(57 days)
The MicroPlex Coil System is 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.
The MCS VFC consists of an implantable coil made of bare platinum alloy. The MCS VFC implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
The MicroPlex Coil System (MCS), VFC is a neurovascular embolization device. The study performed to demonstrate its compliance with acceptance criteria was a bench test summary. This involved various physical and functional tests to ensure the device's safety and effectiveness and its equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly stated as "PASS, acceptance criteria met," indicating that the device must successfully perform the specified function or meet the measurement standard.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Visual/Dimensional Inspection (Perform visual inspection and measurements using device drawing) | Device meets specified visual and dimensional standards | PASS, acceptance criteria met |
| Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance) | Device performs successfully across all simulated use parameters | PASS, acceptance criteria met |
| Detachment Test (Confirm successful detachment according using V-Grip Detachment Controller during simulated use testing) | Successful detachment achieved with the V-Grip Controller | PASS, acceptance criteria met |
| Coil-to-Coupler Weld Test (Test the tensile strength of the coil/coupler weld) | The coil/coupler weld exhibits sufficient tensile strength | PASS, acceptance criteria met |
| Spring Constant (Measure the spring constant force of the coil) | The coil's spring constant force meets specifications | PASS, acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of units tested for each benchmark test. It only provides a summary of results.
- Data Provenance: The tests are described as "Bench Test Summary," implying they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of bench testing. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to clinical or image-based studies. For physical device testing, the "ground truth" is established by engineering specifications and objective measurement methods.
4. Adjudication Method for the Test Set
This information is not applicable to this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in clinical trials or image reads. For bench tests, the pass/fail criteria are objective and determined by measurement against established engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MicroPlex Coil System, VFC is a physical neurovascular embolization device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone "algorithm only" study was not done. This device is a physical medical device, not a software algorithm. Its performance is evaluated through physical and functional bench tests, not algorithmic output against human interpretation.
7. Type of Ground Truth Used
The "ground truth" for this device's performance validation is based on engineering specifications and objective physical measurements. For example, dimensions are compared to device drawings, and tensile strength is measured against a required specification.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As in point 8, there is no training set for a physical medical device.
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P 2 0 2013
510(K) SUMMARY
Trade Name:
Class II, 21 CFR 882.5950
August 22, 2013
MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780
MicroPlex Coil System (MCS), VFC
Neurovascular Embolization Device
Generic Name:
Classification:
Date Submitted
Submitted By:
Contact: Laraine Pangelina
Predicate Device: MicroPlex Coil System (MCS) (K111451)
U.S.A.
Indications for Use:
Bench Test Summary:
The MicroPlex Coil System is 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.
The MCS VFC consists of an implantable coil made of bare platinum alloy. Device Description: The MCS VFC implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
| Test | Results |
|---|---|
| Visual/Dimensional InspectionPerform visual inspection and measurments usingdevice drawing | PASS, acceptance criteria met |
| Simulate UseIntroduction, Tracking, Deployment,Compartmentalizing, Frame Movement, Microcathetermovement, Detachment, Overall Performance | PASS, acceptance criteria met |
| Detachment TestConfirm successful detachment according using V-GripDetachment Controller during simulated use testing | PASS, acceptance criteria met |
| Coil-to-Coupler Weld TestTest the tensile strength of the coil/coupler weld | PASS, acceptance criteria met |
| Spring ConstantMeasure the spring constant force of the coil | PASS, acceptance criteria met |
| CONCLUSION: The results of the bench testing demonstrate that the subject device is safand effective when used according to the instructions for use and performs equivalent to thpredicate device. The testing was used in support of the risk analysis documentation for thesubject device. |
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| Predicate / SubjectTechnologicalComparison: | . .Featureﺎ ﺗﺇ | Predicate Devices | Subject Device |
|---|---|---|---|
| Coil shape | 3D | Same | |
| Coil OD (mm) | 3 - 15 | 1 | |
| Restrained coil length (cm) | 6 - 45 | 3 | |
| Main coil wire material | Platinum/Tungsten (92/8%) alloy | Same | |
| Coupler Material | Platinum (90%)/ iridium (10%) | Same | |
| Adhesive Material | DYMAX 1128-AM-VT UV Adhesive | Same | |
| Stretch resistance filar material | Polyolefin Elastomer or PET | Same | |
| Implant-to-pusher material | Polyolefin elastomer | Same | |
| Delivery method | V-Trak delivery pusher | Same | |
| MRI compatibility | Yes | Yes | |
| Method of supply | Sterile, single use | Same | |
| Packaging configuration | Dispenser coil, pouch,shipping carton | Same |
Summary of Substantial Equivalence: The devices that are 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.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the department's symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2013
MicroVention, Inc. Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K132317
Trade/Device Name: MicroPlex Coil System (MCS), VFC Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: August 22, 2013 Received: August 23, 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.
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Page 2 - Ms. Laraine Pangelina
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 Victor Krauthamer, Ph.D. Acting 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): K132317
Device Name: MicroPlex Coil System (MCS), VFC
Indications For Use: The MicroPlex Coil System is 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 embolization in the peripheral vasculature.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 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.
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K132317
1 Page 1 of
§ 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).