouch5 units per carton box | Same | |
| Method of Sterilization | Ethylene oxide | Same |
Summary of Substantial Equivalence:
The devices that are the subject of this submission are substantially equivalent to the predicate devices with regard to intended use, patient population, device design, materials, processes, and operating principal.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).