(91 days)
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.
Treatment of cerebral aneurysms can be performed either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.
The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.
The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
The provided Special 510(k) K132952 describes the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The submission primarily focuses on the substantial equivalence of these devices to previously cleared predicate devices, with a minor modification related to the V-Trak Advanced delivery pusher. As such, the study summarized is a design verification and validation bench test, along with biocompatibility testing, rather than a clinical study involving human subjects or algorithm performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection (and measurements using device drawing) | Per product drawing | Pass (Met established criteria) |
| Simulated Use (assess deployment, repositioning, and detachment in an aneurysm) | All performance ratings shall be ≥ 3 | Pass (Met established criteria) |
| Pusher Resistance (measure resistance through a microcatheter) | 36.7-53.0 Ω | Pass (Met established criteria) |
| Detachment Zone Tensile (measure breakforce at detachment zone) | ≥ 0.08 lbf | Pass (Met established criteria) |
| Biocompatibility Tests (for HES Coil Implant, MCS Coil Implant, and Delivery Pusher) | Requirement (ISO standards) | Passed (for all listed tests, e.g., MEM Elution, Sensitization, Hemolysis, etc.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the individual bench tests. It refers to "design verification and validation bench tests," which typically involve a specified number of units per test to ensure statistical significance or manufacturing quality. However, the exact number of coils or components tested is not provided.
The data provenance is pre-clinical bench testing conducted in a lab environment. There is no information regarding country of origin for this testing, but it can be inferred to be from the manufacturer, MicroVention, Inc., located in Tustin, California, U.S.A. This is retrospective in the sense that it's performed on manufactured devices for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the reported tests are physical and functional bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "acceptance criteria" are based on engineering specifications and established industry standards (e.g., ISO for biocompatibility).
4. Adjudication Method for the Test Set
This is not applicable as there were no subjective expert assessments that would require adjudication. The tests were objective measurements against defined acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not described in this submission. This type of study would typically be performed for devices involving human interpretation (e.g., imaging devices with AI assistance), which is not the case for this neurovascular embolization device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was not conducted and is not described. This submission is for a physical medical device (coils and delivery system), not a software algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the bench tests was based on:
- Engineering Specifications: For visual inspection and measurements ("Per product drawing").
- Performance Ratings: Based on simulated use scenarios, likely defined by internal engineering or clinical experts within the company to assess deployment, repositioning, and detachment.
- Physical Properties/Standards: For pusher resistance and detachment zone tensile strength, these refer to measurable physical properties with specific numerical ranges.
- International Standards (ISO 10993 series): For biocompatibility testing, compliance with these established standards serves as the ground truth for biological safety.
8. Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a machine learning model.
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DEC 1 9 2013
510(K) SUMMARY
(Prepared November 12, 2013)
MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Laraine Pangelina, Sr. Regulatory Affairs Project Manager
Trade Name:
Generic Name: Neurovascular Embolization Device
Class II, 21 CFR 882.5950 Classification:
Submitted By: MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780 U.S.A.
Contact:
Predicate Devices:
MicroPlex Coil System (MCS) (K103758, K091641, K111451, K103758, K08241, K093919, K090891, K093358, K102365) HydroCoil Embolic System (HES) (K091641, K103758, K113457, K112226, K120908, K090357, K100454, K091641, K080666)
Intended for the endovascular embolization of Indications for Use: intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.
Treatment of cerebral aneurysms can be performed Device Description: either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to
embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.
The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.
The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
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MicroVention : ﺗ
Pre-Clinical Testing:
| Design Verification and Validation Bench Test Summary | |||
|---|---|---|---|
| Test / Test Description | Acceptance Criteria | Test & AcceptanceCriteria same aspredicate device?Y/N | Result |
| Visual InspectionPerform visual inspectionand measurements usingdevice drawing | Per product drawing | Y | PassMet establishedcriteria |
| Simulated UseThe test simulates aneurointerventionalembolization procedure toassess deployment,repositioning, anddetachment in ananeurysm. | All performance ratingsshall be ≥ 3 | Y | PassMet establishedcriteria |
| Pusher ResistanceUsing a digital multimeter,measure the resistancethrough a microcatheter. | 36.7-53.0 $Ω$ | Y | PassMet establishedcriteria |
| Detachment Zone TensileUsing an Instron tester,measure the breakforce atthe detachment zone. | ≥0.08 lbf | Y | PassMet establishedcriteria |
CONCLUSION: The results of the bench testing demonstrate that the subject device is safe and
effective when used according to the instructions for use and performs equivalen device. The testing was used in support of the risk analysis documentation for the subject device.
| Biocompatibility Test Summary - HES Coil Implant | |||
|---|---|---|---|
| Test | Requirement | Result | |
| MEM Elution | 10993-5 | Passed | |
| ISO Cell Culture Agar Overlay | 100 10993-2 | Passed | |
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | |
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | |
| Hemolysis | ISO 10993-4 | Passed | |
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | |
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed | |
| Bacteria Reverse Mutation Assay (Ames) | 180 10993-3 | Passed | |
| 7-day Muscle Implantation | 180 10993-6 | Passed | |
| 13-week Intramuscular Implantation Test | ISO 10993-6 | Passed | |
| 26-week Intramuscular Implantation Test | ISO 10993-6 | Passed |
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AlleroVention
| Biocompatibility Test Summary - MCS Coil Implant | ||||
|---|---|---|---|---|
| Test | Requirement | Result | ||
| MEM Elution | ISO 10993-5 | Passed | ||
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Passed | ||
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | ||
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | ||
| Hemolysis | ISO 10993-4 | Passed | ||
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | ||
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | ||
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed | ||
| Bacteria Reverse Mutation Assay (Ames) | SO 10993-3 | Passed | ||
| 7-day Muscle Implantation | ISO 10993-6 | Passed | ||
| 90-day Intramuscular Implantation Test | ISO 10993-6 | Passed | ||
| 100-day Intramuscular Implantation Test | ISO 10993-6 | Passed | ||
| Biocompatibility Test Summary - Delivery Pusher | ||||
| Test | Requirement | Result | ||
| MEM Elution | ISO 10993-5 | Passed | ||
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Passed | ||
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | ||
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | ||
| Hemolysis | ISO 10993-4 | Passed | ||
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | ||
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | ||
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed |
Predicate / Subject Technological Comparison:
| Feature | MCS Predicate Devices | HES Predicate Devices | Subject Devices |
|---|---|---|---|
| Indications for Use | Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is 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. | Same | Same |
| Device Overview | An implantable coil attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque | Same | Same |
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Special 510(k) MicroPlex Embolic System (MCS) & HydroCoil Embolic System (HES) with V-Trak Advanced Delivery Pusher
MicroVention
| TERUMO | |||
|---|---|---|---|
| positioning markers at the distal end. Theproximal end is inserted into a hand heldbattery powered Detachment Controller.When the Detachment Controller isactivated, the flow of electrical currentheats the polyolefin elastomer filament,resulting in detachment of the implantsegment. The Detachment Controller ispackaged and sold separately. | |||
| Coil shape | Helical, 3D | Same | Same |
| Coil OD (mm) | 1-24 | 1-24 | Same |
| Restrained coillength (cm) | 1-68 | 1-50 | Same |
| Main coil wirematerial | Platinum/Tungsten (92/8%) alloy | Same | Same |
| Coupler Material | Platinum (90%)/ iridium (10%) | Same | Same |
| Adhesive Material | DYMAX 1128-AM-VT UV Adhesive | Same | Same |
| Stretch resistancefilar material | Polyolefin Elastomer or PET | PET | Same |
| Implant-to-pushermaterial | Polyolefin elastomer | Same | Same |
| Delivery method | V-Trak delivery pusher | V-Trak deliverypusher | V-TrakAdvanceddeliverypusher1 |
| 1 The subject device is the same as the predicate devices with the exception of the modified V-Trak Advanced deliver pusher. Other than the colorant in the PET connector tube, the V-TrakAdvanced delivery pusher is essentially the same as the cleared V-Trak delivery pusher. The MCSand HES devices with the V-Trak Advanced delivery pusher are the same with regard to intendeduse and principal of operation. Any differences in technological characteristics do not introduceany new issues of safety or effectiveness. Therefore, it is our conclusion that the MCS and HESdevices with the V-Trak Advanced delivery pusher is substantially equivalent to the predicatedevices. |
Summary of Substantial Equivalence:
The subject devices are the same as the predicate devices with regard to intended use and principal of operation. Any differences in technological characteristics do not introduce any new issues of safety or effectiveness. Therefore, it is our conclusion that the MCS and HES devices with the V-Trak Advanced delivery pusher is substantially equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle symbol, which is a common emblem associated with the U.S. government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2013
MicroVention Terumo c/o Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager MicroVention, Incorporated 1311 Valencia Avenue Tustin, CA 92780
Re: K132952
Trade/Device Name: Microplex Coil System (MCS), Hydrocoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 18, 2013 Received: November 21, 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
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Page 2 - Ms. Laraine Pangelina
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/ResourcesforYou/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.
Joyce M. Whang -S
for Carlos Peña, Ph.D.
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): K132952
Device Name: _ MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Indications For Use:
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.
Prescription Use _ كا (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of 1
§ 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).